[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"melanoma-skin-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:melanoma-skin-cancer":30},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,48,0,25,[9,45,72,109,137,165,220,244,277,302,333,366,398,421,454,490,515,545,568,613,634,655,675,692,719],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100641950","gustabor-phase-2---treating-taste-changes-during-cancer-therapy-a-randomized-study-evaluating-an-ai--based-nutrition-intervention-100641950",false,"NCT07649681","Gustabor Phase 2 - Treating Taste Changes During Cancer Therapy: A Randomized Study Evaluating an AI- Based Nutrition Intervention","GustaborRCT","Inclusion Criteria:\n\n* Age ≥ 18\n* Suffering from one of the following tumor entities: Multiple myeloma, melanoma, urogenital cancer or malignant tumor of the gastrointestinal tract\n* Mainly oral nutrition\n* Subjectively perceived tumor therapy-related taste disorder\n* At least two clinical presentations planned within 12 weeks with a minimum interval of three weeks\n* Ability to participate in nutritional intervention, including use of the online portal and implementation of recipe suggestions (e.g. resources and access to a kitchen), either independently or with third-party support (e.g. by relatives, outpatient care services).\n\nExclusion Criteria:\n\n* Pregnancy\n* Taste disorder explained by other causes (e.g. existing before therapy or COVID disease)\n* Placement in an inpatient care facility","ALL","18 Years",{"count":20,"type":21},198,"ESTIMATED","INTERVENTIONAL",[24],"NA","The study investigates taste disorders that commonly occur during or after cancer treatment, often leading to issues such as malnutrition and treatment discontinuation. Although many non-pharmacological recommendations exist, it is unclear which methods are suitable for which individuals.\n\nThis randomized study aims to compare the effectiveness of individualized dietary recommendations (Gustabor group) with the current standard of care -general recommendations (Control group). Participants will undergo an objective assessment of taste disorders using taste strips and questionnaires. Based on the results, the Gustabor group will receive both general and specific dietary suggestions. These will be accomapnied by AI-generated recipe suggestions tailored to specific taste disorders (e.g., more cold foods in cases of metallic taste). The control group will receive the current standard: a flyer containing general dietary advice for oncology patients previously shown to be beneficial for managing taste alterations. The primary endpoint is the PG-SGA score within 12 weeks of inclusion.",[27,28,29,30,31],"Multiple Myeloma (MM)","GI Cancer","Taste Disorder","Melanoma (Skin Cancer)","Urogenital Cancers","RECRUITING","2026-08-19",{"date":35,"type":36},"2026-08-20","ACTUAL",{"date":38,"type":36},"2026-07-24",{"date":40,"type":21},"2026-12-31",{"name":42,"class":43},"Wuerzburg University Hospital","OTHER",6,{"id":46,"slug":47,"hasResults":12,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":22,"phases":55,"briefSummary":58,"conditions":59,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":71},"100647988","phase-1-investigating-the-combination-of-bexmarilimab-and-nivolumab-in-solid-tumours-melanoma-and-nsclc-100647988","NCT07718243","Investigating the Combination of Bexmarilimab and Nivolumab in Solid Tumours, Melanoma and NSCLC","A Phase I\u002FII Trial of Bexmarilimab and Nivolumab in Patients With Solid Tumours, Non-Small Cell Lung Cancer and Melanoma","BLAZE","Inclusion Criteria:\n\n1. Part A:\n\n   Histologically proven solid tumour, refractory to conventional treatment, or for which no conventional therapy exists or is declined by the patient\n\n   Part B1: Histologically proven NSCLC.\n   * Patient has received at least one but not more than three lines of systemic anticancer therapy for metastatic disease.\n   * Patient has received at least two cycles of immune checkpoint inhibitor and has demonstrated disease progression within 12 weeks of last dose.\n   * Patient has had a benefit to prior immune checkpoint inhibitor defined as greater than 6 months of treatment or partial response.\n   * Patients with actionable EGFR, ALK, or other known genomic alterations must have received at least 1 relevant targeted therapy treatment if available.\n\n   Part B2: Histologically proven cutaneous melanoma.\n   * Patient has received at least one but not more than three lines of systemic anticancer therapy for metastatic disease.\n   * Patient has received at least two cycles of immune checkpoint inhibitor and has demonstrated disease progression within 12 weeks of last dose.\n   * Patients with BRAF mutations must have received relevant targeted therapy.\n   * Patient has had a benefit to prior immune checkpoint inhibitor defined as greater than 6 months of treatment or partial response\n2. Life expectancy of at least 12 weeks\n3. World Health Organisation (WHO) performance status of 0-1 (Appendix 2)\n4. Measurable disease as assessed by iRECIST\n5. Biologically female patients are eligible to participate in the trial if they are not pregnant, not breast feeding and meet one of the following criteria:\n\n   1. a biological woman of childbearing potential (WOCB) who has a negative serum or urine pregnancy test before enrolment and agrees to use a highly effective form of contraception (refer to Appendix 3) from signing the consent form, throughout the trial and for six months afterwards. A biological woman is considered of childbearing potential (WOCBP), i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy.\n   2. A biological woman of non-childbearing potential; a postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a postmenopausal state in biological women not using hormonal contraception or hormonal replacement therapy. However, in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient.\n6. Biologically male patients are eligible to participate in the trial if they meet one of the following criteria:\n\n   1. is fertile and agrees to use and ensure their partners (if WOCBP) use a highly effective form of contraception (refer to Appendix 3) from signing the consent form, throughout the trial and for six months afterwards. Biological men with pregnant or lactating partners must be advised to use barrier method contraception (refer to Appendix 3) to prevent exposure of the foetus or neonate; a biological man is considered fertile after puberty unless permanently sterile by bilateral orchidectomy\n   2. is infertile\n7. Negative serology for human immunodeficiency virus (HIV), hepatitis B virus (HBV), and hepatitis C virus (HCV)\n8. Haematological and biochemical indices within the ranges shown below. These measurements must be performed within one week (Day -7 to Day 1) prior to the patient's first dose of IMP\n\n   Laboratory Test Value required Haemoglobin (Hb) ≥ 9.0 g\u002FdL Absolute neutrophil count ≥ 1.5 x 109\u002FL Platelet count ≥ 100 x 109\u002FL\n\n   Serum bilirubin ≤ 1.5 x ULN; with the following exception:\n\n   Patients with known Gilbert disease who have serum bilirubin level ≤ 3 × ULN may be enrolled\n\n   ALT ≤ 2.5 x ULN unless raised due to tumour in which case up to 5 x ULN is permissible AST ≤ 2.5 x ULN unless raised due to tumour in which case up to 5 x ULN is permissible Renal function Calculated creatinine clearance (using the Wright, Cockcroft \\& Gault formula) Glomerular filtration rate ≥ 30 mL\u002Fmin (uncorrected value)\n9. 18 years or over\n10. Written (signed and dated) informed consent and be capable of co-operating with treatment and follow-up\n\nExclusion Criteria:\n\n1. Radiotherapy (except for palliative reasons), endocrine therapy, immunotherapy or chemotherapy during the previous four weeks (six weeks for nitrosoureas, Mitomycin-C) and 4 weeks for investigational medicinal products) before treatment.\n2. Ongoing toxic manifestations of previous treatments. Exceptions to this are alopecia\u002Fvitiligo, treated endocrinopathies (i.e. on physiological doses of endocrine replacement) or certain Grade 1 toxicities, which in the opinion of the Investigator and the CI should not exclude the patient.\n3. Known untreated or active central nervous system (CNS) metastases (progressing or requiring corticosteroids for symptomatic control). Patients with a history of treated CNS metastases are eligible, provided they meet all of the following criteria:\n\n   * Evaluable or measurable disease outside the CNS is present.\n   * Radiographic stability upon the completion of CNS-directed therapy and no evidence of interim progression between the completion of CNS-directed therapy and the baseline disease assessment\n   * Not requiring corticosteroids.\n4. Major thoracic or abdominal surgery from which the patient has not yet recovered.\n5. At high medical risk because of non-malignant systemic disease including active uncontrolled infection.\n6. Known to be serologically positive for hepatitis B, hepatitis C or human immunodeficiency virus.\n7. Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 14 days prior to the first dose of trial treatment\n8. Has an active autoimmune disease that has required systemic treatment in past 3 months (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs) or is at risk of recurrence. Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment. Patients with a history of inflammatory bowel diseases such as Crohn's disease or ulcerative colitis will be excluded from the study. Patients with Sjogren's syndrome will not be excluded from the study.\n9. Are receiving chronic systemic steroids (\\> 10 mg\u002Fday prednisone equivalent). Use of topical, inhalational, intranasal, and intraocular steroids will be permitted.\n10. Patients that experienced a Grade 3 or higher immune-related AEs from prior treatment with immunotherapy will be excluded from the study.\n11. Has received a live vaccine within 30 days of planned start of study therapy. Note: The inactivated virus vaccines used for seasonal influenza vaccines for injection are allowed; however intranasal influenza vaccines (e.g. FluMist®) are live attenuated vaccines and are not allowed.\n12. Any of the following cardiac criteria:\n\n    * Mean resting corrected QT interval (QTc) \\> 470 msec obtained from 3 consecutive electrocardiograms (ECGs) within 5 minutes of each other.\n    * Known congenital QT syndrome or history of torsades de pointes. Any clinically significant abnormalities in rhythm, conduction or morphology of resting ECG, e.g. complete left bundle branch block, third degree heart block. Controlled atrial fibrillation is allowed.\n    * Experience of any of the following procedures or conditions in the preceding 6 months: coronary artery bypass graft, angioplasty, vascular stent, myocardial infarction, angina pectoris, congestive heart failure New York Heart Association \\[NYHA Grade 2 or above\\], severe valvular disease, uncontrolled hypertension despite optimal therapy.\n13. Prior bone marrow transplant, allogenic tissue\u002Fsolid organ transplant or have had extensive radiotherapy to greater than 25% of bone marrow within eight weeks.\n14. Current malignancies of other types, with the exception of adequately treated cone biopsied in situ carcinoma of the cervix uteri and basal or squamous cell carcinoma of the skin. An exception to this criteria are cancer survivors, who have undergone potentially curative therapy for a prior malignancy, have no evidence of that disease for three years or more and are deemed at negligible risk for recurrence, are eligible for the trial.\n15. Is a patient or plans to participate in another interventional clinical trial, whilst taking part in this study. Participation in an observational trial would be acceptable.\n16. Any other condition which in the Investigator's opinion would not make the patient a good candidate for the clinical trial.\n17. Symptoms of COVID-19 and\u002For documented COVID-19 infection\n18. Hypersensitivity to the active substance or to any of the IMP excipients\n19. Active or known pre-existing or history of non-infectious\u002Finterstitial lung disease\u002Fpneumonitis",{"count":54,"type":21},62,[56,57],"PHASE1","PHASE2","The trial will test if the combination of bexmarilimab and nivolumab can help patients whose cancers have stopped responding to immunotherapy treatment. It will focus on two cancers: non-small cell lung cancer and melanoma. Early research suggests bexmarilimab may change some immune cells inside the tumour so they create a stronger \"attack\" signal, which could help other immune cells recognise and kill cancer cells more effectively. This may make it easier for PD-1 immunotherapy drugs to work again by helping the immune system stay active against the tumour.\n\nThis is a Phase I\u002FII clinical trial. In Phase I, researchers will give increasing doses of bexmarilimab together with a standard (fixed) dose of nivolumab to patients with solid tumours, to find the safest and most suitable dose to use going forward (the recommended Phase 2 dose). In Phase II, the study will treat two groups of patients-one with non-small cell lung cancer and one with melanoma-using that selected dose.",[30,60,61],"Non Small Cell Lung Cancer","Solid Tumor in Advanced Stage","2026-08-14",{"date":64,"type":36},"2026-08-18",{"date":66,"type":21},"2026-08",{"date":68,"type":21},"2030-01-31",{"name":70,"class":43},"Institute of Cancer Research, United Kingdom",2,{"id":73,"slug":74,"hasResults":12,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":78,"eligibilityCriteria":79,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":80,"enrollmentInfo":81,"targetDuration":4,"studyType":22,"phases":83,"briefSummary":84,"conditions":85,"keywords":91,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":103,"completionDateStruct":104,"leadSponsor":106,"locationsCount":108},"100651415","68ga-sorb-petct-imaging-in-patients-with-solid-tumors-100651415","NCT07760012","68Ga-SorB PET\u002FCT Imaging in Patients With Solid Tumors","A Prospective, Single-Center, Open-Label Exploratory Study of 68Ga-SorB PET\u002FCT Imaging for the Diagnosis of Sortilin-Positive Solid Tumors","SORB-PET","Inclusion Criteria:\n\n* \\- Adults aged 18 to 75 years.\n* Histologically confirmed or clinically suspected melanoma, hepatocellular carcinoma, lung cancer, breast cancer, pancreatic cancer, or ovarian cancer.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Adequate hematologic, hepatic, renal, and coagulation function:\n* White blood cell count ≥ 4.0 × 10\\^9\u002FL or absolute neutrophil count ≥ 1.5 × 10\\^9\u002FL;\n* Platelet count ≥ 100 × 10\\^9\u002FL;\n* Hemoglobin ≥ 90 g\u002FL;\n* PT or APTT ≤ 1.5 × upper limit of normal (ULN);\n* Total bilirubin ≤ 1.5 × ULN;\n* ALT and AST ≤ 2.5 × ULN (or ≤ 5 × ULN for participants with liver metastases);\n* ALP ≤ 2.5 × ULN (or ≤ 4.5 × ULN for participants with bone or liver metastases);\n* Blood urea nitrogen and serum creatinine ≤ 1.5 × ULN.\n* Normal cardiac function.\n* Estimated life expectancy of at least 12 weeks.\n* Willing and able to comply with study procedures and follow-up.\n* At least one measurable target lesion according to RECIST version 1.1.\n* Participants of childbearing potential agree to use effective contraception during the study and for 3 months after PET\u002FCT imaging.\n* Clinically indicated to undergo 18F-FDG PET\u002FCT for tumor evaluation.\n* Able to understand the study procedures and provide written informed consent.\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding women.