[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"melanoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:melanoma":26},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,210,0,25,[9,55,78,111,155,178,207,234,255,294,313,355,377,417,444,466,492,518,548,583,608,628,652,671,751],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":36,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":44,"startDateStruct":47,"completionDateStruct":49,"leadSponsor":51,"locationsCount":54},"100593350","clinical-genetics-branch-eligibility-screening-survey-100593350",false,"NCT07005297","Clinical Genetics Branch Eligibility Screening Survey","Clinical Genetics Branch (CGB) Eligibility Screening Survey","* INCLUSION CRITERIA\n\nThere is no age restriction; therefore, viable neonates may be included. This eligibility screening protocol is intended for individuals meeting one or more of the following criteria:\n\n1. Personal or family history of a diagnosis of a syndrome being actively investigated in one of the following CGB study protocol:\n\n   * Protocol 000678: Medical history of neoplasia of an unusual type, pattern, or number.\n   * Protocol 11C0255: A personal history of adrenal cortical carcinoma or choroid plexus carcinoma at any age, regardless of family history, or family or personal medical history of neoplasia consistent with the diagnosis of LFS or LFL.\n   * Protocol 20C0107: Individuals with a clinical diagnosis of a RASopathy, including Costello syndrome, Noonan syndrome, Noonan syndrome with multiple lentigines, Cardiofaciocutaneous syndrome, Legius syndrome, capillary arteriovenous malformation syndrome, or others, are eligible. Published clinical diagnostic criteria exist for most of the clinical RASopathy syndromes and differ by syndrome. It will be uncommon for individuals to have a clinical diagnosis and not have had molecular genetic testing. All individuals considered by the study team to be at risk for a RASopathy who have not had prior genetic testing will have this completed as part of the study. The rare individuals with a clinical diagnosis of a RASopathy who are not found to carry a corresponding pathogenic or likely pathogenic variant in a known RASopathy gene will be considered for exome analysis for identification of potentially novel RASopathy germline variation.\n   * Protocol 11C0034: An individual with histologically-confirmed PPB and\u002For other DICER1-related tumors\n   * Protocol 02C0052: The participants will be affected by an IBMFS, or be members of a family with an IBMFS, and be at risk of being affected or carriers of the syndrome. Except for the rare X-linked recessive disorder (e.g. some dyskeratosis congenita patients), there should be equal numbers of male and female probands and family members. These IBMFS have been reported in most racial and ethnic groups, and thus all such groups will be included. The age range will be from birth to old age (grandparents of probands). The majority of the probands will be children (10-20% will be adults), and their parents and grandparents will be adults. All racial\u002Fethnic groups are eligible.\n   * Protocol 02C0211: Personal medical history of melanoma of an unusual type, pattern, or number diagnosed at any age.\n   * Protocol 78C0039: Family or personal medical history of neoplasia of an unusual type, pattern, or number\n2. Personal or family history of medical condition, malignancy, and\u002For benign neoplasm suggestive of hereditary cancer predisposition being actively investigated in the following CGB study protocol:\n\n   * Protocol 000678: Known or suspected factor(s) predisposing to neoplasia, either genetic and\u002For congenital factors (birth defects, metabolic phenotype, chromosomal anomalies or Mendelian traits associated with tumors), environmental exposure (medications, occupation, radiation, diet, infectious agents, etc.), or unusual demographic features (very young age of onset, multiple tumors, etc.)\n   * Protocol 11C0255: An individual with a sarcoma diagnosed under the age of 45; AND - At least one first-degree relative (parents, brothers, sisters and children) with a cancer of any kind diagnosed under the age of 45; AND - A third family member who is either a first- or second-degree relative (such as grandparents, aunts, uncles, nieces, nephews, and grandchildren) with cancer diagnosed under the age of 45 or having a sarcoma at any age.\n   * Protocol 001109: On referral, persons \\>= 12 years with Fanconi Anemia (FA) primarily from North America will be included. An individual with FA who is 8 -11 years can also be included if they have a history of persistent oral potentially malignant lesion (OPMLs), dysphagia, or other concerning symptoms. Individuals with prior cancer diagnosis are eligible.\n   * Protocol 11C0034: An individual from the general population with one or more of the unique tumors of the types associated with DICER1 including (but not exclusively), PPB, cystic nephroma, ovarian Sertoli-Leydig cell and other sex cordstromal tumors, ocular medulloepithelioma, nasal chondromesenchymal hamartoma, Wilms tumor, embryonal rhabdomyosarcoma, pineoblastoma, pituitary blastoma, ovarian sarcoma, CNS sarcoma and\u002For thyroid cancer - regardless of their family history. Additional DICER1-related neoplasms may be identified in the future, and they will be added to the protocol as needed\n   * Protocol 02C0052: Fanconi anemia: FA patients have relatively specific birth defects, aplastic anemia, increased chromosome breakage in cells cultured with a DNA crosslinking agent such as mitomycin C (MMC) or diepoxybutane (DEB), pathogenic variant(s) in one of the cloned genes (six genes at this time), or assignment to one of the 7 or more complementation groups. Bone marrow failure is NOT required for the diagnosis, and approximately 25% do not have birth defects. FA has been diagnosed from birth to \\>50 years of age. FA Proven = positive chromosome breakage result, and\u002For pathogenic variant(s) in a known FANC gene. Patients in whom FA is suspected but whose chromosome breakage test is negative will still be considered if they have sufficient findings that lead the Principal Investigator to think they may be somatic mosaics and warrant further evaluation. Diamond Blackfan anemia: DBA patients have pure red cell aplasia with reticulocytopenia. Approximately 30% have physical abnormalities, often involving malformations of the thumbs. Approximately 90% are diagnosed within the first year of life. A pathogenic variant in a known DBA gene (RPS19 is currently the only known gene) is diagnostic, but lack of a pathogenic variant does not rule out DBA, since the cloned gene is responsible for only approximately 25% of the disease. Since many cases are sporadic or occur in families with silent carriers, patients without a positive family history will be included. Currently DBA is diagnosed by clinical findings after exclusion of known causes of red cell aplasia. Approximately 90% have elevated red cell adenosine deaminase levels, a finding which is supportive, but not diagnostic, of DBA. Dyskeratosis congenita: DC patients develop dyskeratotic nails, lacy hyperpigmentation of the skin and mucous membrane leukoplakia as they age (the diagnostic clinical triad; two of the three are required for a firm diagnosis). Findings in young patients may be very subtle, and diagnoses are usually made in teenagers or young adults. More than 75% are male. DC patients are often diagnosed without hematologic abnormalities by dermatologists; however, some patients present with aplastic anemia prior to the evolution of the syndrome-related physical features. A pathogenic variant in the DKC1 gene is diagnostic, but normal DKC1 does not exclude DC. The diagnosis is often clinical, after exclusion of FA and other IBMFS. Shwachman Diamond Syndrome: SDS patients have neutropenia, malabsorption and failure to thrive due to exocrine pancreatic insufficiency. The gene has not yet been cloned. Pancreatic insufficiency is documented by direct measurement of pancreatic enzymes, low serum immunoreactive trypsinogen, or elevated fecal fat levels. Neutropenia requires an absolute neutrophil count of \\\u003C1500\u002Fmm3 on multiple occasions. Other causes of malabsorption such as cystic fibrosis, Pearson syndrome, and Johansson-Blizzard syndrome must be excluded. Cystic fibrosis will be excluded in patients who have a positive sweat test performed at an approved CF center. Amegakaryocytic thrombocytopenia: These patients have early onset thrombocytopenia (\\\u003C150,000\u002Fmm3), usually within the first year of life, due to absent, diminished, or abnormal bone marrow megakaryocytes, without antiplatelet antibodies. Physical examination is often normal; in particular, there are no abnormalities of the radial rays. Pathogenic variant(s) in the MPL gene are diagnostic, but normal MPL does not exclude this diagnosis. Thrombocytopenia absent radii: TAR patients have absent radii, usually bilateral, with intact thumbs (in contrast with FA and trisomy 18, where thumbs are absent if radii are absent), and thrombocytopenia at birth. Other radial aplasia syndromes such as Holt-Oram syndrome or VATER syndrome must be excluded. Severe Congenital Neutropenia: Patients with SCN have persistent and noncyclic low absolute neutrophil counts, with more than 2 measurements \\\u003C200\u002Fmm3, and a history of pyogenic infections during the first year of life, and bone marrow maturation arrest at the promyelocyte\u002Fmyelocyte stage. They do not have birth defects, and they usually have normal hemoglobin and platelet counts. They are designated Kostmann Syndrome (KS) only if there is a pattern of autosomal recessive inheritance. Pathogenic variant(s) in the neutrophil elastase gene (ELA2) are supportive of the diagnosis of SCN, but do not distinguish SCN patients from those with cyclic neutropenia, which is milder and not preleukemic. Many of the cases of SCN have been shown to be due to dominant pathogenic variant(s)s in ELA2. Pearson Syndrome: Pearson syndrome consists of malabsorption, neutropenia, alone or with anemia and\u002For thrombocytopenia, and metabolic acidosis. Onset is in infancy or early childhood. The diagnosis is strongly suspected if bone marrow examination reveals vacuoles in myeloid and erythroid progenitors, and ring sideroblasts. Confirmation derives from detection of deletions in mitochondrial DNA, which range from 2 to 8 kb in size, and include the respiratory enzymes. Absence of reports to date of cancer or leukemia in this syndrome may derive from early death due to the metabolic problems. Other bone marrow failure syndromes: There are occasional patients with a pattern of hematologic abnormalities, physical findings, malignancies, or family histories which are not characteristic of the syndromes described above, but which nonetheless suggests that they have a genetic bone marrow failure syndrome. There may be similar cases in the literature, or in the experience of the investigator, which may ultimately lead to assignment of these patients to a known or new syndrome. There are additional bone marrow failure syndromes which are even more rare, such as Revesz, WT, IVIC, radio-ulnar synostosis, ataxia-pancytopenia, etc. Syndromic classification of extremely rare disorders is facilitated if they are collected in one center. Since malignancy is often part of these syndromes, they will be eligible for enrollment in this protocol.\n   * Protocol 02C0211: Known or suspected factor(s) predisposing to melanoma, either genetic or congenital factors (giant congenital nevi, dysplastic nevi, Spitzoid tumors), or unusual demographic features (e.g., very young age of onset, multiple melanomas, previous history of heritable retinoblastoma, Hodgkin's disease, lymphoma, immunodeficiency syndrome, or organ transplant).\n   * Protocol 10CN188: Diagnose with chordoma or related tumor at any age and any primary site.\n   * Protocol 78C0039: Known or suspected factor(s) predisposing to neoplasia, either genetic and\u002For congenital factors (birth defects, metabolic phenotype, chromosomal anomalies or Mendelian traits associated with tumors), environmental exposure (medications, occupation, radiation, diet, infectious agents, etc.), or unusual demographic features (very young age of onset, multiple tumors, etc.). Personal and family medical history must be verified through questionnaires, interviews, and review of pathology slides and medical records. For familial neoplasms, two or more living affected cases among family members are required. The types of familial tumors that we are currently actively accruing include Familial Cancers: bladder, brain, chordoma, lung, nevoid basal cell carcinoma syndrome (NBCC) Familial Benign Neoplasms: meningiomas, neurofibromatosis 2 (bilateral acoustic neurofibromatosis) The types of familial tumors under active accrual and study are predominantly investigator- and hypothesis-driven. This approach permits CGB investigators to remain alert to the opportunities afforded by clusters of rare tumors in families and individuals, and to be more responsive to the dynamic research priorities in cancer genetics.\n3. Personal or family history of a genetic variant in a hereditary cancer predisposition being actively investigated in the following CGB study protocols:\n\n   * Protocol 11C0255: A personal history of a germline TP53 mutation; or, - A first or second- degree relative of a TP53 mutation carrier, regardless of mutation status\n   * Protocol 20C0107: Individuals with a germline variant (P\u002FLP or a variant of uncertain significance but predicted bioinformatically to be damaging) in a RASopathy-associated gene are eligible. These include but are not limited to: BRAF, CBL, HRAS, KRAS, LZTR1, MAP2K1, MAP2K2, MAP3K8, MRAS, NRAS, PPP1CB, PTPN11, RAF1, RASA1, RASA2, RIT1, RRAS, SHOC2, SOS1, SPRED1. From herein, we refer to 1) individuals with germline pathogenic variation in a RAS pathway gene AND 2) individuals with a clinical RASopathy diagnosis but in whom a genetic variant has not yet been identified as \"carriers.\" The first member of a family to be identified is termed a \"proband.\"\n   * Protocol 11C0034: An individual with a known or suspected DICER1 disease associated variant.\n   * Protocol 02C0052: An individual with a pathogenic variant(s) in a known FANC gene. Individual with Diamond Blackfan Anemia with a pathogenic variant in a known DBA gene (RPS19). Individuals with Dyskeratosis congenita with a pathogenic variant in the DKC1 gene. Individuals with Amegakaryocytic thrombocytopenia with pathogenic variants) in the MPL gene. Individuals with Severe Congenital Neutropenia with a pathogenic variant(s) in the neutrophil elastase gene (ELA2).\n\nEXCLUSION CRITERIA\n\nWhile this protocol is intended to be used by those meeting the inclusion criteria above, there are no explicit exclusion criteria for this study, since the initiative to complete the eligibility screener survey is at the will of the participant or his or her parent\u002Fguardian\u002FLAR.","ALL","1 Year","99 Years",{"count":21,"type":22},1000,"ESTIMATED","OBSERVATIONAL","Background:\n\nClinical Genetics Branch (CGB) researchers study individuals and populations at high genetic risk of cancer in order to improve our understanding of cancer and to improve cancer care. There are currently 6 open clinical genetics studies at the CGB eligible for this screening process.\n\n* 02C0052: Etiologic Investigation of Cancer Susceptibility in Inherited Bone Marrow Failure Syndromes: A Natural History Study (Cancer in Bone Marrow Failure)\n* 11C0255: Clinical, Epidemiologic, and Genetic Studies of Li-Fraumeni Syndrome (Li Fraumeni Syndrome Study)\n* 11C0034: DICER1-Related Pleuropulmonary Blastoma Cancer Predisposition Syndrome: A Natural History Study (Pleuropulmonary Blastoma)\n* 02C0211: Clinical, Laboratory, and Epidemiologic Characterization of Individuals and Families at High Risk of Melanoma (Melanoma-Prone Families)\n* 10CN188: Genetic Clues to Chordoma Etiology: A Protocol to Identify Sporadic Chordoma Patients for Studies of Cancer-susceptibility Genes (Sporadic Chordoma Study)\n\nThe following studies have their own study-specific screeners. If you are interested in these studies, please click the links below to fill out the relevant study screener:\n\n* 001109: Defining the Natural History of Squamous Cell Carcinoma in Fanconi anemia (SCC Screening in FA): https:\u002F\u002Fservice.cancer.gov\u002Ffanconi\n* 20C0107: Clinical, Genetic, and Epidemiologic Study of Children and Adults with RASopathies (RASopathies Study): https:\u002F\u002Fservice.cancer.gov\u002Fmyras\n\nObjective:\n\nTo find people to participate in active CGB cancer research studies.\n\nEligibility:\n\nPeople of any age who meet the eligibility criteria for one of the open CGB cancer research studies. You can learn more about the CGB cancer research studies by clicking on the links to the study-specific websites above. This typically involves a personal or family history of certain cancers that are being studied by researchers at CGB.\n\nDesign:\n\nParticipants will fill out a screening questionnaire to determine if they are eligible to participate in one or more CGB clinical genetics studies. The survey asks about personal health history, including cancer; family history; and genetic testing results and takes 15 to 20 minutes.\n\nEach study has its own eligibility criteria. Survey respondents will select which study (or studies) that are interested in participating in, and the relevant study team(s) will review the screener to determine eligibility to participate in the study. Participants who are determined to be eligible for a study based on their screener will be contacted by the respective study team to learn more about the study and to consent to enroll in the study if they choose to do so. Participants who consent to enroll in a study may be asked to provide medical records; samples such as blood, saliva, or other tissues; and to participate in activities such as phone interviews or surveys. They may be invited for evaluations at the clinical center. Every study activity is voluntary. None of the studies provide treatments. Participants may be contacted to consider enrolling in future studies.",[26,27,28,29,30,31,32,33,34,35],"Melanoma","Li-Fraumeni Syndrome","Pulmonary Blastoma","Chordoma","Congenital Bone Marrow Failure Syndromes","Costello Syndrome","Fanconi Anemia","CFC Syndrome (CFCS)","Legius Syndrome","RASopathies",[32,27,37,38,29,39,35,40,41],"Clinical Genetics Branch, NCI","Hereditary Melanoma","DICER-1 syndrome","Cancer","Inherited Bone Marrow Failure Syndromes","NOT_YET_RECRUITING","2026-08-20",{"date":45,"type":46},"2026-08-21","ACTUAL",{"date":48,"type":22},"2026-08-26",{"date":50,"type":22},"2036-01-01",{"name":52,"class":53},"National Cancer Institute (NCI)","NIH",1,{"id":56,"slug":57,"hasResults":12,"nctId":58,"briefTitle":59,"officialTitle":59,"acronym":4,"eligibilityCriteria":60,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":61,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":63,"conditions":64,"keywords":4,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":70,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":54},"100191818","molecular-testing-for-the-md-anderson-cancer-center-personalized-cancer-therapy-program-100191818","NCT01772771","Molecular Testing for the MD Anderson Cancer Center Personalized Cancer Therapy Program","Inclusion Criteria:\n\n* Patients must have histologically, radiographic, or cytologically documented cancer, suspected glioma, sarcoma, melanoma or hematologic cancer. Patients with benign tumors may also be consented at the discretion of the attending physician if molecular profiling is felt to have potential clinical implications.