[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"renal-cell-carcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:renal-cell-carcinoma":33},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,94,0,25,[9,63,95,119,143,174,195,217,242,267,295,333,361,388,411,435,479,530,568,611,634,655,679,701,720],{"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":24,"briefSummary":26,"conditions":27,"keywords":40,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":51,"lastUpdatePostDateStruct":52,"startDateStruct":55,"completionDateStruct":57,"leadSponsor":59,"locationsCount":62},"100639777","phase-1-a-first-in-human-study-of-hh160-in-patients-with-advanced-solid-tumors-100639777",false,"NCT07623369","A First-in-Human Study of HH160 in Participants With Advanced or Metastatic Solid Tumors","An Open-Label, Multicenter, Phase 1 Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity and Preliminary Antitumor Activity of HH160 Alone or in Combination With Other Antitumor Agents in Patients With Advanced or Metastatic Solid Tumors","Key Inclusion Criteria\n\n1. Adults aged 18 to 75 years with signed informed consent.\n2. Histologically or cytologically confirmed advanced solid tumors meeting phase-specific disease requirements.\n3. At least 1 measurable lesion per RECIST v1.1.\n4. Eastern Cooperative Oncology Group Performance Status (ECOG) Performance Status of 0 or 1 with life expectancy ≥ 12 weeks.\n5. Adequate organ function based on protocol-specified laboratory criteria.\n\nKey Exclusion Criteria\n\n1. Active leptomeningeal disease or uncontrolled\u002Funtreated brain metastases.\n2. History of severe hypersensitivity reactions to monoclonal antibodies, bispecific antibodies, trispecific antibodies, or study drug components.\n3. Other malignancy within 3 years prior to first dose, except specified curatively treated cancers.\n4. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring frequent drainage.\n5. Significant bleeding risk, severe coagulopathy, gastrointestinal hemorrhage, or recent pulmonary hemorrhage\u002Fhemoptysis.\n\nNOTE: Other eligibility criteria may apply.","ALL","18 Years","75 Years",{"count":21,"type":22},299,"ESTIMATED","INTERVENTIONAL",[25],"PHASE1","This study is evaluating the safety, side effects, how the body processes HH160, and its early anticancer activity when given alone or with other cancer treatments in participants with advanced solid tumors. The study will also identify the recommended dose for future studies. The trial includes two phases and is expected to last about 4 years, with treatment and follow-up lasting approximately 6-12 months each.",[28,29,30,31,32,33,34,35,36,37,38,39],"Solid Tumor","Non-small Cell Lung Cancer","Hepatocellular Carcinoma","Colorectal Cancer","Head and Neck Squamous Cell Carcinoma","Renal Cell Carcinoma","Endometrial Cancer","Cervical Cancer","Small-cell Lung Cancer","Triple Negative Breast Cancer","Urothelial Carcinoma","Gastroesophageal Adenocarcinoma",[41,42,29,43,30,44,31,45,46,32,33,47,34,35,36,37,48,38,39,49],"HH160","PD-1×CTLA-4×VEGF-A Antibody","NSCLC","HCC","CRC","GEA","RCC","TNBC","Ovarian Cancer","RECRUITING","2026-08-19",{"date":53,"type":54},"2026-08-21","ACTUAL",{"date":56,"type":54},"2026-06-11",{"date":58,"type":22},"2028-08",{"name":60,"class":61},"Huahui Health","INDUSTRY",3,{"id":64,"slug":65,"hasResults":12,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":69,"eligibilityCriteria":70,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":71,"targetDuration":4,"studyType":23,"phases":72,"briefSummary":74,"conditions":75,"keywords":81,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":94},"100602406","phase-2-a-study-of-sasanlimab-palbociclib-and-axitinib-in-metastatic-renal-cell-carcinoma-100602406","NCT07123090","A Study of Sasanlimab, Palbociclib and Axitinib in Metastatic Renal Cell Carcinoma","A Phase 2 Study of Sasanlimab, Palbociclib and Axitinib in Metastatic Renal Cell Carcinoma - SPARCC","SPARCC","Inclusion Criteria:\n\n* Histologically or cytologically confirmed unresectable advanced or metastatic renal cell carcinoma with a clear cell component or translocation renal cell carcinoma. Patients with clear cell carcinoma and sarcomatoid histology are eligible.\n\n  * a. For tRCC please refer to the following for eligibility definitions:\n\n    * i. TFE3 (Xp11.2) translocation RCC: confirmed by IHC; however, FISH should be utilized if IHC is not optimal (ie, conclusive) or unavailable.\n    * ii. TFEB rearranged RCC: confirmed by FISH; TFEB amplified tumors are excluded.\n  * b. A formalin-fixed, paraffin-embedded (FFPE) tumor tissue block from a de novo tumor biopsy obtained during screening will be required (biopsied tumor lesion should not be a RECIST target lesion). Alternatively, a recently obtained archival FFPE tumor tissue block (not cut slides from a primary or metastatic tumor resection or biopsy) can be provided if the following criteria are met:\n\n    * i. The biopsy or resection was performed within 1 year of registration AND\n    * ii. The patient has not received any intervening systemic anti-cancer treatment from the time the tissue was obtained and registration onto the current study. If an FFPE tissue block cannot be provided as per documented regulations then 15 unstained slides (10 minimum) will be acceptable\n  * c. Availability of an archival FFPE tumor tissue block from primary diagnosis specimen (if available and not provided per above). If an FFPE tissue block cannot be provided as per documented regulations, then 15 unstained slides (10 minimum) will be acceptable.\n* Measurable disease as per RECIST 1.1. See Section 11 for the evaluation of measurable disease.\n* Age ≥ 18 years.\n* ECOG performance status ≤2 (Karnofsky ≥60%, see Appendix A).\n* Normal organ and marrow function as defined below:\n\n  * a. Absolute neutrophil count ≥1.5×109\u002FL\n  * b. Platelets ≥100×109\u002FL\n  * c. Hemoglobin ≥9g\u002FdL (RBC transfusions allowed)\n  * d. Total bilirubin ≤ 1.5 × institutional upper limit of normal (ULN) with the following exception: patients with known Gilbert disease should have a total serum bilirubin ≤ 3 x ULN\n  * e. AST(SGOT)\u002FALT(SGPT) ≤1.5 × ULN\n  * f. Creatinine clearance ≥30 mL\u002Fmin according to the CKD-EPI equation. (APPENDIX C)\n  * g. Urine protein \\\u003C1+ by urinalysis; If ≥1+ protein or otherwise suggestive of any proteinuria above a trace amount (per local institutional standards), a random urine protein and creatinine ratio (UPCR) should be collected. A 24-hour urine collection can also be utilized for direct measurement. When multiple modalities are used, the 24-hour urine measurement takes precedence over the random UPCR; refer to section 6.2 for further guidance.\n* Women of child-bearing potential and men must agree to use adequate contraception (intrauterine device or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. If condoms are used as a barrier method, a spermicidal agent should be added as a double barrier protection. A negative pregnancy serum test should be obtained within 7 days of therapy initiation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she must discontinue treatment immediately. Data on fetal outcome and breast-feeding are to be collected for regulatory reporting and drug safety evaluation. Participants treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 90 days after completion of sasanlimab, axitinib and palbociclib administration.\n* Ability to swallow oral medications.\n* Ability to understand and willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n* Treatment with the following prior therapies:\n\n  * a. Prior systemic therapy for advanced or metastatic RCC.\n  * b. Prior adjuvant or neoadjuvant therapy for RCC if disease progression or relapse has occurred within 12 months of last dose of such therapy. Treatment with an immune checkpoint inhibitor in the adjuvant setting is allowed providing more than 12 months have elapsed since last dose or completion of therapy.\n  * c. Prior treatment with any immunotherapeutic agent (IL-2, IFN-α, anti-PD(L)-1, anti-CTLA-4, or any other antibody or drug targeting T-cell co-stimulation or immune checkpoint pathways).\n  * d. Prior therapy with axitinib or other therapies targeting VEGF pathway in the metastatic setting (adjuvant therapy is allowed).\n\n    e. Prior therapy with any CDK4\u002F6 inhibitor.\n* Participants with untreated brain metastases. Participants with metastatic CNS tumors may participate in this trial, if the participant is ≥ 4 weeks from therapy completion (incl. radiation and\u002For surgery), is clinically stable at the time of study entry and is not receiving corticosteroid therapy \\>10 mg\u002Fday prednisone equivalents. A repeat MRI or CT brain to show stability is required.\n* Wide field radiation therapy ≤ 2 weeks prior to treatment start. Prior palliative radiotherapy to metastatic non-target lesion(s) is permitted if completed at least 48hrs prior to patient registration.\n* Untreated deep vein thrombosis or pulmonary embolism, or event of deep vein thrombosis or pulmonary embolism within 2 weeks of treatment start. Patient should be on at least 1 week of anticoagulation before C1D1.\n* Major surgery\u002Fsurgical procedures within the past 4 weeks prior to registration.\n* The patient has serious and\u002For uncontrolled preexisting medical condition(s) that, in the judgment of the investigator, would preclude participation in this study (for example, interstitial lung disease - also see 3.2.22, severe dyspnea at rest or requiring oxygen therapy, severe renal impairment \\[e.g. estimated creatinine clearance \\\u003C30ml\u002Fmin\\], history of major surgical resection involving the stomach or small bowel, or preexisting Crohn's disease or ulcerative colitis or a preexisting chronic condition resulting in baseline Grade 2 or higher diarrhea).\n* Current or prior use of immunosuppressive medication within 7 days prior to registration, except the following:\n\n  * a. Intranasal, inhaled, topical steroids, or local steroid injections (eg. intra-articular injection).\n  * b. Systemic corticosteroids at physiologic doses ≤10 mg\u002Fday of prednisone or equivalent.\n  * c. Steroids as premedication for hypersensitivity reactions (eg. CT scan premedication).\n* Known severe hypersensitivity reactions to monoclonal antibodies (Grade ≥3) or any history of anaphylaxis.\n* Active autoimmune disease that might deteriorate when receiving an immunostimulatory agents. Patients with diabetes type I, vitiligo, psoriasis, hypo- or hyperthyroidism not requiring immunosuppressive treatment are eligible.\n* Vaccination within 4 weeks of the first dose of sasanlimab and while on trial is prohibited except for administration of inactivated vaccines (for example, inactivated influenza or shingles vaccines). Note, the COVID19 vaccine is not a live vaccine and permitted.\n* Grade ≥3 hemorrhage within 4 weeks of registration.\n* Patient with active systemic bacterial infection (requiring IV antibiotics at the time of initiating study treatment), fungal infection, or detectable viral infection. Patients with known viral infection (such as HIV) are excluded given the potential for interactions between antiretroviral agents and palbociclib and axitinib, and the potential for increased risk of life-threatening infection with therapy that is myelosuppressive. If patients are not known to have HIV, a HIV test is required prior to registration.\n* Patients with known Hepatitis B or Hepatitis C infection are excluded only if there is evidence of active infection (detectable Hepatitis B surface antigen, detectable HBV DNA, or detectable Hepatitis C RNA).\n* Prior allogenic or autologous stem cell or any solid organ transplant.\n* Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of oral drugs (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection).\n* Participants who are currently taking therapeutic doses of warfarin sodium or any other coumadin-derivative anticoagulant. Therapeutic use of low molecular weight heparin and factor Xa inhibitors (eg. apixaban, rivaroxaban) is permitted.\n* Other malignancy diagnosed within 2 years of treatment start unless negligible risk of metastases or death according to the investigator (included but not limited to carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer, ductal carcinoma in situ of the breast, non-muscle invasive urothelial carcinoma, or other malignancy not deemed to impact patients 5-year life expectancy).\n* Has a personal history of any of the following conditions: syncope of cardiovascular etiology, ventricular arrhythmia of pathological origin (including, but not limited to, ventricular tachycardia and ventricular fibrillation), myocarditis, sudden cardiac arrest.\n* Has had any major cardiovascular event within 6 months prior to treatment start, including but not limited to: myocardial infarction, unstable angina, cerebrovascular accident, transient ischemic event or New York Heart Association Class III or IV heart failure.\n* Ongoing cardiac dysrhythmias of NCI CTCAE Grade ≥2 or history of long QTC syndrome. Any history of myocarditis.\n* History of interstitial lung disease or other restrictive lung disease, as well as history of symptomatic respiratory condition considered clinically significant by the investigator. Individuals with a history of radiotherapy to the thorax and any history of pneumonitis will be excluded.\n* Current or past tobacco users with a history of cigarette smoking greater than 30 pack-yrs (i.e., # of packs of cigarettes smoked per day × # of years patient has smoked \\> 30).\n* Participants with a known hypersensitivity to the study compounds or to its excipients.\n* Current use or anticipated need for treatment with drugs or foods that are known strong CYP3A4\u002F5 inhibitors, including their administration within 7 days prior to treatment start (eg. Grapefruit juice or grapefruit\u002Fgrapefruit-related citrus fruits \\[eg. Seville oranges, pomelos\\], ketoconazole, miconazole, itraconazole, voriconazole, , clarithromycin, telithromycin, indinavir, saquinavir, ritonavir, nelfinavir, amprenavir, fosamprenavir nefazodone, lopinavir, troleandomycin, mibefradil, and conivaptan). The topical use of these medications (if applicable), such as 2% ketoconazole cream, is allowed.\n* Current use or anticipated need for drugs that are known strong CYP3A4\u002F5 inducers, including their administration within 14 days prior to treatment start (eg. Phenobarbital, rifampin, phenytoin, carbamazepine, rifabutin, 23albociclib, clevidipine, St John's wort).\n* Participants who have taken herbal medications within 7 days prior to treatment start. Herbal medications include, but are not limited to St. John's wort, Kava, ephedra (ma huang), gingko biloba, dehydroepiandrosterone (DHEA), yohimbe, saw palmetto, and ginseng.\n* Females that are pregnant or breastfeeding.\n* Judgement by the investigator that the patient is unsuitable to participate in the study and the patient is unlikely to comply with study procedures, restrictions and requirements.",{"count":7,"type":22},[73],"PHASE2","The goal of this research study is to evaluate how well and safely the study drugs sasanlimab, palbociclib, and axitinib work for treatment of participants with advanced clear cell renal cell carcinoma (ccRCC) or translocation renal cell carcinoma (tRCC).\n\nThe name of the study drugs involved in this research study is:\n\n* Sasanlimab (a type of monoclonal antibody)\n* Palbociclib (a type of kinase inhibitor)\n* Axitinib (a type of Vascular endothelial growth factor inhibitor)",[76,77,33,78,79,80],"Metastatic Renal Cell Carcinoma","Metastatic Renal Cancer","Advanced Clear Cell Renal Cell Carcinoma","Kidney Cancer","Translocation Renal Cell Carcinoma",[76,77,33,78,79,80,82,83],"ccRCC","tRCC","2026-08-18",{"date":86,"type":54},"2026-08-20",{"date":88,"type":54},"2025-11-24",{"date":90,"type":22},"2028-04-01",{"name":92,"class":93},"Stephanie Berg","OTHER",2,{"id":96,"slug":97,"hasResults":12,"nctId":98,"briefTitle":99,"officialTitle":100,"acronym":4,"eligibilityCriteria":101,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":102,"targetDuration":4,"studyType":23,"phases":104,"briefSummary":99,"conditions":105,"keywords":4,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":111,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":118},"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":103,"type":22},120,[25,73],[106,29,107,33,108,37,32,109,110],"Melanoma","Squamous Cell Carcinoma (Skin)","Merkel Cell Carcinoma","Gastric Cancer\u002FGastroesophageal Junction Cancer","High Grade Serous Ovarian Carcinoma",{"date":51,"type":54},{"date":113,"type":54},"2025-07-29",{"date":115,"type":22},"2029-10-02",{"name":117,"class":61},"AstraZeneca",13,{"id":120,"slug":121,"hasResults":12,"nctId":122,"briefTitle":123,"officialTitle":124,"acronym":4,"eligibilityCriteria":125,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":126,"targetDuration":4,"studyType":23,"phases":128,"briefSummary":129,"conditions":130,"keywords":132,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":134,"lastUpdatePostDateStruct":135,"startDateStruct":136,"completionDateStruct":138,"leadSponsor":140,"locationsCount":142},"100590331","phase-1-study-of-dcc-2812-in-participants-with-advanced-genitourinary-cancers-100590331","NCT06966024","Study of DCC-2812 in Participants With Advanced Genitourinary Cancers","An Open-label, Phase 1 Study of DCC-2812 Monotherapy in Participants With Advanced or Metastatic Renal Cell Carcinoma, Urothelial Cancer, or Castration-Resistant Prostate Cancer","Key Inclusion Criteria:\n\n* Have confirmed Advanced or Metastatic Renal Cell Carcinoma, Urothelial Cancer, or Castration-Resistant Prostate Cancer\n* Able to take oral medication\n* If a female is of childbearing potential, must have a negative pregnancy test prior to enrollment and all participants agree to follow the contraception requirements\n* Adequate organ function and electrolytes\n\nKey Exclusion Criteria:\n\n* Received any prior anticancer therapy or any investigational therapy within a specified timeframe prior to first dose of DCC-2812\n* Impaired cardiac function\n* Major surgery within 28 days of the first dose of study drug",{"count":127,"type":22},60,[25],"This is a multicenter clinical trial to evaluate the safety and preliminary activity of the selective general control nonderepressible 2 (GCN2) activator DCC-2812 as monotherapy in advanced\u002Fmetastatic renal cell carcinoma (RCC), urothelial carcinoma, and castration-resistant prostate cancer.",[33,38,131],"Castration-resistant Prostate Cancer",[133],"Advanced malignancies","2026-08-14",{"date":84,"type":54},{"date":137,"type":54},"2025-08-27",{"date":139,"type":22},"2029-02",{"name":141,"class":61},"Deciphera Pharmaceuticals, LLC",8,{"id":144,"slug":145,"hasResults":12,"nctId":146,"briefTitle":147,"officialTitle":147,"acronym":4,"eligibilityCriteria":148,"healthyVolunteers":149,"sex":17,"minAge":150,"maxAge":4,"enrollmentInfo":151,"targetDuration":4,"studyType":153,"phases":4,"briefSummary":154,"conditions":155,"keywords":159,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":165,"lastUpdatePostDateStruct":166,"startDateStruct":168,"completionDateStruct":4,"leadSponsor":170,"locationsCount":173},"100054306","von-hippel-lindau-vhl-clinical-manifestations-diagnosis-management-and-molecular-bases-of-inherited-renal-and-other-urologic-malignant-disorders-100054306","NCT00001238","Von Hippel-Lindau (VHL): Clinical Manifestations, Diagnosis, Management and Molecular Bases of Inherited Renal and Other Urologic Malignant Disorders","* INCLUSION CRITERIA:\n\nParticipants must be greater than or equal to 2 years of age. All participants and guardians (for children younger than 18 years of age) must sign an informed consent document indicating their understanding of the investigational nature and the risks of this study before any protocol related studies are performed.