\n* Severe dysfunction of major organs (including heart, liver, or kidney) that, in the investigator's judgment, would make participation inappropriate.\n* Inability to tolerate PET\u002FCT imaging or complete study follow-up.\n* Any other condition that, in the investigator's judgment, makes the participant unsuitable for the study.","75 Years",{"count":82,"type":21},50,[24],"This prospective, single-center, open-label exploratory diagnostic study aims to evaluate the safety, feasibility, and diagnostic performance of the novel Sortilin-targeted PET tracer 68Ga-SorB in patients with solid tumors. Eligible participants with confirmed or suspected melanoma, hepatocellular carcinoma, lung cancer, pancreatic cancer, breast cancer, or ovarian cancer will undergo 68Ga-SorB PET\u002FCT imaging. The imaging findings will be compared with standard-of-care 18F-FDG PET\u002FCT, using pathology results and\u002For clinical follow-up as the reference standard.\n\nThe primary objectives are to evaluate the safety and tolerability of 68Ga-SorB, assess imaging feasibility, and characterize tumor uptake using quantitative PET parameters, including SUVmax and tumor-to-background ratio (TBR). Secondary exploratory objectives include comparing lesion detection between 68Ga-SorB PET\u002FCT and 18F-FDG PET\u002FCT, assessing diagnostic sensitivity and specificity, evaluating imaging characteristics across different tumor types, and exploring the correlation between Sortilin expression and tracer uptake. This study will provide preliminary clinical evidence supporting the development of Sortilin-targeted molecular imaging and future theranostic applications.",[30,86,87,88,89,90],"Hepatocellular Carcinoma","Lung Cancer","Breast Cancer","Pancreatic Cancer","Ovarian Cancer",[92,93,94,95,96,97,98,99],"Sortilin","68Ga-SorB","PET\u002FCT","Molecular Imaging","Diagnostic Imaging","Positron Emission Tomography","Radiotracer","Oncology","2026-08-09",{"date":102,"type":36},"2026-08-12",{"date":38,"type":21},{"date":105,"type":21},"2028-12-31",{"name":107,"class":43},"Peking University Third Hospital",1,{"id":110,"slug":111,"hasResults":12,"nctId":112,"briefTitle":113,"officialTitle":114,"acronym":4,"eligibilityCriteria":115,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":116,"targetDuration":4,"studyType":22,"phases":118,"briefSummary":119,"conditions":120,"keywords":124,"overallStatus":128,"whyStopped":4,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":130,"startDateStruct":132,"completionDateStruct":133,"leadSponsor":135,"locationsCount":108},"100650067","phase-2-neoadjuvant-spare-adjuvant-nasa-in-stage-iiib-iv-m1a-melanoma-100650067","NCT07740941","NeoAdjuvant, Spare-Adjuvant (NASA) in Stage IIIB-IV (M1a) Melanoma","NeoAdjuvant, Spare-Adjuvant (NASA) in Stage IIIB- IV (M1a) Melanoma","Inclusion Criteria:\n\n* Written informed consent will be obtained to participate in the study, and HIPAA authorization for the release of personal health information.\n* Subject is willing and able to comply with study procedures based on the judgment of the investigator or protocol designee, including randomization.\n* Age ≥ 18 years at the time of consent.\n* ECOG Performance Status of 0-2.\n* Histological confirmation of cutaneous melanoma or melanoma of unknown primary.\n* AJCC stage IIIB\u002FIVa resectable disease that is measurable by iRECIST criteria.\n* Adequate hematologic, renal, hepatic, and heart function\n\nExclusion Criteria:\n\n* Prior treatment with PD-1 Programmed cell death Protein 1 (PD-1) and Cytotoxic T-lymphocyte Antigen 4 (CTLA-4).\n* Has an active autoimmune disease that requires systemic treatment with the use of disease-modifying agents or immunosuppressive drugs. For corticosteroids, up to 10 mg of prednisone daily, or an equivalent dose, is permitted. Hormone replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.\n* Any condition, including laboratory abnormalities, that, in the opinion of the investigator, places the subject at unacceptable risk if he\u002Fshe were to participate in the study. This includes, but is not limited to, serious medical conditions or psychiatric illnesses that are likely to interfere with participation in this clinical study.",{"count":117,"type":21},55,[57],"This study evaluates the impact of neoadjuvant Programmed cell death Protein 1 (PD-1)-based treatment regimens in patients with resectable stage IIIB-M1a cutaneous or unknown primary melanoma at high risk of relapse without adjuvant therapy after definitive lymphadenectomy and irrespective of pathologic response outcome on the 2-year overall survival (OS). It was hypothesized that neoadjuvant PD1 inhibitor-based treatment without adjuvant treatment does not significantly (non-inferior) impact OS in this study patient population. Patients will be randomized to either two infusions of pembrolizumab or one infusion of ipilimumab plus nivolumab followed by a single infusion of nivolumab. Patients will undergo follow-up and restaging scans to assess event-free survival at 12 months and OS at 24 months after the first neoadjuvant treatment infusion.",[30,121,122,123],"Melanoma Stage Stage IIIB","Melanoma Stage M1","Melanoma Stage IV",[125,126,127],"Programmed cell death Protein 1 inhibitor","pembrolizume","ipilimumab","NOT_YET_RECRUITING","2026-08-03",{"date":131,"type":36},"2026-08-05",{"date":131,"type":21},{"date":134,"type":21},"2029-03",{"name":136,"class":43},"UNC Lineberger Comprehensive Cancer Center",{"id":138,"slug":139,"hasResults":12,"nctId":140,"briefTitle":141,"officialTitle":142,"acronym":4,"eligibilityCriteria":143,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":144,"targetDuration":4,"studyType":22,"phases":146,"briefSummary":147,"conditions":148,"keywords":149,"overallStatus":128,"whyStopped":4,"lastUpdateSubmitDate":158,"lastUpdatePostDateStruct":159,"startDateStruct":160,"completionDateStruct":161,"leadSponsor":163,"locationsCount":108},"100649744","a-comparative-usability-study-of-two-total-body-skin-imaging-systems-100649744","NCT07740642","A Comparative Usability Study of Two Total Body Skin Imaging Systems","A Comparative Usability Study of Two Total Body Skin Imaging Systems: Vectra (3D Total Body Photography With Manual Dermoscopy) Versus Deviskan (Total Body Photography With Automated Non-Contact Dermoscopy)","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Signed informed consent by the participant\n* Sufficient proficiency in German\n* At least one of the following risk criteria for melanoma:\n\n  * Previous melanoma (including in situ)\n  * Suspected melanoma\n  * ≥ 100 common naevi\n  * ≥ 5 dysplastic naevi\n  * dysplastic naevus syndrome\n  * Known CDKN2A mutation\n  * Strong family history for melanoma (≥ first- and\u002For second-degree relatives)\n\nExclusion Criteria:\n\n* Lack of informed consent\n* Immobility. (Patients must be able to stand without support for 30 minutes.)\n* Inability to follow the procedures of the investigation, including inability to follow on-screen instructions or to read (e.g. due to visual impairment or cognitive impairment)\n* Vulnerable Subjects\n* Active skin conditions that may impact the performance of TBP systems or skin cancer screenings\n* Cardiac pacemaker\n* Pregnant women (self reported, no pregnancy test planned)\n* Height below 150 cm or above 195 cm\n* Severe Claustrophobia",{"count":145,"type":21},60,[24],"This study aims to generate evidence on patient and dermatologist perspectives regarding two total body photography systems. Patient and clinician preferences represent key factors in healthcare decision-making. The investigation will also provide data on the time efficiency of each system in a real-world setting.",[30],[150,151,152,153,154,155,156,157],"Screening","Body Photography","Total Body Photography","Dermoscopic Imaging Device","dermoscopy","Body skin imaging","Dysplastic Naevi","CDKN2A Mutation","2026-07-31",{"date":129,"type":36},{"date":129,"type":21},{"date":162,"type":21},"2026-09-30",{"name":164,"class":43},"University Hospital, Basel, Switzerland",{"id":166,"slug":167,"hasResults":12,"nctId":168,"briefTitle":169,"officialTitle":170,"acronym":171,"eligibilityCriteria":172,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":173,"targetDuration":4,"studyType":22,"phases":175,"briefSummary":176,"conditions":177,"keywords":192,"overallStatus":128,"whyStopped":4,"lastUpdateSubmitDate":158,"lastUpdatePostDateStruct":211,"startDateStruct":213,"completionDateStruct":215,"leadSponsor":217,"locationsCount":4},"100646600","a-multicenter-randomized-open-label-trial-evaluating-ctdna-guided-interruption-versus-standard-of-care-immune-checkpoint-inhibitor-ici-therapy-in-patients-with-advanced--metastatic-solid-tumors-100646600","NCT07689812","A Multicenter Randomized Open-Label Trial Evaluating ctDNA-Guided Interruption Versus Standard of Care Immune-Checkpoint Inhibitor (ICI) Therapy In Patients With Advanced \u002F Metastatic Solid Tumors.","A Multicenter Randomized Open-Label Trial Evaluating ctDNA-Guided Interruption Versus Standard of Care Continuous Immune-Checkpoint Inhibitor (ICI) Therapy In Patients With Advanced\u002FMetastatic Solid Tumors","SIGNAL-IO 301","Inclusion Criteria:\n\nGeneral inclusion criteria includes the following selection criteria to be eligible for inclusion in any aspect of the study. Eligibility will be assessed by the investigator:\n\n1. Signed Informed consent\n2. Age ≥ 18 years\n3. ECOG 0-2.\n4. Histologically confirmed advanced\u002Fmetastatic solid tumors including:\n\n   1. Melanoma: Unresectable recurrent, advanced, or metastatic\n   2. NSCLC: Advanced or metastatic\n   3. MSI-High\u002FdMMR CRC: Metastatic\n   4. RCC: Unresectable recurrent, advanced, or metastatic\n   5. Other: Metastatic solid tumors\n5. Received first line ICI monotherapy or dual-ICI therapy (e.g., PD-1\u002FCTLA-4 combination therapy) for a minimum of 12 months (maximum of 15 months) for NSCLC, RCC \\& other metastatic solid tumors, or for a minimum of 6 months (maximum of 9 months) for melanoma and MSI-High \u002FdMMR CRC. Exceptions permitted:\n\n   * For patients with NSCLC: First line platinum-based chemo-ICI regimens if on maintenance ICI +\u002F- pemetrexed.\n   * For patients with melanoma: nivolumab\u002Frelatlimab is permissible.\n6. Radiographic CR\u002FPR: Participants must have CR or PR at the last assessment performed within 6 weeks before randomization according to RECIST v1.1 using a diagnostic CT and\u002For MRI. Radiographic assessment must be confirmed by the BICR prior to randomization.\n7. Known ctDNA-negative with a tissue-informed assay\n\n   * ≥ 2 consecutive ctDNA-negative results at least 6 weeks apart; last test within 1 month of enrollment.\n   * Note: A confirmatory Signatera Genome negative test must be completed at enrollment if previous ctDNA testing performed for clinical care was done with a test other than Signatera Genome.\n8. Adequate organ function:\n\n   1. Hematology: ANC ≥1500\u002FμL; Platelets ≥100000\u002FμL;Hemoglobin ≥9.0g\u002FdL;\n   2. Renal: Serum Cr ≤1.5×ULN or calculated CrCl ≥60 mL\u002Fmin (using Cock-Gault formula);\n   3. Hepatic: Total bilirubin ≤1.5 ×ULN or, for participants with total bilirubin levels \\>1.5×ULN, direct bilirubin within normal limits; AST (SGOT) and ALT (SGPT) ≤2.5×ULN;\n   4. Coagulation: INR or PT, activated partial thromboplastin time (APTT) ≤1.5×ULN Note: Laboratory assessments performed as part of standard of care evaluations during immunotherapy treatment administration may be used to satisfy these eligibility criteria, provided they are obtained within 28 days of enrollment.\n9. Recovery to baseline or ≤ Grade 1 common terminology criteria for adverse events (CTCAE) v6 from AE(s) related to any prior treatments unless AE(s) are deemed clinically non-significant (e.g., Grade 2 alopecia) by the Investigator and\u002For stable on supportive therapy.\n10. No prior malignancy, with the exception of basal cell carcinoma of the skin, superficial bladder cancer, squamous cell carcinoma of the skin, or in situ cancer, or has undergone potentially curative therapy with no evidence of that disease recurrence for 5 years since completion of definitive therapy\n11. Participants must be willing and able to comply with study visits, treatment plans, laboratory tests, and other study procedures\n12. Women of child-bearing potential (WOCBP) and male participants partnering with WOCBP must agree to use highly effective contraception during the treatment phase and at least 180 days post last dose\n13. Patients must be willing to discontinue clinically-directed ctDNA testing for treatment response monitoring during the period of clinical trial testing as dictated by the protocol.\n\nExclusion Criteria\n\nPatients are not eligible for the study if they meet any of the following criteria, as assessed by the investigator:\n\n1. Available alternate treatment options with curative intent, e.g. surgery and \u002F or RT and \u002F or Chemotherapy.\n2. Symptomatic or progressing CNS metastases; or presence of leptomeningeal disease.\n3. Patient has active autoimmune disease that required systemic treatment in the past 2 years, is immunocompromised in the opinion of the Investigator, or is receiving systemic immunosuppressive treatment. (Note: Participants with splenectomy are allowed.) Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc) is not considered a form of systemic treatment.\n4. Patient is receiving systemic steroid therapy ≤3 days prior to enrollment or receiving any other form of immunosuppressive medication with the exception of daily steroid replacement therapy. Note: Use of inhaled corticosteroids, local steroid injection, or steroid eye drops is allowed.\n5. Had allogeneic tissue\u002Fsolid organ transplantation.\n6. Interstitial lung disease or history of pneumonitis that has required oral or IV steroids. Note: Patients with lymphangitic carcinomatosis secondary to NSCLC can be considered as eligible.\n7. Has received or will receive a live vaccine within 30 days prior to enrollment (seasonal flu vaccines that do not contain live vaccine are permitted).\n8. Active infection requiring intravenous systemic therapy.\n9. Known history of human immunodeficiency virus (HIV).\n10. Known active Hepatitis B or C.\n11. Pregnant, breastfeeding, or expecting to conceive or father children within the projected duration of the study.\n12. Currently participating or has participated in a study of an investigational agent or using an investigational device within 4 weeks of enrollment.