\n* Patients must have the ability to understand and the willingness to sign a written informed consent document\n* Patients may be consented without confirming the amount and quality of archival diagnostic or residual tissue available. However, research testing will only be performed on patients who have sufficient archived diagnostic tissue or residual tissue banked in one of the authorized tissue banks at MD Anderson available to proceed with testing. The extent of testing may be modified based on amount of tissue available. If any new tissue acquisition including a biopsy and\u002For surgical resection etc. is being ordered for clinical care or another research study, or an operation is being performed testing can be ordered on that sample\n* Circulating cell-free deoxyribonucleic acid (cfDNA) Cohort: Circulating cell-free DNA next generation sequencing (NGS) testing will be performed with the Clinical Laboratory Improvement Act (CLIA)-certified Guardant360 panel (or equivalent) for select patients. This particular cohort of research collaboration will be supported by Guardant Health, Inc. at no charge to MD Anderson. Patients who are being considered for enrollment into clinical trials in the next 2 lines of therapy may be enrolled. Selected patients may have cfDNA, circulating RNA \u002Fexosome\u002Fcirculating tumor cell testing approaches performed on alternate platforms (eg Foundation ACT)",{"count":62,"type":22},12000,"This study performs standardized testing of tumor tissue samples to learn which genes are mutated (have changed) in order to provide personalized cancer therapy options to cancer patients at MD Anderson. This may help doctors use testing information on tumors to identify clinical trials that may be most relevant to patients. Researchers may also use the information learned from this study to develop a database of the different kinds of mutations in cancer-related genes.",[65,66,67,26,68],"Glioma","Hematopoietic and Lymphoid Cell Neoplasm","Malignant Solid Neoplasm","Sarcoma","RECRUITING",{"date":45,"type":46},{"date":72,"type":46},"2012-03-01",{"date":74,"type":22},"2033-03-01",{"name":76,"class":77},"M.D. Anderson Cancer Center","OTHER",{"id":79,"slug":80,"hasResults":12,"nctId":81,"briefTitle":82,"officialTitle":82,"acronym":83,"eligibilityCriteria":84,"healthyVolunteers":12,"sex":17,"minAge":85,"maxAge":4,"enrollmentInfo":86,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":88,"conditions":89,"keywords":99,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":54},"100633240","study-of-high-precision-evaluation-of-molecular-residual-disease-through-a-platform-for-cancer-tracking-and-interception-sherlock-100633240","NCT07524114","Study of High-Precision Evaluation of Molecular ResiduaL Disease Through a PlatfOrm for Cancer TracKing and Interception (SHERLOCK)","SHERLOCK","Inclusion Criteria:\n\n1. Patients with histopathological confirmation of cancer. Patients whose diagnosis are made by cytology may also be considered for this study. For tumor types that are typically diagnosed using unequivocal imaging findings or biomarker profiles (e.g. hepatocellular cancer, uveal melanoma), they can be eligible without histopathological or cytological confirmation.\n2. Patients must have cancer that is planned for or has undergone curative intent treatment (e.g. surgery, definitive radiation, definitive chemoradiation, adjuvant radiation, adjuvant chemotherapy, adjuvant chemoradiation, etc). Curative intent treatment must be completed within 12 months of study entry. For patients on adjuvant\u002Fmaintenance endocrine or biological therapy (e.g. bevacizumab, immunotherapy, etc), enrollment within 12 months of completion of curative intent treatment is allowed.\n3. Patient must be ≥ 18 years old.\n4. All patients must have signed and dated an informed consent form.\n\nExclusion Criteria:\n\n1\\. History of another active invasive cancer within 2 years prior to study enrolment. Exceptions include squamous and basal cell carcinoma of the skin and carcinoma in situ of the cervix, or malignancy that in the opinion of the investigator, is considered cured with minimal risk of recurrence within 2 years.","18 Years",{"count":87,"type":22},7000,"This study will collect, annotate, and sequence biospecimens (blood, tissue, urine, saliva and surgery drainage) from patients across different cancer types to detect molecular residual disease (MRD). Imaging scans and clinical data will also be gathered. This will allow for early cancer interception, and hopefully prolong relapse-free survival across tumor types. Results of ctDNA testing will be provided for clinical decisions and to determine eligibility for other linked interventional interception therapeutic studies, each of which will have a separate protocol.",[90,91,26,92,93,94,95,96,97,98],"Breast Cancer","Lung Cancer","Gynecologic Cancer","Genitourinary Cancer","Pancreatobiliary Cancer","Gastrointestinal Cancer","Head and Neck Cancer","Rare Cancer","Unknown Primary Tumors",[100,101,102],"Minimal Residual Disease","Liquid Biopsy","Circulating Tumor DNA","2026-08-19",{"date":45,"type":46},{"date":106,"type":46},"2026-03-31",{"date":108,"type":22},"2031-03-31",{"name":110,"class":77},"University Health Network, Toronto",{"id":112,"slug":113,"hasResults":12,"nctId":114,"briefTitle":115,"officialTitle":116,"acronym":4,"eligibilityCriteria":117,"healthyVolunteers":12,"sex":17,"minAge":85,"maxAge":4,"enrollmentInfo":118,"targetDuration":4,"studyType":120,"phases":121,"briefSummary":123,"conditions":124,"keywords":135,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":146,"startDateStruct":147,"completionDateStruct":149,"leadSponsor":151,"locationsCount":154},"100529338","a-study-of-her3-dxd-in-subjects-with-locally-advanced-or-metastatic-solid-tumors-100529338","NCT06172478","A Study of HER3-DXd in Subjects With Locally Advanced or Metastatic Solid Tumors","HERTHENA-PanTumor01 (U31402-277): A Phase 2, Multicenter, Multicohort, Open-Label, Proof of Concept Study of Patritumab Deruxtecan (HER3-DXd; U3-1402) in Subjects With Locally Advanced or Metastatic Solid Tumors","Inclusion Criteria\n\nParticipants must meet all of the following criteria to be eligible for enrollment into the study:\n\n1. Sign and date the informed consent form prior to the start of any study-specific qualification procedures. A separate tissue screening consent will be obtained from all subjects to meet the baseline tumor tissue requirement.\n2. Participants aged ≥18 years (follow local regulatory requirements if the legal age of consent for study participation is \\>18 years old).\n3. Has locally advanced unresectable or metastatic disease (not curable by surgery or radiation) as follows:\n\n   Cutaneous (acral and non-acral) melanoma\n   1. Histologically or cytologically confirmed cutaneous (acral or non-acral) melanoma\n   2. Disease progression while on or after having received treatment with ≥1 prior line of anti-programmed cell death protein (PD-1) or anti-programmed death-ligand 1 (PD-L1) based therapy (previous use of other immune checkpoint inhibitors \\[ICIs\\] \\[ie, anti-CTLA4, anti- LAG-3\\] is acceptable). Prior anti-PD-(L)1 therapy in the adjuvant setting is allowed if there is recurrence within 12 weeks of the last dose. If the participant had BRAFm melanoma, they must have had disease progression on BRAF\u002FMEK inhibitor therapy as well.\n\n      Squamous cell carcinomas of the head and neck\n   3. Squamous cell carcinoma of the head and neck (with a primary location of oral cavity,oropharynx, larynx, hypopharynx) that is human papillomavirus (HPV) positive or negative (as determined by local standard). Excludes tumor location in the nasopharynx, nasal cavity, paranasal sinuses, and unknown primary locations.\n   4. Disease progression after having received treatment with ≥1 and \\\u003C3 prior lines of systemic therapy in the unresectable recurrent or metastatic setting.\n\n      Must have had disease progression on anti-PD-(L)1 (either as monotherapy or in combination with chemotherapy or other therapies). Must also have had disease progression on a platinum-based chemotherapy (PBC) regimen either in the recurrent or metastatic setting or in the locally advanced setting with curative intent.\n\n      Gastric or GEJ adenocarcinoma\n   5. Tumor tissue must be confirmed as negative for HER2 expression (immunohistochemistry \\[IHC\\] 0\u002F1+ or IHC 2+\u002Fin situ hybridization negative) as classified by American Society of Clinical Oncology\u002FCollege of American Pathologists (ASCO-CAP) guidelines and determined prior to enrollment by assessment in a local laboratory that is Clinical Laboratory Improvement Amendments certified (US sites) or accredited based on specific country regulations.\n   6. Disease progression after having received treatment with ≥2 prior lines of therapy that include PBC with or without anti-PD-1 therapy.\n\n      Ovarian Carcinoma\n   7. Pathologically documented high-grade serous epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer.\n   8. Documented disease progression ≥4 weeks after the last dose of PBC and \\\u003C6 months of last dose of PBC in the advanced or metastatic setting. Prior use of folate reductase alpha targeting antibody-drug conjugate (ADC) (ie, mirvetuximab soravtansine) is allowed.\n\n      Cervical Cancer\n   9. Pathologically or cytologically documented recurrent or persistent squamous, adenosquamous, or adenocarcinoma of the uterine cervix.\n   10. Disease progression after having received ≥1 line of systemic therapy in the recurrent or metastatic setting. This may include prior anti-PD-(L)1 treatment and\u002For tissue factor directed ADC (tisotumab vedotin \\[TV\\]) per regional standard of care.\n\n       Endometrial Cancer\n   11. Pathologically or cytologically documented endometrial cancer (carcinoma of any histological sub-type or endometrial carcinosarcoma), irrespective of microsatellite instability (MSI) or mismatch repair (MMR) status.\n   12. Documented disease progression after having received ≥1 prior line of therapy (maximum of 3) PBC containing systemic treatment and an anti-PD(L)-1 therapy-containing regimen (combined or sequential) in the advanced\u002Fmetastatic setting.\n\n       Bladder Cancer\n   13. Pathologically or cytologically documented locally advanced\u002Funresectable or metastatic urothelial carcinoma of the bladder, renal pelvis, ureter, or urethra. Histological variants are allowed if urothelial histology is predominant. Small cell\u002Fneuroendocrine tumors are not allowed even if mixed histology.\n   14. Relapsed or progressed after treatment with ≥1 prior line of therapy (maximum of 3) that contains anti-PD-(L)1 therapy in the perioperative or metastatic setting. At least 1 line of therapy must also contain one of the following treatment modalities: chemotherapy or enfortumab vedotin. Prior fibroblast growth factor receptor (FGFR)-inhibitor treatment for those who are eligible are allowed.\n\n       * Required treatments can be given in combination or sequentially\n       * Prior cisplatin-based therapy or PD-(L)1 inhibitor therapy given for the treatment of muscle invasive urothelial carcinoma is counted as 1 line of therapy\n       * The same regimen administered twice in different disease settings will be counted as 1 line of prior therapy\n       * Participants in the second-line setting who have previously received enfortumab vedotin and pembrolizumab in combination can be enrolled.\n\n       Esophageal Carcinoma\n   15. Pathologically or cytologically documented esophageal squamous cell carcinoma.\n   16. Must have documented disease progression after having received 2 prior lines of therapy including previous PBC with or without an anti-PD-1 therapy-containing regimen (combined or sequential) in the advanced\u002Fmetastatic setting.\n\n       Pancreatic Carcinoma\n   17. Pathologically or cytologically documented unresectable or metastatic pancreatic adenocarcinoma.\n   18. Relapsed or disease progression after having received 1 prior line of systemic therapy in the locally advanced\u002Fmetastatic setting.\n\n       Prostate Cancer\n   19. Pathologically or cytologically documented unresectable locally advanced or metastatic castration-resistant prostate cancer (CRPC).\n   20. Adenocarcinoma of the prostate without neuroendocrine differentiation or small cell histology.\n   21. Surgically or medically castrated, with testosterone levels of \\\u003C50 ng\u002FdL.\n   22. Documented objective progression as determined by radiographic progression for subjects with measurable disease after androgen deprivation.\n   23. Relapsed or disease progression after having received treatment with ≥1 of the following novel hormonal agents: abiraterone, enzalutamide, apalutamide, or darolutamide.\n   24. Relapsed or disease progression after having received ≥1 cytotoxic chemotherapy regimen that included a taxane.\n\n       Gastric Cancer 2L\n   25. Must have had gastric or GEJ adenocarcinoma confirmed as negative for HER2 expression (IHC 0\u002F1+ or IHC 2+\u002Fin situ hybridization negative) as classified by American Society of Clinical Oncology\u002FCollege of American Pathologists (ASCO-CAP) guidelines and determined prior to enrollment by assessment in a local laboratory that is Clinical Laboratory Improvement Amendments certified (US sites) or accredited based on specific country regulations.\n   26. Disease progression after having received treatment with only 1 prior line of systemic anti-cancer therapy that includes 5-FU-based chemotherapy with or without an anti-PD-1 therapy. For subjects whose tumors are claudin (CLDN) 18.2 positive, treatment with 5-FU based chemotherapy with CLDN18.2 directed therapy in the first-line setting is allowed.\n\n   Non-small Cell Lung Cancer aa. Histologically or cytologically documented metastatic or locally advanced nonsquamous NSCLC not amenable to curative surgery or radiation bb. Documentation of absence of actionable driver mutation (ie, ALK rearrangement, BRAF V600E mutation, EGFR-activating mutations \\[exon 19 deletion or L858R mutation\\], EGFR exon 20 insertion mutation, HER2 mutation, KRAS G12C mutation, MET exon 14 skipping mutation, NTRK 1\u002F2\u002F3 gene fusion, RET rearrangement, or ROS1 rearrangement). New testing for these genomic alterations is not required for Screening.\n\n   cc. Relapsed or disease progression after receiving only anti-PD-(L)1 and PBC (ie, platinum doublet) administered in combination or sequentially for metastatic disease.\n\n   Breast Cancer dd. Pathologically documented breast cancer that is assessed as HER2 negative (IHC2+\u002FISH-, IHC1+, or IHC0 per ASCO\u002FCAP guidelines), and HR positive (either ER and\u002For PgR positive \\[ER or PgR ≥1%\\] per ASCO\u002FCAP guidelines). The HER2 and HR results must be from a tumor sample obtained in the metastatic setting.\n\n   ee. Participant must have received one line of chemotherapy for mBC, but not more than one line and must have a clinically or radiologically documented evidence of tumor progression on or after CDK 4\u002F6 inhibitor combined with endocrine therapy; previous treatments with phosphoinositide 3-kinase (PI3K) inhibitors, mammalian target of rapamycin (mTOR) inhibitors, protein kinase B (PKB) inhibitors also known as AKT-inhibitors and poly ADP ribose polymerase (PARP)-inhibitors are allowed.\n4. Has ≥1 measurable lesion on CT or MRI as per RECIST v1.1 by investigator assessment. Prostate cancer participants with bone only disease may be eligible.\n5. Provides a pretreatment tumor tissue sample that meets 1 of the following collection requirements:\n\n   1. Tumor biopsy from ≥1 lesion not previously irradiated and performed since progression with the most recent systemic cancer therapy regimen and prior to signature of the tissue ICF (ARCHIVAL PRETREATMENT sample).\n\n      OR\n   2. Newly obtained pretreatment tumor biopsy from ≥1 lesion not previously irradiated and amenable to sampling, after signature of tissue ICF (FRESH PRETREATMENT sample)\n6. Has Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1 at screening.\n\nExclusion Criteria\n\nParticipants who meet any of the following criteria will be disqualified from entering the study:\n\n1. Has HER2-positive gastric cancer as classified by ASCO-CAP guidelines and determined prior to enrollment by assessment in a local laboratory that is Clinical Laboratory Improvement Amendments certified (US sites) or accredited based on specific country regulations.\n2. Has nasopharyngeal cancer.\n3. Has mucosal or uveal melanoma.\n4. Has a history of (non-infectious) interstitial lung disease (ILD), that required corticosteroids, has current ILD\u002Fpneumonitis, or suspected ILD\u002Fpneumonitis cannot be ruled out by imaging at screening.\n5. Has clinically severe respiratory compromise (based on the investigator's assessment) resulting from intercurrent pulmonary illnesses\n6. Is receiving chronic systemic corticosteroids dosed at \\>10 mg prednisone daily or equivalent anti-inflammatory activity or any form of immunosuppressive therapy prior to Cycle 1 Day 1.\n\n   Participants who require use of bronchodilators, inhaled or topical steroids, or local steroid injections may be included in the study.\n7. Had prior treatment with an anti-HER3 antibody and\u002For antibody-drug conjugate (ADC) that consists of an exatecan derivative that is a topoisomerase I inhibitor (eg, trastuzumab deruxtecan).