\n\nCriteria for Acceptance into this Study (i.e., Disease Categories):\n\nDisease Category I\n\nIndividuals and biologic family members with a suspected or an established diagnosis of an inherited urologic malignancy in which the disease gene is known, including von Hippel-Lindau (VHL) and hereditary papillary renal carcinoma (HPRC).\n\nDisease Category II\n\nIndividuals and biologic family members with a suspected or an established diagnosis of an inherited urologic malignancy in which the disease gene is not yet known, specifically hereditary forms of Type II papillary renal cancer, clear cell renal carcinoma, renal oncocytoma, chromophobe renal carcinoma or Birt Hogg Dube.\n\nDisease Category III\n\nIndividuals and biologic family members who have urologic malignant diseases of suspected, but not proven genetic etiology, including families with more than one individual affected by the same or related cancers. A total of 5000 individuals will be enrolled during the study (i.e., that includes individuals registered since the beginning of the protocols in 1989 (89C0086) and 1999 (99C0101)).\n\nEnrollment per Subject Category (to include both affected and unaffected biologic relatives)\n\nSubject Category A:\n\nCategory A will include individuals, and biologic relatives, who may or may not be affected who will be evaluated in the Warren G. Magnuson Clinical Center. Individuals in this category will be eligible if they or their biologic family members manifest one or more of the following features in a pattern suggestive of a heritable urologic malignant disorder:\n\n* One or more histologically proven or suspected renal carcinomas and\u002For cysts\n* Cerebellar, spinal, medullary or cerebral hemangioblastomas\n* Retinal angioma\n* Pancreatic neuro-endocrine carcinoma,micro cystadenoma and\u002For cysts\n* Pheochromocytoma\n* Papillary cystadenoma of the epididymis or broad ligament\n* Endolymphatic sac tumor\n* Cutaneous fibrofolliculomas or multiple skin-colored papules\n* History of spontaneous pneumothorax\n* Lung cysts\n* Thyroid carcinoma\n* Intestinal polyposis plus\u002Fminus colon cancer\n* Cutaneous or Uterine leiomyoma or uterine leiomyosarcoma, sarcoma\n\nSubject Category B:\n\nCategory B will include individuals and the biologic relatives of patients with inherited urologic malignancies with the above listed clinical findings who live at a distance and who will not be evaluated at the Clinical Center. In some cases, local diagnostic testing may be necessary for these individuals in addition to collection of a blood sample for molecular analysis.\n\nSubject Category C:\n\nCategory C will include biologic relatives who enroll in this study primarily for genetic linkage studies. These individuals will contribute a blood sample for DNA analysis only. No imaging diagnostic testing will be performed on individuals from this category.\n\nEXCLUSION CRITERIA:\n\nNone",true,"2 Years",{"count":152,"type":22},5000,"OBSERVATIONAL","We will investigate the clinical manifestations and molecular genetic defects of heritable urologic malignant disorders. Families with urologic malignancy with known or suspected genetic basis will be enrolled. Affected individuals or individuals suspected of having a germline urologic malignant disorder will undergo periodic clinical assessment and genetic analyses for the purpose of: 1) definition and characterization of phenotype, 2) determination of the natural history of the disorder, and 3) genotype\u002Fphenotype correlation. Genetic linkage studies may be performed in situations in which the genetic basis of the disorder has not been elucidated.\n\n...",[79,156,33,157,158],"Urologic Malignant Disorders","Familial Renal Cancer (FRC)","Clear Cell Renal Cancer",[160,161,162,163,164],"Hereditary Papillary Renal Cancer (HPRC)","Birt Hogg Dube (BHD)","Hereditary Leiomyomatosis and Renal Cell Carcinoma (HLRCC)","Pheochromocytoma","Von Hippel-Lindau (VHL)","2026-08-12",{"date":167,"type":54},"2026-08-13",{"date":169,"type":54},"1990-12-05",{"name":171,"class":172},"National Cancer Institute (NCI)","NIH",1,{"id":175,"slug":176,"hasResults":12,"nctId":177,"briefTitle":178,"officialTitle":179,"acronym":4,"eligibilityCriteria":180,"healthyVolunteers":149,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":181,"targetDuration":4,"studyType":23,"phases":183,"briefSummary":185,"conditions":186,"keywords":4,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":187,"lastUpdatePostDateStruct":188,"startDateStruct":189,"completionDateStruct":191,"leadSponsor":193,"locationsCount":173},"100495631","early-phase-1-neoadjuvant-pembrolizumab-and-lenvatinib-for-renal-cell-carcinoma-100495631","NCT05733715","Neoadjuvant Pembrolizumab and Lenvatinib for Renal Cell Carcinoma","Randomized Pilot Clinical Trial of Neoadjuvant Pembrolizumab +\u002F- Lenvatinib for High Risk Renal Cell Carcinoma","Inclusion Criteria:\n\n1. Male\u002Ffemale participants who are at least 18 years of age on the day of signing informed consent with histologically confirmed diagnosis of renal cell carcinoma will be enrolled in this study.\n2. Male participants are eligible to participate if they agree to the following during the intervention period and for at least 7 days after the last dose of lenvatinib:\n\n   * Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent OR\n   * Must agree to use contraception unless confirmed to be azoospermic (vasectomized or secondary to medical cause o Agree to use a male condom plus partner use of an additional contraceptive method when having penile-vaginal intercourse with a woman of child-bearing potential (WOCBP) who is not currently pregnant. Note: Men with a pregnant or breastfeeding partner must agree to remain abstinent from penile-vaginal intercourse or use a male condom during each episode of penile-vaginal penetration.\n3. A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies:\n\n   * Is not a WOCBP OR\n   * Is a WOCBP and using a contraceptive method that is highly effective (with a failure rate of \\\u003C1% per year), with low user dependency, or be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) during the intervention period and for at least 120 days post pembrolizumab or 30 days post lenvatinib, whichever occurs last.\n4. The participant (or legally acceptable representative if applicable) provides written informed consent for the trial.\n5. Histologically or cytologically confirmed diagnosis of renal cell carcinoma based on newly obtained renal mass core biopsy performed during study screening procedures.\n6. Renal cell carcinoma with clinical stage cT2 to cT4 based on screening CT or MRI imaging assessment and eligible for surgical resection.\n\n   Note: Patients with regional nodal involvement (cN+) may be included irrespective of clinical T stage, provided disease is deemed \"resectable\" per treating urologic surgeon.\n7. Have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1. Evaluation of ECOG is to be performed within 7 days prior to the first dose of study intervention.\n8. Have adequately controlled BP with or without antihypertensive medications, defined as BP ≤150\u002F90 mm Hg with no change in antihypertensive medications within 1 week prior to randomization.\n9. Have adequate organ function.\n\nExclusion Criteria:\n\n1. A WOCBP who has a positive urine pregnancy test within 24 hours prior to first dose of lenvatinib (ARM A only) or within 72 hours prior to first dose of pembrolizumab (ARMS A and B) (see Appendix 3).\n2. Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX 40, CD137).\n3. Has received prior systemic anti-cancer therapy including investigational agents within 4 weeks prior to randomization.\n4. Has had major surgery within 3 weeks prior to first dose of study interventions.\n5. Has evidence of distant metastatic disease on CT\u002FMRI scans Note: Regional nodal metastases and\u002For ipsilateral adrenal metastasis are acceptable, if deemed resectable per primary urologic surgeon.\n6. Has a need for urgent surgical resection per treating investigator\n7. Has preexisting ≥Grade 3 gastrointestinal or non-gastrointestinal fistula.\n8. Has a LVEF ≤40%, as determined by multigated acquisition (MUGA) or echocardiogram (ECHO).\n9. Subjects having \\> 1+ proteinuria on urine dipstick testing, unless a 25-hour urine collection for quantitative assessment indicates that the urine protein is \\\u003C1 g\u002F24 hours.\n10. Prolongation of QTcF interval to \\>480 ms.\n11. Has clinically significant cardiovascular disease within 12 months from first dose of study intervention, including New York Heart Association Class III or IV congestive heart failure, unstable angina, myocardial infarction, cerebral vascular accident, or cardiac arrhythmia associated with hemodynamic instability. Note: Medically controlled arrhythmia would be permitted.\n12. Gastrointestinal malabsorption or any other condition that might affect the absorption of lenvatinib per investigator discretion\n13. Active hemoptysis (bright red blood of at least 0.5 teaspoon) within 3 weeks prior to the first dose of study drug.\n14. Has received a live vaccine or live-attenuated vaccine within 30 days prior to the first dose of study drug. Administration of killed vaccines is allowed.\n15. Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study intervention.\n16. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug.\n17. Has a known additional malignancy that is progressing or has required active treatment within the past 3 years. Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, non-invasive urothelial carcinoma, low- or intermediate-risk prostate cancer, or carcinoma in situ (eg, breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded.\n18. Has severe hypersensitivity (≥Grade 3) to pembrolizumab or lenvatinib and\u002For any of their excipients.\n19. Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment and is allowed.\n20. Has a history of (non-infectious) pneumonitis\u002Finterstitial lung disease that required steroids or has current pneumonitis\u002Finterstitial lung disease.\n21. Has an active infection requiring systemic therapy.\n22. Has a known history of Human Immunodeficiency Virus (HIV) infection.\n23. Has a known history of Hepatitis B (defined as Hepatitis B surface antigen \\[HBsAg\\] reactive) or known active Hepatitis C virus (defined as HCV RNA \\[qualitative\\] is detected) infection.\n24. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator.\n25. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.\n26. Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of trial treatment.\n27. Has had an allogenic tissue\u002Fsolid organ transplant.",{"count":182,"type":22},30,[184],"EARLY_PHASE1","This study will evaluate the effect of investigational drugs, pembrolizumab alone or pembrolizumab with lenvatinib, on the immune systems response to kidney cancer when given before and after surgery to remove kidney cancer.",[33],"2026-08-11",{"date":167,"type":54},{"date":190,"type":54},"2023-05-03",{"date":192,"type":22},"2028-12",{"name":194,"class":93},"Abramson Cancer Center at Penn Medicine",{"id":196,"slug":197,"hasResults":12,"nctId":198,"briefTitle":199,"officialTitle":200,"acronym":4,"eligibilityCriteria":201,"healthyVolunteers":12,"sex":17,"minAge":202,"maxAge":4,"enrollmentInfo":203,"targetDuration":4,"studyType":23,"phases":204,"briefSummary":205,"conditions":206,"keywords":4,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":208,"lastUpdatePostDateStruct":209,"startDateStruct":210,"completionDateStruct":212,"leadSponsor":214,"locationsCount":94},"100615827","phase-1-gcar1-a-chimeric-antigen-receptor-car-t-cell-therapy-for-relapsedrefractory-gpnmb-expressing-solid-tumours-100615827","NCT07297667","GCAR1, a Chimeric Antigen Receptor (CAR) T-CELL Therapy for Relapsed\u002FRefractory GPNMB-Expressing Solid Tumours","A Phase I Study of GCAR1, a Chimeric Antigen Receptor (CAR) T-CELL Therapy for Participants With Selected Relapsed\u002FRefractory GPNMB-Expressing Solid Tumours","Inclusion Criteria:\n\n* Archival tumour specimen must be positive for GPNMB with high expression by immunohistochemistry (central laboratory testing).\n* Histologically and\u002For cytologically confirmed diagnosis of one of the following tumours that is advanced\u002F metastatic\u002F recurrent or unresectable, for which no curative therapy exists.\n* alveolar soft part sarcoma\n* renal cell carcinoma (excluding clear cell)\n* triple negative breast cancer (ER, PR and HER-2 negative as defined by ASCO\u002FCAP criteria)\n* Must have a formalin fixed paraffin embedded tissue block (from primary or metastatic tumour) available and must have provided informed consent for the release of the block.\n* Presence of radiologically documented disease.\n* Measurable disease as defined by RECIST 1.1.\n* ASPS participants ≥ 15 years of age.\n* TNBC and RCC participants ≥ 18 years of age.\n* ECOG performance status of 0 or 1 or Karnofsky or Lansky \\> 60.\n* Anticipated life expectancy of ≥ 6 months.\n* Must have received prior systemic therapy as shown below;\n* ASPS - completed all systemic therapy available that has been shown to improve survival (unless contraindicated).\n* TNBC\n\n  1. Progressive disease following at least one line of systemic treatment for metastatic disease which must include an ADC (all participants) and an ICI (participants whose tumours express PD-L1).\n  2. ≤3 lines of treatment for metastatic disease.\n  3. Must have had at least 1 prior line of cytotoxic chemotherapy for breast cancer, in any setting, which must have included an anthracycline and a taxane (unless contraindicated).\n* RCC - must have progressive disease following at least one line of systemic treatment for metastatic disease that must have included an ICI and a VEGFR targeted agent (unless contraindicated).\n* Participants must have recovered to ≤ grade 1 from all reversible toxicity related to prior therapies.\n* Adequate washout must be followed per protocol.\n* Previous major surgery is permitted ≥21 days prior to enrollment\n* Prior external beam radiation is permitted ≥28 prior to enrollment. Concurrent radiotherapy is not permitted.\n* Adequate hematologic and biochemical parameters.\n* Consent and assent, when applicable, must be appropriately obtained in accordance with applicable local and regulatory requirements. Each participant or their parent\u002F legal guardian (if applicable) must sign a consent form prior to screening onto the trial to document their willingness to participate.\n* Fit for leukapheresis and has adequate venous access for cell collection.\n* Must be accessible for treatment and follow up at the participating centre for a minimum of 12 months or for as long as is deemed necessary by the treating physician.\n* Participants of childbearing potential must have agreed to use a highly effective contraceptive method.\n\nExclusion criteria\n\n* Participants on active anticancer therapy for other advanced or metastatic malignancies.\n* Concurrent treatment with other anti-cancer therapy\n* Prior therapy with a gene therapy product or any adoptive T cell therapy or prior GPNMB targeting therapy.\n* Live attenuated vaccination administered within 30 days prior to or planned within 30 days after GCAR1 therapy.\n* Primary immunodeficiency or history of severe autoimmune disease (including: Crohn's disease, rheumatoid arthritis, systemic lupus) requiring immunosuppressive agents\u002F systemic disease modifying agents within 2 years of enrollment.