\n13. Use of any commercial ctDNA or liquid biopsy monitoring outside of the study protocol during the treatment monitoring phase within the protocol.",{"count":174,"type":21},920,[24],"This is a multicenter, open-label, randomized (1:1) trial designed to evaluate whether ctDNA-guided interruption of immune-checkpoint inhibitor (ICI) therapy provides comparable survival to standard of care (SoC) continuous ICI therapy in patients with histologically confirmed advanced\u002Fmetastatic non-small cell lung cancer (NSCLC), melanoma, microsatellite instability-high (MSI-High)\u002FDeficient Mismatch Repair (dMMR) colorectal cancer (CRC), renal cell carcinoma (RCC) and other solid tumors. This study will be conducted in up to 100 sites.",[178,179,180,181,30,182,183,184,185,186,187,188,189,190,191],"NSCLC (Advanced Non-small Cell Lung Cancer)","NSCLC (Non-small Cell Lung Cancer)","NSCLC (Non-small Cell Lung Carcinoma)","NSCLC","Melanoma (Skin) Stage IV","CRC","MSI High Colorectal Cancer","DMMR Colorectal Cancer","RCC, Renal Cell Cancer","RCC","Solid Tumors","Metastatic Solid Tumors","Advanced Solid Tumors","Advanced Solid Tumors Cancer",[193,194,195,196,197,181,198,199,200,201,183,202,187,203,204,205,206,207,208,209,210],"ctDNA","Circulating tumor DNA","Immune checkpoint inhibitor","ICI","Non-small cell lung cancer","Melanoma","Microsatellite Instability-High\u002Fdeficient Mismatch Repair","MSI-High\u002FdMMR","Colorectal Cancer","Renal cell carcinoma","Metastatic solid tumors","Signatera","Molecular residual disease","MRD","Biomarker-guided therapy","Adjuvant therapy","Tumor-informed assay","Advanced solid tumor",{"date":212,"type":36},"2026-08-04",{"date":214,"type":21},"2026-12",{"date":216,"type":21},"2034-03",{"name":218,"class":219},"Natera, Inc.","INDUSTRY",{"id":221,"slug":222,"hasResults":12,"nctId":223,"briefTitle":224,"officialTitle":225,"acronym":226,"eligibilityCriteria":227,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":228,"targetDuration":4,"studyType":22,"phases":230,"briefSummary":231,"conditions":232,"keywords":235,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":158,"lastUpdatePostDateStruct":238,"startDateStruct":239,"completionDateStruct":241,"leadSponsor":242,"locationsCount":108},"100614524","investigating-real-time-immunotherapy-symptoms-study-100614524","NCT07280715","Investigating Real-Time Immunotherapy Symptoms Study","Digital Remote Patient Monitoring and Triage During Cancer Immunotherapy","IRIS","Inclusion Criteria:\n\n* receiving immune checkpoint inhibitor therapy at UPMC Hillman Cancer Center for melanoma;\n* age 18 years or older;\n* ability to read and write in English;\n* owns and uses a smartphone capable of running study applications\n\nExclusion Criteria:\n\n* under 18 years old; and\n* unable to read and write in English",{"count":229,"type":21},40,[24],"The goal of this study is to evaluate the feasibility of using information from wearable devices and self-reported symptoms to remotely monitor patients during immunotherapy. The main questions it aims to answer are:\n\n* Is the digital remote patient monitoring tool feasible and acceptable to patients?\n* Do the alerts and guidance improve symptom management, quality of life, and engagement with the care team during treatment?\n\nParticipants will:\n\n* Complete a demographic questionnaire at the beginning of the study and quality-of-life and health questionnaires at the beginning, midpoint, and end of study.\n* As feasible: At the beginning and end of the study, complete an in-person physical function assessment measuring balance (Short Physical Performance Battery).\n\nIf participant is randomly assigned to the intervention group, they will also:\n\n* Complete weekly symptom ratings via digital remote patient monitoring tool\n* Wear a Fitbit activity tracker as feasible for 90 days.\n* At the end of the study, complete a semi-structured interview to provide feedback on the study.",[233,30,234],"Cancer","Immunotherapy",[236,237],"quality of life","adverse events",{"date":212,"type":36},{"date":240,"type":36},"2026-06-17",{"date":40,"type":21},{"name":243,"class":43},"University of Pittsburgh",{"id":245,"slug":246,"hasResults":12,"nctId":247,"briefTitle":248,"officialTitle":249,"acronym":250,"eligibilityCriteria":251,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":252,"targetDuration":4,"studyType":22,"phases":253,"briefSummary":254,"conditions":255,"keywords":256,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":268,"lastUpdatePostDateStruct":269,"startDateStruct":271,"completionDateStruct":273,"leadSponsor":275,"locationsCount":108},"100645299","clinical-study-on-high-fiber-diet-and-short-term-fasting-in-melanoma-under-immunotherapy-with-checkpoint-inhibition-100645299","NCT07680452","Clinical Study on High-fiber Diet and Short-term Fasting in Melanoma Under Immunotherapy With Checkpoint Inhibition","Exploratory Clinical Study on High-fiber Diet and Short-term Fasting in Melanoma Under Immunotherapy With Checkpoint Inhibition","Melafit","Inclusion Criteria:\n\n* Histologically or cytologically confirmed stage IIB-IIIC melanoma\n* Indication for immune checkpoint inhibition as monotherapy as determined by the tumor board\n* No prior systemic melanoma therapy\n* ECOG 0 or 1\n* ≥ 18 years of age\n\nExclusion Criteria:\n\n* Pregnancy or breastfeeding\n* Underweight (BMI ≤19.5)\n* Pre-existing eating disorder\n* Severe internal medical conditions (e.g., renal insufficiency with creatinine \\> 2 mg\u002FdL) or secondary malignancy\n* Current vegan diet or prolonged fasting (≤ 4 days) within the last 6 months\n* Use of antibiotics within 4 weeks prior to the start of the study intervention",{"count":145,"type":21},[24],"The treatment of melanoma has improved significantly in recent years. A modern form of cancer treatment known as immunotherapy with checkpoint inhibitors plays a key role in this. These drugs help the immune system better recognize and fight cancer cells. Nevertheless, it remains a challenge to maximize treatment effectiveness while minimizing side effects.\n\nOne possible approach to influencing treatment efficacy and tolerability is diet. A high-fiber diet, as recommended by the German Nutrition Society, increases the effectiveness of immunotherapy, in part through its influence on gut bacteria (the gut microbiota). Initial studies also show that short-term fasting (i.e., eating nothing or very little for a limited period) reduces the side effects of immunotherapy in mouse models and improves the tolerability of chemotherapy in humans.\n\nThis study investigates the feasability of a study on short-term fasting, in addition to a high-fiber diet in patiens with melanoma undergoing immunotherapy.\n\n40 participants will follow a high-fiber diet based on the recommendations of the German Nutrition Society. Additionally, half of the participants will undergo periodic cycles of short-term fasting of 72h with each immunotherapy. Another 20 participants will not undergo any intervention and serve as a control group.\n\nThe goal is to determine whether this study concept is feasible. Exploratory outcomes include, quality of life, fatigue, tolerability of the therapy, impact on disease progression, immune system (flow cytometry) and gut bacteria (microbiome).\n\nThe results are intended to help understand whether targeted dietary measures can support the effectiveness of modern cancer treatments.",[30],[257,258,259,260,261,262,263,264,265,266,267],"fasting","diet","fiber","high-fiber","melanoma","STF","short-term fasting","microbiome","checkpoint-inhibitor","checkpoint-inhibition","immunotherapy","2026-07-27",{"date":270,"type":36},"2026-07-29",{"date":272,"type":36},"2026-07-28",{"date":274,"type":21},"2028-12-05",{"name":276,"class":43},"Charite University, Berlin, Germany",{"id":278,"slug":279,"hasResults":12,"nctId":280,"briefTitle":281,"officialTitle":281,"acronym":282,"eligibilityCriteria":283,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":284,"targetDuration":4,"studyType":22,"phases":286,"briefSummary":287,"conditions":288,"keywords":291,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":296,"startDateStruct":297,"completionDateStruct":298,"leadSponsor":300,"locationsCount":71},"100646625","phase-2-dietary-fiber-to-induce-gut-microbiota-mediated-response-to-immunotherapy-in-melanoma-100646625","NCT07686835","Dietary Fiber to Induce Gut Microbiota-mediated Response to Immunotherapy in Melanoma.","FIGURE-IM","Inclusion Criteria:\n\n* Histologically confirmed cutaneous melanoma classified as irresectable stage III or stage IV disease\n* Measurable disease according to RECIST 1.1 criteria\n* Age ≥ 18 years\n* Starting standard-of-care treatment with ICI in first line\n* Written informed consent must be given\n* Able to read and understand Dutch or English\n* Able to comply with study procedures (e.g. willing to provide fecal samples)\n\nExclusion Criteria:\n\n* Symptomatic brain metastases\n* Received prior immunotherapy; previous (neo)adjuvant treatment is allowed if the last administration is at least 6 months ago\n* Use of systemic immunosuppressive medications\n* Use of laxatives up to 1 week prior to start of ICI\n* Use of supplements that alter bowel function or gut microbiota such as fibers\u002Fprebiotics, probiotics, synbiotics, or postbiotics up to 1 month prior to start of ICI\n* Use of antibiotics up to 1 months prior to start of ICI\n* Use of proton pumps inhibitors (PPI's) up to 3 months prior to start of ICI\n* Pregnant or lactating\n* Current participation in another clinical trial requiring the use of study medication\n* Has a known allergy to plants such as lettuce, sage, tarragon, chicory, artichoke, chamomile, daisy, or sunflower.\n* Has a medical history of gastrointestinal resection (appendectomy is allowed)\n* Has active inflammatory bowel disease",{"count":285,"type":21},70,[57],"Previous research has shown that a higher fiber intake may have a beneficial effect on the intestinal health and improve the effectiveness of immunotherapy, but this is not certain. The objective of this double-blinded randomized clinical trial is to analyze, whether increased dietary fiber intake by patients with metastatic melanoma will increase the relative amount of Bifidobacterium, which in turn stimulates immune cell activity and improves the response to immunotherapy.",[182,30,289,290,198],"Melanoma Metastatic","Melanoma Advanced",[292,293,294,295],"microbiota","gut microbiota","dietary fiber","life-style",{"date":268,"type":36},{"date":158,"type":21},{"date":299,"type":21},"2029-04-30",{"name":301,"class":43},"Radboud University Medical Center",{"id":303,"slug":304,"hasResults":12,"nctId":305,"briefTitle":306,"officialTitle":307,"acronym":4,"eligibilityCriteria":308,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":309,"targetDuration":4,"studyType":22,"phases":311,"briefSummary":312,"conditions":313,"keywords":315,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":323,"lastUpdatePostDateStruct":324,"startDateStruct":326,"completionDateStruct":328,"leadSponsor":330,"locationsCount":332},"100615077","phase-1-study-of-amxt-1501-and-dfmo-in-combination-with-standard-therapies-in-advanced-solid-tumors-100615077","NCT07287917","Study of AMXT 1501 and DFMO in Combination With Standard Therapies in Advanced Solid Tumors","A Phase 1b\u002F2 Trial Investigating the Safety and Efficacy of Oral AMXT 1501 and Oral DFMO in Combination With Standard of Care in Patients With Advanced Solid Tumors Who Progressed After Prior Therapies","Inclusion Criteria:\n\nPatients will be eligible for study participation only if they meet ALL the inclusion criteria applicable to their diagnosis.\n\n1. Understand and sign the informed consent form (ICF) and be willing to comply with all study procedures before any study specific procedures are conducted.\n2. ≥18 years old at the time of signing the informed consent.\n3. Diagnosed with unresectable, locally advanced, or metastatic solid tumors including ER+ HER2- breast cancer (Cohort 1) or melanoma (Cohort 2)\n\n   a.Underlying malignant disease must be histologically or cytologically documented b.For breast cancer patients: locally advanced or metastatic breast cancer with one or more actionable PIK3CA\u002FAKT1\u002FPTEN-alterations following progression on at least 2 endocrine-based regimens in the metastatic setting or recurrence on or within 12 months of completing adjuvant therapy. Patients who are candidates to start therapy with capivasertib are eligible for enrollment. Patients previously treated with PIK3CA inhibitors will be allowed into the study. Premenopausal patients with ER+ HER2-breast cancer may be enrolled and should be maintained on an agent for ovarian suppression (i.e., luteinizing hormone-releasing hormone \\[LHRH\\] agonist) as part of SOC.\n\n   c.For melanoma patients: patients with unresectable metastatic cutaneous melanoma that progressed on any prior immune checkpoint inhibitor and, if BRAF600 mutant positive, a BRAF or mitogen-activated protein kinase (MEK) inhibitor or both as shown below: i.Patient have to have resolution of all immune checkpoint inhibitor-related adverse events to Grade 0-1 and prednisone ≤10 mg\u002Fday for at least 2 weeks. Histologically or cytologically confirmed diagnosis of unresectable Stage III or metastatic melanoma not amenable to local therapy.\n\n   ii.Patients must have progressed or shown intolerance to any prior immune checkpoint inhibitors.\n\n   iii.Patients with BRAF gene mutant melanoma must have had a prior treatment regimen (progressed or shown intolerance) that included vemurafenib, dabrafenib, or an approved BRAF gene and or MEK protein inhibitor. However, patients who may continue to be candidates for second line immune check point inhibitors can be enrolled prior to initiation for BRAF gene or MEK inhibitors.\n\n   iv.Patients with incurable malignancies may be enrolled regardless of the number of prior treatment lines, as long as in the opinion of the Investigator, the patient would be unlikely to tolerate or derive clinically meaningful benefit from other available treatment options (FDA Guidance for Industry: Cancer Clinical Trial Eligibility Criteria: Available Therapy in Non-Curative Settings. July 2022).\n\n   d.Has evaluable or measurable disease by tumor Response Evaluable Criteria in Solid Tumors version 1.1 (RECIST 1.1) at the time of enrollment. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.\n\n   e.Patients with brain previously treated stable brain metastases may participate provided they are radiologically stable, i.e., without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study treatment.\n4. Patients must be willing to undergo a fresh tumor biopsy at Screening and during treatment if safe and clinically feasible. An archival sample is allowed if obtained within 1 year prior to the first dose of study drug. However, lack of tumor biopsy by itself will not preclude patients from enrollment.\n5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at Screening or Day 1.\n6. Life expectancy of at least 12 weeks.\n7. Adequate organ function defined as:\n\n   a.Absolute neutrophil count (ANC) ≥1.5×109\u002FL without granulocyte colony-stimulating factor (G-CSF) support within 7 days preceding the laboratory assessment b.Platelet ≥100×109\u002FL, without transfusion within 7 days preceding the laboratory assessment c.Hemoglobin ≥9 g\u002FdL, without transfusion support within 7 days preceding the laboratory assessment d.Activated partial thromboplastin time\u002Fpartial thromboplastin time (aPTT\u002FPTT) ≤1.5×ULN e.Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5×ULN (if liver metastases are present, then ≤5×ULN is allowed) f.Total serum bilirubin ≤1.5×ULN, except for patients with known Gilbert's Syndrome in whom ≤3×ULN is permitted. Confirmation of Gilbert's diagnosis requires elevated unconjugated (indirect) bilirubin values; normal complete blood count in previous 12 months, blood smear, and reticulocyte count; normal aminotransferases and alkaline phosphatase in previous 12 months g.The patient is clinically euthyroid (whether treated or untreated) h.Renal: Serum creatinine ≤1.5×ULN or creatinine clearance ≥60 mL\u002Fmin\u002F1.73 m2 for patients with serum creatinine levels \\>1.5×ULN i.Any Grade 3 or higher laboratory abnormalities should be discussed and approved by the Sponsor Medical Monitor or designee prior to enrollment (even if not considered clinically significant)\n8. Fully recovered from acute toxic effects of prior anti-neoplastic therapies. The following minimum periods from treatment apply:\n\n   1. Myelosuppressive chemotherapy: At least 21 days after the last dose of myelosuppressive chemotherapy (42 days if prior nitrosourea).