\n8. Has history of other active malignancy within 3 years prior to Cycle 1 Day 1, except the following:\n\n   1. Adequately treated nonmelanoma skin cancer\n   2. Adequately treated intraepithelial carcinoma of the cervix\n   3. Any other curatively treated in situ disease\n9. Has any evidence of severe or uncontrolled diseases (eg, active bleeding diatheses, active serious infection) psychiatric illness\u002Fsocial situations, geographical factors, substance abuse, or other factors that, in the investigator's opinion, make it high risk for the subject to participate in the study or that would jeopardize compliance with the protocol\n10. Has previously received topoisomerase-1 inhibitors (e.g., irinotecan) treatment in the advanced or metastatic disease setting.",{"count":119,"type":22},740,"INTERVENTIONAL",[122],"PHASE2","This is a proof-of-concept study designed to investigate HER3-DXd monotherapy in locally advanced unresectable or metastatic solid tumors. The study is enrolling cohorts of participants with melanoma \\[cutaneous\u002Facral\\], squamous cell carcinomas of the head and neck (SCCHN), HER2-negative gastric cancer ovarian carcinoma, cervical cancer, endometrial cancer, bladder cancer, esophageal carcinoma, pancreatic carcinoma, prostate cancer, second-line gastric cancer, lung cancer, and breast cancer.",[125,26,96,126,127,128,129,130,131,132,133,134,91,90],"Advanced Solid Tumor","Gastric Cancer","Ovarian Carcinoma","Cervical Cancer","Endometrial Cancer","Bladder Cancer","Esophageal Cancer","Pancreatic Carcinoma","Prostate Cancer","Non-small Cell Lung Cancer (NSCLC)",[125,26,96,126,136,137,138,139,140,141,142,143,144,145,91,90],"Ovarian carcinoma","Cervical cancer","Endometrial cancer","Bladder cancer","Esophageal carcinoma","Pancreatic carcinoma","Prostate cancer","Patritumab Deruxtecan","HER3-DXd","U3-1402",{"date":45,"type":46},{"date":148,"type":46},"2024-02-26",{"date":150,"type":22},"2028-10-10",{"name":152,"class":153},"Daiichi Sankyo","INDUSTRY",86,{"id":156,"slug":157,"hasResults":12,"nctId":158,"briefTitle":159,"officialTitle":160,"acronym":4,"eligibilityCriteria":161,"healthyVolunteers":12,"sex":17,"minAge":85,"maxAge":162,"enrollmentInfo":163,"targetDuration":4,"studyType":120,"phases":165,"briefSummary":166,"conditions":167,"keywords":168,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":172,"startDateStruct":173,"completionDateStruct":175,"leadSponsor":177,"locationsCount":54},"100256733","phase-2-a-phase-2-trial-for-metastatic-melanoma-using-adoptive-cell-therapy-with-tumor-infiltrating-lymphocytes-plus-il-2-either-alone-or-following-the-administration-of-pembrolizumab-100256733","NCT02621021","A Phase 2 Trial for Metastatic Melanoma Using Adoptive Cell Therapy With Tumor Infiltrating Lymphocytes Plus IL-2 Either Alone or Following the Administration of Pembrolizumab","A Phase II Trial for Metastatic Melanoma Using Adoptive Cell Therapy With Tumor-Infiltrating Lymphocytes Plus IL-2 Either Alone or Following the Administration of Pembrolizumab","-INCLUSION CRITERIA:\n\n1. Measurable metastatic melanoma with at least one lesion that is resectable for TIL generation.\n2. Confirmation of diagnosis of metastatic melanoma by the Laboratory of Pathology of NCI.\n3. Patients must have received at least one prior therapy for metastatic melanoma.\n4. Patients with 3 or fewer brain metastases that are less than 1 cm in diameter and asymptomatic are eligible. Lesions that have been treated with stereotactic radiosurgery must be clinically stable for 1 month after treatment for the patient to be eligible. Patients with surgically resected brain metastases are eligible.\n5. Greater than or equal to 18 years and less than or equal to 72 years.\n6. All participants must sign a written informed consent.\n7. All participants must be willing to sign a durable power of attorney\n8. Clinical performance status of ECOG 0 or 1.\n9. Patients of both sexes must be willing to practice birth control from the time of enrollment on this study and for up to four months after treatment.\n10. Serology:\n\n    * Seronegative for HIV antibody. (The experimental treatment being evaluated in this protocol depends on an intact immune system. Patients who are HIV seropositive can have decreased immune-competence and thus are less responsive to the experimental treatment and more susceptible to its toxicities.)\n    * Seronegative for hepatitis B antigen, and seronegative for hepatitis C antibody. If hepatitis C antibody test is positive, then patient must be tested for the presence of antigen by RT-PCR and be HCV RNA negative.\n11. Individuals of child-bearing potential must be willing to undergo a pregnancy test prior to the start of treatment because of the potentially dangerous effects of the treatment on the fetus.\n12. Individuals of child-bearing potential (IOCBP) must agree to use highly effective contraception (hormonal, intrauterine device \\[IUD, abstinence, surgical sterilization starting at the time of study entry, for the duration of study therapy, and 12 months after the last dose of combined chemotherapy\n\n    Individuals that can father children must agree to use an effective method of contraception (barrier, surgical sterilization, abstinence) for the duration of the study treatment and for 4 months after the last dose of combined chemotherapy. We also will recommend individuals that can father children ask their partners to be on highly effective birth control (hormonal, intrauterine device (IUD), surgical sterilization).\n\n    NOTE: IOCBP is defined as any female who has experienced menarche and who has not undergone successful surgical sterilization or who is not postmenopausal.\n\n    NOTE: Certain malignancies may secrete hormones that produce false positive pregnancy tests. Serial blood testing (e.g. HCG measurements) and\u002F or ultrasound may be performed for clarification.\n\n    IOCBP must not donate, or retrieve for their own use, ova from the time of study treatment initiation and throughout the study treatment period, and for at least 12 months after the final study drug(s) administration. Individuals that can father children must not freeze or donate sperm for at least 12 months after the final study drug(s) administration.\n13. Nursing participants must be willing to discontinue nursing from study treatment initiation through 4 months after the last dose of the study drug(s).\n14. Hematology\n\n    * Absolute neutrophil count greater than 1000\u002Fmm3 without the support of filgrastim\u002Fbiosimilar\n    * WBC greater than or equal to 2500\u002Fmm3\n    * Platelet count greater than or equal to 800,000\u002Fmm3\n    * Hemoglobin \\> 8.0 g\u002Fdl\n15. Chemistry\n\n    * Serum ALT\u002FAST less than or equal to 2.5 times ULN\n    * Serum Creatinine less than or equal to 1.6 mg\u002Fdl\n    * Total bilirubin less than or equal to 1.5 mg\u002Fdl, except in patients with Gilbert's Syndrome, who must have a total bilirubin less than 3.0 mg\u002FdL.\n16. Patients must have completed any prior systemic therapy at the time of enrollment.\n17. Patients must demonstrate progressive disease at the time of treatment. (Note: Patients who have received tyrosine kinase inhibitors (e.g. vemurafinib) may be treated if they present with stable disease at the time of treatment).\n18. Patients must be co-enrolled in protocol 03-C-0277.\n\nEXCLUSION CRITERIA:\n\n1. Individuals of child-bearing potential who are pregnant or nursing because of the potentially dangerous effects of the treatment on the fetus or infant.\n2. Any form of primary immunodeficiency (such as Severe Combined Immunodeficiency Disease).\n3. Concurrent opportunistic infections (The experimental treatment being evaluated in this protocol depends on an intact immune system. Patients who have decreased immune competence may be less responsive to the experimental treatment and more susceptible to its toxicities.)\n4. Active systemic infections requiring anti-infective treatment, coagulation disorders or any other active major medical illnesses.\n5. History of major organ autoimmune disease\n6. Concurrent systemic steroid therapy.\n7. History of severe immediate hypersensitivity reaction to any of the agents used in this study.\n8. Grade 3 or 4 major organ Immune-related Adverse Events (IRAEs) clinically attributed to anti PD-1\u002FPD-L1 monotherapy. Previously screened participants that experience these IRAEs after resection for creation of TIL are excluded from Arm 2, but may be eligible for assignment to Arm 3. NOTE: For the purposes of this protocol, thyroid is not considered a major organ.\n9. History of coronary revascularization or ischemic symptoms.\n10. For select patients with a clinical history prompting cardiac evaluation: last LVEF less than or equal to 45%\n11. For select patients with a clinical history prompting pulmonary evaluation: known FEV1 less than or equal to 50%.\n12. Patients who are receiving any other investigational agents.","72 Years",{"count":164,"type":22},53,[122],"Background:\n\nCell therapy is an experimental cancer therapy. It takes young tumor infiltrating lymphocytes (Young TIL) cells from a person s tumors and grows them in a lab. Then they are returned to the person. Researchers think adding the drug pembrolizumab might make the therapy more effective.\n\nObjective:\n\nTo test if adding pembrolizumab to cell therapy is safe and effective to shrink melanoma tumors.\n\nEligibility:\n\nPeople ages 18-72 years with metastatic melanoma OF THE SKIN\n\nDesign:\n\nParticipants will be screened with:\n\nPhysical exam\n\nCT, MRI, or PET scans\n\nX-rays\n\nHeart and lung function tests if indicated\n\nBlood and urine tests\n\nBefore treatment, participants will have:\n\nA piece of tumor taken from a biopsy or during surgery in order to grow TIL cells\n\nLeukapheresis: Blood flows through a needle in one arm and into a machine that removes white blood cells.\n\nThe rest of the blood returns through a needle in the other arm.\n\nAn IV catheter placed in the chest for getting TIL cells, aldesleukin, and pembrolizumab (if assigned)\n\nParticipants will stay in the hospital for treatment. This includes:\n\nDaily chemotherapy for 1 week\n\nFor some participants, pembrolizumab infusion 1 day after chemotherapy\n\nTIL cell infusion 2-4 days after chemotherapy, then aldesleukin infusion every 8 hours for up to 12 doses\n\nFilgrastim injections to help restore your blood counts\n\nRecovery for 1-3 weeks\n\nAfter treatment, participants will:\n\nTake an antibiotic and an antiviral for at least 6 months, as applicable\n\nIf assigned, have pembrolizumab treatment every 3 weeks for 3 more doses. They may have another round.\n\nHave 2-day follow-up visits every 1-3 months for 1 year and then every 6 months",[26],[26,169,170,171],"Skin Cancer","Immunotherapy","Cell Therapy",{"date":43,"type":46},{"date":174,"type":46},"2015-12-04",{"date":176,"type":22},"2029-06-16",{"name":52,"class":53},{"id":179,"slug":180,"hasResults":12,"nctId":181,"briefTitle":182,"officialTitle":183,"acronym":4,"eligibilityCriteria":184,"healthyVolunteers":12,"sex":17,"minAge":85,"maxAge":4,"enrollmentInfo":185,"targetDuration":4,"studyType":120,"phases":187,"briefSummary":182,"conditions":189,"keywords":4,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":198,"lastUpdatePostDateStruct":199,"startDateStruct":200,"completionDateStruct":202,"leadSponsor":204,"locationsCount":206},"100601788","phase-1-a-study-to-investigate-safety-of-azd6750-in-adult-participants-with-select-advanced-or-metastatic-solid-tumors-100601788","NCT07115043","A Study to Investigate Safety of AZD6750 in Adult Participants With Select Advanced or Metastatic Solid Tumors","A Phase I\u002FII Open-label Dose Escalation and Expansion Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of AZD6750, a CD8 Guided IL-2 Agent Alone and in Combination With Other Anti-cancer Agents in Participants With Select Advanced or Metastatic Solid Tumors","Inclusion criteria:\n\n* Participant ≥ 18 year\n* ECOG PS of 0 to 1\n* Provision of 'archival' tumor specimen\n* At least one measurable lesion according to RECIST v1.1,\n* Minimum life expectancy of 12 weeks\n* Adequate and stable cardiac function\n* Adequate bone marrow, liver and kidney function\n* Body weight ≥ 35 kg\n* Capable of giving signed informed consent\n\nModule 1 specific inclusion criteria:\n\n• Participants with locally advanced or metastatic select solid tumors (MM, Squamous cell carcinoma of skin, MCC, NSCLC, Head and neck squamous cell carcinoma, Gastric cancer\u002Fgastroesophaegeal junction cancer, RCC, HGSOC, Triple negative breast cancer) who have received adequate SoC\n\nModule 2 specific inclusion criteria:\n\n* Participants with Stage IV NSCLC Dose Escalation\u002FBackfills\n\n  1. Have received at least one prior regimen in metastatic setting (2L+ NSCLC). Participants with actionable tumor alterations should have received targeted therapy if locally available OR\n  2. Have not received systemic therapy (1L NSCLC) and have PD-L1 expression ≥ 1%.\n\n     Dose Expansion\n\n  \u003C!-- -->\n\n  1. Have not received systemic therapy (1L NSCLC) and have PD-L1 expression ≥ 1%.\n\n     Exclusion criteria:\n* Any evidence of:\n\nSevere or uncontrolled systemic diseases including respiratory, cardiac or tumor-related conditions\n\n* History or planned organ or allogeneic stem cell transplantation.\n* Active or prior documented autoimmune or inflammatory disorders, within the past 3 years\n* Any prior toxicities that led to permanent discontinuation of prior immunotherapy\n* Persistent toxicities (CTCAE Grade ≥ 2) caused by previous anti-cancer therapy\n* Brain metastases unless treated, asymptomatic, stable, and not requiring continuous corticosteroids\n* Acute untreated or symptomatic malignant spinal cord compression, or a history of leptomeningeal carcinomatosis.\n* Active uncontrolled or chronic infection of hepatitis B, hepatitis C\n* Prior history of Grade ≥ 3 non-infectious pneumonitis.\n* Participant requires chronic immunosuppressive therapy (including steroids \\> 10 mg prednisone\u002Fday or equivalent).\n* Receipt of live attenuated vaccine within 30 days.\n\nModule 2 specific exclusion criteria:\n\n* Previous treatment with anti-TIGIT therapy\n* 1L NSCLC participants with genetic alteration such as EGFR that has a targeted therapy in 1L as per local SoC",{"count":186,"type":22},120,[188,122],"PHASE1",[26,190,191,192,193,194,195,196,197],"Non-small Cell Lung Cancer","Squamous Cell Carcinoma (Skin)","Renal Cell Carcinoma","Merkel Cell Carcinoma","Triple Negative Breast Cancer","Head and Neck Squamous Cell Carcinoma","Gastric Cancer\u002FGastroesophageal Junction Cancer","High Grade Serous Ovarian Carcinoma","2026-08-18",{"date":103,"type":46},{"date":201,"type":46},"2025-07-29",{"date":203,"type":22},"2029-10-02",{"name":205,"class":153},"AstraZeneca",13,{"id":208,"slug":209,"hasResults":12,"nctId":210,"briefTitle":211,"officialTitle":212,"acronym":4,"eligibilityCriteria":213,"healthyVolunteers":12,"sex":17,"minAge":85,"maxAge":4,"enrollmentInfo":214,"targetDuration":4,"studyType":120,"phases":216,"briefSummary":218,"conditions":219,"keywords":220,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":198,"lastUpdatePostDateStruct":226,"startDateStruct":227,"completionDateStruct":229,"leadSponsor":231,"locationsCount":233},"100535060","phase-3-a-study-with-combinations-of-anti-lag-3-and-anti-pd-1-antibodies-in-adult-participants-with-advanced-or-metastatic-melanoma-harmony-head-to-head-100535060","NCT06246916","A Study With Combinations of Anti-LAG-3 and Anti-PD-1 Antibodies in Adult Participants With Advanced or Metastatic Melanoma (Harmony Head-to-Head)","A Phase 3 Study of Fixed Dose Combinations of Fianlimab and Cemiplimab Versus Relatlimab and Nivolumab in Participants With Unresectable or Metastatic Melanoma","Key Inclusion Criteria:\n\n1. Participants with histologically confirmed unresectable stage III and stage IV (metastatic) melanoma per American Joint Committee on Cancer (AJCC), eighth revised edition.\n2. Participants must not have received prior systemic therapy for unresectable or metastatic melanoma as described in the protocol.\n3. Measurable disease per RECIST version 1.1.\n4. Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤1\n5. Adequate bone marrow, hepatic, and kidney function\n6. Known B-Rapidly Accelerated Fibrosarcoma protein (BRAF) V600 mutation status or submitted sample for BRAF V600 mutation assessment as described in the protocol\n\nKey Exclusion Criteria:\n\nMedical Conditions:\n\n1. Uveal, acral or mucosal melanoma.\n2. Ongoing or recent (within 2 years) evidence of an autoimmune disease that required systemic treatment with immunosuppressive agents as described in the protocol.\n3. Uncontrolled infection with human immunodeficiency virus (HIV), hepatitis B (HBV), or hepatitis C virus (HCV) infection; or diagnosis of immunodeficiency that is related to, or results in chronic infection. Mild cancer-related immunodeficiency (such as immunodeficiency treated with gamma globulin and without chronic or recurrent infection) is allowed.\n\n   Prior\u002FConcomitant Therapy:\n4. Prior immune checkpoint inhibitor therapy other than anti-PD1\u002FPD-L1 as described in the protocol\n5. Systemic immune suppression as described in the protocol.\n\n   Other Comorbidities:\n6. Participants with a history of myocarditis.\n7. Troponin T (TnT) or troponin I (TnI) \\>2x institutional upper limit of normal (ULN).\n8. Active or untreated brain metastases or spinal cord compression as described in the protocol.\n\nNote: Other protocol-defined Inclusion\u002F Exclusion Criteria apply.",{"count":215,"type":22},560,[217],"PHASE3","This study is researching an experimental drug called fianlimab (also known as REGN3767), combined with another medication called cemiplimab (also known as REGN2810), called \"study drugs\". The study is focused on patients with a type of skin cancer known as melanoma. The aim of the study is to see how safe and effective the combination of fianlimab and cemiplimab is in treating melanoma, in comparison with the combination of two medications, relatlimab and nivolumab, commercialized under the brand name Opdualag™ and approved for the treatment of melanoma in adults and children.\n\nThe study is looking at several other research questions, including:\n\n* What side effects may happen from taking the study drugs.\n* How much study drug is in the blood at different times.\n* Whether the body makes antibodies against the study drugs (which could make the drug less effective or could lead to side effects)",[26],[221,222,223,224,225],"Unresectable Melanoma","Metastatic Melanoma","Advanced Melanoma","Stage III","Stage IV",{"date":103,"type":46},{"date":228,"type":46},"2024-09-09",{"date":230,"type":22},"2033-07-10",{"name":232,"class":153},"Regeneron Pharmaceuticals",111,{"id":235,"slug":236,"hasResults":12,"nctId":237,"briefTitle":238,"officialTitle":239,"acronym":4,"eligibilityCriteria":240,"healthyVolunteers":12,"sex":17,"minAge":85,"maxAge":19,"enrollmentInfo":241,"targetDuration":4,"studyType":120,"phases":243,"briefSummary":244,"conditions":245,"keywords":4,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":198,"lastUpdatePostDateStruct":248,"startDateStruct":249,"completionDateStruct":251,"leadSponsor":253,"locationsCount":54},"100320607","phase-1-ulixertinibpalbociclib-in-patients-with-advanced-pancreatic-and-other-solid-tumors-100320607","NCT03454035","Ulixertinib\u002FPalbociclib in Patients With Advanced Pancreatic and Other Solid Tumors","Ulixertinib (BVD-523) in Combination With Palbociclib in Patients With Advanced Solid Tumors With Expansion Cohort in Previously Treated Metastatic Pancreatic Cancer and Metastatic RAS-mutant and NF1-mutant (no BRAFV600 Mutations) Melanoma","Inclusion Criteria:\n\n1. Written informed consent and HIPAA authorization for release of personal health information. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.\n2. Age ≥ 18 years at the time of consent (no upper age limit)\n3. Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 2\n4. Tumor Eligibility:\n\n   1. Dose escalation cohorts: Histologically confirmed advanced solid tumor refractory to standard of care therapy, or for which there is no accepted standard of care\n   2. Expansion cohort (at RP2D): metastatic pancreatic cancer or malign melanoma patients who have received at least one line of therapy in the metastatic setting\n   3. Expansion cohort (at RP2D) for histologically confirmed unresectable stage III or stage IV melanoma with the following additional eligibility requirements:\n\n      * Tumors molecular profiling genetic aberrations: NRASG12\u002FG13\u002FQ61, KRASG12\u002FG13, HRASG12\u002FG13, any amplifications of the NRAS, KRAS, or HRAS genes. For NF1 mutations, subjects with loss-of-function NF1mutations and without any BRAFV600 mutations will be enrolled.