\n* Active or uncontrolled infections or with serious illnesses or medical conditions which would not permit the participant to be managed according to the protocol including but not limited to:\n* Hepatitis B or C virus (HBV or HCV). For participants with previous HBV or HCV infection who are currently on treatment, they are eligible if they have an undetectable viral load via quantitative PCR and\u002For nucleic acid testing\n* HIV positive by serology and PCR\n* Uncontrolled fungal, bacterial, viral or other infection\n* Current infection with HTLV-1\n* Tuberculosis\n* Syphilis\n* West Nile Virus\n* Untreated and\u002For uncontrolled cardiovascular conditions and\u002For symptomatic cardiac dysfunction (including cardiac ventricular arrhythmias requiring medication, history of 2nd or 3rd degree atrioventricular conduction defects) or unstable angina congestive heart failure or myocardial infarction within the previous year.\n* Known sensitivity or allergy to fludarabine, cyclophosphamide or any of their components, or to GCAR1 or any of its components.\n* Active intracerebral metastases or leptomeningeal disease. Participants who have received definitive treatment, are clinically stable and do not require corticosteroids are eligible to participate in the trial.\n* Pregnant or breastfeeding women.","15 Years",{"count":182,"type":22},[25],"Only enrolling in Canada.\n\nThe purpose of this study is to identify the highest dose of GCAR1, a chimeric antigen receptor (CAR-T) cell therapy, that can be tolerated without causing very severe side effects, and to see what effects GCAR1 has on selected cancers",[207,33,37],"Alveolar Soft Part Sarcoma","2026-08-10",{"date":165,"type":54},{"date":211,"type":54},"2026-07-30",{"date":213,"type":22},"2033-09-01",{"name":215,"class":216},"Canadian Cancer Trials Group","NETWORK",{"id":218,"slug":219,"hasResults":12,"nctId":220,"briefTitle":221,"officialTitle":222,"acronym":4,"eligibilityCriteria":223,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":224,"targetDuration":4,"studyType":23,"phases":226,"briefSummary":227,"conditions":228,"keywords":229,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":233,"lastUpdatePostDateStruct":234,"startDateStruct":235,"completionDateStruct":237,"leadSponsor":239,"locationsCount":241},"100607986","phase-1-a-first-in-human-study-of-bms-986506-in-participants-with-advanced-clear-cell-renal-cell-carcinoma-ccrcc-100607986","NCT07195682","A First-in-Human Study of BMS-986506 in Participants With Advanced Clear Cell Renal Cell Carcinoma (ccRCC)","A Phase 1\u002F1b Open-label, Multi-center Study of BMS-986506 in Participants With Advanced Clear Cell Renal Cell Carcinoma (ccRCC)","Inclusion Criteria\n\n* Participants must have histologically confirmed diagnosis of locally advanced or metastatic ccRCC.\n* For part 1: Participants must have already had at least two different treatment plans in the past, including immunotherapy and a targeted therapy.\n* For part 2: Participants must have had at least one standard treatment plan that included both a PD-1\u002FL1 inhibitor and a VEGF-TKI (either together or one after the other).\n* Part 3: Participants must have had at least 1 standard treatment regimen (including a PD-1\u002FL1 checkpoint inhibitor and\u002For a VEGF-TKI).\n* Part 4: Participants must not have received prior systemic therapy for metastatic RCC, but may have received prior adjuvant therapy for completely resected RCC with PD-1 inhibitor if recurrence occurred at least 6 months after the last dose of adjuvant or neoadjuvant therapy.\n* Eastern Cooperative Oncology Group performance status of 0 to 1.\n\nExclusion Criteria\n\n* Inability to administer and\u002For tolerate oral medication without chewing, breaking, crushing, or otherwise altering the product dosage form.\n* Part 2A: Participants who have received more than 3 prior systemic regimens for locally advanced or metastatic ccRCC including prior treatment with HIF2a inhibitors.\n* Part 2A and Part 4: Participants who have received prior treatment with belzutifan (or another HIF2a inhibitor).\n* Part 3B and Part 4B: Participants who have received prior ipilimumab (or another anti-CTLA-4 containing antibody).\n* Participants who have hypoxia as defined by a pulse oximeter reading \\\u003C 92% at rest or requires intermittent or chronic supplemental oxygen.\n* Participants who have received colony-stimulating factors (eg, G-CSF, GM-CSF or recombinant EPO) within 28 days prior to the first dose of study intervention.\n* Part 3 and Part 4: Participants with a history of Grade ≥3 immune-mediated AEs leading to discontinuation of prior immunotherapy.\n* Other protocol-defined Inclusion\u002FExclusion criteria apply.",{"count":225,"type":22},281,[25],"This is a first-in-human study of BMS-986506 in participants with advanced Clear Cell Renal Cell Carcinoma (ccRCC). The primary objective of this study is to find out if BMS-986506 is safe and can be tolerated when taken alone or in combination by participants with ccRCC.",[33],[230,231,82,232],"Metastatic clear cell renal cell carcinoma","Advanced clear cell renal cell carcinoma","Kidney cancer","2026-08-07",{"date":187,"type":54},{"date":236,"type":54},"2026-01-15",{"date":238,"type":22},"2031-04-03",{"name":240,"class":61},"Bristol-Myers Squibb",11,{"id":243,"slug":244,"hasResults":12,"nctId":245,"briefTitle":246,"officialTitle":247,"acronym":248,"eligibilityCriteria":249,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":250,"targetDuration":4,"studyType":153,"phases":4,"briefSummary":252,"conditions":253,"keywords":254,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":259,"lastUpdatePostDateStruct":260,"startDateStruct":261,"completionDateStruct":263,"leadSponsor":265,"locationsCount":173},"100650818","identification-and-description-of-patients-with-high-risk-non-metastatic-rcc-100650818","NCT07753343","Identification and Description of Patients With High-risk Non Metastatic RCC","Identification and Description of Patients With High-risk Non Metastatic RCC (UroCCR 127)","HIROES","Inclusion Criteria:\n\n* Adult patients diagnosed with local RCC or high-risk locally advanced RCC,\n* Included in UroCCR register between 1st january 2014 and 31st december 2023,\n* Consenting to participate in UroCCR and UroCCR-Chain registers.\n\nExclusion Criteria:\n\n* Patients with metastatic disease at inclusion,\n* Patients not linked between UroCCR and SNDS datasources,\n* Patients with hereditary RCC.",{"count":251,"type":22},6109,"Renal cell carcinoma (RCC) is the 14th most common cancer worldwide. Surgery is the standard of care for localized RCC, however, the risk of recurrence varies widely among patients. Adjuvant pembrolizumab has been shown to improve outcomes after nephrectomy but is associated with substantial toxicity and high costs. This study uses real-world data from the French UroCCR-Chain registry to characterize the natural history, management, and outcomes of non-metastatic RCC in France, with the aim of informing adjuvant treatment decisions",[33],[255,256,257,258],"renal cell carcinoma (RCC) high-risk RCC","real life","UroCCR","UroCCR-Chain","2026-08-05",{"date":233,"type":54},{"date":262,"type":54},"2026-04-17",{"date":264,"type":22},"2028-04-17",{"name":266,"class":93},"University Hospital, Bordeaux",{"id":268,"slug":269,"hasResults":12,"nctId":270,"briefTitle":271,"officialTitle":272,"acronym":4,"eligibilityCriteria":273,"healthyVolunteers":12,"sex":17,"minAge":274,"maxAge":4,"enrollmentInfo":275,"targetDuration":4,"studyType":23,"phases":277,"briefSummary":279,"conditions":280,"keywords":281,"overallStatus":285,"whyStopped":4,"lastUpdateSubmitDate":286,"lastUpdatePostDateStruct":287,"startDateStruct":289,"completionDateStruct":291,"leadSponsor":293,"locationsCount":173},"100494995","transplantation-of-reconstructed-renal-allografts-following-ex-vivo-partial-nephrectomy-100494995","NCT05725421","Transplantation of Reconstructed Renal Allografts Following Ex-Vivo Partial Nephrectomy","Oncologic, Functional and Surgical Outcomes for Patients Undergoing Radical Nephrectomy for Low-Risk Renal Cell Carcinoma and Recipients of Reconstructed Renal Allografts Following Ex-Vivo Partial Nephrectomy","Inclusion Criteria:\n\nFor Donors:\n\n* Adults \\> 50 years\n* Willing and able to understand and sign informed consent\n* Must have high-quality pre-operative cross-sectional imaging (CT or MRI) to determine tumor characteristics and perform parenchymal volume analysis for split renal function\n* Patient who is a candidate for partial nephrectomy for cT1a mass who understands that partial nephrectomy is standard of care for such mass but wishes to be an altruistic kidney donor (primary incentive is altruism) via radical nephrectomy with loss of the entire kidney.\n* Functional considerations:\n\n  o Normal baseline renal function, with eGFR \\> 80 ml\u002Fmin\u002F1.73 m2\n  * No proteinuria on urine dipstick (negative\u002Ftrace considered negative)\n  * Predicted new baseline GFR (NBGFR) following radical nephrectomy would be ≥ 45\n  * NBGFR would be calculated using previously described equation based on split renal function (SFR) and renal functional compensation (RFC)\n  * NBGFR = global GFR x (SRFcontralateral from PVA) x 1.25 (average amount of RFC)2\n* Tumor characteristics on pre-operative cross-sectional imaging:\n\n  * Tumor appears well-encapsulated\n  * Tumor appears amenable to ex-vivo partial nephrectomy with reconstruction that will leave ≥75% of the functioning parenchyma intact and well vascularized\n  * Low risk of complications for the recipient after ex-vivo PN based on surgeon judgment\n  * Tumor is cT1a which is defined as ≤ 4cm and confined\n  * Reconstructed kidney is likely to provide NBGFR for the recipient of \\>30 ml\u002Fmin\u002F1.73 m2. This can be estimated as (global GFR)(SRFipsilateral) x 0.75(estimate that at least 75% of the function will be saved during ex vivo tumor excision and reconstruction). Of note most such kidneys will experience some positive functional compensation but this might be mitigated by a small amount of functional loss related to ischemia. Most studies suggest that this will really be an underestimate of the final GFR in the recipient.\n\nFor Recipients:\n\n* Age \\>60\n* Able to understand and willing to sign informed consent\n* Presence of ESRD or CKD5 with likely progression to ESRD\n* Does not have potential living donor\n* Not likely to receive a more \"ideal\" donor kidney due to significant comorbidities and\u002For age\n\nExclusion Criteria:\n\nFor Donors:\n\n* Known familial RCC syndrome\n* Functional considerations:\n\n  o \\\u003C 50 years of age\n  * Preoperative GFR \\\u003C 80 ml\u002Fmin\u002F1.73 m2\n  * Proteinuria on urine dipstick or urinalysis (≥1+ considered positive)\n  * Predicted new baseline GFR (NBGFR) following radical nephrectomy would be \\\u003C 45\n  * NBGFR would be calculated using previously described equation based on split renal function (SFR) and renal functional compensation (RFC)\n  * NBGFR = global GFR x (SRFcontralateral from PVA) x 1.25 (average amount of RFC)2\n* Comorbidities with risk of deteriorating renal function:\n\n  * Hypertension requiring three or more anti-hypertensives\n  * Diabetes mellitus requiring insulin or with end organ damage\n  * Morbid obesity\n  * History of nephrolithiasis or other\n* Tumor characteristics on pre-operative cross-sectional imaging:\n\n  o Tumor has infiltrative features\n  * Tumor is \\> 4cm (does not meet criteria for cT1a stage)\n  * Regional lymphadenopathy, branch or main renal vein invasion, or other imaging findings suggestive of locally advanced disease\n* Kidney characteristics on pre-operative cross-sectional imaging:\n\n  * More than one renal artery unless can be readily and safely reconstructed\n  * More than one renal vein unless can be readily and safely reconstructed\n  * Duplicated collecting system unless can be readily and safely reconstructed\n* High-risk features on renal mass biopsy (if obtained) or intraoperative pathology\n\n  o Malignant non-RCC pathology\n\n  o Rhabdoid or sarcomatoid differentiation\n\n  o Grade 4\n\n  o Positive or concerning margins during tumor excision\n* Must be deemed appropriate living donor candidate per the standard living donor selection process at the Cleveland Clinic o All altruistic living donors undergo a complete evaluation by medical providers and social workers ensuring that they are appropriate candidates to undergo this procedure. This evaluation includes direct query into any history of psychiatric comorbidities and\u002For substance abuse. If present, this prompts a formal evaluation by psychiatry prior to confirmation of donor candidacy.\n\nFor Recipients:\n\n• Traditional contraindications to kidney transplantation at the Cleveland Clinic would apply, including the following directly from the Transplant Care Pathway:\n\n* Active, untreated bacterial, fungal, or viral infections. Once treated, patients may be reconsidered. Patients with human immunodeficiency virus (HIV)14 or chronic hepatitis15 infections will be evaluated on an individual basis.\n* Active malignancy, except non-melanoma skin cancer and other selected low-grade, low-stage cancers (e.g., bladder, kidney, prostate). The American Society of Transplant (AST) clinical practice guidelines published in 2001 are dated. Improved methods of cancer prognostication are available on a cancer-specific basis.16 An acceptable disease-free waiting period may be needed prior to transplantation depending on the cancer type (stage\u002Fgrade) and treatment modality. Expert opinion from an oncological specialist may be needed to facilitate decisions about wait-listing or performance of a transplant.\n* Medical non-adherence, substance abuse or behaviors leading to a failure to achieve a therapeutic physician\u002Ftransplant team-patient alliance.\n* Life expectancy of less than five years independent of renal disease.\n* Advanced circulatory disease (cardiac, cerebral, peripheral), pulmonary disease or other non-renal conditions such that transplantation would pose a significant risk for morbidity\u002Fmortality.\n* Obesity with body mass index (BMI) \\> 38, or an abdominal wall configuration that in the judgment of the evaluating surgeon poses undue complication risk.\n* Active nicotine abuse (in any form).\n* Poor functional status independent of renal disease.\n* Considering the average waiting times for a deceased donor kidney is more than 3 years, only transplant candidates 72 years or younger will be accepted for evaluation. Suitable candidates may remain on the waiting list up to the age of 75-year-old. They will be delisted if no transplantation has occurred.\n* Cumulative burden of disease defined as multiple medical conditions that on their own may not preclude listing but that in combination are deemed not suitable by the transplant selection committee.","60 Years",{"count":276,"type":22},5,[278],"NA","This study is designed to investigate a novel approach to offer more ESRD participants the benefits associated with renal transplantation by increasing the supply of available allografts",[33],[282,283,284],"Radical Nephrectomy","Renal Allograft","Ex-Vivo Partial Nephrectomy","NOT_YET_RECRUITING","2026-08-04",{"date":288,"type":54},"2026-08-06",{"date":290,"type":22},"2026-09",{"date":292,"type":22},"2027-06",{"name":294,"class":93},"Case Comprehensive Cancer Center",{"id":296,"slug":297,"hasResults":12,"nctId":298,"briefTitle":299,"officialTitle":300,"acronym":4,"eligibilityCriteria":301,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":302,"targetDuration":4,"studyType":23,"phases":304,"briefSummary":305,"conditions":306,"keywords":318,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":325,"lastUpdatePostDateStruct":326,"startDateStruct":327,"completionDateStruct":329,"leadSponsor":331,"locationsCount":276},"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":303,"type":22},78,[25],"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.",[31,307,106,49,308,309,30,33,310,311,312,313,314,315,316,317],"Pancreatic Cancer","Gastric Cancer","Esophageal Cancer","Breast Cancer","Sarcoma","Bladder Cancer","Lung Cancer","Prostate Cancer","Cervical Cancers","Head and Neck Cancers","Adrenal Gland Tumors",[319,320,321,322,323,324],"Oncolytic Virus Therapy","Advanced Solid Tumors","Metastatic Cancer","Refractory Cancer","Immunotherapy","Vaccinia Virus","2026-08-03",{"date":259,"type":54},{"date":328,"type":54},"2025-08-25",{"date":330,"type":22},"2027-05-31",{"name":332,"class":61},"ViroMissile, Inc.",{"id":334,"slug":335,"hasResults":12,"nctId":336,"briefTitle":337,"officialTitle":338,"acronym":4,"eligibilityCriteria":339,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":340,"targetDuration":4,"studyType":23,"phases":341,"briefSummary":342,"conditions":343,"keywords":350,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":352,"lastUpdatePostDateStruct":353,"startDateStruct":354,"completionDateStruct":356,"leadSponsor":358,"locationsCount":360},"100616025","phase-1-open-label-phase-12-study-of-neo-811-in-subjects-with-locally-advanced-or-metastatic-non-resectable-clear-cell-renal-cell-carcinoma-100616025","NCT07300241","Open-Label Phase 1\u002F2 Study of NEO-811 in Subjects With Locally Advanced or Metastatic Non-Resectable Clear Cell Renal Cell Carcinoma","An Open-Label, First-in-Human, Phase 1\u002F2 Dose Escalation and Expansion Study of NEO-811 in Subjects With Locally Advanced or Metastatic Non-Resectable Clear Cell Renal Cell Carcinoma","Inclusion Criteria:\n\n* Subjects with locally advanced or metastatic non-resectable clear cell renal cell carcinoma (ccRCC).\n* Subjects must have progressed on or refused standard therapies.\n* Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0 or 1.\n* Estimated life expectancy, in the judgment of the Investigator, of at least 12 weeks.\n* Formalin-fixed paraffin-embedded (FFPE) tumor tissue, newly obtained or archival, is mandatory for enrollment to the study.\n* Measurable disease as defined by RECIST v1.1.