\n   2. Hematopoietic growth factors: At least 14 days after the last dose of a long-acting growth factor (e.g., Neulasta) or 7 days for short-acting growth factor.\n   3. Biologic (anti-neoplastic agent): At least 7 days after the last dose of a biologic agent. For agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur.\n\n   The duration of this interval must be discussed with the Sponsor Medical Monitor or designee.\n\n   d.Monoclonal antibodies: \\>21 days must have elapsed from the infusion of last dose of antibody and toxicity related to antibody therapy must be recovered to Grade ≤1.\n\n   e.Radiation therapy: Patients must have had their last fraction of craniospinal or focal irradiation a minimum of 8-12 weeks prior to enrollment.\n\n   f.Stem cell transplant: Patients must be ≥3 months since autologous stem cell transplant. Patients who received allogenic stem cell transplant or solid organ transplant are not eligible for study.\n\n   g.For combination with pembrolizumab cohort: Patients with Grade ≤2 neuropathy may be eligible, as may patients with endocrine-related Grade ≤2 AEs requiring treatment or hormone replacement.\n9. Active secondary malignancies will not be allowed, with the exception of:\n\n   a.Adequately treated basal cell carcinoma, squamous cell carcinoma of the skin, or in situ cervical cancer b.Adequately treated Stage 1 cancer from which the patient is currently in remission and has been in remission for ≥2 years c.Low-risk prostate cancer with Gleason score \\\u003C7 and prostate-specific antigen \\\u003C10 ng\u002FmL d.Any other cancer from which the patient has been disease-free for ≥3 years\n10. Patient compliance and geographic proximity (as determined by the Investigator) to allow adequate follow-up.\n11. Both male and female patients must be willing to consent to using highly effective contraception (refer to Section 9.1.10) prior to study entry, while on treatment, and at least 3 months thereafter.\n12. Able to take oral medications.\n\nExclusion Criteria:\n\nPatients will not be eligible for study participation if they meet ANY of the exclusion criteria.\n\n1. Patients with melanoma only:\n\n   i. Radiation therapy, or biological cancer therapy within 4 weeks prior to the first dose of study drug, or not recovered from the AEs due to cancer therapies administered more than 4 weeks earlier ii.Expected to require any other form of systemic or localized antineoplastic therapy while on study.\n\n   iii.Chronic systemic steroid therapy within 2 weeks before the planned date of the first dose of randomized treatment or on any other form of immunosuppressive medication.\n2. Intolerant to any component of combination or standard of care therapies.\n3. History or presence of clinically relevant central nervous system (CNS) pathology such as epilepsy, seizure, paresis, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis. Patient has known active CNS metastases and\u002For carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable, i.e., without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study treatment.\n4. Active inflammatory neurological disorders (e.g., Guillain-Barre Syndrome, amyotrophic lateral sclerosis, multiple sclerosis).\n5. Treatment with radiation therapy, surgery, chemotherapy, or immunotherapy within 4 weeks prior to study entry (6 weeks for nitrosoureas or Mitomycin C). No prior use of Adriamycin is allowed. Limited prior palliative radiation may be permissible no less than 2 weeks prior to C1D1 with approval from the Sponsor Medical Monitor or designee.\n6. Targeted small molecule therapy within 7 days prior to initiation of trial therapy. Chemotherapy within 14 days prior to initiation of trial therapy.\n7. Active autoimmune disease (e.g., lupus, rheumatoid arthritis, Sjogren's syndrome) requiring systemic treatment (i.e., disease modifying agents, corticosteroids, or immunosuppressive drugs) in the past 2 years. Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.\n8. History of or presence of clinically significant cardiovascular disease, e.g.,\n\n   a. Inadequately controlled or uncontrolled hypertension (defined as systolic blood pressure \\>150 mmHg and\u002For diastolic blood pressure \\>100 mmHg on antihypertensive medications.) b. Atherosclerotic cardiovascular disease including history of myocardial infarction, unstable angina, angina, coronary artery disease, cerebrovascular accident (CVA) or transient ischemic attack (TIA). History of coronary revascularization including coronary artery bypass graft (CABG), percutaneous coronary intervention (PCI) or stent placement is excluded. c. Elevated Troponin I or BNP (or NT-proBNP) blood levels above the upper limit of normal at screening or baseline on C1D1.\n\n   d. Heart failure or abnormal left ventricular ejection fraction (e.g., EF \\\u003C50%).\n\n   e. Atrial or ventricular arrhythmias, including atrial fibrillation, ventricular tachycardia. Patients with pacemakers or ICDs (implantable cardioverter defibrillators) are excluded.\n\n   f. Known cardiac involvement of a systemic disease (e.g., as in SLE, rheumatoid arthritis, psoriatic arthritis, systemic sclerosis\n9. History or presence of ECG abnormalities, e.g.,\n\n   a. Congenital or acquired prolonged QTc. Screening QTcF \\> 450ms is excluded. b. Bundle branch block including right or left bundle branch block, left anterior or posterior fascicular block, second, and 3rd degree AV block, clinically significant ST segment elevations or depressions (e.g., ≥1 mm elevation or ≥0.5 mm depression), arrhythmias. Sinus arrhythmia is not excluded. Asymptomatic sinus bradycardia is not excluded.\n10. Had major surgery, other than diagnostic surgery, within 4 weeks prior to Day 1.\n11. Have active bacterial, viral, or fungal infections requiring systemic therapy.\n12. Women who are pregnant or lactating. NOTE: Women of childbearing potential (WOCBP) must have a \"negative\" serum pregnancy test within 1 week prior to treatment.\n\n    a.Women not OCBP is defined as: i.Postmenopausal with \\>1 year since last menses and:\n\n1.If \\\u003C65 years old, follicle-stimulating hormone (FSH) \\>40 mIU\u002FmL. 2.If ≥65 years old and not on hormone replacement therapy (HRT), FSH \\>30 mIU\u002FmL.\n\n3.If ≥65 years old and on HRT, the FSH requirement is not applicable. Postmenopausal females on HRT will be allowed if HRT has been stable for ≥6 months prior to dosing of study drug(s).\n\n4.Written medical documentation of being sterilized (e.g., hysterectomy, double oophorectomy, bilateral salpingectomy) with the procedure performed ≥6 months prior to dosing study drug(s).\n\nNote: Tubal ligation is not considered a form of permanent sterilization. 13.Patients may not have any unresolved toxicity Grade \\>1 from previous anticancer therapy, except for stable chronic toxicities that are not expected to resolve (i.e., peripheral neuropathy, alopecia, etc.). Patients who have an ongoing requirement for thyroid replacement therapy from prior exposure to an immune checkpoint inhibitor but who are clinically euthyroid are permitted (whether treated or untreated).\n\n14.Have an unwillingness or inability to comply with required procedures in this protocol.\n\n15.Current active liver disease from any cause, including hepatitis A (hepatitis A virus immunoglobulin M \\[Hep A IgM\\] positive), hepatitis B (hepatitis B virus \\[HBV\\] surface antigen positive), or hepatitis C (hepatitis C virus \\[HCV\\] antibody positive, confirmed by HCV ribonucleic acid). Patients with HCV with undetectable virus after treatment are eligible. Patients with a prior history of HBV are eligible if quantitative polymerase chain reaction (PCR) for HBV DNA is negative. Note that elevated levels of biotin may interfere with viral serology testing.\n\n16.Have a serious nonmalignant disease that, in the opinion of the Investigator or the Sponsor Medical Monitor or designee, could compromise protocol objectives.\n\n17.Patients who are currently receiving any other investigational agent or who have received an investigational agent within the last 28 days, with the exception of any patient who participated in Study AMXT1501-101A.\n\n18.Known gastrointestinal (GI) disease or procedure that could interfere with the absorption of study drug, including inability to swallow whole capsules or tablets or conditions that may interfere with absorption. The Sponsor Medical Monitor or designee should be contacted for any questions regarding this exclusion criterion.\n\n19.Patients who have exhibited allergic reactions or intolerability to a similar structural compound, biological agent, or formulation as study drugs used in this study, including AMXT 1501, DFMO, and SOC therapies.\n\n20.Use of other hormonal therapies are not permitted during the study in the breast cancer cohort (Cohort 1). Exception: premenopausal women with ER+\u002FHER2- breast cancer should be maintained on an LHRH agonist for ovarian suppression.\n\n21.Use of biotin (i.e., Vitamin B7) or supplements containing biotin higher than the daily adequate intake of 30 μg. Note: Patients who switch from a high dose to a dose of ≤30 μg\u002Fday are eligible for study entry.\n\n22.Uncontrolled, acute, or life-threatening bacteria, viral, or fungal infection. Patients with ongoing use of prophylactic antibiotics, antifungals, or antivirals are eligible if no evidence of active infection, this includes COVID patients.\n\nException: Patients with well-controlled HIV (e.g., CD4 \\>350\u002Fmm3 and undetectable viral load) are eligible.\n\n23.Patient has an active or prior history of autoimmune disease. Exception: patients with type 1 diabetes (if stable, well-controlled, and not brittle), vitiligo, hypo- or hyperthyroid disease, or autoimmune alopecia are permitted if the condition does not require immunosuppressive treatment.\n\n24.Known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin, non-metastatic squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy.\n\n25.Combination with pembrolizumab specific additional exclusion criteria:\n\n1. Has severe hypersensitivity (≥Grade 3) to pembrolizumab and\u002For any of its excipients.\n2. Has received radiation therapy to the lung that is \\>30 Gy within 6 months of the first dose of trial treatment.\n3. Has a history of (non-infectious) pneumonitis\u002Finterstitial lung disease that required steroids or has current pneumonitis\u002Finterstitial lung disease.\n4. Has history of an allogeneic stem cell transplant or a solid organ transplant.\n5. Has a history of radiation pneumonitis. (Note: Cannot receive prior radiotherapy within 2 weeks of start of pembrolizumab. Note: Participants must have recovered from all radiation-related toxicities and not require corticosteroids. A 1-week washout is permitted for palliative radiation \\[≤2 weeks of radiotherapy\\] to non-CNS disease.",{"count":310,"type":21},92,[56,57],"This study will evaluate the safety, tolerability, and preliminary effectiveness of AMXT 1501 and DFMO when combined with standard treatments for advanced solid tumors. The trial includes two groups:\n\n* Cohort 1: Patients with ER+ \u002F HER2- breast cancer receiving fulvestrant and capivasertib\n* Cohort 2: Patients with unresectable or metastatic cutaneous melanoma receiving pembrolizumab\n\nThe Phase 1b portion will find the recommended Phase 2 dose (RP2D). The Phase 2 portion will further evaluate clinical activity at the RP2D using response criteria for solid tumors (RECIST 1.1).\n\nThe study will also evaluate pharmacokinetics, pharmacodynamics, disease control, and overall safety.",[30,314],"HER2-low Hormone Receptor Positive Breast Cancer",[316,261,317,318,319,320,321,322],"breast cancer","AMXT 1501","DFMO","polyamine inhibitor","advanced solid tumor","combination therapy","polyamine","2026-07-14",{"date":325,"type":36},"2026-07-15",{"date":327,"type":36},"2026-01-26",{"date":329,"type":21},"2028-12-29",{"name":331,"class":219},"Aminex Therapeutics, Inc.",17,{"id":334,"slug":335,"hasResults":12,"nctId":336,"briefTitle":337,"officialTitle":338,"acronym":339,"eligibilityCriteria":340,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":341,"targetDuration":4,"studyType":22,"phases":343,"briefSummary":344,"conditions":345,"keywords":346,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":357,"lastUpdatePostDateStruct":358,"startDateStruct":360,"completionDateStruct":362,"leadSponsor":364,"locationsCount":71},"100635722","sun-exposure-and-activities-after-skin-cancer-optimization-of-mhealth-interventions-100635722","NCT07556380","Sun Exposure and Activities After Skin Cancer: Optimization of mHealth Interventions","SESAME: Sun Exposure and Activities After Skin Cancer: Optimization of mHealth Interventions","SESAME","Inclusion Criteria:\n\n* Is able to speak, read and write in English\n* Had previous melanoma diagnosis with no melanoma treatment in the last three months\n* Has no current Melanomas or untreated skin cancer\n* Reports spending at least 15 minutes outside per day during Spring\u002F Summer on both weekdays and weekends\n* Owns a smartphone with access to both Bluetooth and WIFI\n* Is willing to use the UV device and Actigraph during waking hours\n* Is willing to download and use a study app\n* Is willing to actively participate in the study for up to 1 year\n\nExclusion Criteria:\n\n* Has a medical condition preventing moderate-to-vigorous physical activity (MVPA) or a doctor recommendation to avoid MVPA\n* Is currently enrolled in another study on MVPA",{"count":342,"type":21},150,[24],"The purpose of this study is to evaluate 5 different smartphone administered sun protection interventions that aim to reduce unprotected sun exposure in melanoma survivors. Participants are asked to wear an ultraviolet (UV) device and an activity monitor (Actigraph) to measure their daily UV exposure and track their physical activity for three separate assessment weeks and complete daily surveys. After the first assessment week, eligible participants are assigned up to 5 different sun protection interventions that are administered through a smartphone application for 8 weeks. Following 8-week use of the sun protection interventions, participants complete another assessment week. At the end of the assessment week, participants provide feedback on the design and usability of the UV device, smartphone application and each of the sun protection interventions that they experienced. One year later, participants are contacted again to complete a final assessment week.",[30],[347,348,349,198,350,233,351,352,353,354,355,356],"Wearable","Smartphone","Device","Physical activity","Actigraph","Sun protection","Sunscreen","Goals","Health","Ultraviolet radiation","2026-07-08",{"date":359,"type":36},"2026-07-10",{"date":361,"type":36},"2025-04-01",{"date":363,"type":21},"2027-09-01",{"name":365,"class":43},"Northwestern University",{"id":367,"slug":368,"hasResults":12,"nctId":369,"briefTitle":370,"officialTitle":371,"acronym":4,"eligibilityCriteria":372,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":373,"targetDuration":4,"studyType":22,"phases":374,"briefSummary":375,"conditions":376,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":357,"lastUpdatePostDateStruct":391,"startDateStruct":392,"completionDateStruct":394,"leadSponsor":396,"locationsCount":108},"100619216","phase-1-sl-28-for-advanced-solid-tumours-100619216","NCT07341737","SL-28 for Advanced Solid Tumours","A Phase 1\u002F2, Multicentre, Open-Label, Dose Escalation and Expansion Study to Assess the Safety, Pharmacokinetics, and Preliminary Efficacy of SL-28 in Patients With Advanced Solid Tumours","Inclusion Criteria:\n\n* Ability