\n      * Documented disease refractory to at least one PD1\u002FPD-L1 inhibitor, defined as disease progression following at least two infusions of the same drug.\n      * Subjects with RAS-mutant and NF1-mutant (no concurrent BRAFV600 mutations) melanoma that have not taken prior immune checkpoint inhibitors will be allowed if they are not eligible to receive prior immune checkpoint inhibitors due to requirement for immunosuppression\n5. Measurable or non-measurable (but evaluable) disease according to RECIST v1.1 for dose escalating cohorts; measurable disease as per RECIST v1.1 required for expansion cohort\n6. Life expectancy ≥ 12 weeks\n7. Recovered from all reversible acute toxic effects of last anti-cancer treatment (other than alopecia) to ≤Grade 1 or baseline. Patients with baseline neuropathy that is ≤ grade 2 are eligible for enrollment.\n8. Demonstrate adequate organ function as defined in the table below; all screening labs to be obtained within 28 days prior to day -6 of ulixertinib\n\n   Hemoglobin (Hgb) ≥ 9 g\u002FdL Absolute Neutrophil Count (ANC) ≥ 1,500 \u002Fmm3 Platelets ≥ 100,000\u002Fmm3 Creatinine ≤1.5 x upper limit of normal (ULN) or Calculated creatinine clearance ≥ 60 mL\u002Fmin using the Cockcroft-Gault formula Bilirubin ≤ 1.5 x ULN Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) ≤ 2.5 x ULN; if tumor involvement of the liver ≤ 5 x ULN\n9. Adequate cardiac function; left ventricular ejection fraction (LVEF) \\>50% as assessed by ultrasound\u002Fechocardiography (ECHO) and corrected QT interval (QTc)\n10. Females of childbearing potential must have a negative serum pregnancy test within 3 days prior to day -6 of ulixertinib. NOTE: Females are considered of childbearing potential unless they are surgically sterile (have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are naturally postmenopausal for at least 12 consecutive months\n11. Females of childbearing potential and males must be willing to abstain from heterosexual activity\\* or use effective methods of contraception from the time of informed consent until 120 days after treatment discontinuation. Acceptable contraception methods can be comprised of an intrauterine device (IUD), vasectomy of a female subject's male partner, contraceptive rod implanted into the skin, OR use of two of the following: diaphragm with spermicide (cannot be used in conjunction with cervical cap\u002Fspermicide), cervical cap with spermicide (nulliparous women only), contraceptive sponge (nulliparous women only), male condom or female condom (cannot be used together), hormonal contraceptive.\\] \\*Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject.\n12. Subject is willing and able to comply with study procedures based on the judgment of the investigator or protocol designee.\n13. Willing to provide archival tissue (if available) and consent to mandatory pretreatment and on-treatment biopsy as deemed safe by the treating physician (expansion cohort only) for research purposes only.\n\nExclusion Criteria:\n\n1. Pregnant or breastfeeding (NOTE: breast milk cannot be stored for future use while the mother is being treated on the study)\n2. Treatment with any cancer-directed therapy (chemotherapy, hormonal therapy, biologic, radiation or immunotherapy, etc.) or investigational drug within 28 days or 5 half-lives (whichever is shorter) prior to day -6 of ulixertinib\n3. A history or current evidence\u002Frisk of retinal vein occlusion (RVO) or central serous retinopathy (CSR).\n4. Major surgery within 28 days prior to day -6 of ulixertinib\n5. Not willing to avoid grapefruit, grapefruit juices, grapefruit hybrids, oranges, pummelos, and exotic citrus fruits from 7 days prior to day -6 of ulixertinib and during the entire study due to potential CYP3A4 interaction with the study medications.\n6. Intake of any herbal preparations or medications (including, but not limited to, Saint John's Wort and ginkgo biloba) and dietary supplements within 7 days prior to day -6 of ulixertinib due to potential CYP3A4 interaction with the study medications\n7. Unable or unwilling to discontinue use of any drug known to be a strong inhibitor of CYP3A4, CYP1A2 or CYP2D6 or strong inducer of CYP3A4 (prohibited inducers and inhibitors must be discontinued within 2 weeks prior to day -6 of ulixertinib; see section 10.3 Appendix C)\n8. Unable or unwilling to discontinue use of any drug known to be a sensitive CYP3A4 substrate with a narrow therapeutic index as defined in the protocol.\n9. Central nervous system metastases are allowed only for patients RAS-mutated and NF1-mutant melanoma cohorts (1) no leptomeningeal disease is present, (2) Intracranial disease is controlled by prior therapies, as evidenced by brain imaging 2 weeks post treatment indicating no new intracranial disease, (3) stable or decreasing dose of steroids is provided patient on ≤ 20mg of prednisone or it's equivalent daily.\n10. Any important medical illness or abnormal laboratory finding that would increase the risk of participating in the study (based on the investigator's judgment)\n11. Psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n12. Has a known additional malignancy that is active and\u002For progressive requiring treatment; non-melanoma skin cancers, non-invasive bladder cancer, and carcinoma in situ of the cervix, prior history of prostate cancer provided the patient is not undergoing active systemic treatment other than hormonal therapy and has documented PSA that is undetectable (\\\u003C0.2ng\u002FmL), prostate carcinoma in remission and did not receive systemic treatment, papillary thyroid cancer did not receive adjuvant radioactive iodine, Stage Rai stage 0 Chronic lymphocytic leukemia does not require systemic treatment, lymphoma, hairy-cell leukemia, or myelodysplasia is in complete remission and or other cancer for which the patient has been disease-free for at least two years.\n\n    Has a known additional malignancy that is active and\u002For progressive requiring treatment.\n13. Impaired GI function or GI disease that may significantly impair absorption (e.g., inflammatory bowel disease (IBD), malabsorption syndrome, small bowel resection, uncontrolled vomiting or diarrhea)\n14. Inability to swallow oral medications\n15. Patients with autoimmune diseases that require systemic corticosteroid treatment \\>20 mg methylprednisolone equivalent.",{"count":242,"type":22},45,[188],"This phase I study is designed to establish the safety, maximally tolerated dose (MTD) and recommended phase II dose (RP2D) of the ERK inhibitor ulixertinib (BVD-523) when combined with the CDK4\u002F6 inhibitor palbociclib.",[246,247,26],"Tumor, Solid","Pancreatic Cancer",{"date":103,"type":46},{"date":250,"type":46},"2018-01-30",{"date":252,"type":22},"2028-02-03",{"name":254,"class":77},"UNC Lineberger Comprehensive Cancer Center",{"id":256,"slug":257,"hasResults":12,"nctId":258,"briefTitle":259,"officialTitle":260,"acronym":4,"eligibilityCriteria":261,"healthyVolunteers":12,"sex":17,"minAge":85,"maxAge":262,"enrollmentInfo":263,"targetDuration":4,"studyType":120,"phases":265,"briefSummary":267,"conditions":268,"keywords":273,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":285,"lastUpdatePostDateStruct":286,"startDateStruct":287,"completionDateStruct":289,"leadSponsor":291,"locationsCount":293},"100311904","phase-4-dabrafenib-andor-trametinib-rollover-study-100311904","NCT03340506","Dabrafenib and\u002For Trametinib Rollover Study","Open Label, Multi-center Roll-over Study to Assess Long Term Safety in Patients Who Have Completed a Global Novartis or GSK Sponsored Dabrafenib and\u002For Trametinib Study","Inclusion Criteria:\n\n* Patient is currently receiving treatment with dabrafenib\u002Ftrametinib monotherapy or combination within a Novartis or former GSK sponsored study which has fulfilled the requirements for the primary objective.\n* In the opinion of the Investigator would benefit from continued treatment.\n\nExclusion Criteria:\n\n* Patient has been previously permanently discontinued from study treatment in the parent protocol.\n* Patient's indication is commercially available and reimbursed in the local country.\n* Patient currently has unresolved toxicities for which dabrafenib and\u002For trametinib dosing has been interrupted in the parent study.","100 Years",{"count":264,"type":22},100,[266],"PHASE4","This study is to provide access for patients who are receiving treatment with dabrafenib and\u002For trametinib in a Novartis-sponsored Oncology Global Development, Global Medical Affairs or a former GSK-sponsored study who have fulfilled the requirements for the primary objective, and who are judged by the investigator as benefiting from continued treatment in the parent study as judged by the Investigator at the completion of the parent study.",[26,269,270,271,272],"Non Small Cell Lung Cancer","Solid Tumor","Rare Cancers","High Grade Glioma",[274,275,276,277,278,26,279,222,223,91,280,269,281,282,283,284,272],"Tafinlar","Mekinist","Dabrafenib","Trametinib","Adult","Melanoma Stage IV","NSLC","BRAF V600 Mutation","BRAF Gene Mutation","Solid tumor","Rare cancers","2026-08-17",{"date":198,"type":46},{"date":288,"type":46},"2018-01-26",{"date":290,"type":22},"2032-12-28",{"name":292,"class":153},"Novartis Pharmaceuticals",33,{"id":295,"slug":296,"hasResults":12,"nctId":297,"briefTitle":298,"officialTitle":298,"acronym":4,"eligibilityCriteria":299,"healthyVolunteers":12,"sex":17,"minAge":85,"maxAge":4,"enrollmentInfo":300,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":301,"conditions":302,"keywords":305,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":308,"lastUpdatePostDateStruct":309,"startDateStruct":310,"completionDateStruct":4,"leadSponsor":312,"locationsCount":54},"100054764","evaluation-for-nci-surgery-branch-clinical-research-protocols-100054764","NCT00001823","Evaluation for NCI Surgery Branch Clinical Research Protocols","* INCLUSION CRITERIA:\n\nAge \\>= 18 years.\n\nPatient suspected of having, or with biopsy proven, malignant disease.\n\nPatient is able to understand and willing to sign a written informed consent document.\n\nPatient is being evaluated for treatment on an NCI-SB protocols.\n\nEXCLUSION CRITERIA:\n\nWomen of child-bearing potential who are pregnant or plan to become pregnant because of the potentially dangerous effects of some of the screening procedures (e.g., nuclear medicine or other imaging scans) on the fetus.",{"count":87,"type":22},"Background:\n\nThe National Cancer Institute Surgery Branch (NCI-SB) has developed experimental therapies that involve taking white blood cells from patients' tumor or from their blood, growing them in the laboratory in large numbers, and then giving the cells back to the patient.\n\nObjective:\n\nThis study will allow patients to under screening and evaluation for participation in NC-SB Protocols.\n\nEligibility:\n\nPatients 18 years or older must meet the minimum eligibility criteria for an NCI-SB treatment protocol.\n\nDesign\n\nPatients will undergo testing and evaluations as required by the appropriate NCI-SB treatment protocol.\n\n...",[303,26,304,91,130],"Synovial Cell Cancer","Colorectal Cancer",[40,306,170,307],"Gene Therapy","Clinical Trial","2026-08-15",{"date":198,"type":46},{"date":311,"type":46},"1999-07-11",{"name":52,"class":53},{"id":314,"slug":315,"hasResults":12,"nctId":316,"briefTitle":317,"officialTitle":318,"acronym":4,"eligibilityCriteria":319,"healthyVolunteers":12,"sex":17,"minAge":85,"maxAge":4,"enrollmentInfo":320,"targetDuration":4,"studyType":120,"phases":322,"briefSummary":323,"conditions":324,"keywords":334,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":346,"lastUpdatePostDateStruct":347,"startDateStruct":348,"completionDateStruct":350,"leadSponsor":352,"locationsCount":354},"100431255","phase-1-a-study-of-bms-986340-as-monotherapy-and-as-combination-therapy-in-participants-with-advanced-solid-tumors-100431255","NCT04895709","A Study of BMS-986340 as Monotherapy and as Combination Therapy in Participants With Advanced Solid Tumors","A Phase 1\u002F2 Study of BMS-986340 as Monotherapy and as Combination Therapy in Participants With Advanced Solid Tumors","Inclusion Criteria\n\n* Fresh pre-treatment and on-treatment tumor biopsy must be provided for biomarker analysis.\n* Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and at least 1 lesion accessible for biopsy. Fine needle biopsy, cytology, and bone lesion biopsies are not acceptable.\n* Eastern Cooperative Oncology Group Performance Status of 0 or 1.\n* Radiographically documented progressive disease on or after the most recent therapy.\n* Received standard-of-care therapies, (except for Part 1C, 2C and 2D, where participants with prior docetaxel use for the advanced\u002Fmetastatic setting will be excluded), including an available programmed death (ligand)-1 inhibitor known to be effective in the tumor type for which they are being evaluated.\n* Advanced or metastatic disease and have received, be refractory to, not be a candidate for, or be intolerant of existing therapies known to provide clinical benefit for the condition of the participant.\n\nExclusion Criteria\n\n* Women who are pregnant or breastfeeding.\n* Primary central nervous system (CNS) malignancy.\n* Untreated CNS metastases.\n* Leptomeningeal metastases.\n* Concurrent malignancy requiring treatment or history of prior malignancy active within 2 years prior to the first dose of study treatment.\n* Active, known, or suspected autoimmune disease.\n* Condition requiring systemic treatment with either corticosteroids within 14 days or other immunosuppressive medications within 30 days of the first dose of study treatment.\n* Prior organ or tissue allograft.\n* Uncontrolled or significant cardiovascular disease.\n* Major surgery within 4 weeks of study drug administration.\n* History of or with active interstitial lung disease or pulmonary fibrosis.\n* Other protocol-defined inclusion\u002Fexclusion criteria apply.",{"count":321,"type":22},1109,[188,122],"The purpose of this study is to assess the safety, tolerability, and recommended dose(s) of BMS-986340 as monotherapy and in combination with nivolumab, docetaxel, or Pumitamig in participants with advanced solid tumors. This study is a first-in-human (FIH) study of BMS-986340 in participants with advanced solid tumors.",[128,325,326,327,328,329,330,331,26,332,333],"Gastric\u002FGastroesophageal Junction Adenocarcinoma","Microsatellite Stable Colorectal Cancer","Non-Small-Cell Lung Cancer","Squamous Cell Carcinoma of Head and Neck","Carcinoma, Renal Cell","Urothelial Carcinoma","Pancreatic Adenocarcinoma","Ovarian Neoplasms","Triple Negative Breast Neoplasms",[335,128,336,337,338,325,339,326,340,341,327,342,343,328,329,330,331,26,332,333,344,345],"BMS-986340","CRC","First-in-human","GEJ","HNSCC","MSS CRC","Nivolumab","NSCLC","SCCHN","Docetaxel","Pumitamig","2026-08-14",{"date":285,"type":46},{"date":349,"type":46},"2021-05-27",{"date":351,"type":22},"2031-08-31",{"name":353,"class":153},"Bristol-Myers Squibb",47,{"id":356,"slug":357,"hasResults":12,"nctId":358,"briefTitle":359,"officialTitle":359,"acronym":4,"eligibilityCriteria":360,"healthyVolunteers":361,"sex":17,"minAge":362,"maxAge":19,"enrollmentInfo":363,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":365,"conditions":366,"keywords":368,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":346,"lastUpdatePostDateStruct":372,"startDateStruct":373,"completionDateStruct":4,"leadSponsor":375,"locationsCount":376},"100061062","clinical-laboratory-and-epidemiologic-characterization-of-individuals-and-families-at-high-risk-of-melanoma-100061062","NCT00040352","Clinical, Laboratory, and Epidemiologic Characterization of Individuals and Families at High Risk of Melanoma","* INCLUSION CRITERIA:\n* On referral, persons \\>=4 weeks old of any sex, race or ethnicity will be considered for inclusion in the study because of the criteria noted below.\n* Affected: An individual who meets any of the following criteria will be eligible to participate in this study:\n\n  * personal medical history of melanoma of an unusual type, pattern, or number diagnosed at any age; or,\n  * known or suspected factor(s) predisposing to melanoma, either genetic or congenital factors (giant congenital nevi, dysplastic nevi, Spitzoid tumors), or unusual demographic features (e.g., very young age of onset, multiple melanomas, previous history of heritable retinoblastoma, Hodgkin s disease, lymphoma, immunodeficiency syndrome, or organ transplant).\n  * Ability of the individual or their parent or legal guardian, to understand, and their willingness to provide informed consent.\n* Unaffected: An individual who meets any of the following criteria will be eligible to participate in this study:\n\n  * family medical history of melanoma of an unusual type, pattern, or number; or,\n  * known or suspected factor(s) predisposing to melanoma, either genetic or congenital factors (giant congenital nevi, dysplastic nevi. Spitzoid tumors), or unusual demographic features (e.g., very young age of onset, multiple melanomas, previous history of heritable retinoblastoma, Hodgkin s disease, lymphoma, immunodeficiency syndrome, or organ transplant).\n  * Ability of the individual or their parent, or legal guardian to understand, and their willingness to provide informed consent.\n* Personal and family medical history must be verified through questionnaires, interviews, and review of pathology slides and medical records.\n\nEXCLUSION CRITERIA:\n\n* Referred individuals and families for whom reported diagnoses cannot be verified;\n* Inability to provide informed consent",true,"4 Weeks",{"count":364,"type":22},3000,"This study will investigate how genetic and environmental factors contribute to the development of melanoma, a type of skin cancer, and related conditions.\n\nIndividuals \\>=4 weeks with a personal or family history of melanoma or atypical spitzoid\u002FSpitz tumor may be eligible for this study. Participants will:\n\n* Fill out one or two questionnaires about their personal and family medical history.\n* Provide written consent for researchers to review their medical records and pathology materials related to their care and those of deceased relatives with melanomas, tumors, cancer, or other related illnesses for whom they are the next-of-kin or legally authorized representative.\n* Donate a blood or cheek cell sample to be used for genetic studies. (The blood sample is collected through a needle in an arm vein. The cheek cell sample is obtained either by gently brushing the inside of the mouth with a soft brush or by swishing a tablespoon of mouthwash and then spitting it into a container.)\n* Undergo a skin biopsy (removal of a small piece of skin tissue) for genetic study. For this procedure, the area of skin to be removed is numbed with a local anesthetic and a 1\u002F4-inch piece of skin is excised with a cookie cutter-like instrument. The wound is then covered with a band-aid.