\n* Adequate hematologic, hepatic, and renal function defined as:\n\n  * Hemoglobin ≥10 g\u002FdL,\n  * Absolute neutrophil count ≥1000 cells\u002FµL,\n  * Platelet count ≥100,000\u002FµL,\n  * AST and ALT ≤2.5 × ULN, or AST and ALT ≤5 × ULN for subjects with liver metastases,\n  * Total bilirubin ≤1.5 × ULN,\n  * Estimated glomerular filtration rate (eGFR) ≥60 mL\u002Fmin.\n* Subject can swallow oral medications and does not have a condition that could impair the oral bioavailability of the study drug.\n* Other inclusion criteria per protocol.\n\nExclusion Criteria:\n\n* Non-clear cell predominant RCC histologic subtypes.\n* Leptomeningeal disease or symptomatic active CNS metastases with exceptions for asymptomatic treated CNS metastases per protocol.\n* Prior or concurrent malignancies with exceptions per protocol.\n* History of hepatitis B virus (HBV), hepatitis C virus (HCV), or HIV infection.\n* Other exclusion criteria per protocol.",{"count":182,"type":22},[25],"The NEO-811-101 study is an open-label, first-in-human, Phase 1\u002F2 dose escalation and expansion study testing NEO-811, an ARNT molecular glue degrader, in subjects with locally advanced or metastatic non-resectable clear cell renal cell carcinoma. The study will test NEO-811 initially as a monotherapy.",[344,33,47,345,82,346,347,348,349],"Clear Cell Renal Cell Carcinoma","Clear Cell Renal Cell Carcinoma Metastatic","VHL-Associated Clear Cell Renal Cell Carcinoma","VHL-Associated Renal Cell Carcinoma","Kidney Cancer Metastatic","Kidney Cancers",[82,33,344,351,79],"VHL","2026-07-31",{"date":325,"type":54},{"date":355,"type":54},"2025-12-19",{"date":357,"type":22},"2027-09",{"name":359,"class":61},"Neomorph, Inc",12,{"id":362,"slug":363,"hasResults":12,"nctId":364,"briefTitle":365,"officialTitle":366,"acronym":367,"eligibilityCriteria":368,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":369,"targetDuration":4,"studyType":23,"phases":371,"briefSummary":373,"conditions":374,"keywords":375,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":352,"lastUpdatePostDateStruct":380,"startDateStruct":381,"completionDateStruct":383,"leadSponsor":385,"locationsCount":387},"100610424","phase-3-a-clinical-study-of-belzutifan-and-zanzalintinib-in-people-with-recurrent-kidney-cancer-following-adjuvant-therapy-mk-6482-033-100610424","NCT07227402","A Clinical Study of Belzutifan and Zanzalintinib in People With Recurrent Kidney Cancer Following Adjuvant Therapy (MK-6482-033)","A Phase 3, Randomized, Open-label Study of Belzutifan + Zanzalintinib Versus Cabozantinib in Participants With Advanced RCC Who Experienced Disease Recurrence During or After Prior Adjuvant Anti-PD-1\u002FL1 Therapy (LITESPARK-033)","LITESPARK-033","Inclusion Criteria:\n\nThe main inclusion criteria include but are not limited to the following:\n\n* Has a histologically confirmed diagnosis of unresectable, advanced renal cell cancer (RCC) with clear cell component (with or without sarcomatoid features) i.e., Stage IV renal cell cancer per American Joint Committee on Cancer (AJCC) (8th Edition)\n* Has measurable disease per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1)\n* Has disease recurrence during adjuvant anti-programmed cell death 1\u002Fprogrammed cell death ligand 1 (PD-1\u002FL1) therapy or recurrence ≤24 months following the last dose of adjuvant anti-PD-1\u002FL1 therapy\n* Has received no other prior systemic therapy for their RCC except for their adjuvant anti-PD-1\u002FL1 therapy\n\nExclusion Criteria:\n\nThe main exclusion criteria include but are not limited to the following:\n\n* Has clinically significant cardiovascular disease within 12 months from first dose of study intervention, including New York Heart Association Class III or IV congestive heart failure, unstable angina, new-onset angina, pulmonary embolism, myocardial infarction, cerebral vascular accident, or cardiac arrhythmia associated with hemodynamic instability\n* Had deep vein thrombosis within 3 months before randomization unless stable, asymptomatic, and treated with therapeutic anticoagulation for at least 4 weeks before randomization\n* Has a left ventricular ejection fraction ≤50% or below the institutional (or local laboratory) normal range as determined by multigated acquisition or echocardiogram\n* Has had major surgery within 8 weeks before randomization or has not adequately recovered from major surgery or has ongoing surgical complications\n* Has current pneumonitis\u002Finterstitial lung disease\n* Has symptomatic pleural effusion (for example cough, dyspnea, pleuritic chest pain), ascites, or pericardial fluid requiring drainage within 4 weeks prior to randomization\n* Has a gastrointestinal disorder including those associated with a high risk of perforation or fistula formation\n* Has a serious active nonhealing wound\u002Fulcer\u002Fbone fracture\n* Has a requirement for hemodialysis or peritoneal dialysis\n* Has history of human immunodeficiency virus infection\n* Has hepatitis B or hepatitis C virus\n* Has pharmacologically uncompensated, symptomatic hypothyroidism\n* Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention",{"count":370,"type":22},904,[372],"PHASE3","Researchers are looking for more ways to treat advanced renal cell carcinoma (RCC) that is recurrent. Researchers want to learn if recurrent advanced renal cell carcinoma (RCC) responds (gets smaller or goes away) after treatment with belzutifan (MK-6482) and zanzalintinib compared to cabozantinib.\n\nThe goal of this study is to learn if:\n\nPeople who take belzutifan and zanzalintinib live longer overall and without the cancer getting worse than people who take cabozantinib.",[33],[376,377,378,379],"Carcinoma","Renal cell","Belzutifan","Zanzalintinib",{"date":325,"type":54},{"date":382,"type":54},"2025-11-26",{"date":384,"type":22},"2032-02-27",{"name":386,"class":61},"Merck Sharp & Dohme LLC",127,{"id":389,"slug":390,"hasResults":12,"nctId":391,"briefTitle":392,"officialTitle":393,"acronym":4,"eligibilityCriteria":394,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":395,"targetDuration":4,"studyType":153,"phases":4,"briefSummary":397,"conditions":398,"keywords":401,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":352,"lastUpdatePostDateStruct":404,"startDateStruct":405,"completionDateStruct":407,"leadSponsor":409,"locationsCount":94},"100521972","petmr-for-characterization-of-renal-masses-rms-100521972","NCT06076538","PET\u002FMR for Characterization of Renal Masses (RMs)","Prospective Observational Study Using PET\u002FMR for Characterization of Renal Masses (RMs)","Inclusion Criteria:\n\n* Patients with known solid (\\>25% total volume enhances) renal mass\n* Renal mass size measuring \\>2 to ≤7 cm\n* Age \\>18 years\n* Ability to understand and the willingness to sign a written informed consent.\n\nExclusion Criteria:\n\n* Pregnancy\n* Prior percutaneous biopsy of the renal mass\n* Prior treatment of the renal mass\n* Prior hemorrhage in the renal mass\n* Contraindication to MRI or PET\n* Renal mass not eligible for ccLS based on prior imaging (i.e., containing macroscopic fat \\[classic angiomyolipoma\\] or enhancing less than 25% of its volume \\[considered a cystic renal mass\\])\n* Genetic syndrome predisposing to renal masses (e.g., VHL, BHD, TSC, etc.);\n* More than 3 renal masses at time of initial diagnosis",{"count":396,"type":22},97,"The frequency of kidney tumors found incidentally on imaging studies performed for unrelated reasons continues to increase leading to more surgeries and ablations for the treatment of renal masses thought to be cancer. However, about 20% of these masses are not cancerous and do not require treatment. Many cancerous kidney tumors are indolent and can be followed safely with imaging (i.e., particularly tumors \\\u003C2 cm and in patients with limited life expectancy), while some tumors are both malignant and aggressive, with a higher potential to spread outside the kidney and require treatment.\n\nThe purpose of this observational study is to assess the ability of Fludeoxyglucose (18F) (FDG) PET\u002FMR to distinguish different types of kidney tumors. The investigators hypothesize that PET\u002FMR will better show differences between aggressive and both indolent and benign kidney masses compared to the currently used radiologic scans.\n\nParticipants will be selected from those who have been scheduled to receive a contrast-enhanced MRI for their regular care due to a suspicious kidney mass. Participants will have their MRI on a hybrid PET\u002FMR scanner capable of obtaining both MRI and PET images. While they are receiving their standard of care MRI exam, patients will also receive a research FDG PET exam. Participants will have an IV placed for administration of the MRI contrast agent, just as they would if they were not taking part in the study. The same IV will be used to give the FDG radiopharmaceutical for the PET scan and furosemide (a diuretic), to help empty the bladder before the scan and help better see the kidneys on the scans. Both FDG and furosemide are FDA approved medications. Participants will have only one visit with the research team which will last \\~2.5 hours and will include collection of the participant's regularly scheduled MRI.\n\nIf participants undergo surgery to remove the tumor, the study will collect samples of the removed tissue for research. If participants receive a biopsy of the tumor, the study may collect an additional sample of the tumor for research.\n\nAfter the PET\u002FMRI, participants will not have additional visits with the study team, but the study team may call every 6-12 months for up to 2 years to see how they are doing and ask about their health. The study team will review the medical record for any changes to their diagnosis, updates to their medical history, new scans ordered by their regular doctor, or recent lab or biopsy results.",[399,33,400],"Renal Tumor","Renal Tumor, Benign",[402,33,403],"Renal Mass","PET\u002FMR",{"date":286,"type":54},{"date":406,"type":54},"2023-08-01",{"date":408,"type":22},"2028-06-01",{"name":410,"class":93},"University of Texas Southwestern Medical Center",{"id":412,"slug":413,"hasResults":12,"nctId":414,"briefTitle":415,"officialTitle":416,"acronym":4,"eligibilityCriteria":417,"healthyVolunteers":12,"sex":17,"minAge":418,"maxAge":4,"enrollmentInfo":419,"targetDuration":4,"studyType":23,"phases":421,"briefSummary":422,"conditions":423,"keywords":4,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":211,"lastUpdatePostDateStruct":429,"startDateStruct":430,"completionDateStruct":432,"leadSponsor":434,"locationsCount":118},"100437840","phase-2-testing-of-bevacizumab-erlotinib-and-atezolizumab-in-combination-for-advanced-stage-kidney-cancer-100437840","NCT04981509","Testing of Bevacizumab, Erlotinib, and Atezolizumab in Combination for Advanced-Stage Kidney Cancer","A Phase 2 Study of Bevacizumab, Erlotinib and Atezolizumab in Subjects With Advanced Hereditary Leiomyomatosis and Renal Cell Cancer (HLRCC) Associated or Sporadic Papillary Renal Cell Cancer","Inclusion Criteria:\n\n* Patients must have:\n\n  * A diagnosis of HLRCC with a histologic or cytologic confirmation of RCC consistent with this diagnosis (Cohort 1) OR\n  * Cytologically or histologically confirmed sporadic\u002Fnon-HLRCC papillary renal cell carcinoma (presence of papillary component) (Cohort 2)\n* Patients must have advanced RCC with measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as \\>= 20 mm (\\>= 2 cm) by chest x-ray or as \\>= 10 mm (\\>= 1 cm) with CT scan, MRI, or calipers by clinical exam. To be considered pathologically enlarged and measurable, a lymph node must be \\>= 15 mm (\\>= 1.5 cm) in short axis\n* Patients must have received no more than two prior regimens targeting the VEGF pathway and no prior bevacizumab therapy in the metastatic\u002Fadvanced setting. No prior treatment with PD-1 or PD-L1 inhibitors in the metastatic\u002Fadvanced setting. No prior therapy is required for eligibility\n* Age \\>= 12 years\n* Eastern Cooperative Oncology Group (ECOG) performance status =\\\u003C 2 (Karnofsky \\>= 60%)\n* Absolute neutrophil count \\>= 1,000\u002FmcL\n* Platelets \\>= 100,000\u002FmcL\n* Total bilirubin =\\\u003C 1.5 x institutional upper limit of normal (ULN) (\\\u003C 3 x upper limit of reference range in patients with known\u002Fsuspected Gilbert's disease)\n* Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \\[SGOT\\])\u002Falanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \\[SGPT\\]) =\\\u003C 2.5 x institutional ULN (or =\\\u003C 5 x upper limit of reference range if considered to be related to liver or bone metastases by the principal investigator \\[PI\\])\n* Alkaline phosphatase =\\\u003C 2.5 x institutional ULN (or =\\\u003C 5 x upper limit of reference range if considered to be related to liver or bone metastases by the PI)\n\n  * Note: For pediatric patients (\\\u003C 18 years of age), ULN for alkaline phosphatase will be defined as 390 IU\u002FL for males and 320 IU\u002FL for females\n* Glomerular filtration rate (GFR) \\>= 30 mL\u002Fmin\u002F1.73 m\\^2\n\n  * Note: For pediatric patients (\\\u003C 18 years of age) the following creatinine thresholds will be utilized. Patients with a creatinine that exceeds this threshold will require further testing with a confirmation of GFR \\>= 40 as determined by either 24-hour urine collection or with radioisotope based nuclear medicine evaluation\n  * Age: 12 to \\\u003C 13 years; Maximum serum creatinine (mg\u002FdL): 1.2 (male); 1.2 (female)\n  * Age: 13 to \\\u003C 16 years; Maximum serum creatinine (mg\u002FdL): 1.5 (male); 1.4 (female)\n  * Age: 16 to \\\u003C 18 years; Maximum serum creatinine (mg\u002FdL): 1.7 (male); 1.4 (female)\n\n    * The threshold creatinine values in this table were derived from the Schwartz formula for estimating GFR, utilizing child length and stature data published by the Centers for Disease Control and Prevention (CDC)\n* Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with an undetectable viral load within 6 months are eligible for this trial\n* For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated\n* Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load\n* Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression\u002Frecurrence for \\>= 3 months and the patient no longer requires more than a physiologic dose of steroids\n* Patients does not have a prior or concurrent invasive malignancy; patients are eligible if a prior or concurrent invasive malignancy exists, but the natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen\n* Patients with a known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better\n* The effects of study drugs on the developing human fetus are unknown. For this reason, all women and men of childbearing potential must agree to use adequate contraception (including but not limited to abstinence, barrier methods, hormonal contraceptives \\[birth control pills, injections, or implants\\], intrauterine device \\[IUD\\], tubal ligation, vasectomy) prior to study entry and for 6 months after completion of study therapy. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, and 6 months after completion of study drugs administration\n* Subjects must provide archival tissue block or unstained tumor tissue or be willing to undergo biopsy to collect samples for retrospective central pathology review\n* The ability of subject or parent\u002Fguardian to understand and the willingness to sign a written informed consent document or subjects with impaired decision making capacity (IDMC) if they are represented by a legally authorized representative (LAR)\n\nExclusion Criteria:\n\n* Any prior systemic therapy to treat the patient's kidney cancer within 4 weeks or, if known, 5 half-lives of the prior agent (whichever is shorter) prior to cycle 1 day 1\n* Other prior therapies for kidney cancer: Radiotherapy \\\u003C 2 weeks prior to cycle 1, day 1\n* Major surgical procedure \\\u003C 28 days before cycle 1, day 1. Surgical wounds must be healed prior to starting therapy\n* Patients who have not recovered from adverse events due to prior systemic anti-cancer therapy (i.e., have residual toxicities \\> grade 1 of the Common Terminology Criteria for Adverse Events \\[CTCAE\\] version \\[v\\]5, pre-treatment baseline or to a level permitted under other sections of inclusion\u002Fexclusion criteria) with the exception of alopecia or electrolyte abnormalities that can be corrected to =\\\u003C grade 1 prior to treatment initiation\n* Treatment with any other investigational agent within 4 weeks prior to cycle 1, day 1\n* Treatment with systemic immunostimulatory agents (including, but not limited to, interferon \\[IFN\\]-alpha or interleukin \\[IL\\]-2) within 6 weeks prior to cycle 1, day 1\n* Treatment with systemic immunosuppressive medications (including, but not limited to, prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor \\[anti-TNF\\] agents) within 2 weeks prior to cycle 1, day 1\n\n  * Patients who have received acute, low dose, systemic immunosuppressant medications (e.g., a one-time dose of dexamethasone for nausea or for purposes of pre-medication prior to radiology studies) may be enrolled\n  * The use of inhaled corticosteroids and mineralocorticoids (e.g., fludrocortisone) for patients with orthostatic hypotension or adrenocortical insufficiency is allowed\n* Hypercalcemia \\> grade 1 of the CTCAE v5 that is not corrected prior to treatment initiation\n* Patients taking bisphosphonate therapy for symptomatic hypercalcemia. Use of bisphosphonate therapy for other reasons (e.g., bone metastasis or osteoporosis) is allowed\n* History of autoimmune disease, including, but not limited to, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjogren's syndrome, Bell's palsy, Guillain-Barre syndrome, multiple sclerosis, autoimmune thyroid disease, vasculitis, or glomerulonephritis\n\n  * Patients with a history of autoimmune hypothyroidism on a stable dose of thyroid replacement hormone may be