to provide written informed consent prior to any study-related procedures and to understand the nature, purpose, and potential risks of the study\n* Adult males and females ≥18 years of age at screening\n* Life expectancy of at least 3 months\n* Histologically or cytologically confirmed unresectable advanced solid tumor (recurrent, metastatic, or locally advanced)\n* Disease refractory to, intolerant of, or refusal of standard therapies, including immunotherapy and molecular\u002Fbiomarker-directed treatments, as determined by the Principal Investigator (PI) or delegate\n* Eligible tumor types include:\n* Head and neck squamous cell carcinoma\n* Thoracic malignancies (small-cell lung cancer, non-small cell lung cancer, esophageal cancer)\n* Gastrointestinal malignancies (gastric, liver, colorectal, pancreatic adenocarcinoma)\n* Genitourinary malignancies (bladder, renal cell, prostate cancer)\n* Gynecologic malignancies (ovarian, endometrial cancer)\n* Breast cancer and melanoma\n* Evaluable disease per RECIST v1.1\n* ECOG performance status 0-1 (or up to 2 at PI discretion)\n* Adequate organ function, defined as:\n* Total bilirubin ≤1.5 × ULN (≤2.0 × ULN for liver metastases or Gilbert's syndrome)\n* AST, ALT, alkaline phosphatase ≤2.5 × ULN (≤5 × ULN if liver metastases, at PI discretion)\n* Creatinine clearance ≥50 mL\u002Fmin (Cockcroft-Gault) or eGFR ≥50 mL\u002Fmin (CKD-EPI)\n* Absolute neutrophil count ≥1,000\u002Fmm³\n* Platelet count ≥100,000\u002Fmm³\n* Hemoglobin ≥90 g\u002FL without transfusion within 2 weeks\n* Prothrombin time and aPTT ≤1.5 × ULN (or stable INR if on anticoagulation)\n\nFemale patients:\n\n-Non-childbearing potential (surgically sterile or postmenopausal), or of childbearing potential with negative pregnancy tests and agreement to effective contraception through 90 days post-dose\n\nMale patients:\n\n* Agreement not to donate sperm for 90 days post-dose\n* Agreement to use adequate contraception as applicable\n* Suitable venous access for blood sampling\n* Willingness and ability to comply with study procedures and protocol requirements\n\nExclusion Criteria:\n\n* Ongoing toxicities ≥ Grade 2 per NCI CTCAE v5.0 (except alopecia, fatigue, sensory neuropathy, or adequately treated endocrine deficiencies)\n* NYHA Class III or IV heart disease, myocardial infarction within 6 months, unstable arrhythmia, or ischemia on ECG\n* QTcF \\>470 ms (females) or \\>450 ms (males)\n* Active, uncontrolled bacterial, viral, or fungal infection requiring systemic therapy\n* Requirement for systemic corticosteroids or other immunosuppressive therapy that cannot be discontinued ≥14 days prior to dosing\n* Prior therapies within restricted timeframes:\n* Immune checkpoint inhibitors or biologics within 28 days\n* Antineoplastic therapies, surgery, radiotherapy, or radiopharmaceuticals within 21 days\n* Unapproved investigational drugs within 5 half-lives\n* Nitrosoureas or mitomycin C within 6 weeks\n* Concurrent malignancy within 5 years, except specified low-risk cancers\n* Pregnancy or breastfeeding\n* Known HIV, hepatitis B (HBsAg positive), or hepatitis C infection\n* Inability or unwillingness to comply with protocol procedures\n* History of anaphylaxis or significant allergy interfering with participation\n* Clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, neurologic, psychiatric, or immunologic disease within 6 months\n* Conditions affecting drug absorption, distribution, metabolism, or excretion\n* Receipt of live vaccines within 28 days prior to screening\n* Participation in another investigational study within 30 days prior to screening",{"count":145,"type":21},[56,57],"Second Life Therapeutics is developing SL-28, an allogeneic, non-genetically modified cell-based therapy for the treatment of advanced solid tumours. The company has recently demonstrated a novel, non-genetic approach to modulate immune cell activity through targeted manipulation of the Universal Receptive System. The purpose of this open label, multi-center clinical trial is to evaluate the anti-tumor activity, safety, and pharmacokinetics, single-agent SL-28 in patients with a diverse array of solid tumors. The study includes an initial Phase 1 dose escalation to determine recommended dose(s) for expansion of SL-28 as a monotherapy and Phase 2 expansion cohorts. The study will enroll patients with advanced solid tumours, including those who failed previous lines of chemo- and immunotherapies.",[377,378,379,380,381,382,383,384,385,386,387,388,389,30,88,90,390,201],"Head & Neck Cancer","Pancreas Carcinoma","Pancreas Cancer, Metastatic","Lung Adenocarcinoma","Lung Cancer (NSCLC)","Lung Cancer (Non-Small Cell)","Esophageal Cancer","Stomach (Gastric) Cancer","Liver Cancer","Intestinal Cancer","Bladder Cancer","Renal Cancer","Prostate Cancer","Endometrial Cancer",{"date":359,"type":36},{"date":393,"type":21},"2026-07-13",{"date":395,"type":21},"2027-03-01",{"name":397,"class":219},"Second Life Therapeutics",{"id":399,"slug":400,"hasResults":12,"nctId":401,"briefTitle":402,"officialTitle":403,"acronym":404,"eligibilityCriteria":405,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":406,"targetDuration":4,"studyType":407,"phases":4,"briefSummary":408,"conditions":409,"keywords":410,"overallStatus":128,"whyStopped":4,"lastUpdateSubmitDate":413,"lastUpdatePostDateStruct":414,"startDateStruct":415,"completionDateStruct":417,"leadSponsor":419,"locationsCount":108},"100646518","melanoma-brain-metastasis-treated-with-cyberknife-100646518","NCT07691255","MELanoma Brain Metastasis Treated With CYberknife","Impact of Stereotactic Radiosurgery With Cyberknife In Patients With Brain Melanoma Metastases In The Era Of New Drugs","MELCY","Inclusion Criteria:\n\n* Age \\> 18\n* Written informed consent for treatment and research purposes\n* Melanoma Brain Metastases (MBM) diagnosed with brain MRI\u002FCT\n* MBM treatable with stereotactic radiotherapy\n* Systemic therapy (immunotherapy, target therapy, or both) is allowed, as concurrent or non-concurrent treatment with stereotactic radiotherapy\n\nExclusion Criteria:\n\n* Leptomeningeal neoplastic infiltration\n* Previous whole-brain radiotherapy or surgical removal of brain metastases\n* Patients with histological diagnosis of non-cutaneous melanoma (e.g. uveal melanoma)",{"count":82,"type":21},"OBSERVATIONAL","Melanoma is a type of cancer that can spread to the brain, making the disease harder to treat and worsening both survival and quality of life.\n\nIn recent years, treatments have improved significantly thanks to advances in surgery, radiotherapy, immunotherapy, and targeted therapy. These new treatments have greatly increased survival rates for patients with metastatic melanoma.\n\nThis study focuses on stereotactic radiosurgery, a highly precise form of radiotherapy used to treat brain metastases. Researchers want to better understand how this treatment works when combined with immunotherapy or targeted therapy, and whether the timing and sequence of treatments can improve outcomes.\n\nBetween 2026 and 2028, patients treated at the IEO for melanoma brain metastases will be observed and their clinical data collected. The goal is to improve future treatment strategies and help doctors choose the best therapeutic approach for each patient.",[30],[411,412],"Stereotactic radiotherapy","Brain metastases","2026-07-02",{"date":357,"type":36},{"date":416,"type":21},"2026-06",{"date":418,"type":21},"2030-01-01",{"name":420,"class":43},"European Institute of Oncology",{"id":422,"slug":423,"hasResults":12,"nctId":424,"briefTitle":425,"officialTitle":426,"acronym":4,"eligibilityCriteria":427,"healthyVolunteers":12,"sex":17,"minAge":428,"maxAge":429,"enrollmentInfo":430,"targetDuration":4,"studyType":22,"phases":431,"briefSummary":432,"conditions":433,"keywords":439,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":445,"lastUpdatePostDateStruct":446,"startDateStruct":448,"completionDateStruct":450,"leadSponsor":452,"locationsCount":108},"100624165","navigation-intervention-for-adolescent-and-young-adult-cancer-survivors-100624165","NCT07406087","Navigation Intervention for Adolescent and Young Adult Cancer Survivors","Adaptation and Implementation of an Evidence-Based Patient Navigation Intervention for Adolescent and Young Adult Cancer Survivors","Inclusion Criteria:\n\n* Received diagnosis of local or regional breast, ovarian, cervical, testicular, colon\u002Frectal, melanoma, endometrial, sarcoma, or thyroid cancer between the ages of 15-39 years (\"index cancer\")\n* Current age 21-45 years\n* Diagnosed and treated for index cancer within Kaiser Permanente Southern California adult medical oncology and\u002For surgery\n* Current Kaiser Permanente insurance coverage\n\nExclusion Criteria:\n\n* Patients with a history of or current diagnosis of leukemia or lymphoma\n* Patients with metastatic disease at diagnosis","21 Years","45 Years",{"count":7,"type":21},[24],"The investigators propose to: 1) Adapt an evidence-based cancer-focused patient navigation (PN) program for the Adolescent and Young Adult (AYA) cancer survivor population; and 2) Plan and conduct an effectiveness-implementation trial of this program within Kaiser Permanente Southern California (KPSC). PLEASE NOTE: This study is awarded in two phases. The UG3 phase has been awarded for the first two years; upon successful completion of this phase by meeting pre-defined milestones, the National Cancer Institute (NCI) will provide funding for the second phase of the study (Years 3-6), which will allow our team to conduct a trial to determine the effectiveness of the implementation of the adapted PN program for the AYA cancer survivor population. This application is focused on the initial UG3 phase and will update the protocol for the UH3 trial upon successful completion of the UG3 milestones and receipt of the UH3 award.\n\nThe primary objectives in the UG3 phase of the study are to adapt and tailor an existing PN program to meet the needs of AYA cancer survivors and the local clinical context via (a) interviews with key stakeholders (patients, clinicians, administrators) and (b) guidance from our AYA Primary Care Survivorship Council. The investigators will conduct a pilot study of the adapted PN program and refine the program to enhance acceptability to patients and clinicians, enhance feasibility and effectiveness, and develop and pilot evaluation tools and methods prior to the start of the UH3 phase of the trial, which will be a larger trial. Objectives will be updated for the UH3 phase once awarded.",[88,90,434,435,436,30,390,437,438],"Cervical Cancer","Testicular Cancer","Colon Rectal Cancer","Sarcoma","Thyroid Cancer",[440,441,442,443,444],"Adolescent and Young Adult","Cancer Survivors","Patient Navigation","Adaptations","Implementation Science","2026-07-01",{"date":447,"type":36},"2026-07-06",{"date":449,"type":36},"2026-03-15",{"date":451,"type":21},"2027-08",{"name":453,"class":43},"Kaiser Permanente",{"id":455,"slug":456,"hasResults":12,"nctId":457,"briefTitle":458,"officialTitle":459,"acronym":460,"eligibilityCriteria":461,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":462,"targetDuration":4,"studyType":407,"phases":4,"briefSummary":464,"conditions":465,"keywords":472,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":481,"lastUpdatePostDateStruct":482,"startDateStruct":484,"completionDateStruct":486,"leadSponsor":488,"locationsCount":489},"100618120","predicting-response-to-immunotherapy-from-analysis-of-live-tumor-biopsies-elephas-05-100618120","NCT07327489","Predicting Response to Immunotherapy From Analysis of Live Tumor Biopsies (ELEPHAS-05)","Predicting Response to Immunotherapy From Analysis of Live Tumor Biopsies","ELEPHAS-05","Inclusion Criteria:\n\n1. Able and willing to provide informed consent for participation\n2. Age ≥18 years at time of consent.\n3. Have a suspected or confirmed cancer diagnosis that is to be evaluated by means of a biopsy.\n4. Subjects who are newly diagnosed or have suspected cancer must be treatment-naïve at the time of biopsy. All other subjects should have the biopsy performed before starting their next line of treatment.\n\nExclusion Criteria:\n\n1. Have a known auto-immune disease or prior condition (prior organ transplant, chronic kidney or liver disease) that renders them ineligible for immunotherapy (IO) treatment.\n2. Severely immunocompromised person(s). Examples include patients on immunosuppressants, HIV positive patients on antiretrovirals, post transplantation patients.\n3. Pregnant person(s).",{"count":463,"type":21},2000,"This study will collect tumor specimens with correlated clinical and demographic data from patients who are undergoing a biopsy or similar procedure to obtain tumor tissue as a normal course of their medical management or diagnostic work-up for suspected or confirmed cancer.",[233,234,191,387,466,201,185,467,390,468,469,385,470,471,30],"TNBC, Triple Negative Breast Cancer","MSI-H Colorectal Cancer","Head and Neck Cancer","Kidney Cancer","NSCLC (Non-small-cell Lung Cancer)","Skin Cancer",[234,473,474,233,475,476,477,478,479,480],"Live Tumor Biopsy","Elephas","Imaging","Tumor Cutting","Treatment Response","Core Needle Biopsy","Forceps Biopsy","Punch Biopsy","2026-06-25",{"date":483,"type":36},"2026-06-29",{"date":485,"type":36},"2025-04-14",{"date":487,"type":21},"2038-04",{"name":474,"class":219},8,{"id":491,"slug":492,"hasResults":12,"nctId":493,"briefTitle":494,"officialTitle":495,"acronym":496,"eligibilityCriteria":497,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":498,"targetDuration":4,"studyType":22,"phases":500,"briefSummary":501,"conditions":502,"keywords":503,"overallStatus":128,"whyStopped":4,"lastUpdateSubmitDate":507,"lastUpdatePostDateStruct":508,"startDateStruct":510,"completionDateStruct":511,"leadSponsor":513,"locationsCount":108},"100641208","bright-light-therapy-in-patients-with-melanoma-or-non-small-cell-lung-cancer-nsclc-who-are-receiving-first-line-immune-checkpoint-blockade-100641208","NCT07661966","Bright Light Therapy in Patients With Melanoma or Non-small Cell Lung Cancer (NSCLC) Who Are Receiving First-Line Immune Checkpoint Blockade","A Pilot Trial of Bright Light Therapy in Patients Receiving First Line Immune Checkpoint Blockade","IIT BLT","Inclusion Criteria:\n\n1. Age ≥18 years.\n2. Histologically confirmed diagnosis of advanced, unresectable melanoma or NSCLC.\n3. Presence of measurable tumor burden.\n4. Scheduled to receive first-line cancer-directed therapy with an immune checkpoint blockade-containing regimen, as monotherapy or combination (e.g. pembrolizumab, ipilimumab + nivolumab, ICB + chemotherapy).\n5. ECOG performance status 0-2.\n6. Able to provide informed consent.\n7. Access to reliable internet connection via WiFi or personal hotspot\n\nExclusion Criteria:\n\n1. Previous exposure to immune checkpoint blockade.\n2. Pregnant or breastfeeding.\n3. Use of melatonin or pharmacologic sleep aids (e.g., zolpidem, trazodone, benzodiazepines) within 14 days prior to enrollment.\n4. Diagnosis of bipolar disorder or history of mania or hypomania.\n5. Active psychosis, suicidal ideation, or recent psychiatric hospitalization (\\\u003C3 months).\n6. Poorly controlled seizures.\n7. Chronotype classified as extremely early or extremely late, based on the Munich Chronotype Questionnaire (MSFsc \\\u003C 2:00 or \\> 5:00).\n8. Night shift work within the past 30 days or expected during the intervention.\n9. Travel across ≥2 time zones within the past 14 days.\n10. Diagnosed or suspected untreated moderate to severe obstructive sleep apnea.\n11. Migraine with photophobia.