\n\nParticipants may be asked to travel to the NIH Clinical Center for evaluation, including a medical history, physical examination, and some of the following procedures:\n\n* Full body skin examination to evaluate the type and number of moles and document any evidence of sun damage to the skin. The examination involves all the skin from the scalp to the bottoms of the feet. After the examination, a medical photographer will photograph the skin, with close-ups of skin lesions marked by the examiner. If there are parts of the skin the participant does not want examined or photographed, he or she can tell the examiner.\n* Blood draw of about 120 milliliters (4 ounces) or less\n* Skin biopsy\n* Cheek cell sample\n* X-rays, ultrasound and magnetic resonance imaging (MRI) studies to detect tumors or changes in tumors or other types of changes in specific tissues. MRI is a diagnostic test that uses strong magnetic fields and radiowaves to examine body tissues. The subject lies on a table that is moved into a large tunnel-like machine (the scanner) for about 45 minutes to 1 hour.\n\nWhen the tests are finished, a doctor will discuss the results with the participant and the need, if any, for clinical follow-up.",[26,367],"Dysplastic Nevus Syndrome",[169,369,370,371,26],"Risk Factors","Melanoma Precursors","Genetics",{"date":285,"type":46},{"date":374,"type":46},"2002-07-01",{"name":52,"class":53},2,{"id":378,"slug":379,"hasResults":12,"nctId":380,"briefTitle":381,"officialTitle":382,"acronym":4,"eligibilityCriteria":383,"healthyVolunteers":12,"sex":17,"minAge":384,"maxAge":4,"enrollmentInfo":385,"targetDuration":4,"studyType":120,"phases":387,"briefSummary":388,"conditions":389,"keywords":400,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":408,"lastUpdatePostDateStruct":409,"startDateStruct":410,"completionDateStruct":412,"leadSponsor":414,"locationsCount":416},"100480603","phase-1-a-study-to-learn-about-the-study-medicine-called-pf-07799544-as-monotherapy-or-in-combination-in-people-with-advanced-solid-tumors-100480603","NCT05538130","A Study to Learn About the Study Medicine Called PF-07799544 as Monotherapy or in Combination in People With Advanced Solid Tumors","A PHASE 1A\u002FB OPEN-LABEL MASTER STUDY OF PF-07799544 AS A SINGLE-AGENT AND IN COMBINATION WITH OTHER TARGETED AGENTS IN PARTICIPANTS WITH BRAF-MUTANT MELANOMA AND OTHER SOLID TUMORS","Phase 1b Inclusion Criteria:\n\n* Diagnosis of advanced\u002Fmetastatic solid tumor (excluding colorectal cancer)\n* Measurable disease by RECIST version 1.1\n* Evidence of a BRAF V600 mutation\n* Prior therapy per tumor cohort\n* Adequate organ function per protocol\n\nPhase 1b Exclusion Criteria:\n\n* Other active malignancy within 3 years\n* Presence of leptomeningeal disease\n* History or current evidence of retinal vein occlusion (RVO) or history of retinal degenerative disease\n* Concurrent neuromuscular disorder associated with elevated creatine kinase (CK)\n* Active gastrointestinal disease as defined per protocol\n* History of interstitial lung disease as defined per protocol","16 Years",{"count":386,"type":22},124,[188],"The purpose of this clinical trial is to learn the safety and effects of the study medicine (PF-07799544) alone or in combination as a potential cancer treatment for adults with advanced solid tumors. The study will be conducted in two parts: PF-07799544 as a single agent (Phase 1a) and PF-07799544 in combination with another study medicine called PF-07799933 (Phase 1b).\n\nPhase 1a is no longer open for enrollment. In Phase1b (noted as \"this study\"), we are seeking participants who have:\n\n* a solid tumor which is metastatic or recurrent (excluding colorectal cancer)\n* tumor with the mutation (abnormal gene) called \"BRAF V600\"\n* received required prior treatment for cancer per cohort assigned.\n\nAll participants in this study will receive both study medicines. Both study medicines are tablets that are taken by mouth at home twice a day.\n\nParticipants will receive study medicines until their cancer is no longer responding, unacceptable side effects, or 2 years. Participants may continue to receive study therapy beyond 2 years. We will examine the experiences of people receiving the study medicines. This will help us determine if the study medicines are safe and effective.",[26,65,390,391,392,393,394,395,396,397,272,398,399],"Thyroid Cancer","Non-Small Cell Lung Cancer","Malignant Neoplasms","Brain Neoplasms","Advanced or Metastatic Solid Tumors","HGG","LGG","Low Grade Glioma","Differentiated Thyroid Cancer","NSCLC (Non-small Cell Lung Cancer)",[401,402,403,404,405,406,407],"solid tumors","BRAF","advanced solid tumors","B-Raf","MAPK","neoplasms","BRAF V600","2026-08-13",{"date":346,"type":46},{"date":411,"type":46},"2022-11-30",{"date":413,"type":22},"2029-06-18",{"name":415,"class":153},"Pfizer",83,{"id":418,"slug":419,"hasResults":12,"nctId":420,"briefTitle":421,"officialTitle":422,"acronym":423,"eligibilityCriteria":424,"healthyVolunteers":12,"sex":17,"minAge":85,"maxAge":4,"enrollmentInfo":425,"targetDuration":4,"studyType":120,"phases":427,"briefSummary":429,"conditions":430,"keywords":431,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":435,"lastUpdatePostDateStruct":436,"startDateStruct":437,"completionDateStruct":439,"leadSponsor":441,"locationsCount":443},"100646205","timing-of-immunotherapy-in-melanoma-100646205","NCT07696715","Timing of Immunotherapy in Melanoma","Timing of Immunotherapy in Melanoma (TIME-NL): Dancing to the Beat of the Circadian Rhythm","TIME-NL","Inclusion Criteria:\n\n* Histologically or cytologically confirmed cutaneous melanoma, classified as irresectable (stage III) or metastatic (stage IV) disease.\n* At least 18 years of age.\n* World Health Organization (WHO) Performance Status 0-1.\n* Measurable disease according to RECIST 1.1.\n* Starting treatment with standard-of-care combination immunotherapy (ipilimumab+nivolumab) as first line treatment.\n* Signed informed consent form\n\nExclusion Criteria:\n\n* Uveal or mucosal melanoma (unknown primary melanoma is allowed).\n* Use of systemic immunosuppressive medications. Inhaled or topical steroids are permitted.\n* Use of adrenal replacement medications, e.g. hydrocortisone.\n* Use of melatonin agonists.\n* Prior systemic therapy for irresectable\u002Fmetastatic melanoma (prior T-VEC is allowed)\n* Prior systemic therapy for resectable melanoma in the last 6 months (neo-adjuvant and adjuvant treatment is allowed if at least 6 months ago).\n* Use of investigational drugs.",{"count":426,"type":22},170,[428],"NA","The TIME-NL trial is a multicenter, randomized, open-label clinical trial in the Netherlands to assess the effect of the timing of the first administration of standard-of-care intravenous combination immunotherapy (early morning versus afternoon) in patients with metastatic melanoma. Patients will be randomized 1:1 to start standard-of-care ICI administration either before 10am (early morning arm; arm A) or after 1pm (afternoon arm; arm B). Patients will be stratified according to performance status and study center. The randomized clinical trial will be part of a hybrid design in which data from the randomized clinical trial will be combined with observational data.",[26],[432,433,434],"melanoma","chronoimmunotherapy","timing","2026-08-12",{"date":408,"type":46},{"date":438,"type":46},"2026-08-10",{"date":440,"type":22},"2033-09-30",{"name":442,"class":77},"Radboud University Medical Center",5,{"id":445,"slug":446,"hasResults":12,"nctId":447,"briefTitle":448,"officialTitle":449,"acronym":4,"eligibilityCriteria":450,"healthyVolunteers":12,"sex":17,"minAge":85,"maxAge":162,"enrollmentInfo":451,"targetDuration":4,"studyType":120,"phases":452,"briefSummary":453,"conditions":454,"keywords":457,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":435,"lastUpdatePostDateStruct":460,"startDateStruct":461,"completionDateStruct":463,"leadSponsor":465,"locationsCount":54},"100272786","phase-1-administering-peripheral-blood-lymphocytes-transduced-with-a-cd70-binding-chimeric-antigen-receptor-to-people-with-cd70-expressing-cancers-100272786","NCT02830724","Administering Peripheral Blood Lymphocytes Transduced With a CD70-Binding Chimeric Antigen Receptor to People With CD70 Expressing Cancers","A Phase I\u002FII Study Administering Peripheral Blood Lymphocytes Transduced With a CD70-Binding Chimeric Antigen Receptor to Patients With CD70-Expressing Cancers","* INCLUSION CRITERIA:\n* For Phase I: Evaluable, unresectable cancer expressing CD70 as assessed by immunohistochemistry of resected tissue (greater than or equal to 2+ CD70 positive on greater than or equal to 50% of cancer cells, or greater than or equal to 1+ CD70 positive on greater than or equal to 75% of cancer cells).\n* For Phase II: Measurable (per RECIST v1.1 criteria), unresectable cancer expressing CD70 as assessed by immunohistochemistry of resected tissue (greater than or equal to 2+ CD70 positive on greater than or equal to 50% of cancer cells, or greater than or equal to 1+ CD70 positive on greater than or equal to 75% of cancer cells).\n* Confirmation of the diagnosis of cancer by the NCI Laboratory of Pathology.\n* Patients must have previously received at least one standard therapy for their cancer (if available) and have been either non-responders (progressive disease) or have recurred.\n* Patients with 3 or fewer brain metastases that are less than or equal to 1 cm in diameter and asymptomatic are eligible. Lesions that have been treated with stereotactic radiosurgery must be clinically stable for 1 month after treatment for the patient to be eligible. Patients with surgically resected brain metastases are eligible.\n* Age greater than or equal to 18 years and less than or equal to 72 years.\n* Clinical performance status of ECOG 0 or 1\n* Patients of both sexes must be willing to practice birth control from the time of enrollment on this study and for 12 months after the last dose of combined chemotherapy for women and for four months after treatment for men.\n* Women of child-bearing potential must be willing to undergo a pregnancy test prior to the start of treatment because of the potentially dangerous effects of the treatment on the fetus.\n\nNOTE: Certain malignancies may secrete hormones that produce false positive pregnancy tests. Serial blood testing (e.g. HCG measurements) and\u002F or ultrasound may be performed for clarification.\n\n-Serology\n\n--Seronegative for HIV antibody. (The experimental treatment being evaluated in this protocol depends on an intact immune system. Patients who are HIV seropositive may have decreased immune-competence and thus be less responsive to the experimental\n\ntreatment and more susceptible to its toxicities.)\n\n* Seronegative for hepatitis B antigen, and seronegative for hepatitis C antibody. If hepatitis C antibody test is positive, then patient must be tested for the presence of antigen by RT-PCR and be HCV RNA negative.\n\n  -Hematology\n* ANC greater than 1000\u002Fmm(3) without the support of filgrastim\n* WBC greater than or equal to 2500\u002Fmm(3)\n* Platelet count greater than or equal to 80,000\u002Fmm(3)\n* Hemoglobin \\> 8.0 g\u002FdL. Subjects may be transfused to reach this cut-off.\n\n  -Chemistry\n* Serum ALT\u002FAST less than or equal to 5.0 times ULN\n* Serum creatinine less than or equal to 1.6 mg\u002FdL\n* Total bilirubin less than or equal to 2.0 mg\u002FdL, except in patients with Gilbert s Syndrome who must have a total bilirubin less than 3.0 mg\u002FdL.\n\n  * Patients must have completed any prior systemic therapy at the time of enrollment.\n\nNote: Patients may have undergone minor surgical procedures or limited field radiotherapy within the four weeks prior to enrollment, as long as related major organ toxicities have recovered to grade 1 or less.\n\n* Ability of subject to understand and the willingness to sign a written informed consent document.\n* Willing to sign a durable power of attorney.\n* Subjects must be co-enrolled on the NCI-SB cell harvest protocol 03-C-0277 (Cell Harvest and Preparation for Surgery Branch Adoptive Cell Therapy Protocols).\n\nEXCLUSION CRITERIA:\n\n* Women of child-bearing potential who are pregnant or breastfeeding because of the potentially dangerous effects of the treatment on the fetus or infant.\n* Concurrent systemic steroid therapy.\n* Active systemic infections requiring anti-infective treatment, coagulation disorders, or any other active or uncompensated major medical illnesses.\n* Any form of primary immunodeficiency (such as Severe Combined Immunodeficiency Disease).\n* History of hematopoietic autoimmune disease or any autoimmune disease requiring immunosuppressive measures.\n* Concurrent opportunistic infections (The experimental treatment being evaluated in this protocol depends on an intact immune system. Patients who have decreased immune-competence may be less responsive to the experimental treatment and more susceptible to its toxicities).\n* History of severe immediate hypersensitivity reaction to cyclophosphamide, fludarabine, or aldesleukin.\n* History of coronary revascularization or ischemic symptoms.\n* For select patients with a clinical history prompting cardiac evaluation: last known LVEF less than or equal to 45%.\n* For select patients with a clinical history prompting pulmonary evaluation: known FEV1 less than or equal to 50% predicted.\n* Patients who are receiving any other investigational agents.",{"count":386,"type":22},[188,122],"Background:\n\nIn a new cancer therapy, researchers take a person s blood, select a certain white blood cell to grow in the lab, and then change the genes of these cells using a virus. The cells are then given back to the person. This is called gene transfer. For this study, researchers will modify the person s white blood cells with anti-CD70.\n\nObjectives:\n\nTo see if a gene transfer with anti-CD70 cells can safely shrink tumors and to be certain the treatment is safe.\n\nEligibility:\n\nAdults age 18 and older diagnosed with cancer that has the CD70-expressing cancer.\n\nDesign:\n\nParticipants will be screened with medical history, physical exam, scans, and other tests. They may by admitted to the hospital. Leukapheresis will be performed. For this, blood is removed through a needle in the arm. A machine separates the white blood cells. The rest of the blood is returned through a needle in the other arm.\n\nEligible participants will have an intravenous catheter placed in their upper chest. Over several days, they will get chemotherapy drugs and the anti-CD70 cells. They will recover in the hospital.\n\nParticipants will take an antibiotic for 6 months after treatment. They will repeat leukapheresis.\n\nParticipants will visit the clinic every 1-3 months for the first year after treatment, every 6 months for the second year, and then as determined by their physician. Follow-up visits will take 1-2 days. At each visit, participants will have lab tests, imaging studies, and a physical exam.\n\nThroughout the study, blood will be taken and participants will have many tests to determine the size and extent of their tumor and the treatment s impact.",[247,455,90,26,456],"Renal Cell Cancer","Ovarian Cancer",[458,455,171,459,170],"Metastatic Solid Cancers","CAR T-Cells",{"date":408,"type":46},{"date":462,"type":46},"2017-04-06",{"date":464,"type":22},"2030-01-01",{"name":52,"class":53},{"id":467,"slug":468,"hasResults":12,"nctId":469,"briefTitle":470,"officialTitle":471,"acronym":4,"eligibilityCriteria":472,"healthyVolunteers":12,"sex":17,"minAge":85,"maxAge":4,"enrollmentInfo":473,"targetDuration":4,"studyType":120,"phases":474,"briefSummary":475,"conditions":476,"keywords":477,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":483,"lastUpdatePostDateStruct":484,"startDateStruct":485,"completionDateStruct":487,"leadSponsor":489,"locationsCount":491},"100629565","phase-1-pharmacokinetics-safety-and-immunogenicity-comparison-of-bmab1700-and-opdivo-as-adjuvant-monotherapy-in-participants-with-melanoma-100629565","NCT07476326","Pharmacokinetics, Safety, and Immunogenicity Comparison of Bmab1700 and Opdivo® as Adjuvant Monotherapy in Participants With Melanoma","A Randomized, Double-Blind, Parallel, Multicenter, Two-Arm Study to Compare the Pharmacokinetics, Safety, and Immunogenicity Between Bmab1700 and Opdivo® After Complete Resection of Stage IIB\u002FC, Stage III, or Stage IV Melanoma","Inclusion Criteria:\n\n1. Participants greater than or equal to (\\>=)18 years of age on the day of signing informed consent (follow local regulatory requirements if the legal age of consent for study participation is \\>18 years old).\n2. Able to understand and willing to provide consent using the study Informed Consent Form (ICF). The voluntarily signed ICF must be obtained before any study-specific procedures are performed.\n3. Histologically or cytologically confirmed Stage IIB, Stage IIC, Stage III, or Stage IV melanoma (per American Joint Committee on Cancer, 8th edition) that was completely surgically resected. Complete surgical resection requires removal of all clinically or radiographically evident regional disease. Completion of lymph node dissection is not required unless clinically indicated. Participants must have been surgically rendered free of disease with negative margins on resected specimens documented by appropriate pathology and surgical reports.\n4. Complete surgical resection of melanoma must have been performed within 12 weeks before randomization.\n5. All participants must have disease-free status documented by a complete physical examination and imaging studies before randomization.\n6. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.\n7. Participants must have recovered from melanoma related surgery and its complications before randomization, as per investigator.\n\nExclusion Criteria:\n\n1. History of ocular\u002Fuveal melanoma.\n2. Participants with an active, known, or suspected autoimmune disease are to be excluded from participation. Participants who have received systemic treatment for an autoimmune disease within the past 2 years before randomization (eg, with disease-modifying agents, corticosteroids, or immunosuppressive drugs) are also excluded.\n3. History of active malignancy other than melanoma under study within 3 years before randomization, except for locally curable early-stage cancers (carcinoma in situ or Stage I) that have been curatively treated, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast.\n4. Participants with a condition requiring systemic treatment with either corticosteroids \\>10 mg daily prednisone or equivalent or other immunosuppressive medications within 14 days before randomization. Inhaled or topical steroids, and adrenal replacement steroid doses \\\u003C=10 mg daily prednisone or equivalent, are permitted in the absence of active autoimmune disease\n5. Female participants who are pregnant or breastfeeding at the screening visit, or who intend to become pregnant or breastfeed at any time during the study and for 150 days after the last dose of study intervention.\n6. Use of an investigational agent or an investigational device within 28 days or 5 half-lives (if half-life is known for the investigational agent), whichever is longer, before randomization or have not recovered from AEs associated with such therapies to Grade 1 or below (based on CTCAE Version 6.0).