eligible\n  * Patients with controlled type 1 diabetes mellitus on a stable insulin regimen may be eligible\n  * Patients with eczema, psoriasis, lichen simplex chronicus of vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis would be excluded) are permitted provided that they meet the following conditions:\n\n    * Patients with psoriasis must have a baseline ophthalmologic exam to rule out ocular manifestations\n    * Rash must cover less than 10% of body surface area (BSA)\n    * The disease is well controlled at baseline and only requiring low potency topical steroids (e.g., hydrocortisone 2.5%, hydrocortisone butyrate 0.1%, fluocinolone 0.01%, desonide 0.05%, alclometasone dipropionate 0.05%)\n    * No acute exacerbations of the underlying condition within the last 12 months (not requiring psoralen plus ultraviolet A radiation \\[PUVA\\], methotrexate, retinoids, biologic agents, oral calcineurin inhibitors; high potency or oral steroids)\n* History of idiopathic pulmonary fibrosis, pneumonitis (including drug-induced), organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing pneumonia, etc.), or evidence of active pneumonitis. History of radiation pneumonitis in the radiation field (fibrosis) is permitted\n* Patients with untreated latent or active tuberculosis (TB) are excluded\n* Severe infections within 4 weeks prior to cycle 1, day 1, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia\n* Administration of a live, attenuated vaccine within 4 weeks before cycle 1, day 1 or anticipation that such a live, attenuated vaccine will be required during the study and up to 5 months after the last dose of atezolizumab\n\n  * NOTE: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (e.g., Flu-Mist) are live attenuated vaccines and are not allowed. Influenza vaccination should be given during influenza season only (approximately October to March)\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection requiring intravenous antibiotics, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n* Poorly controlled hypertension with at least 2 occasions of elevated blood pressure separated by a 24-hour periodd within a week before treatment initiation, despite optimal medical management. (Adults: resting systolic blood pressure greater than 140 mmHg or diastolic blood pressure greater than 90 mmHg. Pediatric \\[\\\u003C 18 years old\\]: Blood pressure \\[BP\\] \\>= the 95th percentile for age, height, and sex). History of hypertensive crisis or hypertensive encephalopathy\n* Patients with prior allogeneic bone marrow transplantation or prior solid organ transplantation\n* History of anaphylactic or severe allergic reactions attributed to compounds of similar chemical or biologic composition to the study agents\n* Patients with myocardial infarction, gastrointestinal (GI) perforation\u002Ffistula, intraabdominal abscess, or cerebrovascular accidents within 6 months before cycle 1, day 1\n* Documented baseline proteinuria \\> 1000 mg\u002Fday on 24-hour urine collection. Only patients with 1+ or greater proteinuria on urinalysis (UA) and a spot urine protein:creatinine ratio of \\> 0.5 will undergo a 24-hour urine collection for quantitation of proteinuria\n* Pregnant women are excluded from this study because study drugs may have the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with study drugs, breastfeeding should be discontinued if the mother is treated with study drugs\n* Serious, non-healing wound or ulcer; bone fracture within 3 months prior to treatment initiation\n* Concomitant therapy with systemic medications or herbal supplements that are known strong inhibitors or inducers of CYP450 3A4, or strong CYP1A2 inducers. To determine the impact of a concomitant drug on CYP enzymes see the FDA-approved product labeling and\u002For tertiary compendia (e.g., Inhibitors and Inducers of Cytochrome P450 Enzymes)\n* Patients who use tobacco or nicotine products and cannot stop their use of these products for the duration of study treatment\n* Significant vascular disease (e.g., aortic aneurysm requiring surgical repair or recent arterial thrombosis) within 6 months prior to cycle 1, day 1\n* History of or active hemoptysis within 1 month prior to cycle 1 day 1\n* History of grade \\>= 4 venous thromboembolism\n* History or evidence of inherited bleeding diathesis or significant coagulopathy at risk of bleeding (i.e., in the absence of therapeutic anticoagulation)\n* Current or recent (\\\u003C 10 days prior to initiation of study treatment) use of aspirin (\\> 325 mg\u002Fday), or clopidogrel (\\> 75 mg\u002Fday)\n\n  * Note: The use of full-dose oral or parenteral anticoagulants for therapeutic purpose is permitted as long as the International Normalized Ratio (INR) and\u002For a partial thromboplastin time (PTT) is within therapeutic limits (according to institution standards) within 7 days prior to initiation of study treatment and the patient has been on a stable dose of anticoagulants for \\>= 2 weeks prior to initiation of study treatment. Prophylactic use of anticoagulants is allowed. However, the use of direct oral anticoagulant therapies such as dabigatran (Pradaxa \\[registered trademark\\]) and rivaroxaban (Xarelto \\[registered trademark\\]) may be used per PI discretion","12 Years",{"count":420,"type":22},65,[73],"This phase II trial studies the effects of combination therapy with bevacizumab, erlotinib, and atezolizumab in treating patients with hereditary leiomyomatosis and kidney cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). Bevacizumab is in a class of medications called antiangiogenic agents. They work by stopping the formation of blood vessels that bring oxygen and nutrients to tumors. This may slow the growth and spread of tumors. Erlotinib is in a class of medications called kinase inhibitors. It works by blocking the action of a protein called EGFR that signals cancer cells to multiply. This helps slow or stop the spread of cancer cells. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Combination therapy with bevacizumab, erlotinib, and atezolizumab may stabilize or shrink advanced hereditary leiomyomatosis and kidney cancer.",[424,425,33,426,427,428],"Hereditary Leiomyomatosis and Renal Cell Carcinoma","Papillary Renal Cell Carcinoma","Sporadic Papillary Renal Cell Carcinoma","Stage III Renal Cell Cancer AJCC v8","Stage IV Renal Cell Cancer AJCC v8",{"date":352,"type":54},{"date":431,"type":54},"2022-06-10",{"date":433,"type":22},"2027-12-31",{"name":171,"class":172},{"id":436,"slug":437,"hasResults":12,"nctId":438,"briefTitle":439,"officialTitle":440,"acronym":4,"eligibilityCriteria":441,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":442,"targetDuration":4,"studyType":23,"phases":444,"briefSummary":445,"conditions":446,"keywords":4,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":471,"lastUpdatePostDateStruct":472,"startDateStruct":473,"completionDateStruct":475,"leadSponsor":477,"locationsCount":173},"100614857","phase-2-the-cancer-connected-access-and-remote-expertise-beyond-walls-program-to-provide-in-home-cancer-treatment-and-improve-treatment-satisfaction-in-cancer-patients-living-in-the-florida-panhandle-and-surrounding-areas-100614857","NCT07285044","The Cancer Connected Access and Remote Expertise Beyond Walls Program to Provide In-Home Cancer Treatment and Improve Treatment Satisfaction in Cancer Patients Living in the Florida Panhandle and Surrounding Areas","Cancer CARE (Connected Access and Remote Expertise) Beyond Walls - Pilot, Phase 2 Clinical Trial to Evaluate Administration of Cancer-Directed Therapy in the Patient's Homes Versus in Clinic in the Florida Panhandle and Surrounding Areas","Inclusion Criteria:\n\n* Patient has had adequate tolerability of their clinical standard of care treatment, in the opinion of their treating physician, and no clinically significant drug-related reactions occurred prior to consent\n* Participant must be receiving a standard-of-care treatment regimen listed in this protocol that is being used in accordance with standard medical practice. Specifically, it must be either a) Food and Drug Administration (FDA)-approved for the participant's disease indication, or b) recommended in nationally recognized professional guidelines (e.g. National Comprehensive Cancer Network \\[NCCN\\], American Society of Clinical Oncology \\[ASCO\\], American Society of Hematology \\[ASH\\], etc.) as standard of care for the disease indication. Off-label use is permitted only if supported by such guidelines\n* A social stability screener, used per standard of care, indicates patient is appropriate to participate in the CCBW program\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, 2 or 3 at the discretion of the treating physician\n* Female or male patients age \\>= 18 years at the time of consent\n* Willing and able to comply with the study protocol in the investigator's judgement\n* Patients with histologically confirmed malignancy who are currently receiving treatment with one of the eligible treatment regimens. Patients with hepatocellular carcinoma (HCC) are eligible based on imaging diagnosis alone: histologic confirmation is not required.\n\n  * Note: patients diagnosed with any of the following disease types may receive any of the eligible regimens listed. Additionally, patients receiving hormonal or immunotherapy, such as nivolumab or pembrolizumab, may receive these infusions in home supplemental to any of the regimens identified. Co-administration with hormonal agents such as anti-androgens, poly(ADP-ribose) polymerase (PARP) inhibitors, oral gonadotrophin releasing hormone (GnRh) antagonists, estrogens, selective estrogen receptor modulators (SERMs), or aromatase inhibitors are allowed, however combinations of oral regimens only are not permitted. Patients may receive any combination of any listed medications or regimens\n  * Eligible disease cancer types:\n\n    * Amyloidosis\n    * Basal cell carcinoma\n    * Biliary\n    * Bladder\n    * Breast\n    * Cervical\n    * Colorectal\n    * Endometrial\n    * Fallopian tube\n    * Gastroesophageal\n    * Glioblastoma\n    * Head and neck\n    * Hepatocellular\n    * Hodgkin lymphoma\n    * Lung\n    * Mantle cell lymphoma\n    * Merkle cell carcinoma\n    * Multiple myeloma\n    * Melanoma\n    * Myelodysplastic syndrome\n    * Ovarian\n    * Pancreatic\n    * Peritoneal\n    * Prostate\n    * Renal cell carcinoma\n    * Squamous cell carcinoma\n    * Urothelial carcinoma\n  * Eligible regimens\n\n    * Atezolizumab +\u002F- bevacizumab\n    * Avelumab\n    * Bevacizumab\n    * Bortezomib\n    * Cemiplimab\n    * Daratumumab +\u002F- bortezomib\n    * Darbepoetin alpha\n    * Degarelix\n    * Denosumab (Xgeva)\n    * Durvalumab\n    * Fluorouracil +\u002F- bevacizumab\n    * Fulvestrant\n    * Goserelin\n    * Ipilimumab +\u002F- Nivolumab\n    * Lanreotide\n    * Leuprolide\n    * Nivolumab\n    * Nivolumab + relatlimab\n    * Octreotide\n    * Pembrolizumab\n    * Pertuzumab +\u002F- trastuzumab\n    * Trastuzumab +\u002F- pertuzumab\n    * Zoledronic acid (Zometa)\n* Willingness to follow birth control requirements for females and males of reproductive potential\n* Resides within the Florida Panhandle and surrounding area serviced by the at-home healthcare supplier utilized for the study and a paramedic network\n* Patient's residence has an existing Wi-Fi connection or can be connected using using a mobile Wi-Fi device provided as part of the program so as to enable a reliable connection with the remote CCBW Command Center at Mayo Clinic\n* Patients who, according to documentation from their treating provider, plan to continue the eligible treatment regimen they are currently prescribed for \\>= 12 weeks from the time of registration\n* Provide written informed consent\n* Ability to complete questionnaire(s) by themselves or with assistance\n* Willing to return to enrolling institution for follow-up (during the Active Monitoring Phase of the study)\n\nExclusion Criteria:\n\n* Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens\n* Receiving any investigational agent which would be considered as a treatment for the primary neoplasm.\n\n  * Note: oral concomitant medications for oncologic indications will be maintained per standard of care treatment and not considered part of the trial. Any nononcologic medication, regardless of route of administration will be maintained per standard of care treatment and also not considered part of the trial; therefore, patients receiving oral anti-cancer or other medications per standard of care treatment in addition to any of the medications listed are considered eligible for this trial\n* Individuals who require continuous (24\u002F7) assistance with daily living and are unable to independently manage the technology required for study participation, unless a caregiver is available and willing to provide consistent support throughout the study\n* Current inpatient hospitalization (excluding admission to the Advanced Care at Home program)",{"count":443,"type":22},27,[73],"This phase II trial studies whether providing cancer treatment in the home is preferred over the traditional clinic setting and if it improves treatment satisfaction in cancer patients living in the Florida Panhandle and surrounding areas. Typically, drug-related cancer care is provided at a medical center which causes patients to have to spend considerable time away from their family, friends, and familiar surroundings. This may add to the physical, emotional, social, and financial burden for patients and their families during this difficult time in their lives. The Cancer Connected Access and Remote Expertise (CARE) Beyond Walls (CCBW) program uses a specialized care team trained to provide cancer treatment in the patient's home setting. It is designed to support remote connection between the home health team and providers and Mayo clinic. This may be preferred over the traditional clinic setting which may improve treatment satisfaction in cancer patients living in the Florida Panhandle and surrounding areas.",[447,448,449,450,451,452,453,454,455,456,457,458,459,30,460,461,462,463,106,108,464,465,466,467,468,469,33,470,38],"Amyloidosis","Basal Cell Carcinoma","Biliary Tract Carcinoma","Bladder Carcinoma","Breast Carcinoma","Cervical Carcinoma","Colorectal Carcinoma","Endometrial Carcinoma","Fallopian Tube Carcinoma","Gastroesophageal Junction Carcinoma","Glioblastoma","Head and Neck Carcinoma","Hematopoietic and Lymphatic System Neoplasm","Hodgkin Lymphoma","Lung Carcinoma","Malignant Solid Neoplasm","Mantle Cell Lymphoma","Multiple Myeloma","Myelodysplastic Syndrome","Ovarian Carcinoma","Pancreatic Carcinoma","Primary Peritoneal Carcinoma","Prostate Carcinoma","Squamous Cell Carcinoma","2026-07-28",{"date":211,"type":54},{"date":474,"type":54},"2025-12-18",{"date":476,"type":22},"2026-12-18",{"name":478,"class":93},"Mayo Clinic",{"id":480,"slug":481,"hasResults":12,"nctId":482,"briefTitle":483,"officialTitle":484,"acronym":4,"eligibilityCriteria":485,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":486,"targetDuration":4,"studyType":23,"phases":488,"briefSummary":489,"conditions":490,"keywords":494,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":471,"lastUpdatePostDateStruct":521,"startDateStruct":523,"completionDateStruct":525,"leadSponsor":527,"locationsCount":529},"100377763","phase-1-study-of-inbrx-106-and-inbrx-106-in-combination-with-pembrolizumab-keytruda-in-subjects-with-locally-advanced-or-metastatic-solid-tumors-hexavalent-ox40-agonist-100377763","NCT04198766","Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)","An Open-Label, Multicenter, First-in-Human, Dose-Escalation, Multicohort, Phase 1\u002F2 Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab in Subjects With Locally Advanced or Metastatic Solid Tumors","Select Inclusion Criteria:\n\n* Males or females aged ≥18 years.\n* Parts 1 and 3 (escalation cohorts): Subjects with locally advanced or metastatic non resectable solid tumors, whose disease has progressed despite all standard therapies or for whom no further standard or clinically acceptable therapy exists.\n* Part 2 (single-agent expansion cohort): Subjects with NSCLC, melanoma, HNSCC, G\u002FGEA, RCC, or TCC, with histologically confirmed, locally advanced or metastatic, non-resectable disease, which has progressed despite all standard therapies including CPI or for whom no standard or clinically acceptable therapy exists.\n* Part 4 (expansion cohorts in combination with pembrolizumab, with or without chemotherapy): Subjects with melanoma (all types), HNSCC, G\u002FGEA, RCC, TCC, NSCLC, or MSI-high, TMB-high, MMR-deficient tumors, with histologically confirmed, locally advanced or metastatic, non resectable disease, which is either CPI-naive (melanoma, HNSCC, NPC) or progressed despite all standard therapies including CPI (NSCLC, RCC, TCC, uveal melanoma, MSI-high, TMB-high, or MMR-deficient solid tumors) or for whom no standard or clinically acceptable therapy exists.\n* For Cohort F3 (NSCLC), subjects may have progressed on no more than 2 lines of standard therapy that must include at least one PD-1\u002FL1 regimen.\n* For Cohort F4 (HNSCC and NPC), subjects may be previously treated with no more than 1 prior chemotherapy regimen in metastatic setting. Prior PD-1\u002FL1 in curative (neo-adjuvant\u002Fadjuvant) setting is allowed only if completed \\>\u002F= 6 months prior to progression to local recurrence or metastatic disease.\n* For Cohort F8, subjects must have previously untreated, histologically confirmed Stage II, IIIA or IIIB (T3-4N2) NSCLC. Lymph node disease requires histologic confirmation, while T3 disease requires only radiographic documentation. Subjects need to be able to undergo planned surgery.\n* All subjects with non-squamous NSCLC must have documentation of absence of tumor activating EGFR mutations and absence of ALK gene rearrangements.