\n12. Presence of ocular or photosensitivity conditions affecting vision (i.e. advanced bilateral cataracts not yet operated, advanced glaucoma with substantial visual field loss, optic nerve disease, ocular surgery within the past 3 months with unresolved visual symptoms, color blindness).",{"count":499,"type":21},12,[24],"This study is being done to test whether bright light therapy can be used to synchronize patients' circadian rhythms and allow ICB (immune-checkpoint blockade) therapy to be administered at a time in the circadian rhythm that optimizes clinical outcomes. This trial will test the feasibility of delivering bright light therapy (BLT) to patients undergoing ICB therapy.\n\nThis trial asks participants to spend 60 minutes every morning receiving daily bright light therapy for at least 7 days prior to starting Immune Checkpoint blockade-containing regimens (e.g. anti-PD-1 and\u002For anti-CTLA-4 alone or in combination with chemotherapy). The bright light therapy will be delivered via the Circadian OS iPad application.\n\nThere is evidence that a person's circadian rhythm can affect the response to immunotherapy. The circadian rhythm is a natural, internal process that regulates the sleep-wake cycle. Many patients with cancer have disrupted circadian rhythms and it's possible that disrupted circadian rhythms decrease the likelihood of responding to immunotherapy.\n\nThe idea is to use bright light therapy, delivered via the Circadian OS iPad application, for an hour in the morning to synchronize your circadian rhythm for a week before your planned immunotherapy. The investigators hope that this will increase the likelihood of a response to immunotherapy, however in this study, the investigators are mainly concerned with whether the bright light therapy is tolerable to patients.",[30,179],[496,504,505,506],"Bright Light Therapy","Circadian","Circadian Rhythm","2026-06-23",{"date":509,"type":36},"2026-06-26",{"date":416,"type":21},{"date":512,"type":21},"2027-12",{"name":514,"class":43},"Weill Medical College of Cornell University",{"id":516,"slug":517,"hasResults":12,"nctId":518,"briefTitle":519,"officialTitle":520,"acronym":521,"eligibilityCriteria":522,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":523,"enrollmentInfo":524,"targetDuration":4,"studyType":22,"phases":526,"briefSummary":527,"conditions":528,"keywords":529,"overallStatus":128,"whyStopped":4,"lastUpdateSubmitDate":535,"lastUpdatePostDateStruct":536,"startDateStruct":538,"completionDateStruct":540,"leadSponsor":542,"locationsCount":108},"100642267","phase-2-a-phase-ii-trial-of-tumour-infiltrating-lymphocyte-adoptive-cell-therapy-in-patients-with-immune-checkpoint-inhibitor-resistant-unresectable-or-metastatic-melanoma-100642267","NCT07651618","A Phase II Trial of Tumour Infiltrating Lymphocyte Adoptive Cell Therapy in Patients With Immune Checkpoint Inhibitor Resistant Unresectable or Metastatic Melanoma","PERTIL-01: A Phase II Trial of Tumour Infiltrating Lymphocyte Adoptive Cell Therapy in Patients With Immune Checkpoint Inhibitor Resistant Unresectable or Metastatic Melanoma","PERTIL-01","Inclusion Criteria:\n\n1. Adult patients = 18 years = 70 years of age.\n2. ECOG 0-1 (Appendix A: Eastern Cooperative Oncology Group Performance Status Scale) with an estimated life expectancy of \\> 6 months\n3. Histologically confirmed unresectable or stage IV melanoma as per AJCC 8th edition. Unresectable melanoma is defined where the lesions are deemed to be unresectable by the treating surgeon.\n4. Metastatic melanoma with at least 1 surgically accessible metastatic lesion (or aggregate lesions) with an estimated minimum diameter of = 1.5 cm\n5. Measurable disease per RECIST 1.1 criteria (in addition to the resected lesion).\n6. At least one anti-PD1 containing line of systemic therapy for unresectable or metastatic melanoma. Alternatively, one prior line of an adjuvant or neoadjuvant anti-PD1 containing regimen and all related adverse events have either returned to baseline or stabilized.\n\nExclusion Criteria:\n\n1. Life expectancy of less than 3 months.\n2. Metastatic uveal melanoma.\n3. Requirement for immunosuppressive doses of systemic corticosteroids (\\>10 mg\u002Fday prednisone or equivalent) or other immunosuppressive drugs (e.g. mycophenolate, infliximab, or others) within the last 3 weeks prior to patient screening. Participants receiving steroids as replacement therapy for adrenocortical insufficiency at =10 mg\u002Fday of prednisone or another steroid equivalent dose are acceptable.\n4. Participant has symptomatic untreated brain metastases.\n\n   * A participant with historically treated brain metastases (ie, treatment was completed \\>60 days prior to consenting for study participation) may be considered for study participation if the participant is clinically and radiologically stable for = 60 days\n   * Participants with previously known asymptomatic brain metastases who do not clinically require treatment may be enrolled.\n5. More than three melanoma brain metastases or evidence of leptomeningeal disease\n\nOther protocol defined exclusion criteria could apply.","70 Years",{"count":525,"type":21},10,[57],"The goal of this study is to determine the activity of Perkileucel, a tumour infiltrating lymphocyte (TIL) adoptive cell transfer therapy (ACT), in patients with unresectable stage III or metastatic melanoma who have progressed on previous treatment with immune checkpoint inhibitors in the adjuvant or metastatic setting.\n\nStudy details:\n\nAll participants will receive the investigational treatment, Perkileucel. To create this therapy, participants need to undergo surgical excision of a melanoma lesion to harvest the TILs prior to treatment. Once the TILs have been manufactured, participants will be admitted to hospital to receive 5 days of chemotherapy to prepare their body (lymphodepletion) for the TIL-ACT. Treatment with TIL-ACT will then be given on Day 0 as a single intravenous infusion followed by up to 6 intravenous infusions of high-dose interleukin 2. Blood tests and other assessments will be performed regularly to monitor safety and response.\n\nThe total duration of the study is 8 years. Safety will be assessed throughout the full duration of the study. Patients will be monitored for delayed adverse events.\n\nThis study will show whether Perkileucel can help control melanoma that has not responded to other treatments and demonstrate feasibility of manufacture and delivery of this treatment in an Australian healthcare setting.",[30,289],[530,198,531,532,533,534],"Unresectable Melanoma","Perkileucel","TILs","Tumour Infiltrating Lymphocytes","Metastatic Melanoma","2026-06-11",{"date":537,"type":36},"2026-06-16",{"date":539,"type":21},"2026-07",{"date":541,"type":21},"2032-04",{"name":543,"class":544},"East Metropolitan Health Service, Australia","OTHER_GOV",{"id":546,"slug":547,"hasResults":12,"nctId":548,"briefTitle":549,"officialTitle":549,"acronym":550,"eligibilityCriteria":551,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":552,"targetDuration":4,"studyType":22,"phases":554,"briefSummary":555,"conditions":556,"keywords":558,"overallStatus":128,"whyStopped":4,"lastUpdateSubmitDate":535,"lastUpdatePostDateStruct":562,"startDateStruct":563,"completionDateStruct":564,"leadSponsor":566,"locationsCount":108},"100641655","evaluating-a-decision-aid-for-sentinel-lymph-node-biopsy-in-intermediate-risk-melanoma-100641655","NCT07653087","Evaluating a Decision Aid for Sentinel Lymph Node Biopsy in Intermediate-Risk Melanoma","Mel73","Inclusion Criteria:\n\n1. Adults (≥18 years old) with a histologically confirmed diagnosis of cutaneous melanoma.\n2. Clinical stage I or II disease, for whom sentinel lymph node biopsy (SLNB) is being considered.\n3. Patients with either:\n\n   * An estimated risk of sentinel lymph node metastasis between 5 and 10 percent based on the MIA risk calculator, or\n   * A discordant risk scenario will be defined as a case in which the individualized probability of sentinel lymph node metastasis predicted by the MIA model falls into a different risk category (\\\u003C5%, 5-10%, or \\>10%) than the category suggested by clinicopathologic staging features used in NCCN guideline-based counseling.\n4. Willingness and ability to comply with study procedures.\n5. Ability to provide informed consent.\n6. Pregnant women, and other vulnerable populations are not specifically excluded unless they meet other exclusion criteria; the study presents minimal risk.\n\nExclusion Criteria:\n\n1. Patients with clinical evidence of nodal or distant metastatic disease at the time of consultation.\n2. Patients with prior sentinel lymph node biopsy or nodal surgery for the current melanoma diagnosis.\n3. Inability to speak or read English.\n4. Inability or unwillingness to provide informed consent.\n5. Prisoners",{"count":553,"type":21},66,[24],"This research study is testing a decision aid to help patients think through whether to have sentinel lymph node biopsy for melanoma.\n\nSentinel lymph node biopsy (SLNB) can be a difficult decision for some patients because the potential benefits and risks may not be clear. This study is being done to learn whether providing structured, easy-to-understand information helps patients feel more informed and less uncertain about their decision.\n\nPatients in this study will be given a paper decision aid (DA). Patients will be given other short questionnaires to complete before and after the decision aid.",[557,30],"Sentinel Lymph Node Biopsy (SLNB)",[559,198,560,561],"SLNB","Sentinel Lymph Node Biopsy","Decision Aid",{"date":240,"type":36},{"date":416,"type":21},{"date":565,"type":21},"2028-01",{"name":567,"class":43},"University of Virginia",{"id":569,"slug":570,"hasResults":12,"nctId":571,"briefTitle":572,"officialTitle":573,"acronym":574,"eligibilityCriteria":575,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":576,"targetDuration":4,"studyType":22,"phases":578,"briefSummary":579,"conditions":580,"keywords":583,"overallStatus":128,"whyStopped":4,"lastUpdateSubmitDate":605,"lastUpdatePostDateStruct":606,"startDateStruct":608,"completionDateStruct":609,"leadSponsor":611,"locationsCount":4},"100641002","phase-2-phoenix-ecp--extracorporeal-photopheresis-for-immune-related-colitis-andor-hepatitis-in-advanced-melanoma-with-inadequate-response-to-steroid-exposure-100641002","NCT07619898","PHOENIX-ECP- Extracorporeal Photopheresis for Immune-related Colitis and\u002For Hepatitis in Advanced Melanoma With Inadequate Response to Steroid Exposure","PHOENIX- A Phase 2, Randomized, Controlled, Open-label, Multicenter Study to Evaluate the Efficacy and Safety\u002FTolerability of Extracorporeal Photopheresis (ECP) Versus Best Available Therapy (BAT) for the Treatment of Immune-related Colitis or Hepatitis With Inadequate Response to Corticosteroids in Participants With Unresectable or Metastatic Melanoma Treated With Immune Checkpoint Inhibitors (ICI)","PHOENIX-ECP","Inclusion Criteria:\n\n1. Participants diagnosed with unresectable or metastatic melanoma ( Stage III and Stage IV) received ICI treatment (e.g., anti-PD-1, anti-PD-L1, anti-LAG-3, anti-CTLA-4 antibody, as ICI monotherapy or ICI combination therapy) and ICI paused or discontinued because of the development of ir-colitis or ir-hepatitis.\n2. Participants diagnosed with ir-colitis and\u002For ir-hepatitis with a severity of Grade 2 or higher, based on ASCO Guidelines (\n3. Participants with endoscopic evidence of ir-colitis\n4. Participants with inadequate response to corticosteroids, as defined per protocol\n5. Participants who have Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2.\n\nExclusion Criteria:\n\n1. Presence of irAEs in addition to and other than ir-colitis and\u002For ir-hepatitis, with a higher severity grade than the irAE for inclusion (ir-colitis\u002Fir-hepatitis) based on ASCO guidelines.\n2. Participant has a diagnosis of uveal melanoma as the sole melanoma subtype\n3. Treatment of ir-colitis or ir-hepatitis with any systemic therapy other than corticosteroids\n4. Concurrent conditions which may require treatment with high dose corticosteroid (\\> 1 milligram per kilogram per day \\[mg\u002Fkg\u002Fday\\]) and interfere with the corticosteroid tapering schedule recommended by the protocol.\n5. Pre-existing liver disease\n6. Active alcohol use disorder\n7. Concomitant treatment with any chemotherapy or targeted therapy for the treatment of unresectable or metastatic melanoma.\n8. Use of any investigational agent within 5 half-lives of the investigational agent prior to randomization.\n9. Contraindications or known allergic reaction to any of study intervention and\u002For procedures\n10. Participants unable to tolerate the fluid shift associated with the ECP procedure.\n11. Positive result for active or previous viral infections: covid-19, hepatitis B\u002FC, CMV, EBV, adenovirus\n12. History of previous or concurrent malignancies within the last 3 years, other than unresectable or metastatic melanoma.",{"count":577,"type":21},112,[57],"Extracorporeal photopheresis (ECP) is an immunomodulatory therapy in which the photoactivating agent methoxsalen (also known as UVADEX) is used in combination with ultraviolet A (UVA) light.\n\nImmune checkpoint inhibitor therapy is widely used for the treatment of several cancers, including melanoma. However, a common immune-related adverse event associated with this therapy is Immune-related colitis or hepatitis. Corticosteroids are typically the first-line treatment for this condition, but some participants do not respond adequately.\n\nThe purpose of this study is to evaluate the efficacy of ECP in the treatment of immune-related (ir)-colitis and ir-hepatitis with inadequate response to corticosteroids, and to compare its efficacy to other second-line immunosuppressant therapies. The ECP procedure in this study is performed using the CELLEX® device, a fully closed-loop extracorporeal blood circulation device. The CELLEX device is used in conjunction with methoxsalen.",[581,582,30],"Colitis","Hepatitis",[198,584,585,586,587,588,589,590,591,592,593,594,349,595,596,597,598,599,600,601,581,602,603,604],"Immune-related adverse events","Immune-related colitis","Immune checkpoint inhibitor toxicity","Checkpoint inhibitor-induced colitis","Checkpoint inhibitor-induced hepatitis","Metastatic melanoma","Unresectable melanoma","Immune checkpoint Inhibitors","Extracorporeal photopheresis","ECP","UVADEX","Methoxsalen","Steroid-refractory","Corticosteroid refractory","Phase 2 clinical trial","Randomized controlled trial","Cellex","8-Mop","Ir-AE","Ir-AE Colitis","Ir-AE Hepatitis","2026-05-27",{"date":607,"type":36},"2026-06-02",{"date":539,"type":21},{"date":610,"type":21},"2029-12",{"name":612,"class":219},"Therakos LLC",{"id":614,"slug":615,"hasResults":12,"nctId":616,"briefTitle":617,"officialTitle":618,"acronym":619,"eligibilityCriteria":620,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":621,"targetDuration":4,"studyType":22,"phases":623,"briefSummary":624,"conditions":625,"keywords":4,"overallStatus":128,"whyStopped":4,"lastUpdateSubmitDate":626,"lastUpdatePostDateStruct":627,"startDateStruct":629,"completionDateStruct":630,"leadSponsor":632,"locationsCount":4},"100640202","phase-1-comparing-intravenous-or-intradermal-administration-of-anti-ctla-4-in-combination-with-anti-pd1-treatment-in-patients-with-melanoma-100640202","NCT07615881","Comparing Intravenous or Intradermal Administration of Anti-CTLA-4 in Combination With Anti-PD1 Treatment in Patients With Melanoma","Changes in the Tumour Microenvironment After Intravenous or Intradermal Administration of Anti-CTLA-4 in Combination With Anti-PD1 Treatment in Patients With Melanoma","IpiD","Inclusion Criteria:\n\n* Patient must be of age ≥ 18 years, and have a histologically confirmed diagnosis of locally advanced, surgically incurable, or metastatic cutaneous melanoma.