\n7. Any antineoplastic therapy after the complete resection of melanoma under study (eg, chemotherapy, radiation therapy, targeted agents, biotherapy, or limb perfusion).\n8. Participants who have received a live\u002Fattenuated vaccine within 28 days before randomization. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella\u002Fzoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin, and typhoid vaccine.\n9. Expected to receive any other form of antineoplastic therapy during the clinical study.\n10. Participants who received previous systemic therapy with any of the following: anti-programmed cell death-protein 1 (PD-1), anti programmed cell death-ligand 1 (PD-L1), anti-programmed cell death-ligand 2 (PD-L2), anti-CD137, anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) antibodies (including nivolumab or pembrolizumab or ipilimumab or other CTLA-4 targeting agents), chimeric antigen receptor T-cell therapy cells, or any agents targeting the IL-2 pathway or other T-cell co-stimulation\u002F checkpoint pathways.\n11. Treatment with complementary medications (eg, herbal supplements or traditional medicines) with an antineoplastic intent to treat the melanoma within 2 weeks before randomization. Such medications are permitted if they are used as supportive care.\n12. Participants will be excluded if clinical assessment or laboratory investigations before randomization demonstrate any of the following:\n\n    1. White blood cells: less than (\\\u003C) 2000 per microliter\n    2. Neutrophils: \\\u003C1500 per microliter\n    3. Platelets: \\\u003C100 \\*103 per microliter\n    4. Hemoglobin: \\\u003C9.0 gram per deciliter (g\u002FdL)\n    5. Participants with estimated creatinine clearance (CrCl) (measured or calculated) less than or equal to (\\\u003C=) 40 milliliter per minute (mL\u002Fmin).\n\n       • CrCl: using the Cockroft-Gault formula:\n       * Female CrCl = \\[(140 - age in years) \\* weight in kilogram (kg) \\* 0.85\\] divided by (72 \\* serum creatinine in milligram per deciliter \\[mg\u002FdL\\])\n       * Male CrCl = \\[(140 - age in years) \\* weight in kg \\* 1.00\\] divide by (72 \\* serum creatinine in mg\u002FdL)\n    6. Aspartate aminotransferase: greater than (\\>) 2.5 \\* upper limit of normal (ULN)\n    7. Alanine aminotransferase: \\>2.5 \\* ULN\n    8. Total bilirubin \\>1.5 \\* ULN (except participants with Gilbert Syndrome who must have a total bilirubin level of \\\u003C3.0 \\* ULN)\n13. Participants positive for human immune deficiency virus (HIV-1 and HIV-2) tests. Screening for HIV infection must adhere to local regulatory guidelines and confirm the absence of HIV-1 and HIV-2 infection.\n\n    Note: Participants with documented HIV infection may be enrolled where required by local regulatory or ethics committee guidance, provided all the following criteria are met:\n    * The participant is on stable antiretroviral therapy for at least 12 weeks prior to the first dose of study treatment, and no planned change in antiretroviral therapy regimen during the PK sampling period.\n    * Adequate immune function, defined as: CD4+ T cell count greater than or equal to (\\>=) 350 cells per millimeter cube (cells\u002Fmm\\^3) at screening\n    * No history of uncontrolled or recent Acquired Immunodeficiency Syndrome (AIDS) defining illness, that is \\[ie\\], no active AIDS defining condition within the past 12 months\n    * Undetectable viral RNA load\n14. Participants having positive test result for hepatitis B virus (HBV) or hepatitis C virus (HCV) indicating presence of virus, eg, hepatitis B surface antigen (Australia antigen) positive, or hepatitis C antibody (anti- HCV) positive (except if HCV RNA negative).\n15. Participants with history or current evidence of any clinically significant medical condition (including but not limited to physical examination, vital signs, electrocardiogram \\[ECG\\] findings, laboratory results), or ongoing therapy, that could confound study results, increase participation risk, or are deemed not in the participant's best interest by the treating investigator.\n16. Known history of allergy or hypersensitivity to IMP components.\n17. Known history of severe hypersensitivity reaction (Grade \\>=3) to any monoclonal antibody.\n18. Participants who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness.\n19. Has documented or known current alcohol\u002Fdrug abuse that precludes the participant's ability to adhere to the protocol.\n20. Prisoners or participants who are involuntarily incarcerated.",{"count":186,"type":22},[188],"The purpose of this study is to investigate the pharmacokinetics (PK) similarity of Bmab1700 (an intended nivolumab biosimilar), compared with United States (US)-licensed Opdivo, in participants after complete surgical removal of melanoma.",[26],[478,479,480,481,482],"Neoplasm","Programmed cell death-protein 1(PD-1)","Cytotoxic T-lymphocyte-associated protein 4 (CTLA-4)","Monoclonal antibody","Immunoglobulins","2026-08-11",{"date":408,"type":46},{"date":486,"type":22},"2026-08",{"date":488,"type":22},"2028-02-16",{"name":490,"class":153},"Biocon Biologics UK PLC",48,{"id":493,"slug":494,"hasResults":12,"nctId":495,"briefTitle":496,"officialTitle":497,"acronym":498,"eligibilityCriteria":499,"healthyVolunteers":12,"sex":17,"minAge":85,"maxAge":4,"enrollmentInfo":500,"targetDuration":4,"studyType":120,"phases":502,"briefSummary":503,"conditions":504,"keywords":505,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":438,"lastUpdatePostDateStruct":512,"startDateStruct":513,"completionDateStruct":514,"leadSponsor":516,"locationsCount":54},"100651435","exercise-and-nutritional-intervention-in-patients-with-melanoma-receiving-immunotherapy-100651435","NCT07761871","Exercise and Nutritional Intervention in Patients With Melanoma Receiving Immunotherapy","Effects of Randomized Controlled Exercise and Nutritional Interventions on Muscle Mass, Volume, Fat Infiltration, and Clinical Outcomes in Patients With Malignant Melanoma Receiving Immunotherapy","MEL-FIT-IO","Inclusion Criteria:\n\n* Age 18 years or older.\n* Confirmed diagnosis of malignant melanoma, stage II, III, or IV.\n* Planned first-line or adjuvant treatment with immune checkpoint inhibitors.\n* Life expectancy greater than 6 months.\n* Sufficient knowledge of the Slovenian language.\n* Ability to provide written informed consent and comply with the study protocol.\n\nExclusion Criteria:\n\n* Previous treatment with immune checkpoint inhibitors or disease recurrence after previous treatment with immune checkpoint inhibitors.\n* Symptomatic brain metastases.\n* Contraindications to magnetic resonance imaging, such as MRI-incompatible metallic implants.\n* Neurological diseases affecting the skeletal muscular system, such as muscular dystrophy.\n* Any condition that, in the investigator's judgment, prevents participation or the safe performance of study assessments.\n* Participation in another study that includes structured physical exercise as part of its protocol.",{"count":501,"type":22},40,[428],"The purpose of this randomized study is to evaluate whether a six-month program of structured resistance exercise combined with individualized nutritional support can preserve or improve skeletal muscle mass and muscle quality in adults with stage II to IV malignant melanoma who are starting treatment with immune checkpoint inhibitors.\n\nParticipants will be randomly assigned either to the exercise and nutritional intervention in addition to standard oncology care or to standard oncology care alone. The study aims to obtain complete measurements from at least 40 participants.\n\nAssessments will be performed at baseline, after 3 months, and after 6 months. They will include magnetic resonance imaging of the thigh, dual-energy X-ray absorptiometry, bioelectrical impedance analysis, indirect calorimetry, clinical data, and patient-reported outcomes. The study will compare changes in skeletal muscle mass and volume, fatty infiltration of skeletal muscle, sarcopenia, body composition, resting energy expenditure, quality of life, fatigue, treatment tolerance, treatment delays, and early treatment discontinuation between the two groups.\n\nTreatment with immune checkpoint inhibitors is provided as part of routine clinical care and is not the investigational intervention.",[26],[506,507,508,509,510,511],"Immune Checkpoint Inhibitors","Resistance Exercise","Nutritional Intervention","Skeletal Muscle Mass","Muscle Quality","Sarcopenia",{"date":435,"type":46},{"date":486,"type":22},{"date":515,"type":22},"2029-06",{"name":517,"class":77},"Institute of Oncology Ljubljana",{"id":519,"slug":520,"hasResults":12,"nctId":521,"briefTitle":522,"officialTitle":523,"acronym":4,"eligibilityCriteria":524,"healthyVolunteers":12,"sex":17,"minAge":85,"maxAge":4,"enrollmentInfo":525,"targetDuration":4,"studyType":120,"phases":527,"briefSummary":528,"conditions":529,"keywords":4,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":438,"lastUpdatePostDateStruct":540,"startDateStruct":541,"completionDateStruct":543,"leadSponsor":545,"locationsCount":547},"100534718","phase-1-a-study-of-mgc026-in-participants-with-advanced-solid-tumors-100534718","NCT06242470","A Study of MGC026 in Participants With Advanced Solid Tumors","A Phase 1\u002F1b First-in-Human, Open Label, Dose Escalation and Cohort Expansion Study of MGC026 in Participants With Advanced Solid Tumors","Inclusion Criteria:\n\n* Adults ≥ 18 years old, able to provide informed consent\n* Adequate performance and laboratory parameters\n* Availability of archival or formalin-fixed paraffin-embedded tumor tissue sample. Participants may undergo a fresh tumor biopsy to obtain a specimen for testing if an archival tumor sample is not available. Participants with no available archival tissue sample who cannot safely undergo a fresh biopsy as determined by consultation between the sponsor and investigator are eligible\n* Unresectable, locally advanced or metastatic solid tumors including: squamous cell cancer (SCC) of the head and neck, esophageal SCC, squamous and non-squamous non-small cell lung cancer, small cell lung cancer, bladder cancer, sarcoma, endometrial cancer, melanoma, castration resistant prostate cancer, breast cancer, ovarian cancer, cervical cancer, colorectal cancer gastric or gastroesophageal cancer, pancreatic carcinoma, clear cell renal cell cancer or hepatocellular cancer.\n* Measurable disease per RECIST v1.1. Participants with metastatic CRPC without measurable disease are eligible.\n* Must be willing to use highly effective methods of birth control from the time of consent through 7 months after discontinuation of MGC026.\n* Not pregnant or breastfeeding.\n\nExclusion Criteria:\n\n* Any underlying medical or psychiatric condition impairing participant's ability to receive, tolerate, or comply with the planned treatment or study procedures.\n* Another cancer that required treatment within the past 2 years, with the exception of those with low risk of cancer spreading or death such as adequately treated non melanomatous skin cancer, localized prostate cancer (Gleason Score \\\u003C 6), or carcinoma in situ.\n* Patients with history of prior central nervous system (CNS) metastasis must have been treated, be asymptomatic, and not have concurrent treatment for CNS disease, progression of CNS metastases on magnetic resonance imaging, computed tomography or positron emission tomography, or history of leptomeningeal disease or cord compression at the time of enrollment.\n* Treatment with surgery, systemic cancer therapy, immunotherapy, chimeric antigen receptor-T therapy, or anti-hormonal within protocol specified intervals.\n* Prior treatment with any B7-H3 targeted agent for cancer or any ADC with a topoisomerase payload.\n* Prior autologous or allogeneic stem cell or solid organ transplant.\n* Clinically significant cardiovascular, pulmonary, or gastrointestinal disorders.\n* Active viral, bacterial, or systemic fungal infection requiring parenteral treatment within 1 week of first study drug administration.\n* Known history of hepatitis B or C infection or known positive test for hepatitis B surface antigen or core antigen, or hepatitis C polymerase chain reaction.\n* Known positive testing for human immunodeficiency virus or history of acquired immune deficiency syndrome.\n* History of primary immunodeficiency.\n* Major trauma or major surgery within 4 weeks of first study drug administration.\n* Known hypersensitivity to recombinant proteins.",{"count":526,"type":22},250,[188],"The study is designed to understand the safety, tolerability, pharmacokinetics, immunogenicity, and preliminary antitumor activity of MGC026 in participants with relapsed or refractory, unresectable, locally advanced or metastatic solid tumors The study has a dose escalation portion and a cohort expansion portion of the study.\n\nParticipants will receive MGC026 by intravenous (IV) infusion. The dose of MGC026 will be assigned at the time of enrollment. Participants may receive up to 35 treatments if there are no severe side effects and as long as the cancer does not get worse. Participants will be monitored for side effects, and progression of cancer, have blood samples collected for routing laboratory work, and blood samples collected for research purposes.",[125,530,531,328,269,532,130,68,129,26,533,128,304,126,534,535,536,537,538,90,456,539],"Advanced Cancer","Metastatic Cancer","Small-cell Lung Cancer","Castration Resistant Prostatic Cancer","Gastro-esophageal Cancer","Pancreas Cancer","Clear Cell Renal Cell Carcinoma","Hepatocellular Carcinoma","Platinum-resistant Ovarian Cancer","Esophageal Squamous Cell Cancer (SCC)",{"date":483,"type":46},{"date":542,"type":46},"2024-03-06",{"date":544,"type":22},"2028-10",{"name":546,"class":153},"MacroGenics",12,{"id":549,"slug":550,"hasResults":12,"nctId":551,"briefTitle":552,"officialTitle":553,"acronym":4,"eligibilityCriteria":554,"healthyVolunteers":12,"sex":17,"minAge":85,"maxAge":4,"enrollmentInfo":555,"targetDuration":4,"studyType":120,"phases":557,"briefSummary":558,"conditions":559,"keywords":572,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":438,"lastUpdatePostDateStruct":576,"startDateStruct":577,"completionDateStruct":579,"leadSponsor":581,"locationsCount":582},"100505262","phase-1-a-study-of-mq710-with-and-without-pembrolizumab-in-people-with-solid-tumor-cancer-100505262","NCT05859074","A Study of MQ710 With and Without Pembrolizumab in People With Solid Tumor Cancer","A First-In-Human Phase I, Open Label, Safety and Tolerability Study of Escalating Multiple Doses of Intratumoral MQ710, a Multi-Transgene Expressing Modified Vaccinia Virus Ankara-Based Virotherapy, Alone and in Combination With the Systemic Checkpoint Inhibitor Pembrolizumab in Solid Tumors","Inclusion Criteria:\n\n* Age 18 or over\n* Histologically or cytologically documented advanced or metastatic cancer that has relapsed from or is refractory to standard treatment in two lines of prior therapy in the advanced setting unless there are fewer than two FDA approved lines of therapy for the particular disease, or for which no standard treatment is available\n* At least 2 tumors suitable for direct or ultrasound-guided injection defined as at least one cutaneous, subcutaneous, or nodal lesion or aggregate of lesions, ≥0.5 cm for any single lesion and cumulative lesion dimensions. One lesion must meet criteria for RECIST measurable disease if in Part 2. Note: One lesion will be biopsied (if possible)\n* Mandatory initial screening biopsy\n\n  a. For patients undergoing surgical excision\u002Fresection: i. Tumor deemed accessible and safe for biopsy by the Investigator ii. Willing to consent to biopsy and surgical procedure iii. Patient able to undergo surgical procedure and appropriate anesthesia b. For patients not undergoing surgical excision\u002Fresection to obtain mandatory screening biopsy: i. Tumor deemed accessible and safe for biopsy by the Investigator ii. Willing to consent to initial tumor biopsy\n* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1\n* Patients with no curative treatment options available including surgery and\u002For definitive radiation or patients in which these modalities are associated with significant morbidity\n* Patients with advanced disease who have received and progressed on standard therapy or have disease for which there is no standard therapy or have contraindications to standard therapy\n\nPart 1a: Patients with cutaneous squamous cell carcinoma (cSCC), basal cell carcinoma (BCC), melanoma, Merkel cell carcinoma, sebaceous carcinoma, extramammary Paget's disease, Kaposi sarcoma, HNSCC, adnexal carcinoma, and angiosarcoma, as well as patients with cutaneous neoplasms that are separate primaries with morbidity from multiple surgeries that have failed standard therapy. Any malignancy with superficial cutaneous or subcutaneous lesions or palpable lymph nodes may be eligible based on the discretion of the investigator.\n\n* Part 2a: Patients with cutaneous squamous cell carcinoma (cSCC), basal cell carcinoma (BCC), melanoma, Merkel cell carcinoma, sebaceous carcinoma, extramammary Paget's disease, Kaposi sarcoma, HNSCC, adnexal carcinoma, and angiosarcoma, as well as patients with cutaneous neoplasms that are separate primaries with morbidity from multiple surgeries that have failed standard therapy. BCC will also be included, given that pembrolizumab has not been approved for this condition, although cemiplimab is approved.\n* Parts 1b and 2b: Patients must have cSCC, Merkel cell carcinoma, melanoma, or head and neck squamous cell carcinoma. These patients should be refractory to anti-PD-1 therapy, with the exception of patients with HNSCC with PD-L1 expression \\\u003C1.\n* Parts 1a, 2a and 2b: Patients with BRAF-mutated melanoma should have received BRAF-targeted therapy.\n* Predicted life expectancy of 3 months or more (in both Part 1 and Part 2)\n* Participant or their legally authorized representative (LAR able to provide written informed consent to participate\n* Ability to comply with study procedures in the Investigator's opinion\n* Adequate renal function as defined by Cr \\\u003C2 mg\u002FdL\n* Adequate hepatic function\n\n  1. Serum bilirubin ≤1.5 x ULN\n  2. AST and ALT ≤2.5 ULN (no liver mets)\n  3. AST and ALT ≤5.0 ULN (for patients with liver mets)\n* Adequate bone marrow and hematologic function\n\n  1. Coagulation function adequate (PT and aPTT within x1.5 ULN)\n  2. Platelets ≥ 75,000\u002Fmm\\^2\n  3. ANC ≥ 1000\u002FuL\n* Females of child-bearing potential must have a negative pregnancy test within 14 days prior to enrollment and on day of treatment. All patients must agree to use adequate contraception prior to study entry, for the duration of study participation, and up to 90 days after the last dose of MQ710\n* Part 2 only: at least one measurable site of disease according to RECIST criteria\n* Prior non-immunotherapy, anti-tumor treatment including endocrine, chemical\u002Fradiotherapy, targeted therapy, or major surgery (but not anti-PD1\u002F- L1 therapies) was discontinued for more than 4 weeks prior to enrollment\n* Patients who have failed prior anti-PD1\u002F-PDL1 may be included. Washout of anti-PD1\u002F-PDL1 at least 3 weeks prior to initiation of therapy in Part 1a and 2a. No washout period is required for Part 1b and 2b.