\n* PD-L1 by IHC (22C3): Parts 1 and 3: IHC optional. Part 2: IHC result mandatory but any score allowed. Combined Positive Score (CPS) ≥ 1% (or Tumor Proportion Score ≥50% for NSCLC; for TMB-high tumors, any TPS% is allowed). Part 4: Combined Positive Score (CPS) ≥ 1% (or Tumor Proportion Score ≥50% for NSCLC; for TMB-high tumors, any TPS% is allowed). For Cohort F8, any TPS (including 0%) is acceptable.\n* Adequate hematologic, coagulation, hepatic and renal function and ECOG score as defined per protocol.\n\nSelect Exclusion Criteria:\n\n* Prior exposure to OX40 agonists. Exposure to anti-PD-1 and\u002For anti PD-L2 CPIs or an agent targeting other co-stimulatory T-cell receptor pathways.\n* Receipt of any investigational product or any approved anticancer drug(s) or biological product(s) within 4 weeks prior to the first dose of study drug with certain exceptions.\n* Hematologic malignancies (e.g., ALL, AML, MDS, CLL, CML, NHL, Hodgkin's lymphoma and multiple myeloma)\n* Prior or concurrent malignancies. Exception: Subjects with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessments of INBRX-106.\n* Grade ≥ 3 immune-related adverse events (irAEs) or irAE that lead to discontinuation of prior immunotherapy. Some exceptions as defined per protocol apply.\n* Active autoimmune disease or documented history of autoimmune disease that required systemic steroids or other immunosuppressive medications. Certain exceptions as defined in protocol apply.\n* Diagnosis of immunodeficiency or treatment with systemic immunosuppressive medications within 7 days prior to the first dose of study drug. Certain exceptions as defined in protocol apply.\n* History of hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) infection. Exceptions as defined in protocol apply.\n* Active interstitial lung disease (ILD) or pneumonitis or a history of ILD or pneumonitis requiring treatment with steroids or other immunosuppressive medications.\n* Clinically significant cardiac condition, including myocardial infarction, uncontrolled angina, viral myocarditis, cerebrovascular accident, or other acute uncontrolled heart disease \\\u003C 3 months prior to enrollment on this trial; left ventricular ejection fraction (LVEF) \\\u003C 50%; New York Heart Association (NYHA) Class III or IV congestive heart failure; or uncontrolled hypertension; or oxygen saturation \\\u003C92% on room air.\n* Active, hemodynamically significant pulmonary embolism within 12 weeks prior to enrollment on this trial.\n* Major surgery within 4 weeks prior to enrollment on this trial.\n* Anti-infectious drug treatments (i.e., antibiotics) within 4 weeks prior to the first dose of study drug.\n* Prior organ allograft transplantations or allogeneic peripheral blood stem cell (PBSC) or bone marrow (BM) transplantation.\n* Additional in- and exclusion criteria per protocol.",{"count":487,"type":22},340,[25,73],"This is a Phase 1\u002F2, open-label, non-randomized, 4-part trial to determine the safety profile and identify the maximum tolerated dose (MTD) and\u002For recommended Phase 2 dose (RP2D) of INBRX 106 administered as a single agent or in combination with the anti-PD-1 checkpoint inhibitor (CPI) pembrolizumab (Keytruda®). KEYTRUDA is a registered trademark of Merck Sharp \\& Dohme LLC, a subsidiary of Merck \\& Co., Inc., Rahway, NJ, USA.",[28,491,492,106,308,33,38,493],"Non-Small Cell Lung Cancer","Head and Neck Cancer","Resectable Non-Small-Cell Lung Cancer",[495,496,497,492,313,491,498,499,500,501,502,323,503,504,505,506,507,508,509,510,511,512,513,376,514,515,516,517,518,43,519,520],"Phase 1 and Phase 2","Phase 1 and Phase 2 Clinical Trial","Solid Tumors","OX40 receptor agonist","PD-L1 positive","Pembrolizumab","Keytruda","Chemotherapy","HNSCC","Oropharyngeal cancer","Hypopharyngeal cancer","Oral cancer","INBRX-106","Neoplasms, Glandular and Epithelial","Neoplasms by Histologic Type","Neoplasms","Neoplasms, Squamous Cell","Head and Neck Neoplasms","Neoplasms by Site","Carcinoma, Squamous Cell","Molecular Mechanisms of Pharmacological Action","Antineoplastic Agents, Immunological","Antineoplastic Agents","Squamous Cell Carcinoma of Head and Neck","Neoadjuvant","Adjuvant",{"date":522,"type":54},"2026-07-29",{"date":524,"type":54},"2019-12-10",{"date":526,"type":22},"2033-07",{"name":528,"class":61},"Inhibrx Biosciences, Inc",42,{"id":531,"slug":532,"hasResults":12,"nctId":533,"briefTitle":534,"officialTitle":535,"acronym":536,"eligibilityCriteria":537,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":538,"enrollmentInfo":539,"targetDuration":4,"studyType":153,"phases":4,"briefSummary":541,"conditions":542,"keywords":4,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":559,"lastUpdatePostDateStruct":560,"startDateStruct":562,"completionDateStruct":564,"leadSponsor":566,"locationsCount":567},"100602476","destiny-pantumour04-100602476","NCT07124000","DESTINY-PANTUMOUR04","Effectiveness of T-DXd Across HER2-positive Solid Tumors in Patients Who Have Received Prior Systemic Treatment and Have no Satisfactory Alternative Treatment Options: A Hybrid Observational Study","DP-04","Inclusion Criteria:\n\n1. Adults aged ≥18 years\n2. Patients with locally advanced, unresectable, or metastatic HER2-positive (IHC 3+) solid tumors who have received prior systemic treatment for metastatic or advanced disease and have no satisfactory alternative treatment options as determined by the Investigator (see Exclusion Criterion 1 for excluded solid tumors);\n3. A clinician decision has been made for treatment with T-DXd in accordance with the FDA label;\n4. HER2-positive (IHC 3+) by local testing prior to study enrolment at the time of signed and dated informed consent;\n5. Patients who are willing and able to provide a signed and dated informed consent.\n\nExclusion Criteria:\n\n1. Primary diagnosis of adenocarcinoma of the breast, adenocarcinoma of the colon or rectum, NSCLC, adenocarcinoma of the gastric body or gastroesophageal junction or hematological malignancies;\n2. Prior T-DXd therapy;\n3. Patients without a baseline assessment of tumor burden undertaken prior to initiating T-DXd.\n4. Patient is participating in a clinical trial at time of enrolment","130 Years",{"count":540,"type":22},100,"This study will evaluate the effectiveness of T-DXd in patients with HER2-positive (IHC 3+) locally advanced, unresectable, or metastatic solid tumors who have received prior systemic treatment for metastatic or advanced disease and have no satisfactory alternative treatment options in a real-world setting in the US",[543,544,312,35,34,309,545,546,492,547,106,548,549,550,49,307,314,33,551,311,552,553,554,555,556,557,558],"Adenocarcinoma (NOS)","Anal Cancer","Gall Bladder Cancer","Gastrointestinal Stromal Tumour","Liver Cancer","Mouth Cancer","Nasopharangeal Cancer","Neuroendocrine, Gastrointestinal Cancer","Salivary Gland Cancer","Small Cell Lung Cancer","Testicular Cancer","Throat Cancer","Thyroid Cancer","Urethral Cancer","Vaginal Cancer","Vulvar Cancer","2026-07-21",{"date":561,"type":54},"2026-07-22",{"date":563,"type":54},"2025-09-18",{"date":565,"type":22},"2028-03-30",{"name":117,"class":61},18,{"id":569,"slug":570,"hasResults":12,"nctId":571,"briefTitle":572,"officialTitle":573,"acronym":4,"eligibilityCriteria":574,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":575,"targetDuration":4,"studyType":23,"phases":577,"briefSummary":578,"conditions":579,"keywords":589,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":601,"lastUpdatePostDateStruct":602,"startDateStruct":604,"completionDateStruct":606,"leadSponsor":608,"locationsCount":610},"100519732","phase-1-safety-and-efficacy-of-neo212-in-patients-with-astrocytoma-idh-mutant-glioblastoma-idh-wildtype-or-brain-metastasis-100519732","NCT06047379","Safety and Efficacy of NEO212 in Patients With Astrocytoma IDH-mutant, Glioblastoma IDH-wildtype or Brain Metastasis","An Open-label Phase 1\u002F2 Dose Finding, Safety and Efficacy Study of Oral NEO212 in Patients With Astrocytoma IDH-mutant, Glioblastoma IDH-wildtype or Uncontrolled Brain Metastasis in Patients With Select Solid Tumors.","Inclusion Criteria:\n\n* Patient must be ≥ 18yrs of age.\n* Patient must have the ability to understand, and the willingness to sign, a written informed consent form.\n* Patient has been on a stable or decreasing dose of steroids for at least five days prior to the date of informed consent.\n* Any toxicity from prior therapy must be resolved or at maximum Grade 1 prior to initiation of NEO212.\n* If progression of disease occurs within 90 days or conformal radiation, the progression\u002Frecurrence must be outside of the radiation field or proven by biopsy\u002Fresection.\n* Patient with Astrocytoma IDH-mutant, Glioblastoma IDH-wildtype must have a Karnofsky Performance Status (KPS) of ≥ 60.\n* Patient with select solid tumors must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.\n* Patient must have an expected survival or at least three months.\n* Patient must have a baseline MRI of the brain with gadolinium within 14 days of administration of NEO212.\n* Patient with select solid tumors must have a baseline CT scan with IV contrast and oral contrast of neck, chest, abdomen and pelvis within 14 days of administration of NEO212.\n* Patients must be able to comply with all study assessments.\n* If patient suffers from seizures (s)he must be controlled on a stable dose of anti-epileptics for 14-days prior to the date of informed consent.\n* Patient must have adequate organ and marrow function as follows:\n\n  * Absolute neutrophil count ≥ 1,500\u002Fmicroliter\n  * Platelets ≥ 100,000\u002Fmicroliter\n  * Total bilirubin within normal institutional limits\n  * AST (SGOT) \u002F ALT (SPGT) ≤ 2.5 x institutional upper limit of normal\n  * Creatinine clearance (CrCl) of \\>60 mL\u002Fmin (using the Cockcroft-Gault formula or 24- hour urine collection).\n* Female patients of child-bearing potential and male patients must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) for 30 days prior to the first dose of NEO212, for the duration of study participation, and for 90 days following completion of therapy.\n\nA female of child-bearing potential is any women (regardless of sexual orientation, not having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:\n\n* Has not undergone a hysterectomy or bilateral oophorectomy; or\n* Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has not had menses at any time in the preceding 12 consecutive months).\n* A negative serum pregnancy test will be required of all female patients of child-bearing potential within seven days prior to the receipt of NEO212.\n* A serum pregnancy test will be repeated immediately if pregnancy is suspected.\n\nPhase 1: (dose escalation)\n\n* Patient must:\n\n  * have radiographically confirmed Astrocytoma IDH-mutant, Glioblastoma IDH-wildtype following previous radiation therapy or treatment with temozolomide and radiation, or\n  * have select solid tumors with uncontrolled metastases to the brain (confirmed by cranial CT or MRI) that is not controlled by surgery or radiation therapy and receiving one of the protocol approved SOC regimens.\n* Patients receiving prior systemic therapy must have a minimum wash-out period (defined as the period prior to receipt of the first dose of NEO212) of:\n\n  * 28 days or 5 half-lives (whichever is shorter) elapsed from the administration from any experimental agent;\n  * 2 weeks from administration of immunotherapies;\n  * 28 days from administration of cytotoxic agents; and\n  * 7 days from administration of non-cytotoxic agents (interferon, tamoxifen, thalidomide, cis-retinoic acid, and herbal medicine).\n\nNOTE: No washout is necessary for alternating electrical fields.\n\nPhase 2a: (safety run-in)\n\n* Patient must have select solid tumors with uncontrolled metastases to the brain (confirmed by cranial CT or MRI) that is not controlled by surgery or radiation therapy and receiving one of the protocol approved SOC regimens.\n* Patients receiving prior systemic therapy must be receiving one of the protocol approved Standard of Care (SOC) regimens.\n* Patient must have measurable\u002Fevaluable CNS disease per RANO or RANO-BM criteria.\n* Patient must have measurable\u002Fevaluable systemic disease per RECIST v1.1 criteria.\n\nPhase 2b: (efficacy)\n\n* Patient must:\n\n  * have radiographically confirmed Astrocytoma IDH-mutant, Glioblastoma IDH-wildtype following previous radiation therapy or treatment with temozolomide and radiation, or\n  * have select solid tumors with uncontrolled metastases to the brain (confirmed by cranial CT or MRI) that is not controlled by surgery or radiation therapy and receiving one of the protocol approved SOC regimens.\n* Patients receiving prior systemic therapy must be receiving one of the protocol approved Standard of Care (SOC) regimens.\n* Patient must have measurable\u002Fevaluable CNS disease per RANO or RANO-BM criteria\n* Patient with select solid tumors must have measurable\u002Fevaluable systemic disease per RECIST v1.1 criteria.\n* Creatinine clearance (CrCl) of \\>60 mL\u002Fmin (using the Cockcroft-Gault formula or 24-hour urine collection). Female patients of child-bearing potential and male patients must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) for 30 days prior to the first dose of NEO212, for the duration of study participation, and for 90 days following completion of therapy.\n\nExclusion Criteria: (all Phases)\n\n* Patient in Phase 1 concurrently receiving any other antitumor therapy.\n* Patient in Phase 2a or 2b who is concurrently receiving any SOC therapy not listed in Appendix 1.\n* Patients with metastases to the spinal cord parenchyma.\n* Patients with metastases to the meninges.\n* Patient has received stereotactic or highly conformal radiotherapy to CNS lesions within 2 weeks before receipt of NEO212.\n* Patient with history of known leptomeningeal involvement.\n* Patient has prior history or new diagnosis of secondary cancer within five years prior to the date of informed consent, except for basal cell carcinoma or squamous cell carcinoma of the skin.\n* Patient has a corrected QT interval (using Fridericia's correction formula) (QTcF) of \\>470 msec, a history of additional risk factors for TdP (e.g. heart failure, hypokalemia), and\u002For the use of concomitant medications that prolong QT\u002FQTc interval.\n* Patient had surgery within 7 days prior to the date of informed consent.\n* Patient has not recovered to Grade 1 from treatment related adverse events due to chemotherapy, immunotherapy, or radiation therapy.\n* Patient had prior treatment with perillyl alcohol.\n* Patient has a history of allergic reactions attributed to perillyl alcohol.\n* Patients in Phase 2b with Astrocytoma IDH-mutant, or Glioblastoma IDH-wildtype who have had more than one recurrence or progression of his\u002Fher primary CNS tumor(s).",{"count":576,"type":22},134,[25,73],"This multi-site, Phase 1\u002F2 clinical trial is an open-label study to identify the safety, pharmacokinetics, and efficacy of a repeated dose regimen of NEO212 alone for the treatment of patients with radiographically-confirmed progression of Astrocytoma IDH- mutant, Glioblastoma IDH-wildtype, and the safety, pharmacokinetics and efficacy of a repeated dose regimen of NEO212 when given with select SOC for the treatment of solid tumor patients with radiographically confirmed uncontrolled metastases to the brain.