\n* European Cooperative Oncology Group (ECOG)\u002FWorld Health Organisation (WHO) performance status of 0 or 1.\n* Patient must be eligible for anti-PD-1 treatment with nivolumab (group 1) or with ipilimumab + nivolumab (group 2) according to the treating physician.\n* Patient must have one or more tumour lesions of which a biopsy can safely be obtained according to standard clinical practice.\n* Patients must have a life expectancy of 3 months or greater.\n* Patients must have measurable disease (according to RECIST v1.1) with at least one cutaneous metastasis. Note: measurable disease defined as: at least 1 visceral or nodal\u002Fsoft tissue melanoma lesion that can be accurately and serially measured in at least 1 dimension and for which the longest diameter is ≥ 10 mm as measured by CT scan or MRI. Lymph nodes must measure ≥ 15 mm in their short axis to be considered measurable by CT-scan or MRI.\n* Adequate bone marrow, hepatic, renal and coagulation function (to be conducted within 7 days prior to start therapy, during the baseline period):\n\n  * Leukocyte count ≥ 3,5 × 109 \u002F L\n  * Platelets ≥ 100 × 109 \u002F L.\n  * Total bilirubin ≤ 3 × the upper limit of normal (ULN).\n  * ASAT and ALAT ≤ 3.0 × ULN; except patients with documented liver metastases ASAT and\u002For ALAT ≤ 5.0 × ULN.\n  * (Estimated) creatinine clearance ≥ 45 mL\u002Fmin\u002F1,73 m2.\n  * Albumin ≥ 30g \u002F L\n  * LDH ≤ 2 x ULN\n* Women of childbearing potential (WOCBP) must use contraception during the study and for 23 weeks after the last dose of nivolumab.\n* Men who are sexually active with WOCBP must use contraception during the study plus 7 months after the last dose of nivolumab.\n* Written and signed informed consent.\n\nExclusion Criteria:\n\n* Primary uveal or mucosal melanoma.\n* Prior treatment with CTLA-4 inhibitor or agonist, or anti-PD1, except for adjuvant nivolumab \\> 6 months ago.\n* Prior radiotherapy is permitted except on RECIST v1.1 target lesions within 2 weeks of start of trial treatment. Irradiated lesions without progression before start of treatment cannot be target lesions. Note: Patients must have recovered from all radiation-related toxicities, and not require corticosteroids.\n* Patient has 12-lead ECG significant findings during screening, per Investigator's as sessment.\n* History of another malignancy (that is progressing or requires active treatment) within the previous 5 years. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cancer that has undergone potentially curative therapy.\n* Patient has a confirmed active SARS-CoV-2 infection.\n* Patient has serious non-malignant disease or conditions that, in the opinion of the Investigator, could compromise patient safety or protocol objectives.\n* Patient has brain or bone-marrow metastasis that, in the opinion of the Investigator, could compromise patient safety or protocol objectives.\n* Active systemic infections requiring therapy, or signs or symptoms of a systemic infection within two weeks prior to baseline.\n* Patient has used systemic corticosteroids to treat inflammatory or autoimmune symptoms within 15 days or other immunosuppressive drugs within 30 days prior to screening. Exceptions:\n\n  * Patients that require intermittent use of inhalation or topical corticosteroids are eligible for the study.\n  * Patient has received acute, low-dose, systemic immunosuppressant medications (e.g., a one-time dose of dexamethasone for nausea) that, in the opinion of the Investigator, will not compromise protocol objectives.\n* Patient has had treatment with systemic immunosuppressive medications (including but not limited to prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumour necrosis factor agents) within 2 weeks prior to baseline.\n* Patient has had treatment with systemic immunostimulatory agents (including but not limited to interferons \\[IFNs\\] or interleukin-2 \\[IL-2\\]) within 6 weeks or 5 half-lives of the drug, whichever is shorter, prior to baseline.\n* Known history or evidence of immunodeficiency states (e.g., organ transplant, leukaemia, human immunodeficiency virus (HIV), hepatitis B, hepatitis C or known acquired immunodeficiency syndrome (AIDS)). NOTE: Testing for HIV must be performed at sites were mandated locally.\n* Patient has had any major surgery within 4 weeks prior to enrolment or major surgery is scheduled during the study, with the exception of procedures that are part of the study site IIS.\n* Patient has any safety laboratory test results (clinical chemistry, haematology, and urinalysis) that, in the opinion of the Investigator, could compromise patient safety or protocol objectives.\n* Patient has any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of the ICI treatment, or that may affect the interpretation of the results or render the patient at high risk from complications.\n* Patient has history of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanised antibodies or fusion proteins or known allergy to the study IMP ingredients and\u002For the proposed ICI therapy.\n* Pregnancy or breastfeeding.\n* Patient has a history of alcohol or drug abuse within the last year.\n* Currently participating in or has participated in a study of an investigational agent within 30 days of baseline or has not recovered from adverse events due to agents administered more than 4 weeks earlier, except A Phase 1a\u002F1b, Multi-Centre, Open-Label, Dose-Escalation and Dose-Expansion Study in Patients with Solid Tumor Malignancies to Evaluate GEH200520 Injection \u002F GEH200521 (18F) Injection Safety and Tolerability, Positron Emission Tomography Imaging, Pharmacokinetics, and Changes in Imaging after Treatment; NCT05629689, EU Trial number: 2024-515218-42-00.\n* For any reason, patient is considered by the local investigator to be an unsuitable candidate to participate in this study.",{"count":622,"type":21},18,[56,57],"This study investigates whether a single intradermal (i.d.) injection of low-dose anti-CTLA-4 (ipilimumab), given at the tumour site, can enhance immune activation when combined with standard intravenous (i.v.) anti-PD-1 therapy in patients with advanced melanoma. While combined checkpoint inhibition is effective, it is associated with high toxicity, creating a need for strategies that maintain efficacy with fewer side effects.\n\nPreclinical and early clinical data suggest that local (intradermal) CTLA-4 blockade can stimulate systemic anti-tumour immune responses with reduced toxicity, potentially by reactivating suppressed T cells in tumour-draining lymph nodes. This study compares systemic immune effects of intradermal versus standard intravenous CTLA-4 administration, both combined with nivolumab.\n\nThe primary objective is to assess systemic immune activation by measuring changes in CD4+ and CD8+ T-cell frequencies and ICOS expression in peripheral blood. Additional immune monitoring includes blood sampling, tumour biopsies, and advanced imaging using FDG-PET\u002FCT and a novel CD8-targeted PET tracer. The study is a prospective, open-label pilot trial in patients with metastatic melanoma, with follow-up for clinical outcomes and immune response over approximately 13 weeks.",[30],"2026-05-22",{"date":628,"type":36},"2026-05-29",{"date":539,"type":21},{"date":631,"type":21},"2029-07",{"name":633,"class":43},"Amsterdam UMC, location VUmc",{"id":635,"slug":636,"hasResults":12,"nctId":637,"briefTitle":638,"officialTitle":639,"acronym":4,"eligibilityCriteria":640,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":641,"enrollmentInfo":642,"targetDuration":4,"studyType":407,"phases":4,"briefSummary":644,"conditions":645,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":646,"lastUpdatePostDateStruct":647,"startDateStruct":649,"completionDateStruct":651,"leadSponsor":653,"locationsCount":108},"100640574","liquid-biopsy-multi-omics-and-biomarker-development-in-melanoma-100640574","NCT07584291","Liquid Biopsy Multi-Omics and Biomarker Development in Melanoma","Multi-Omics Analysis of Liquid Biopsy and Development of Clinical Biomarkers in Melanoma: A Prospective Cohort Study","Inclusion Criteria:\n\n* Diagnosed with acral or cutaneous melanoma according to the \"Melanoma Diagnosis and Treatment Guidelines.\"\n* Underwent sentinel lymph node biopsy with complete information available.\n* Archived melanoma tissue samples available with complete information.\n* Complete basic demographic and clinical information.\n* Age 18-80 years, any sex.\n\nExclusion Criteria:\n\n* Patients with severe organic diseases, immunodeficiency disorders, organ absence, or organ transplantation.\n* Patients diagnosed with mucosal melanoma according to the \"Melanoma Diagnosis and Treatment Guidelines.\"\n* Patients with other concurrent malignant tumors (e.g., basal cell carcinoma, lung cancer).\n* Incomplete patient information or pathological sample data.","80 Years",{"count":643,"type":21},200,"This prospective, observational cohort study aims to explore the multi-omics profiles of liquid biopsies and develop clinical biomarkers in melanoma. Two hundred participants with pathologically confirmed acral or cutaneous melanoma who are scheduled to receive standard first-line immunotherapy will be enrolled. Blood samples will be collected at baseline and every 3 weeks during treatment, along with radiological assessments every 12 weeks. Tumor tissue will be obtained at surgery after approximately 3 months of therapy. Using microfluidic-based circulating tumor cell isolation, exosome enrichment, ctDNA analysis, and integrative multi-omics approaches, the study will compare molecular features across primary tumors, metastases, and liquid biopsy components. The primary outcomes are progression-free survival and overall survival, assessed up to 36 months. Secondary outcomes include changes in circulating tumor cell counts, ctDNA concentrations, exosomal biomarker levels, pathological response rate at surgery, and the predictive accuracy of a multi-omics model for treatment response. The findings are expected to provide a basis for personalized monitoring and treatment strategies in melanoma.",[30],"2026-05-12",{"date":648,"type":36},"2026-05-13",{"date":650,"type":36},"2025-07-01",{"date":652,"type":21},"2028-05-30",{"name":654,"class":43},"Xijing Hospital",{"id":656,"slug":657,"hasResults":12,"nctId":658,"briefTitle":659,"officialTitle":660,"acronym":4,"eligibilityCriteria":661,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":80,"enrollmentInfo":662,"targetDuration":4,"studyType":22,"phases":664,"briefSummary":665,"conditions":666,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":667,"lastUpdatePostDateStruct":668,"startDateStruct":670,"completionDateStruct":672,"leadSponsor":674,"locationsCount":108},"100640582","exploratory-study-with-parallel-controls-on-the-safety-and-efficacy-of-neoadjuvant-low-branched-chain-amino-acid-diet-in-combination-with-anti-pd-1-monoclonal-antibody-for-stage-iii-melanoma-100640582","NCT07586891","Exploratory Study With Parallel Controls on the Safety and Efficacy of Neoadjuvant Low Branched-Chain Amino Acid Diet in Combination With Anti-PD-1 Monoclonal Antibody for Stage III Melanoma","A Randomized, Double-Blind, Single-Center, Exploratory Study With Parallel Controls on the Safety and Efficacy of Neoadjuvant Low Branched-Chain Amino Acid Diet in Combination With Anti-PD-1 Monoclonal Antibody for Stage III Melanoma","Inclusion Criteria:\n\n* Patients with histopathologically or cytologically confirmed Stage III malignant melanoma. Stage III is defined as the presence of at least one clinically accessible lymph node metastasis or in-transit metastasis. Patients with mucosal or ocular melanoma are excluded; those with melanoma of unknown primary are also excluded.\n* No prior radiotherapy or systemic chemotherapy. No treatment with anti-PD-1, anti-PD-L1, anti-PD-L2 monoclonal antibodies, anti-CTLA-4 monoclonal antibody, interferon (IFN), or targeted agents within the last month.\n* Life expectancy ≥ 6 months.\n* At least one measurable lesion as defined by RECIST version 1.1.\n* Patients must have provided written informed consent to participate voluntarily in this trial and must be between 18 and 75 years of age on the day of signing the consent form.\n* ECOG (Eastern Cooperative Oncology Group) performance status score of 0 or 1.\n* Adequate organ function as assessed by the following laboratory values (within 4 weeks prior to the start of study drug treatment):\n\n  1. Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹\u002FL\n  2. Platelets ≥ 100 × 10⁹\u002FL\n  3. Hemoglobin ≥ 90 g\u002FL (no transfusion within 14 days prior to enrollment)\n  4. Serum creatinine ≤ 1.5 × upper limit of normal (ULN)\n  5. Serum total bilirubin ≤ 1.5 × ULN\n  6. AST (SGOT) and ALT (SGPT) ≤ 2.5 × ULN or ≤ 5 × ULN (for patients with liver metastases)\n  7. Prothrombin time (PT)\u002FInternational Normalized Ratio (INR) and activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN (unless the patient is on anticoagulant therapy, in which case PT or aPTT must be within the therapeutic range intended for the anticoagulant).\n* For women of childbearing potential, a negative urine or serum pregnancy test within 7 days prior to receiving the first dose of the study drug.\n* Female patients of childbearing potential who enroll in the study must be willing to use adequate contraception for up to 12 months after the last dose of the study drug.\n\nExclusion Criteria:\n\n* The patient is currently participating, or has participated in a clinical trial of an investigational drug or medical device within 4 weeks prior to the first dose of the study drug.\n* The patient has received any anti-tumor therapy within the past month, including but not limited to chemotherapy, radiotherapy, immunotherapy (such as anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibodies, or any other antibody targeting T-cell co-regulatory pathways), etc.\n* The patient has received systemic corticosteroid therapy (\\>10 mg\u002Fkg prednisone or equivalent) within two weeks prior to the first dose, or any other form of immunosuppressive therapy.\n* The patient has a known history of hematologic malignancies, primary brain tumors, sarcoma, or other primary solid tumors, unless the patient has been cured and has had no evidence of recurrence for 5 years. Exceptions include cured basal cell carcinoma of the skin and carcinoma in situ of the cervix.\n* The patient has known central nervous system (CNS) metastases and\u002For carcinomatous meningitis.\n* The patient has a history of severe hypersensitivity reaction to another monoclonal antibody (mAb) therapy.\n* The patient has an active autoimmune disease that has required systemic treatment in the past 2 years (e.g., with corticosteroids or immunosuppressive drugs). Replacement therapies (such as thyroxine, insulin, or physiologic corticosteroid replacement for adrenal or pituitary insufficiency) are not considered systemic treatments and are allowed. Exceptions include patients with vitiligo, type I diabetes mellitus, or childhood asthma\u002Fatopy.