\n\nExclusion Criteria:\n\n* Splenectomy\n* Active infections requiring antibiotics, physician monitoring or recurrent fevers (\\>38.0 ℃) associated with a clinical diagnosis of active infection\n* Acute or chronic active viral disease or positive test for hepatitis B virus, hepatitis C virus, human immunodeficiency virus (HIV) with CD4 count \\\u003C100mg\u002Fm3, or received treatment with antivirals or nucleoside analogs such as those used in the treatment of hepatitis B (e.g. lamivudine, adefovir, tenofovir, telbivudine, entecavir), ribavirin, cidofovir, diaminopurine analogs, methyladenosine analogs, or interferon alpha within 4 weeks of initiation of study treatment .a. Patients with HIV are allowed on study if CD4 count is \\>100 cells\u002Fmm3.\n* Incomplete recovery from surgery, incomplete healing of an incision site\n* Any of the following in the 3 months before the first dose of study treatment: Grade 3 or 4 gastrointestinal bleeding\u002Fhaemorrhage (unless due to resected tumour), treatment-resistant peptic ulcer disease, erosive oesophagitis or gastritis, infectious or inflammatory bowel disease, diverticulitis, pulmonary embolism or other uncontrolled thrombo-embolic event, history or evidence of haemoptysis or menorrhagia\n* History of myocardial infarction, myocarditis, congestive heart failure (as defined by New York Heart Association Functional Classsification III or IV), unstable angina, serious uncontrolled cardiac arrhythmia,or significant cardiovascular or cerebrovascular event in the 6 months before the first dose of study treatment\n* Uncontrolled infection within 6 months prior to study entry.\n* History of significant bleeding requiring hospitalization in the 12 months before the first dose of study treatment\n* Treatment with PD-1\u002Fprogrammed death ligand (PD-L1), cytotoxic T-lymphocyte associated protein 4 (CTLA-4), or any other (including experimental) immune checkpoint inhibitor or immune-stimulatory treatment in the 3 weeks before the first dose of study treatment\n* Prior chemotherapy, radiotherapy, biological cancer therapy (not including anti-PD1\u002F-L1 immunotherapies), targeted therapy, investigational drug, or major surgery 28 days prior to enrollment or has not recovered to Common Terminology Criteria for Adverse Events (CTCAE) grade 1 or better from adverse event due to cancer therapy administered more than 28 days prior to enrollment with the exception of grade 2 or better for alopecia and neuropathy.\n* Has known active CNS metastases and\u002For carcinomatous meningitis\n* Received live vaccine within 28 days prior to enrollment\n* Patient is pregnant or breast-feeding, or expecting to conceive or father children within the duration of the trial\n* Patients with tumor that directly contacts, encases or penetrates a major blood vessel, pericardium, gastrointestinal tract, or other hollow organs that may lead to perforation due to tumor necrosis\n* Patients at risk of airway compromise in the event of post-injection tumor swelling\u002Finflammation based on investigator judgement\n* History or evidence of autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs)\n* History of chronic liver disease or evidence of hepatic cirrhosis\n* History of idiopathic pulmonary fibrosis, pneumonitis (including drug induced), organizing pneumonia, active interstitial lung disease (ILD) requiring treatment with systemic steroids\n* Baseline pulse oximetry less than 92% on room air\n* History of re-irradiation to a field which includes the carotid arteries\n* History of leukemia: ALL and CLL (patients with a history of aggressive lymphomas in remission or patients with a history of allogeneic stem cell transplants are eligible if no longer on immunosuppressive therapy and without evidence of GvHD)\n* Current use of steroids such as prednisone 10 mg\u002Fdaily or greater (or its equivalent) or immunosupressants within 2 weeks of initiation of study treatment\n* Any serious or uncontrolled medical disorder that, in the opinion of the Investigator or the Medical Monitor, may increase the risk associated with study participation or study treatment administration, impair the ability of the patient to receive protocol therapy or interfere with the interpretation of study results\n* Any other medical or psychological condition that would preclude participation in the study or compromise ability to give informed consent\n* Known allergy to MQ710 transgene products or formulation.\n* Patient requires anticoagulation therapy, such as warfarin.",{"count":556,"type":22},56,[188],"Participants of this study will have a diagnosis of a solid tumor cancer that has come back to its original location or spread beyond its original location (advanced), came back (relapsed) or worsened (refractory) after standard treatments, or no standard treatments are available for the participants' cancer. The purpose of this study if to find the highest dose of MQ710 that causes few or mild side effects in participants with a solid tumor cancer diagnosis.",[560,561,562,563,564,26,193,565,566,567,195,339,568,569,570,530,531,571,270],"Cutaneous Squamous Cell Carcinoma","SCC - Squamous Cell Carcinoma","Basal Cell Carcinoma","BCC","BCC - Basal Cell Carcinoma","Sebaceous Carcinoma","Extramammary Paget Disease","Kaposi Sarcoma","Adnexal Carcinoma","Angiosarcoma","Cutaneous Neoplasm","Refractory Cancer",[560,561,562,563,26,193,565,566,567,195,339,568,569,570,530,531,571,573,574,575,270],"MQ710","Memorial Sloan Kettering Cancer Center","22-278",{"date":435,"type":46},{"date":578,"type":46},"2023-05-04",{"date":580,"type":22},"2028-05-04",{"name":574,"class":77},7,{"id":584,"slug":585,"hasResults":12,"nctId":586,"briefTitle":587,"officialTitle":587,"acronym":4,"eligibilityCriteria":588,"healthyVolunteers":12,"sex":17,"minAge":85,"maxAge":19,"enrollmentInfo":589,"targetDuration":4,"studyType":120,"phases":591,"briefSummary":592,"conditions":593,"keywords":595,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":600,"lastUpdatePostDateStruct":601,"startDateStruct":602,"completionDateStruct":604,"leadSponsor":606,"locationsCount":54},"100459619","novel-rna-lipid-particle-rna-lp-vaccine-for-anti-pd-1-antibody-therapy-sensitization-100459619","NCT05264974","Novel RNA-lipid Particle (RNA-LP) Vaccine for Anti-PD-1 Antibody Therapy Sensitization","Inclusion Criteria:\n\n* Adults ≥ 18 years old\n* ECOG performance ≤ 2\n* Lab values within the specified ranges:\n\n  * Hemoglobin ≥ 8G\u002FDL\n  * Platelets ≥ 100 thou\u002Fcumm\n  * Absolute Neutrophil Count (ANC) ≥ 1000 thou\u002Fcumm\n  * Serum total bilirubin ≤ 1.5 x upper limit of normal (ULN)\n  * AST and ALT ≤ 2.5 x ULN; If confirmed liver metastases: AST and ALT ≤ 5 x ULN\n  * Creatinine clearance (CrCl) ≥ 15 ml\u002Fmin (based on modified Cockcroft and Gault formula)\n* Must have measurable disease that is amenable to surgical sampling for RNA extraction, amplification, and loading of lipid particles\n* Subjects must not have more than one active malignancy at the time of enrollment (subjects with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen \\[as determined by the treating physician and approved by the PI\\] may be included)\n* Written informed consent obtained from the subject.\n* Participants of childbearing potential must have a negative serum pregnancy test at screening\n* Participants of childbearing potential must be using an adequate method of contraception to avoid pregnancy throughout the study and for at least four months after the last dose of study treatment to minimize the risk of pregnancy. Prior to study enrollment, participants of childbearing potential must be advised of the importance of avoiding pregnancy during trial participation and the potential risk factors for an unintentional pregnancy.\n* Subjects with partners of child-bearing potential must agree to use physician-approved contraceptive methods (e.g., abstinence, condoms, vasectomy) throughout the study and should avoid conceiving children for four months following the last dose of study treatment and must agree to not donate sperm during the study treatment period or for four months following the last dose of study treatment.\n\nAdditional eligibility criteria for subjects with melanoma:\n\n* Patients with stage II, stage III, or resected stage IV melanoma who received anti-PD-1-based therapy in the adjuvant or neoadjuvant setting (either monotherapy or combination therapy) and experienced progressive disease (PD) per RECIST 1.1 during treatment or within 6 months of completing the planned course of therapy. This includes patients who:\n\n  * Were planned to receive approximately 1 year of anti-PD-1-based therapy in the adjuvant setting but discontinued early due to toxicity and relapsed within 6 months of discontinuation;\n  * Received neoadjuvant anti-PD-1-based therapy (with or without subsequent surgery), including patients planned to complete approximately 1 year of total perioperative anti-PD-1-based therapy (neoadjuvant ± adjuvant), and experienced PD during therapy or within 6 months of completion or discontinuation;\n  * Received short-course neoadjuvant anti-PD-1-based therapy (including combination regimens), underwent surgery, were subsequently managed with surveillance (including those achieving pathologic complete response), and experienced relapse within 6 months of completion of neoadjuvant therapy.\n* Patients with unresectable or widespread metastatic (stage IV) melanoma who experienced PD per treating physician while receiving anti-PD-1-based therapy (either monotherapy or combination therapy) in any line of treatment.\n* Patients with unresectable or widespread metastatic (stage IV) melanoma who:\n\n  * Completed a planned course of anti-PD-1-based therapy (monotherapy or combination), including planned treatment durations of approximately 1 year or 2 years, and experienced PD within 6 months of completion; or\n  * Were planned to receive anti-PD-1-based therapy (for either 1 year or 2 years) but discontinued early due to toxicity and experienced PD within 6 months of discontinuation.\n* Both cutaneous and non-cutaneous melanoma subtypes (including uveal, mucosal, and acral lentiginous) are eligible.\n* Patients must:\n\n  * Have no contraindication to continued immune checkpoint therapy;\n  * Not have rapidly progressive disease requiring urgent alternative therapy; and\n  * Have no other viable approved salvage treatment options available, or decline currently approved salvage therapies.\n\nAdditional eligibility criteria for subjects with soft tissue sarcoma:\n\n* Evidence of spindle cell, pleomorphic, round cell, or epithelioid morphology on pathology suggestive of sarcoma as determined by a sarcoma pathologist\n* Evidence of progression or resistance to therapy as defined by the treating physician.\n* Must have measurable disease per RECIST 1.1\n* Original tumor site from soft tissue location i.e. lipomatous tissue, musculature, skin\n* Evidence of unresectable stage II disease; stage III or stage IV disease\n* Subjects with prior exposure to an immune checkpoint inhibitor (ICI) are eligible for enrollment; however, prior ICI therapy is not required unless receipt of an ICI constitutes part of the FDA-approved standard of care for their disease.\n\nExclusion Criteria:\n\n* Subjects that have an active second malignancy, however, previously treated early stage malignancies with no evidence of disease recurrence after 3 years of follow-up will be allowed\n* Subjects with a history of immune-mediated treatment-related adverse reactions leading to discontinuation of prior aPD1 therapy or severe hypersensitivity reaction to any monoclonal antibody or any other baseline risk in the opinion of the investigator that precludes continued use of aPD1 therapy\n* Patients with known active and symptomatic brain metastases or leptomeningeal metastases at time of inclusion. Patients with isolated brain lesions that have been treated with stereotactic radiosurgery or surgical resection as part of oligometastatic initial management prior to start of immunotherapy may be eligible as long as they have no new disease and are asymptomatic at time of inclusion.\n* If patients develop new brain metastases during the time between tumor sampling and vaccine generation and administration, patients may remain on study as long as they can receive definitive stereotactic radiosurgery or surgery to brain metastases and be able to resume systemic therapy within 6 weeks of discovery of new brain metastases.\n* Subjects who received an investigational drug in another clinical trial must wait 28 days or at least 5 half-lives of the study drug, whichever is shorter, prior to enrollment in this study\n* Patients must not have required systemic corticosteroids (anything greater than 10mg of prednisone of equivalent, daily) or other immunosuppressive medications within 14 days of the start of trial treatment.\n* Subjects with known active infection or immunosuppressive disease within seven days prior to tissue collection for vaccine creation or within seven days prior to vaccine administration (subjects on prophylactic agents are acceptable)\n* Subjects with any known life-threatening illness, medical condition, or organ system dysfunction (aside from their cancer), which in the investigator's opinion, could compromise subject safety\n* Subjects with known active hepatitis B virus or untreated hepatitis C virus, and, patients with previous history of hepatitis C who completed treatment for HCV are not excluded as long as they have no detectable viral load.\n* Subjects with known human immunodeficiency virus with CD4+T cells ≤ 350 cells\u002Ful, a positive viral load as determined by institutional standard testing, or a known history of AIDS defining opportunistic infection within the last 12 months per subject medical records.\n* Known clinically relevant active autoimmune disease that would pose significant risk to the patient's life should a flare ensue. Patients with chronic autoimmune rheumatologic endocrine, or psoriatic skin diseases may still be eligible pending they are not receiving systemic immunosuppression at the time of treatment as previously described and that patients are aware of the increased risk of flare provocation with treatment.\n* Symptomatic congestive heart failure (NYHA Class 3 or 4)\n* Subjects with unstable angina pectoris\n* Known unstable cardiac arrythmias, abnormalities or transmural myocardial infarction within the last 6 months of treatment\n* Subjects who are post-splenectomy or otherwise asplenic\n* Personal history of anaphylactic reaction to previous vaccination\n* Known hypersensitivity to the active substance or to any of the excipients\n* Participants of childbearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for at least 4 months after the last dose of study treatment\n* Participants who are confirmed to be pregnant or breastfeeding\n* Known history of any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of protocol therapy or that might affect the interpretation of the results of the study or that puts the subject at high risk for treatment complications, in the opinion of the treating physician\n* Administration of a vaccine containing live virus within 30 days prior to the first dose of trial treatment. Note: Most flu vaccines are killed viruses, with the exception of the intra-nasal vainer (Flu-Mist) which is an attenuated live virus and therefore prohibited for 30 days prior to first dose. Non-live versions of the COVID vaccine are allowed.\n* Prisoners or subjects who are involuntarily incarcerated, or subjects who are compulsorily detained for treatment of either a psychiatric or physical illness.\n* Subjects with sarcoma originating from bone or cartilage\n* Sarcomatous malignancies lacking metastatic potential i.e. well-differentiated liposarcoma, dermatofibrosarcoma protuberans, desmoid fibromatosis, etc.",{"count":590,"type":22},18,[188],"The goal of this phase I trial is to evaluate the toxicity and feasibility of a tumor-specific RNA-NP vaccine in patients with stage IIB-IV melanoma who have evidence of progressive disease by RECIST 1.1 criteria while receiving adjuvant aPD1 therapy, or those who progress within 6 months of completion of adjuvant treatment, or unresectable stage II soft tissue sarcoma or stage III-IV soft tissue sarcoma.",[26,594],"Soft Tissue Sarcoma",[432,596,597,598,599],"immunotherapy","vaccines","RNA-NP","soft tissue sarcoma","2026-08-07",{"date":438,"type":46},{"date":603,"type":46},"2026-03-17",{"date":605,"type":22},"2026-12",{"name":607,"class":77},"University of Florida",{"id":609,"slug":610,"hasResults":12,"nctId":611,"briefTitle":612,"officialTitle":613,"acronym":614,"eligibilityCriteria":615,"healthyVolunteers":12,"sex":17,"minAge":85,"maxAge":4,"enrollmentInfo":616,"targetDuration":4,"studyType":120,"phases":618,"briefSummary":619,"conditions":620,"keywords":4,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":600,"lastUpdatePostDateStruct":621,"startDateStruct":622,"completionDateStruct":624,"leadSponsor":626,"locationsCount":627},"100408110","nodal-radiation-therapy-for-sentinel-lymph-node-positive-melanoma-100408110","NCT04594187","Nodal Radiation Therapy for Sentinel Lymph Node Positive Melanoma","The Role of Nodal Radiation Therapy in Sentinel Lymph Node Positive Melanoma","MelPORT","Inclusion Criteria:\n\n* Must be planned for post-operative immunotherapy\n* No evidence of distant metastasis as determined by clinical examination and any form of imaging\n* No evidence of clinically involved lymph nodes prior to SLNB\n* Pathologically confirmed sentinel lymph node positive melanoma with high risk features (extracapsular extension \\[ECE\\] or 0.5 mm+ nodal tumor implant or 2+ involved nodes or lymphovascular invasion of the primary tumor)\n* Has provided written informed consent for participation in this trial\n* Eastern Cooperative Oncology Group (ECOG) performance status of 3 or less\n* Life expectancy greater than 6 months\n* Patients capable of childbearing are using adequate contraception\n* Available for follow-up\n\nExclusion Criteria:\n\n* Complete lymph node dissection (CLND) of the nodal basin containing the positive SLN\n* Distant metastasis\n* Previous radiation therapy (RT) to the nodal area planned for RT such that the prior RT field would be included in the current treatment field. In other words, treatment on this trial would require re-irradiation of tissues\n* Women who are pregnant\n* Adults unable to consent, individuals who are not yet adults, pregnant women and prisoners will be excluded from this study",{"count":617,"type":22},168,[122],"This phase II trial seeks to determine the role of nodal radiation therapy after sentinel lymph node biopsy (SLNB) for patients with high risk sentinel lymph node positive melanoma who are planned for immunotherapy without completion lymph node dissection. Prior studies of patients with more advanced melanoma have shown nodal radiation therapy can decrease the risk of nodal recurrence but it is not known if this same benefit will be seen in patients with high risk sentinel lymph node positive disease who are planned for immunotherapy.",[26],{"date":438,"type":46},{"date":623,"type":46},"2020-08-07",{"date":625,"type":22},"2027-12-31",{"name":76,"class":77},3,{"id":629,"slug":630,"hasResults":12,"nctId":631,"briefTitle":632,"officialTitle":633,"acronym":4,"eligibilityCriteria":634,"healthyVolunteers":12,"sex":17,"minAge":635,"maxAge":4,"enrollmentInfo":636,"targetDuration":4,"studyType":120,"phases":637,"briefSummary":638,"conditions":639,"keywords":640,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":644,"lastUpdatePostDateStruct":645,"startDateStruct":646,"completionDateStruct":648,"leadSponsor":650,"locationsCount":54},"100647266","aggressive-lipid-lowering-therapy-in-ici-treated-melanoma-100647266","NCT07704918","Aggressive Lipid Lowering Therapy in ICI-Treated Melanoma","Lipid Lowering Therapy for Atherosclerotic Disease in Melanoma Patients Receiving Immune Checkpoint Inhibitors","Inclusion Criteria:\n\n* Provision to sign and date the consent form.