\n\nThe study will have three phases, Phase 1, Phase 2a and Phase 2b.",[580,581,582,35,31,309,583,308,584,32,106,108,585,586,587,588,29,33,552,470,38],"Diffuse Astrocytoma, IDH-Mutant","Glioblastoma, IDH-wildtype","Brain Metastases, Adult","Esophageal Squamous Cell Carcinoma","Gastroesophageal Junction Adenocarcinoma","Microsatellite Instability-High Solid Malignant Tumor","Mismatch Repair Deficient Solid Malignant Tumor","Microsatellite Instability-High Colorectal Cancer","Mismatch Repair Deficient Colorectal Cancer",[590,591,457,592,593,594,595,596,597,598,599,600],"Astrocytoma","IDH-mutant","IDH-wildtype","Brain Metastases","CNS Tumor","GBM","NeOnc","Anova","NEO212","NEO100","TMZ","2026-07-15",{"date":603,"type":54},"2026-07-16",{"date":605,"type":54},"2023-11-01",{"date":607,"type":22},"2027-08-31",{"name":609,"class":61},"Neonc Technologies, Inc.",7,{"id":612,"slug":613,"hasResults":12,"nctId":614,"briefTitle":615,"officialTitle":616,"acronym":4,"eligibilityCriteria":617,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":618,"enrollmentInfo":619,"targetDuration":4,"studyType":23,"phases":621,"briefSummary":622,"conditions":623,"keywords":624,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":627,"lastUpdatePostDateStruct":628,"startDateStruct":629,"completionDateStruct":631,"leadSponsor":633,"locationsCount":182},"100596780","phase-1-substudy-03c-a-study-of-combination-therapies-in-participants-with-renal-cell-carcinoma-with-recurrent-disease-during-or-after-anti-pd-l1-therapy-mk-3475-03ckeymaker-u03-100596780","NCT07049926","Substudy 03C: A Study of Combination Therapies in Participants With Renal Cell Carcinoma With Recurrent Disease During or After Anti-PD-(L)1 Therapy (MK-3475-03C\u002FKEYMAKER-U03)","A Phase 1b\u002F2 Study of Immune and Targeted Combination Therapies in Participants With RCC (KEYMAKER-U03): Substudy 03C in Participants With Recurrent Disease During or After Anti-PD-(L)1 Adjuvant Therapy","The main inclusion criteria include but are not limited to the following:\n\n* Has a histologically confirmed diagnosis of unresectable locally advanced\u002Fmetastatic renal cell carcinoma (RCC) with clear cell component\n* Has received no other prior systemic therapy for treatment of advanced\u002Fmetastatic clear cell renal cell carcinoma (ccRCC) except for adjuvant programmed cell death ligand 1 (PD-(L)1) therapy\n* Has disease recurrence during adjuvant anti- PD-(L)1 therapy or ≤24 months following the last dose of adjuvant anti-PD-(L)1 therapy\n* Is able to swallow oral medication\n* Submits an archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated\n* Participants receiving bone resorptive therapy (must have therapy initiated at least 2 weeks before allocation\u002Frandomization)\n* Has adequately controlled blood pressure (BP) with or without antihypertensive medications, defined as BP ≤140\u002F90 mm Hg with no change in antihypertensive medications within 1 week before allocation\u002Frandomization\n* Has adequate organ function\n\nThe main exclusion criteria include but are not limited to the following:\n\n* Has clinically significant hematuria, hematemesis, or hemoptysis of (\\>2.5 mL) of red blood, or other history of significant bleeding\n* Has clinically significant cardiovascular disease within 12 months from first dose of study intervention\n* Has deep vein thrombosis within 3 months before allocation\u002Frandomization unless stable, asymptomatic, and treated with therapeutic anticoagulation for at least 4 weeks before allocation\u002Frandomization\n* Has history of idiopathic pulmonary fibrosis, organizing pneumonia, or evidence of active pneumonitis\n* Has serious wound, ulcer or bone fracture or has had major surgery within 8 weeks before first dose of study intervention\n* Has symptomatic pleural effusion (for example cough, dyspnea, pleuritic chest pain), ascites, or pericardial fluid requiring drainage in the last 4 weeks before allocation\u002Frandomization\n* Has gastrointestinal (GI) disorders, including those associated with a high risk of perforation or fistula formation\n* Has malabsorption due to prior GI surgery or GI disease\n* Has moderate to severe hepatic impairment\n* Has received colony-stimulating factors within 28 days prior to intervention allocation\u002Frandomization\n* Has received prior radiotherapy within 2 weeks of start of study intervention, or has radiation-related toxicities, requiring corticosteroids\n* Is currently receiving strong inhibitors of cytochrome P450 3A4 (CYP3A4) that cannot be discontinued for the duration of the study\n* Has received a live or live attenuated vaccine within 30 days before the first dose of study intervention\n* Is currently receiving anticoagulants or platelet inhibitors that cannot be discontinued for the duration of the study\n* Have been previously allocated\u002Frandomized to study intervention in any sub study of protocol MK-3475-U03\n* Has a known additional malignancy that is progressing or has required active treatment within the past 3 years\n* Has known active central nervous system (CNS) metastases and\u002For carcinomatous meningitis\n* Has radiographic evidence of encasement or invasion of a major blood vessel, or of intratumoral cavitation\n* Has active autoimmune disease that has required systemic treatment in the past 2 years\n* Has an active infection requiring systemic therapy\n* Has history of human immunodeficiency virus (HIV) infection\n* Has hepatitis B or hepatitis C virus infection","120 Years",{"count":620,"type":22},140,[25,73],"Substudy 03C is part of a larger research study that is testing experimental treatments for renal cell carcinoma (RCC). The larger study is the umbrella study (U03).\n\nThe goal of substudy 03C is to evaluate the safety and efficacy of experimental combinations of investigational agents in participants with clear cell renal cell carcinoma (ccRCC) who have recurrent disease during or after anti-programmed cell death 1\u002Fprogrammed cell death ligand 1 (PD-\\[L\\]1) adjuvant therapy.\n\nThis substudy will have two phases: a safety lead-in phase and an efficacy phase. The safety lead-in phase will be used to demonstrate a tolerable safety profile for the combination of investigational agents. There will be no hypothesis testing in this study",[33],[625,626],"Vascular Endothelial Growth Factor Receptor-Tyrosine Kinase Inhibitor (VEGFR-TKI)","Hypoxia-Inducible Factor-2α (HIF-2α)","2026-07-14",{"date":603,"type":54},{"date":630,"type":54},"2025-07-20",{"date":632,"type":22},"2031-10-26",{"name":386,"class":61},{"id":635,"slug":636,"hasResults":12,"nctId":637,"briefTitle":638,"officialTitle":639,"acronym":640,"eligibilityCriteria":641,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":642,"targetDuration":644,"studyType":153,"phases":4,"briefSummary":645,"conditions":646,"keywords":4,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":647,"lastUpdatePostDateStruct":648,"startDateStruct":649,"completionDateStruct":651,"leadSponsor":653,"locationsCount":173},"100314496","registry-platform-urologic-cancer-100314496","NCT03374267","Registry Platform Urologic Cancer","Clinical Research Platform On Urologic Cancer Treatment And Outcome (Registry Platform Urologic Cancer; CARAT)","CARAT","Inclusion Criteria:\n\nCohorts aRCC and aUBC (prospective)\n\n* Female and male patients with aRCC or aUBC (locally advanced, inoperable or metastatic)\n* Patients at start of their first-line systemic treatment for aRCC or aUBC\n* Written informed consent\n\n  * Patients participating in the PRO module: signing of in-formed consent form and completion of baseline questionnaire before start of initial systemic treatment\n  * Patients not participating in the PRO module: within twelve weeks after start of systemic first-line for aRCC or aUBC\n* Age ≥ 18 years\n\nCohort High-risk MIUC (prospective and retrospective)\n\n* Histologically proven muscle-invasive urothelial carcinoma (MIUC) of the lower or upper urinary tract (ICD-10 C65, C66, C67.x, C68.x). Mixed histologies are allowed (main compo-nent must be urothelial carcinoma, with minor variants accept-ed).\n* Radical surgery (e.g., radical cystectomy, nephroureterecto-my) between October 1, 2021 and October 31, 2024.\n* High-risk of recurrence, defined as follows: Post-operative, pathological tumor status\n\n  * ypT2-ypT4 and\u002For ypN+ and without clinically detectable metastases (M0) at cystectomy for patients with prior neo-adjuvant chemotherapy or\n  * pT3-pT4 and\u002For pN+ and without clinically detectable me-tastases (M0) at cystectomy for patients without prior neo-adjuvant chemotherapy.\n* Age ≥ 18 years at the time of surgery.\n* Written informed consent (only if patient is alive at time of data entry; not applicable for inclusion of deceased patients' data)\n\nCohort MIBC (prospective)\n\n* Diagnosis of MIBC (muscle-invasive bladder cancer; ICD-10 C67.x; cT2-T4aN0M0 or T1-T4aN1M0).\n* Histologically proven muscle-invasive urothelial carcinoma. Mixed histologies are allowed (main component must be urothelial histology, with minor variants accepted).\n* Age ≥ 18 years at the time of diagnosis.\n* Written informed consent within 15 weeks from diagnosis of MIBC.\n\nExclusion Criteria:\n\nCohorts aRCC and aUBC (prospective)\n\n* Patients with prior systemic therapy for aRCC or aUBC\n* No systemic treatment for aRCC or aUBC\n\nCohort High-risk MIUC (prospective and retrospective)\n\n* Partial cystectomy or partial nephrectomy of the primary tumor as definitive therapy\n* Metastatic disease (M1) at the time of surgery\n\nCohort MIBC (prospective)\n\n* Clinically detectable metastases (M1) at the time of diagnosis.\n* Treatment in palliative intention (for tumors considered inoperable).",{"count":643,"type":22},2230,"3 Years","The purpose of the project is to set up a national, prospective, longitudinal, multicenter cohort study with associated satellites, a tumor registry platform, to document uniform data on characteristics, molecular diagnostics, treatment and course of disease, to collect patient-reported outcomes and to establish a decentralized biobank for patients with advanced renal cell carcinoma or urothelial cancer in Germany.",[33,38],"2026-07-10",{"date":627,"type":54},{"date":650,"type":54},"2017-12-07",{"date":652,"type":22},"2034-03",{"name":654,"class":61},"iOMEDICO AG",{"id":656,"slug":657,"hasResults":12,"nctId":658,"briefTitle":659,"officialTitle":660,"acronym":661,"eligibilityCriteria":662,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":663,"targetDuration":4,"studyType":23,"phases":664,"briefSummary":665,"conditions":666,"keywords":4,"overallStatus":285,"whyStopped":4,"lastUpdateSubmitDate":670,"lastUpdatePostDateStruct":671,"startDateStruct":673,"completionDateStruct":675,"leadSponsor":677,"locationsCount":173},"100646617","phase-1-neoantigen-peptide-vaccine-plus-pembrolizumab-in-renal-cell-carcinoma-100646617","NCT07686744","Neoantigen Peptide Vaccine Plus Pembrolizumab in Renal Cell Carcinoma","A Phase I Clinical Trial of Personalized Neoantigen Peptide Vaccine in Combination With Pembrolizumab for the Safety and Efficacy in Patients With Advanced, Recurrent or Refractory Renal Cell Carcinoma","NPVPP","Inclusion Criteria:\n\n1. Histologically or cytologically confirmed Stage III or IV, locally advanced, recurrent or metastatic renal cell carcinoma (RCC) not amenable to curative surgery\n2. Disease stability for ≥3 months after prior single pembrolizumab therapy, with documented progression or intolerance to standard treatment\n3. At least one measurable lesion per RECIST v1.1 (longest diameter ≥10 mm for non-lymph node lesions; short axis ≥15 mm for lymph nodes; or bone lesions confirmed by CT\u002FMRI)\n4. Age ≥18 years\n5. Estimated life expectancy ≥3 months\n6. ECOG performance status 0-3\n7. Availability of tumor tissue (biopsy or archival specimen) for whole exome sequencing (WES) and RNA sequencing (RNA-seq), with ≥50 tumor gene mutations detectable\n8. Adequate organ function as defined by laboratory parameters within 14 days prior to enrollment:\n\n   8.1 Hematologic: Absolute Neutrophil Count(ANC) ≥1.5×10⁹\u002FL, platelet count ≥100×10⁹\u002FL, hemoglobin ≥90 g\u002FL; 8.2 Hepatic: total bilirubin(TBIL) ≤1.5×Upper Limit of Normal(ULN), Aspartate Aminotransferase(AST)\u002FAlanine Aminotransferase(ALT) ≤2.5×ULN (≤5×ULN if liver metastases present); 8.3 Renal: serum creatinine ≤1.5×ULN or creatinine clearance ≥50 mL\u002Fmin (Cockcroft-Gault formula); 8.4 Coagulation: international normalized ratio(INR) ≤1.5, activated partial thromboplastin time(APTT) ≤1.5×ULN; 8.5 Cardiac: Left Ventricular Ejection Fractions(LVEF) ≥50% by echocardiography;\n9. Ability to comply with study procedures and follow-up schedule;\n10. Signed informed consent form;\n11. For women of childbearing potential: negative serum pregnancy test (Human Chorionic Gonadotropin sensitivity ≤25 IU\u002FL) within 7 days prior to enrollment; agreement to use effective contraception during study and for 4 weeks after last dose;\n12. For men: agreement to use effective contraception during study and for 4 weeks after last dose.\n\nExclusion Criteria:\n\n1. Pregnant or lactating women\n2. Prior treatment with:\n\n   2.1 Two or more lines of immune checkpoint inhibitor (ICI) systemic therapy; 2.2 CTLA-4 inhibitor (e.g., ipilimumab); 2.3 Tumor vaccine therapy (including neoantigen vaccine, dendritic cell vaccine, etc.); 2.4 Chemotherapy specifically for renal cell carcinoma; 2.5 Allogeneic hematopoietic stem cell or solid organ transplantation;\n3. Active autoimmune disease or other immune-mediated disorders requiring systemic immunosuppressive therapy;\n4. Participation in another investigational drug study within 4 weeks prior to first dose;\n5. Active infection including:\n\n   5.1 Known Human Immunodeficiency Virus(HIV) infection; 5.2 Active hepatitis B (HBsAg positive and Hepatitis B Virus-DNA \\>500 IU\u002FmL) or hepatitis C (HCV-RNA positive); 5.3 Active tuberculosis (T-SPOT or PPD positive with clinical symptoms, or chest CT suggestive of active TB); 5.4 Severe infection requiring intravenous antibiotics within 2 weeks prior to enrollment, or uncontrolled systemic infection;\n6. Symptomatic central nervous system (CNS) metastases; exception: patients with treated CNS metastases stable for ≥4 weeks without neurological symptoms and without corticosteroid requirement;\n7. Uncontrolled comorbidities including:\n\n   7.1 Symptomatic congestive heart failure (New York Heart Association Class III-IV); 7.2 Unstable angina or myocardial infarction within 6 months; 7.3 Uncontrolled arrhythmia; 7.4 Uncontrolled hypertension (systolic ≥160 mmHg or diastolic ≥100 mmHg despite standard treatment); 7.5 Active peptic ulcer or gastrointestinal bleeding; 7.6 Active interstitial lung disease or pulmonary fibrosis;\n8. Other malignancy within 5 years (except cured cervical carcinoma in situ, basal cell carcinoma, or squamous cell skin carcinoma);\n9. Live vaccine administration within 4 weeks prior to enrollment or planned during study (inactivated vaccines allowed);\n10. Known hypersensitivity to peptide vaccine components, adjuvants (e.g., Montanide ISA-51, Poly-ICLC), or pembrolizumab;\n11. Sarcomatoid or rhabdoid RCC as predominant histology (mixed histology allowed if non-pure sarcomatoid\u002Frhabdoid);\n12. Any condition that, in the investigator's opinion, would compromise patient safety or compliance;\n13. Any other condition that the investigator considers unsuitable for study participation.",{"count":142,"type":22},[25],"This is a Phase I, single-center, open-label, single-arm clinical trial to evaluate the safety and efficacy of personalized neoantigen polyepitope peptide vaccine combined with pembrolizumab in patients with advanced, recurrent or refractory renal cell carcinoma (RCC).\n\nBackground: Renal cell carcinoma is one of the most common malignancies of the urinary system. Although pembrolizumab has become a standard first-line treatment, the objective response rate (ORR) of monotherapy is only 20-40%, and most patients eventually develop primary or acquired resistance. Tumor neoantigens are specific antigens produced by tumor-specific gene mutations, with high immunogenicity and tumor specificity, making them ideal targets for tumor immunotherapy. Preliminary clinical studies have shown that neoantigen vaccines can produce synergistic effects when combined with pembrolizumab.\n\nStudy Design: This is an investigator-initiated trial (IIT) conducted at Peking University First Hospital. The study will enroll 5-8 patients in two stages: an initial safety assessment cohort (3 patients) followed by an expansion cohort (5 additional patients) if safety criteria are met. The study drug is a personalized neoantigen polyepitope peptide vaccine (Neo-RCC), produced by Mingzhibenyuan Medical Technology (Beijing) Co., Ltd., based on whole exome sequencing (WES) and transcriptome sequencing (RNA-seq) of each patient's tumor tissue. The vaccine is administered via subcutaneous injection in combination with Polyinosinic-polycytidylic acid stabilized with poly-L-lysine and carboxymethylcellulose (Poly-ICLC) adjuvant, with a priming phase (5 injections on Days 0, 3, 7, 14, 21) and a boosting phase (3 injections on Weeks 6, 12, and 20), totaling 8 injections. Pembrolizumab (200 mg intravenous \\[IV\\] every 3 weeks \\[Q3W\\]) is administered concurrently as combination therapy.\n\nPrimary Objective: To evaluate the safety of the personalized neoantigen peptide vaccine in advanced RCC patients, as measured by the incidence and severity of treatment-emergent adverse events (TEAE) graded by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.\n\nSecondary Objectives: To evaluate pharmacokinetic characteristics; to assess efficacy including objective response rate (ORR), duration of response (DOR), disease control rate (DCR), progression-free survival (PFS), and overall survival (OS) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.\n\nKey Eligibility Criteria: Adults (≥18 years) with Stage III or IV, locally advanced, recurrent or metastatic non-surgical RCC who have achieved disease stability for ≥3 months after prior targeted therapy combined with pembrolizumab; measurable disease per RECIST v1.1; Eastern Cooperative Oncology Group (ECOG) performance status 0-3; adequate organ function; and ≥50 tumor gene mutations detectable from biopsy tissue.\n\nSafety Monitoring: A Data Safety Monitoring Board (DSMB) will oversee patient safety. Dose-limiting toxicities (DLT) are defined according to protocol-specified criteria. If ≥2 DLTs occur in the initial cohort, the adjuvant dose will be reduced by 50% and the study will proceed with a de-escalation cohort.",[33,667,668,669],"Advanced","Recurrent","Refractory","2026-06-29",{"date":672,"type":54},"2026-07-07",{"date":674,"type":22},"2026-09-01",{"date":676,"type":22},"2029-09-01",{"name":678,"class":93},"Jian Lin",{"id":680,"slug":681,"hasResults":12,"nctId":682,"briefTitle":683,"officialTitle":683,"acronym":684,"eligibilityCriteria":685,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":686,"targetDuration":4,"studyType":23,"phases":688,"briefSummary":689,"conditions":690,"keywords":4,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":692,"lastUpdatePostDateStruct":693,"startDateStruct":695,"completionDateStruct":697,"leadSponsor":699,"locationsCount":173},"100523867","locally-ablative-therapy-in-oligo-progressive-genitourinary-tumors-layover-100523867","NCT06101290","Locally Ablative TherapY in Oligo-ProgressiVe GEnitourinary TumoRs (LAYOVER)","LAYOVER","Inclusion Criteria:\n\n1. Must have one of the following histologically and\u002For biochemically confirmed genitourinary malignancies:\n\n   1. Cohort A: prostate cancer\n   2. Cohort B: urothelial carcinoma\n   3. Cohort C: renal cell carcinoma\n2. Provision of signed and dated informed consent form.\n3. Stated willingness to comply with all study procedures and availability for the duration of the study.\n4. Age ≥18 years at time of consent.\n5. Currently on systemic therapy and a candidate to continue their current line of systemic therapy with no more than a planned 30-day break to allow for local ablative therapy.\n6. ≥ 1 line of systemic therapy for metastatic disease with ≥ 3 months of clinical benefit on most recent line of systemic therapy prior to the development of new metastatic lesions. \\[Clinical benefit: Treating provider assessment that majority of the tumor burden is stable on current systemic treatment and not requiring an immediate change in systemic treatment\\]\n7. ≤ 5 progressing or new metastatic lesions.\n8. All progressing or new metastatic lesions can be safely treated with locally ablative therapies at discretion of treating radiation oncologist and\u002F interventional radiologist.\n\nExclusion Criteria:\n\n1. Medical comorbidities precluding locally ablative therapies.\n2. History of treatment related toxicities that limit or prohibit application of locally ablative therapies.\n3. Progressing intracranial lesions.",{"count":687,"type":22},150,[278],"This is a phase 2 pragmatic study that evaluates the clinical benefit of continuing systemic therapy with the addition of locally ablative therapies for oligo-progressive solid tumors as the primary objective. The primary outcome measure is the time to treatment failure (defined as time to change in systemic failure or permanent discontinuation of therapy) following locally ablative therapy.",[314,691,38,33],"Oligoprogressive","2026-06-25",{"date":694,"type":54},"2026-06-30",{"date":696,"type":54},"2023-12-05",{"date":698,"type":22},"2035-01-15",{"name":700,"class":93},"University of California, Davis",{"id":702,"slug":703,"hasResults":12,"nctId":704,"briefTitle":705,"officialTitle":706,"acronym":4,"eligibilityCriteria":707,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":708,"targetDuration":4,"studyType":23,"phases":710,"briefSummary":711,"conditions":712,"keywords":4,"overallStatus":285,"whyStopped":4,"lastUpdateSubmitDate":713,"lastUpdatePostDateStruct":714,"startDateStruct":716,"completionDateStruct":717,"leadSponsor":719,"locationsCount":173},"100575328","consolidative-metastasis-and-primary-directed-therapy-mpdt-for-renal-cell-carcinoma-rcc-100575328","NCT06770855","Consolidative Metastasis and Primary Directed Therapy (MPDT) for Renal Cell Carcinoma (RCC)","A Phase II Study of Total Consolidative Metastasis-and-primary Directed Therapy (MPDT) for Renal Cell Carcinoma (RCC).","Inclusion Criteria:\n\n* Histologically or cytologically confirmed diagnosis of clear cell renal cell carcinoma (mixed histology acceptable but must have clear cell component)\n* Metastatic clear cell RCC with 5 or fewer metastases at enrollment (excluding pulmonary nodules \\\u003C1.0cm)\n* Stable disease or partial response as assessed by investigators following at least 6 months of immune checkpoint blockade-based therapy.\n* Has disease amenable for total consolidative focal therapy (this will be determined by a multidisciplinary team which may include a combination of medical oncologists, urologists, interventional radiologists, and radiation oncologists).\n* ECOG performance status \\\u003C 2\n* Must have archival tissue (slide or Formalin-Fixed Paraffin-Embedded tissue) preceding prior systemic treatment for comparison to tissue from consolidation\n* Consolidation surgery and biopsies are strongly encouraged to be within 42 days +\u002F- 7 days of holding systemic therapy.\n\nExclusion Criteria:\n\n* Subjects who have progressed during the first 6 months of immune checkpoint-blockade based therapy as determined by study investigator.\n* Subjects who have a need for urgent focally directed therapy (i.e. symptomatic brain or spinal metastases). Stable spinal metastases resected and\u002For treated with SBRT in advance of or concurrently with immune checkpoint-blockade based therapy are allowed to participate.\n* Any female of child-bearing potential who has a positive urine pregnancy test within 72 hours before screening. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. Participants must be excluded\u002Fdiscontinued from the trial in the event of a positive or borderline positive serum pregnancy test result.",{"count":709,"type":22},23,[278],"This is a non-randomized, open-label phase II study designed to estimate 12-month treatment-free survival rate following total consolidative metastasis-and-primary directed therapy (MPDT) among patients with partial response\u002Fstable disease after at least 6 months of immune checkpoint blockade-based therapy for metastatic clear cell RCC. The investigators hypothesize that patients who undergo total consolidative MPDT followed by systemic therapy discontinuation will have a 12-month treatment-free survival rate of 32% compared to a null hypothesis of 13%",[33],"2026-06-18",{"date":715,"type":54},"2026-06-23",{"date":694,"type":22},{"date":718,"type":22},"2028-09",{"name":194,"class":93},{"id":721,"slug":722,"hasResults":12,"nctId":723,"briefTitle":724,"officialTitle":725,"acronym":4,"eligibilityCriteria":726,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":727,"targetDuration":4,"studyType":23,"phases":729,"briefSummary":730,"conditions":731,"keywords":4,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":756,"lastUpdatePostDateStruct":757,"startDateStruct":759,"completionDateStruct":761,"leadSponsor":763,"locationsCount":173},"100536473","phase-2-comparison-of-in-home-versus-in-clinic-administration-of-subcutaneous-nivolumab-through-cancer-care-connected-access-and-remote-expertise-beyond-walls-ccbw-program-100536473","NCT06265285","Comparison of In-Home Versus In-Clinic Administration of Subcutaneous Nivolumab Through Cancer CARE (Connected Access and Remote Expertise) Beyond Walls (CCBW) Program","MC230716 Pilot Single-Arm, Pragmatic Trial Of In-Home Versus In-Clinic Subcutaneous Nivolumab Administration Through Cancer CARE (Connected Access And Remote Expertise) Beyond Walls (CCBW) Program","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Histologically confirmed malignancies for which treatment with intravenous nivolumab is currently Food and Drug Administration (FDA) approved and who are recommended to initiate a new treatment regimen with single agent intravenous (IV) nivolumab by their treating oncologist for any of the indications outlined below and who are willing to switch to subcutaneous nivolumab. Additionally, patients who are currently receiving single-agent IV nivolumab are eligible, provided they transition to subcutaneous nivolumab on-study, with their first subcutaneous (subQ) dose administered on cycle 1, day 1 of the study.\n\n  * Single agent nivolumab administered in the adjuvant setting for one of the following indications:\n\n    * Completely resected stage IIB\u002FC, III or IV melanoma\n    * Urothelial carcinoma status post radical resection and have a high risk of recurrence\n    * Completely resected esophageal or gastroesophageal junction carcinoma with residual pathologic disease in adult patients who have received neoadjuvant chemoradiotherapy (CRT)\n  * Single agent nivolumab for advanced\u002Fmetastatic cancer for one or more of the following indications:\n\n    * Renal cell carcinoma (RCC) patients who have received prior anti-angiogenic therapy\n    * Non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy (Note: patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving nivolumab)\n    * Unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) after prior fluoropyrimidine- and platinum-based chemotherapy\n    * Unresectable or metastatic cutaneous melanoma\n    * Locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy\n    * Unresectable or metastatic urothelial carcinoma, as first-line treatment in combination with cisplatin and gemcitabine.\n\n      * Subcutaneous nivolumab to be initiated as monotherapy following six cycles of cisplatin + gemcitabine\n    * Recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) with disease progression on or after platinum-based therapy\n    * Microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (CRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan\n  * Patients transitioning to maintenance nivolumab and who are willing to switch to subcutaneous nivolumab after completion of Ipilimumab and nivolumab combination therapy for one or more of the indications listed below (Note: patients who discontinue ipilimumab for immune-related toxicities, but are deemed to be eligible to continue on single agent nivolumab maintenance by their treating oncologist are eligible):\n\n    * First-line treatment of adult patients with intermediate or poor risk advanced renal cell carcinoma (RCC)\n    * Unresectable or metastatic cutaneous melanoma\n    * Hepatocellular carcinoma (HCC) previously treated with sorafenib\n    * Microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (CRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan\n  * Single agent nivolumab administered in the adjuvant setting following neoadjuvant nivolumab with platinum doublet chemotherapy for patients with resectable (tumors ≥ 4 cm and\u002For node positive) non-small cell lung cancer (NSCLC) and no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements\n* Patients have recovered from the effects of any previous chemotherapy, immunotherapy, other prior systemic anticancer therapy, radiotherapy, and\u002For surgery (i.e., residual toxicity no worse than grade 1 \\[grade 2 treatment-associated peripheral neuropathy, grade 2 fatigue and\u002For any grade of alopecia are acceptable assuming all other inclusion criteria are met\\]) before registration\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1\n* Aspartate transaminase (AST) values ≤ 3 × the upper limit of normal (ULN). For patients with documented baseline liver metastasis, the following limits will apply: 5 × ULN for transaminase\n* Alanine transaminase (ALT) values ≤ 3 x the upper limit of normal (ULN). For patients with documented baseline liver metastasis, the following limits will apply: 5 x ULN for transaminase\n* Serum total bilirubin values of ≤ 1.5 x ULN ( ≤ 2 x ULN for patients with known Gilbert's syndrome). For patients with documented baseline liver metastasis, the following limits will apply: 2 x ULN for bilirubin\n* Absolute neutrophil count (ANC) of ≥ 1500\u002FμL\n* Platelet count of ≥ 100,000\u002FμL\n* Hemoglobin of ≥ 9 g\u002FdL (patients may be transfused to this level, if necessary, but transfusion must occur \\> 1 week prior to registration)\n* Serum creatinine ≤ 2.0 x the ULN for the reference laboratory or a calculated creatinine clearance of ≥ 30 mL\u002Fmin by the Cockcroft-Gault Equation measured ≤ 7 days prior to registration\n* Patients are residing ≤ 35 miles of clinic (hub) or within the area serviced by supplier and paramedic network\n* Residence has Wi-Fi to enable a reliable connection with the remote command center\n* Patients have signed Informed Consent Form (ICF)\n* Patients are willing and able to comply with the study protocol in the investigator's judgment\n* Patients are able and willing to complete study questionnaire(s) by themselves or with assistance\n* Women of childbearing potential (WOCBP) must:\n\n  * Have a negative pregnancy test (serum or urine) ≤ 3 days before the first dose of study drug\n  * Be agreeable to use a contraceptive method that is highly effective during the intervention period and for at least 5 months after the last dose and agrees not to donate eggs (ova, oocytes) for the purpose of reproduction for the same time period\n\nExclusion Criteria:\n\n* Patients receiving any other investigational or standard of care agent which would be considered as a treatment for the primary neoplasm and is not part of the eligible treatment regimen\n* Patients requiring 24\u002F7 assistance with activities of daily living (ADLs)\n* Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens\n* Uncontrolled intercurrent illness including, but not limited to:\n\n  * Ongoing or active infection\n  * Symptomatic congestive heart failure\n  * Unstable angina pectoris\n  * Cardiac arrhythmia\n  * Myocardial infarction ≤ 6 months\n  * Wound healing disorder\n  * Psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n* Patients with any severe infection ≤ 4 weeks prior to registration including, but not limited to, hospitalization for complications of infections\n* Patients with an active, known or suspected autoimmune disease. Patients with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll. Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment. Patients with vitiligo, Graves' disease, or psoriasis not requiring systemic treatment within the past 30 days are not excluded. Patients with celiac disease controlled with diet modification are not excluded\n* Patients with a condition requiring systemic treatment with either corticosteroids ( \\> 10 mg daily prednisone equivalent) ≤ 14 days or other immunosuppressive medications ≤ 30 days prior to registration. Inhaled or topical steroids, and adrenal replacement steroid doses \\> 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease\n* Concurrent malignancy (present during screening) requiring treatment or history of prior malignancy active ≤ 2 years prior to registration (i.e., participants with a history of prior malignancy are eligible if treatment was completed at least 2 years before randomization\u002Ftreatment assignment and the patient has no evidence of disease). Participants with history of prior early stage basal\u002Fsquamous cell skin cancer or non-invasive or in situ cancers that have undergone definitive treatment at any time are also eligible\n* Patients have undergone prior solid organ and\u002For non-autologous hematopoietic stem cell or bone marrow transplant\n* Patients with active brain metastases or leptomeningeal metastases, aside from the exceptions below. Participants with brain metastases are eligible if they are:\n\n  * Asymptomatic\n  * Have been treated and participants have neurologically returned to baseline (except for residual signs or symptoms related to the central nervous system \\[CNS\\] treatment), and\n  * There is no MRI evidence of progression for at least 4 weeks after CNS directed therapy is complete and ≤ 28 days prior to registration\n  * In addition, participants must have been either off corticosteroids, or on a stable or decreasing dose of ≤ 10 mg daily prednisone (or equivalent) for at least 2 weeks prior to registration\n* Participants with brain disease treated with whole brain radiation\n* Anticipation of the need for major surgery during the course of study treatment\n* Participants who are pregnant or breastfeeding\n* Treatment with any live attenuated vaccines ≤ 30 days of registration (vaccines that are not live attenuated are allowed, including COVID-19 vaccine)\n* Known human deficiency virus (HIV) positive with an AIDS defining opportunistic infection within the last year, or a current CD4 count \\\u003C 350 cells\u002FuL, aside from the exceptions below. Participants with HIV are eligible if:\n\n  * They have received antiviral therapy (ART) for at least 4 weeks prior to treatment assignment as clinically indicated while enrolled in the study\n  * They continue on ART as clinically indicated while enrolled on study\n  * CD4 counts and viral load are monitored per standard of care by a local healthcare provider\n* History of allergy or hypersensitivity to study drug components\n* Any positive test result for hepatitis B virus (HBV) indicating presence of virus (e.g., hepatitis B surface antigen \\[HBsAg, Australia antigen\\]) positive\n* Any positive test result for hepatitis C virus (HCV) indicating presence of active viral replication (detectable HCV-ribonucleic acid \\[RNA\\]). Note: Participants with positive HCV antibody and an undetectable HCV RNA are eligible to enroll",{"count":728,"type":22},50,[73],"This phase II trial compares the impact of subcutaneous (SC) nivolumab given in an in-home setting to an in-clinic setting on cancer care and quality of life. Currently, most drug-related cancer care is conducted in clinic type centers or hospitals which may isolate patients from family, friends and familiar surroundings for many hours per day. This separation adds to the physical, emotional, social, and financial burden for patients and their families. Traveling to and from medical facilities costs time, money, and effort and can be a disadvantage to patients living in rural areas, those with low incomes or poor access to transport. Studies have shown that cancer patients often feel more comfortable and secure being cared for in their own home environments. SC nivolumab in-home treatment may be safe, tolerable and\u002For effective when compared to in-clinic treatment and may reduce the burden of cancer and improve the quality of life in cancer patients.",[732,733,734,735,736,737,738,739,740,741,584,30,742,743,462,744,745,746,747,748,749,750,33,427,751,752,428,753,754,38,755],"Advanced Esophageal Squamous Cell Carcinoma","Advanced Renal Cell Carcinoma","Clinical Stage II Esophageal Squamous Cell Carcinoma AJCC v8","Clinical Stage IIB Cutaneous Melanoma AJCC v8","Clinical Stage IIC Cutaneous Melanoma AJCC v8","Clinical Stage III Cutaneous Melanoma AJCC v8","Clinical Stage III Esophageal Squamous Cell Carcinoma AJCC v8","Clinical Stage IV Cutaneous Melanoma AJCC v8","Clinical Stage IV Esophageal Squamous Cell Carcinoma AJCC v8","Esophageal Carcinoma","Locally Advanced Urothelial Carcinoma","Lung Non-Small Cell Carcinoma","Metastatic Colorectal Carcinoma","Metastatic Cutaneous Melanoma","Metastatic Esophageal Squamous Cell Carcinoma","Metastatic Head and Neck Squamous Cell Carcinoma","Metastatic Urothelial Carcinoma","Recurrent Esophageal Squamous Cell Carcinoma","Recurrent Head and Neck Squamous Cell Carcinoma","Stage IV Colorectal Cancer AJCC v8","Stage IV Cutaneous Squamous Cell Carcinoma of the Head and Neck AJCC v8","Unresectable Cutaneous Melanoma","Unresectable Esophageal Squamous Cell Carcinoma","Unresectable Urothelial Carcinoma","2026-06-05",{"date":758,"type":54},"2026-06-09",{"date":760,"type":54},"2024-04-30",{"date":762,"type":22},"2026-12-31",{"name":478,"class":93}]