\n* Stated willingness to comply with all study procedures and be available for the duration of the study.\n* Be a male aged ≥55 years or a female aged ≥65 years.\n* For those able to bear children, documentation of menopausal status via approximate last menstrual period or hysterectomy due to contraindication of pregnancy for the CCTA procedure.\n* Have a melanoma diagnosis without prior ICI use and planning to start on ICI therapy (PD-1, PD-L1, CTLA-4, LAG3) as standard of care for their cancer.\n* Plaque stage ≥ 1 on screening CCTA.\n\nExclusion Criteria:\n\n* Any prior major cardiovascular event, defined as myocardial infarction, stroke, coronary revascularization, or other major cardiovascular event determined to be significant by the principal investigator.\n* Meeting any of the standard CCTA contraindications listed below:\n* Allergy to iodinated contrast or history of contrast-induced nephropathy\n* Renal insufficiency (eGFR \\\u003C 45 mL\u002Fmin\u002F1.73 m2 by the Chronic Kidney Disease Epidemiology Collaboration (CKD EPI) or Modification of Diet in Renal Disease (MDRD) equation). A current eGFR value (collected\u002Fcalculated within 3 months from screening visit) is required at baseline.\n* Active arrhythmia (atrial fibrillation, atrial flutter, frequent premature atrial, or ventricular contractions) with poorly controlled rate (i.e., \\> 80 beats per minute). EKG must be performed within 1 year of screening visit.\n* Hemodynamic instability\n* Weight \\> 400 lbs. (181 kg) or above manufacturer-recommended limit for scanner and table, whichever is lower\n* Thyroid cancer in the previous five (5) years or planned radioactive iodine treatment\n* Pregnancy\n* Inability to hold breath for \\> 10 seconds\n* Contraindication to dosing with beta blocker as needed or nitroglycerin prior to CCTA procedure\n* Inability to cooperate with scan acquisition and\u002For breath-hold instructions\n* Any other factor that, in the opinion of the investigator, would increase participant risk or increase the chance of an uninterpretable CCTA\n* If a patient's fast LDL-C is \\> 190 mg\u002FdL, this is consistent with underlying familial hypercholesterolemia, and they will not be eligible for the study.\n* If a patient's CCTA demonstrates previously undiagnosed obstructive coronary disease, they will not be eligible for the study. Obstructive disease will be defined as \\>50% obstruction in the left main coronary artery, or \\>70% obstruction elsewhere in the coronary tree.","55 Years",{"count":501,"type":22},[428],"Immune checkpoint inhibitors (ICIs) are a class of medications that are now standard in the treatment of melanoma. These are standard therapy for melanoma, but long-term side effects on disease in the heart arteries is poorly understood. In this study, melanoma patients receiving ICIs for the first time will undergo a coronary computed tomography angiography (CCTA) scan. CCTA results will be analyzed by the FDA-approved Cleerly TM image analysis pipeline. Patients with disease in their heart arteries will be randomized to usual care or aggressive lipid lowering therapy. Those in the aggressive lipid lowering therapy arm will be seen by a cardiologist and placed on standard lipid lowering medications with a goal of achieving an LDL-C ≤ 55mg\u002FdL. Follow-up CCTA scans will occur at 12-month and 24-month timepoints. The primary outcome of interest will be differences in LDL-C levels between the two arms at the 12-month timepoint. The secondary outcome of interest will be the differences in total plaque volume between the two arms at the 12-month timepoint.",[26],[641,642,643],"atherosclerosis","coronary artery disease","coronary atherosclerosis","2026-08-06",{"date":600,"type":46},{"date":647,"type":22},"2026-12-31",{"date":649,"type":22},"2028-12",{"name":651,"class":77},"University of Colorado, Denver",{"id":653,"slug":654,"hasResults":12,"nctId":655,"briefTitle":656,"officialTitle":657,"acronym":4,"eligibilityCriteria":658,"healthyVolunteers":12,"sex":17,"minAge":85,"maxAge":4,"enrollmentInfo":659,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":660,"conditions":661,"keywords":4,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":663,"lastUpdatePostDateStruct":664,"startDateStruct":665,"completionDateStruct":667,"leadSponsor":669,"locationsCount":54},"100568010","digital-remote-monitoring-of-immune-checkpoint-inhibitor-therapy-induced-toxicity-using-the-vigilant-app-100568010","NCT06675643","Digital Remote Monitoring of Immune Checkpoint Inhibitor Therapy Induced Toxicity Using the Vigilant App","Digital Remote Monitoring of Immune Checkpoint Inhibitor Therapy Induced Toxicity: A Feasibility Study of the Vigilant App (Vigilant-2)","Inclusion Criteria:\n\n* Any skin cancer\u002Fmelanoma patient starting dual \\[ipilimumab\u002Fnivolumab (IPI\u002FNIVO)\\] immune checkpoint inhibitor (ICI) therapy\n\nExclusion Criteria:\n\n* Does not meet inclusion criteria",{"count":264,"type":22},"This study is being done to better understand patient experiences with using a mobile application, known as Vigilant, to monitor symptoms as outpatients and to gather preliminary data on the potential clinical benefit to remote monitoring of adverse events.",[662,26],"Malignant Skin Neoplasm","2026-08-04",{"date":644,"type":46},{"date":666,"type":46},"2024-10-14",{"date":668,"type":22},"2027-03-15",{"name":670,"class":77},"Mayo Clinic",{"id":672,"slug":673,"hasResults":12,"nctId":674,"briefTitle":675,"officialTitle":676,"acronym":4,"eligibilityCriteria":677,"healthyVolunteers":361,"sex":17,"minAge":678,"maxAge":679,"enrollmentInfo":680,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":682,"conditions":683,"keywords":4,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":663,"lastUpdatePostDateStruct":742,"startDateStruct":744,"completionDateStruct":746,"leadSponsor":748,"locationsCount":750},"100464928","collecting-blood-samples-from-patients-with-and-without-cancer-to-evaluate-tests-for-early-cancer-detection-100464928","NCT05334069","Collecting Blood Samples From Patients With and Without Cancer to Evaluate Tests for Early Cancer Detection","Blinded Reference Set for Multicancer Early Detection Blood Tests","Inclusion Criteria:\n\n* Participants with a cancer diagnosis: Documentation of disease:\n\n  * Histologic documentation: Histologically confirmed diagnosis of invasive cancer\n  * Stage: Stage I-IV per American Joint Committee on Cancer (AJCC) 7th edition, with the exception of patients with leukemia, lymphoma, and multiple myeloma\n\n    * For leukemia: Type (chronic lymphocytic leukemia \\[CLL\\], chronic myeloid leukemia \\[CML\\], acute lymphoblastic lymphoma \\[ALL\\], acute myeloid leukemia \\[AML\\])\n    * For lymphoma: Stage I-IV based on Ann Arbor staging\n    * For multiple myeloma: Stage I, II, III based on Revised International Staging System (RISS)\n  * One of the following tumor types:\n\n    * Colorectal\n    * Bladder\n    * Head and neck\n    * Hepatobiliary\n    * Lung\n    * Lymphoma\n    * Leukemia\n    * Ovary \\*\\*\\* For these specific cancer types only, patients may be enrolled prior to histologic confirmation of malignancy. Sites are required to contact the study chairs to review appropriateness for enrollment\n    * Pancreas \\*\\*\\* For these specific cancer types only, patients may be enrolled prior to histologic confirmation of malignancy. Sites are required to contact the study chairs to review appropriateness for enrollment\n    * Multiple myeloma\n    * Gastric, esophageal or gastroesophageal\n    * Breast\n    * Thyroid\n    * Kidney\n\n      * For these specific cancer types only, patients may be enrolled prior to histologic confirmation of malignancy. Sites are required to contact the study chairs to review appropriateness for enrollment\n    * Endometrium\n    * Prostate\n    * Melanoma\n\n      \\*\\*\\* For these specific cancer types only, patients may be enrolled prior to histologic confirmation of malignancy. Sites are required to contact the study chairs to review appropriateness for enrollment\n    * Sarcoma\n* Participants with a cancer diagnosis: No prior definitive systemic or local anti-cancer intervention\n* Participants with a cancer diagnosis: Age \\>= 40 and =\\\u003C 75\n* Participants with a cancer diagnosis: No known current pregnancy by self-report\n* Participants with a cancer diagnosis: No known or prior history of in situ or invasive malignancy (excluding in situ non-melanoma skin cancers) other than the current cancer diagnosis\n* Participants with a cancer diagnosis: Willingness to provide blood samples for research use\n* Participants with a cancer diagnosis: Absence of medical contraindications to a research blood draw volume of 60 mL\n* Participants with a cancer diagnosis: No history of organ transplantation\n* Participants with a cancer diagnosis: Ability to read and comprehend English or Spanish\n\n  \\* Eligibility is restricted to individuals who can comprehend and read English or Spanish given that participation in the study will require the ability to read and complete questionnaires that are available only in those two languages\n* Participants without a cancer diagnosis and without suspicion of cancer: Age \\>= 40 and =\\\u003C 75\n* Participants without a cancer diagnosis and without suspicion of cancer: No known current pregnancy by self-report\n* Participants without a cancer diagnosis and without suspicion of cancer: No known or prior history of in situ or invasive malignancy (excluding in situ non-melanoma skin cancers)\n* Participants without a cancer diagnosis and without suspicion of cancer: Willingness to provide blood samples for research use\n* Participants without a cancer diagnosis and without suspicion of cancer: Absence of medical contraindications to a research blood draw volume of 60 mL\n* Participants without a cancer diagnosis and without suspicion of cancer: No history of organ transplantation\n* Participants without a cancer diagnosis and without suspicion of cancer: Ability to read and comprehend English or Spanish\n\n  \\* Eligibility is restricted to individuals who can comprehend and read English or Spanish given that participation in the study will require the ability to read and complete questionnaires that are available only in those two languages\n* Participants with a high suspicion of cancer: High suspicion of ovarian cancer, pancreatic cancer, kidney cancer, or melanoma by clinical and\u002For radiological assessment, with plans for histologic or cytologic confirmation within 28 days after study blood draw\n\n  \\* Examples of highly suspicious cases include: elevated CA125 and abnormal transvaginal ultrasound, suspicious renal or pancreatic mass on imaging, suspicious cutaneous lesion concerning for melanoma\n* Participants with a high suspicion of cancer: Central review of radiology reports and\u002For clinical documentation conducted by study chairs\n* Participants with a high suspicion of cancer: Age \\>= 40 and =\\\u003C 75\n* Participants with a high suspicion of cancer: No known current pregnancy by self-report\n* Participants with a high suspicion of cancer: No known or prior history of in situ or invasive malignancy (excluding in situ non-melanoma skin cancers) other than the current cancer diagnosis\n* Participants with a high suspicion of cancer: Willingness to provide blood samples for research use\n* Participants with a high suspicion of cancer: Absence of medical contraindications to a research blood draw volume of 60 mL\n* Participants with a high suspicion of cancer: No history or organ transplantation\n* Participants with a high suspicion of cancer: Ability to read and comprehend English or Spanish \\* Eligibility is restricted to individuals who can comprehend and read English and Spanish given that participation in the study will require the ability to read and complete questionnaires that are available only in those two languages","40 Years","75 Years",{"count":681,"type":22},2000,"This study collects blood and tissue samples from patients with cancer and without cancer to evaluate tests for early cancer detection. Collecting and storing samples of blood and tissue from patients with and without cancer to study in the laboratory may help researchers develop tests for the early detection of cancers.",[684,685,686,687,688,689,690,691,692,693,66,694,695,696,67,26,697,698,699,700,68,701,702,703,704,705,706,707,708,709,710,711,712,713,714,715,716,717,718,719,720,721,722,723,724,725,726,727,728,729,730,731,732,733,734,735,736,737,738,739,740,741],"Acute Lymphoblastic Leukemia","Acute Myeloid Leukemia","Ann Arbor Stage I Lymphoma","Ann Arbor Stage II Lymphoma","Ann Arbor Stage III Lymphoma","Ann Arbor Stage IV Lymphoma","Chronic Lymphocytic Leukemia","Chronic Myeloid Leukemia","Gastroesophageal Junction Adenocarcinoma","Head and Neck Carcinoma","Invasive Breast Carcinoma","Kidney Carcinoma","Malignant Hepatobiliary Neoplasm","Muscle-Invasive Bladder Carcinoma","RISS Stage I Plasma Cell Myeloma","RISS Stage II Plasma Cell Myeloma","RISS Stage III Plasma Cell Myeloma","Stage I Bladder Cancer AJCC v6 and v7","Stage I Breast Cancer AJCC v7","Stage I Colorectal Cancer AJCC v6 and v7","Stage I Esophageal Cancer AJCC V7","Stage I Gastric Cancer AJCC V7","Stage I Lung Cancer AJCC v7","Stage I Ovarian Cancer AJCC v6 and v7","Stage I Pancreatic Cancer AJCC v6 and v7","Stage I Prostate Cancer AJCC v7","Stage I Uterine Corpus Cancer AJCC v7","Stage II Bladder Cancer AJCC v6 and v7","Stage II Breast Cancer AJCC v6 and v7","Stage II Colorectal Cancer AJCC v7","Stage II Esophageal Cancer AJCC v7","Stage II Gastric Cancer AJCC v7","Stage II Lung Cancer AJCC v7","Stage II Ovarian Cancer AJCC v6 and v7","Stage II Pancreatic Cancer AJCC v6 and v7","Stage II Prostate Cancer AJCC v7","Stage II Uterine Corpus Cancer AJCC v7","Stage III Bladder Cancer AJCC v6 and v7","Stage III Breast Cancer AJCC v7","Stage III Colorectal Cancer AJCC v7","Stage III Esophageal Cancer AJCC v7","Stage III Gastric Cancer AJCC v7","Stage III Lung Cancer AJCC v7","Stage III Ovarian Cancer AJCC v6 and v7","Stage III Pancreatic Cancer AJCC v6 and v7","Stage III Prostate Cancer AJCC v7","Stage III Uterine Corpus Cancer AJCC v7","Stage IV Bladder Cancer AJCC v7","Stage IV Breast Cancer AJCC v6 and v7","Stage IV Colorectal Cancer AJCC v7","Stage IV Esophageal Cancer AJCC v7","Stage IV Gastric Cancer AJCC v7","Stage IV Lung Cancer AJCC v7","Stage IV Ovarian Cancer AJCC v6 and v7","Stage IV Pancreatic Cancer AJCC v6 and v7","Stage IV Prostate Cancer AJCC v7","Stage IV Uterine Corpus Cancer AJCC v7","Thyroid Gland Carcinoma",{"date":743,"type":46},"2026-08-05",{"date":745,"type":46},"2022-08-18",{"date":747,"type":22},"2027-02-28",{"name":749,"class":77},"Alliance for Clinical Trials in Oncology",744,{"id":752,"slug":753,"hasResults":12,"nctId":754,"briefTitle":755,"officialTitle":756,"acronym":4,"eligibilityCriteria":757,"healthyVolunteers":12,"sex":17,"minAge":85,"maxAge":4,"enrollmentInfo":758,"targetDuration":4,"studyType":120,"phases":760,"briefSummary":761,"conditions":762,"keywords":766,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":770,"lastUpdatePostDateStruct":771,"startDateStruct":772,"completionDateStruct":774,"leadSponsor":776,"locationsCount":443},"100586075","phase-1-idov-immune-for-advanced-solid-tumors-100586075","NCT06910657","IDOV-Immune for Advanced Solid Tumors","A First-in-human, Phase I, Multi-center, Open-label, Dose-escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Evidence of Antitumor Activity of IDOV-Immune in Adult Participants With Advanced Solid Tumors","Key Inclusion Criteria:\n\n* Age ≥ 18 years.\n* Histologically or cytologically confirmed advanced solid tumors that have progressed despite standard therapy, or for which no standard therapy exists.\n* ECOG performance status ≤ 1.\n* Measurable disease per RECIST v1.1.\n* Adequate organ and bone marrow function.\n* At least 28 days since major surgery, prior immunotherapy, or radiotherapy (with exceptions for minor procedures).\n* Negative pregnancy test for women of childbearing potential.\n* Agreement to use effective contraception during treatment and for 3 months after.\n* Ability to provide informed consent and comply with study requirements.\n\nKey Exclusion Criteria:\n\n* Prior treatment with an oncolytic virus.\n* Active or recent vaccinia virus infection or smallpox\u002Fmonkeypox vaccination within 10 years.\n* Active uncontrolled infection requiring systemic treatment.\n* History of hepatitis B, hepatitis C, or HIV (unless meeting protocol-specific criteria).\n* Unresolved ≥ Grade 2 toxicities from prior therapies (except hair loss or stable chronic conditions).\n* Active or symptomatic autoimmune disease requiring systemic therapy.\n* Active or untreated CNS metastases (unless stable per protocol).\n* Significant cardiac disease (e.g., NYHA Class III\u002FIV heart failure).\n* Interstitial lung disease or prior pneumonitis requiring steroids.\n* Conditions requiring chronic immunosuppressive therapy.\n* Severe skin disorders or history of pancreatitis.\n* Bleeding disorders or history of recent serious thromboembolic events.\n* Any medical or psychiatric condition that could interfere with study participation.",{"count":759,"type":22},78,[188],"This is a Phase I clinical trial evaluating an investigational treatment called IDOV-Immune, a type of oncolytic virus therapy, for adults with advanced solid tumors that have not responded to standard treatments. Oncolytic viruses are designed to infect and destroy cancer cells and have the potential to stimulate the immune system to fight the tumor.\n\nThe purpose of this study is to determine the safety of IDOV-Immune, how well it is tolerated, and to identify the highest dose that can be safely given. Researchers will also study how the drug behaves in the body, how the immune system responds to it, and whether it shows any signs of shrinking tumors.\n\nParticipants will receive a single intravenous (IV) infusion of IDOV-Immune and will be closely monitored for side effects and any changes in their cancer.\n\nThis study is being conducted at multiple sites in the United States and Australia.",[304,247,26,456,126,131,537,192,90,68,130,91,133,763,764,765],"Cervical Cancers","Head and Neck Cancers","Adrenal Gland Tumors",[767,768,531,571,170,769],"Oncolytic Virus Therapy","Advanced Solid Tumors","Vaccinia Virus","2026-08-03",{"date":743,"type":46},{"date":773,"type":46},"2025-08-25",{"date":775,"type":22},"2027-05-31",{"name":777,"class":153},"ViroMissile, Inc."]