\n* Any other severe, uncontrolled co-morbid condition that may compromise protocol compliance or interfere with the interpretation of results, including metabolic diseases, active opportunistic or advanced (severe) infections, cardiovascular disease (e.g., Class III or IV heart failure as defined by the New York Heart Association classification, second-degree or greater heart block, myocardial infarction within the past 6 months, unstable arrhythmias or unstable angina, cerebral infarction within 3 months), or pulmonary disease (interstitial lung disease, obstructive pulmonary disease, history of symptomatic bronchospasm). Also included are HIV positivity; HCV positivity; HBsAg or HBcAb positivity with detectable HBV DNA (quantitation limit: 500 IU\u002FmL); or a known history of tuberculosis.\n* The patient has received a live vaccine within 4 weeks prior to the first dose. The patient has received hematopoietic growth factors (e.g., colony-stimulating factors, erythropoietin) within 2 weeks prior to treatment initiation. The patient has undergone major surgical procedures (excluding diagnostic surgery) within 2 weeks prior to treatment initiation.\n* The patient has a known psychiatric or substance abuse disorder that would interfere with cooperation with the requirements of the trial.\n* The patient is pregnant or breastfeeding, or plans to conceive or father children during the study period.\n* Any other severe, acute, or chronic medical or psychiatric condition, or laboratory abnormality that, in the investigator's judgment, may increase the risk associated with study participation or may interfere with the interpretation of study results.",{"count":663,"type":21},80,[24],"1. Primary Objective:\n\n   To evaluate the safety of a low branched-chain amino acid diet (60% of the normal dietary BCAA content) combined with anti-PD-1 monoclonal antibody as neoadjuvant therapy in patients with stage III melanoma, by documenting the incidence of all adverse events (AEs) and serious adverse events (SAEs), and analyzing changes from baseline in physical examinations, vital signs, and laboratory test results.\n2. Secondary Objectives:\n\n   To assess the pathological response rates (including pCR, near-pCR, pPR, and pNR) of the combination therapy in stage III melanoma; to evaluate the objective response rate (ORR) according to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1) and the immune-related RECIST (irRECIST) criteria; and to estimate event-free survival (EFS) and overall survival (OS) through long-term follow-up.\n3. Exploratory Objectives:\n\nTo investigate the quality of life (QoL) in patients receiving the low BCAA diet combined with anti-PD-1 therapy; and to identify predictive biomarkers for treatment outcome differences, such as immune-related gene signatures (e.g., PD-L1 expression) and driver gene mutations in somatic variants.",[30],"2026-05-07",{"date":669,"type":36},"2026-05-14",{"date":671,"type":36},"2024-07-01",{"date":673,"type":21},"2027-06",{"name":654,"class":43},{"id":676,"slug":677,"hasResults":12,"nctId":678,"briefTitle":679,"officialTitle":680,"acronym":4,"eligibilityCriteria":681,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":80,"enrollmentInfo":682,"targetDuration":4,"studyType":22,"phases":683,"briefSummary":685,"conditions":686,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":667,"lastUpdatePostDateStruct":687,"startDateStruct":688,"completionDateStruct":690,"leadSponsor":691,"locationsCount":108},"100637911","early-phase-1-efficacy-and-safety-of-neoadjuvant-cadonilimab-plus-high-dose-recombinant-human-interferon-1b-in-stage-iiiiv-melanoma-100637911","NCT07586904","Efficacy and Safety of Neoadjuvant Cadonilimab Plus High-Dose Recombinant Human Interferon α1b in Stage III\u002FIV Melanoma.","Efficacy and Safety of Neoadjuvant Cadonilimab Plus High-Dose Recombinant Human Interferon α1b in Stage III\u002FIV Melanoma: A Single-Center, Open-Label, Phase Ib Trial","Inclusion Criteria:\n\n* Voluntarily participate in this trial, sign the informed consent form, and be between 18 and 75 years of age, regardless of gender.\n* Patients with histopathologically or cytologically confirmed stage III or resectable stage IV malignant melanoma.\n\n  * Stage III is defined as the presence of at least one clinically accessible lymph node metastasis or in-transit metastasis.\n  * Resectable stage IV is defined as a single distant metastasis, excluding brain metastases or any other metastases that cannot be completely surgically resected.\n  * Mucosal or ocular melanomas are excluded.\n  * Melanomas of unknown primary origin are excluded.\n* Have not received treatment with PD-1, PD-L1, or PD-L2 antibodies, anti-CTLA4 antibodies, interferon (IFN), targeted therapy, radiotherapy, or systemic chemotherapy within the past month.\n* Have an expected survival period of ≥ 6 months.\n* Have at least one measurable lesion according to RECIST version 1.1.\n* Have an ECOG performance status score of 0 or 1.\n* Have adequate organ function, as indicated by the following laboratory values (within 4 weeks prior to the start of study treatment):\n\n  1. Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹\u002FL\n  2. Platelets ≥ 100 × 10⁹\u002FL\n  3. Hemoglobin ≥ 90 g\u002FL (no blood transfusion within 14 days prior to enrollment)\n  4. Serum creatinine ≤ 1.5 × upper limit of normal (ULN)\n  5. Serum total bilirubin ≤ 1.5 × ULN\n  6. AST (SGOT) and ALT (SGPT) ≤ 2.5 × ULN or ≤ 5 × ULN (for patients with liver metastases)\n  7. Prothrombin time (PT)\u002FInternational Normalized Ratio (INR) and activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN (unless the subject is receiving anticoagulant therapy, in which case PT or aPTT must be within the therapeutic range intended for the anticoagulant used).\n\n     8.Female patients of childbearing potential must have a negative urine or serum pregnancy test within 7 days prior to receiving the first dose of the study drug.\n\n     9.Female patients enrolled in the study must be willing to use appropriate contraception methods until 12 months after the last dose of the study drug.\n\n     Exclusion Criteria:\n* The patient is currently participating, or has participated within 4 weeks prior to the first dose of the study drug, in another interventional clinical trial of drugs or medical devices.\n* The patient has received any anti-tumor therapy within the past month, including but not limited to chemotherapy, radiotherapy, immunotherapy (e.g., anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibodies, or any other antibody targeting T-cell co-regulatory pathways), etc.\n* The patient has received systemic steroid therapy (\\>10 mg\u002Fkg prednisone or equivalent) within two weeks prior to the first dose, or any other form of immunosuppressive medication.\n* The patient has a known history of hematologic malignancy, primary brain tumor, sarcoma, or another primary solid tumor, unless the patient has been cured and has had no evidence of recurrence for 5 years. Exceptions include cured basal cell carcinoma of the skin and carcinoma in situ of the cervix.\n* The patient has known central nervous system metastases and\u002For carcinomatous meningitis.\n* The patient has a history of severe hypersensitivity to another monoclonal antibody (mAb) therapy.\n* The patient has had an active autoimmune disease requiring systemic treatment (e.g., with corticosteroids or immunosuppressive drugs) within the past 2 years, and related replacement therapies (e.g., thyroxine, insulin, or physiologic corticosteroid replacement for renal or pituitary insufficiency). Exceptions include patients with vitiligo, type I diabetes, childhood asthma\u002Fatopy.\n* Other severe, uncontrolled concomitant diseases that may affect protocol compliance or interpretation of results, including active opportunistic or advanced (severe) infections; uncontrolled diabetes; cardiovascular disease (e.g., Class III or IV heart failure as defined by the New York Heart Association classification, second-degree or greater heart block, myocardial infarction within the past 6 months, unstable arrhythmias or unstable angina, cerebral infarction within 3 months); pulmonary disease (interstitial lung disease, obstructive pulmonary disease, history of symptomatic bronchospasm); HIV positivity; HCV positivity; HBsAg or HBcAb positivity with detectable HBV DNA (quantitative limit ≥500 IU\u002FmL); or a documented history of tuberculosis.\n* The patient has received a live vaccine within 4 weeks prior to the first dose; hematopoietic growth factors (e.g., colony-stimulating factors, erythropoietin) within 2 weeks prior to treatment initiation; or major surgical procedures (excluding diagnostic surgery) within 2 weeks prior to treatment initiation.\n* The patient has a known psychiatric or substance use disorder that would interfere with cooperation with trial requirements.\n* The patient is pregnant or breastfeeding, or plans to become pregnant or father a child during the study period.\n* Any other severe, acute, or chronic medical or laboratory abnormality that, in the investigator's judgment, could increase the risk associated with study participation or could interfere with the interpretation of study results.",{"count":525,"type":21},[684],"EARLY_PHASE1","1. Primary Objective\n\n   To evaluate the efficacy and safety of cadonilimab in combination with high-dose recombinant human interferon α1b injection as neoadjuvant therapy in patients with stage III\u002FIV melanoma. Assessments include:\n\n   Target lesion response (complete response \\[CR\\], partial response \\[PR\\], stable disease \\[SD\\], progressive disease \\[PD\\]) Objective response rate (ORR) Pathological response rate (pathological complete response \\[pCR\\], near pCR, pathological partial response \\[pPR\\], pathological non-response \\[pNR\\]) Incidence of all adverse events (AEs) and serious adverse events (SAEs) Changes from baseline in physical examinations, vital signs, and laboratory test results.\n2. Exploratory Objectives To investigate the correlation between treatment efficacy\u002Fpatient outcomes and:PD-L1 expression in tumor tissue CD8+ T-cell infiltration Tumor mutational burden (TMB).\n3. Study Significance To conduct a preliminary exploration in support of future multicenter clinical studies.",[30],{"date":669,"type":36},{"date":689,"type":36},"2025-05-01",{"date":673,"type":21},{"name":654,"class":43},{"id":693,"slug":694,"hasResults":12,"nctId":695,"briefTitle":696,"officialTitle":697,"acronym":4,"eligibilityCriteria":698,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":699,"targetDuration":4,"studyType":22,"phases":700,"briefSummary":701,"conditions":702,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":710,"lastUpdatePostDateStruct":711,"startDateStruct":713,"completionDateStruct":715,"leadSponsor":717,"locationsCount":108},"100635632","pilot-study-of-bone-mineral-density-changes-during-anti-pd-1-immunotherapy-100635632","NCT07555210","Pilot Study of Bone Mineral Density Changes During Anti-PD-1 Immunotherapy","Pilot Study Assessment of Bone Mineral Density Changes During Treatment With Anti-PD-1 Immunotherapy Agents","Inclusion Criteria:\n\n1. Age ≥ 18 years.\n2. Patients planning to start or within the first four weeks of treatment with anti-PD-1 immune checkpoint inhibitor therapy either alone or in combination with chemotherapy for curative intent for a known cancer diagnosis (use of immunotherapy must be FDA-approved and not experimental).\n3. Life expectancy of at least 12 months per the discretion of the treating physician.\n\nExclusion Criteria:\n\n1. Patients ineligible for anti-PD-1 therapy.\n2. Patients with metastatic disease.\n3. Patients planning treatment with dual immune checkpoint inhibitor therapy.\n4. Bony fractures in the pelvis, bilateral hips\u002Ffemurs, thoracic spine, or lumbar spine.\n5. Known osteoporosis or osteopenia.\n6. Planned or previous treatment with denosumab, zoledronic acid, or other bisphosphonate therapy in the last six months.\n7. Parathyroid gland disorders, rheumatoid arthritis (unless well-controlled off active biologic therapy without chronic steroid use), CKD stage IV\u002FV, or ESRD.\n8. Inability to comply with study procedures.\n9. Inability to lie flat for 20-25 minutes during an imaging session.\n10. Pregnant or breastfeeding patients.\n11. Medical or psychiatric co-morbidities that, in the opinion of the treating physician, would prevent the patient from successfully participating in the study.",{"count":7,"type":21},[24],"Immune checkpoint inhibitors (ICIs) have revolutionized cancer treatment and work by blocking protein interactions that normally prevent the immune system from recognizing and destroying cancer cells. However, these agents, now approved for over 15 types of cancers and for both early-stage and metastatic disease, are capable of causing inflammation in any organ system of the body that can lead to organ damage, dysfunction, and even death in rare cases. Some patients may suffer acute and treatable complications like joint pain, but some may have irreversible complications like hypothyroidism that requires daily, life-long medication. It is therefore important to fully understand the different types of damage ICIs can cause to better monitor patients receiving ICI therapy.\n\nA rising concern from recent reports in the literature is that ICIs may weaken bone and increase the risk of fractures. In this study, the investigators aim to characterize how ICIs impact the bone by examining several factors in patients undergoing curative-intent ICI treatment either alone or in combination with chemotherapy: bone mineral density, bone volume, and markers of bone turnover in the blood. The study will use two imaging techniques to assess bone mineral density and volume. DXA (dual X-ray absorptiometry) imaging uses low-dose X-rays to measure how dense (or strong) bones are and is often used to diagnose or assess the risk of osteoporosis. High-resolution peripheral quantitative computed tomography (HRpQCT) is a 3D imaging technology that can quantify bone structure and volume and offers high resolution that can be used to assess bone in smaller bones of the peripheral skeleton.\n\nThe investigators hypothesize that ICI treatment will weaken bones and increase the risk of fractures. As ICI therapy is relatively new, a rising number of patients may be at risk of fractures or have low bone density that is not being monitored because there are no guidelines in place notifying physicians of this potential risk to patients. This is study will provide important preliminary data that will be the basis for larger studies in the future aiming to better monitor and potentially treat bone weakening in patients treated with ICIs to reduce the pain, inconvenience, and complications from fragility fractures.",[703,704,30,705,706,707,708,709],"Breast Cancer (Triple Negative Breast Cancer (TNBC))","Renal Cell Carcinoma (Kidney Cancer)","Non-Small Cell Lung Cancer","MSI-H\u002FdMMR Rectal Cancer","Squamous Cell Carcinoma Mouth","Invasive Mammary Carcinoma","Classic Hodgkin Lymphoma","2026-05-04",{"date":712,"type":36},"2026-05-06",{"date":714,"type":36},"2025-08-25",{"date":716,"type":21},"2028-07-01",{"name":718,"class":43},"Jessica Mezzanotte Sharpe",{"id":720,"slug":721,"hasResults":12,"nctId":722,"briefTitle":723,"officialTitle":723,"acronym":724,"eligibilityCriteria":725,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":726,"targetDuration":4,"studyType":22,"phases":728,"briefSummary":730,"conditions":731,"keywords":732,"overallStatus":128,"whyStopped":4,"lastUpdateSubmitDate":736,"lastUpdatePostDateStruct":737,"startDateStruct":739,"completionDateStruct":740,"leadSponsor":742,"locationsCount":4},"100635431","phase-3-superparamagnetic-iron-oxide-for-sentinel-lymph-node-localization-in-patients-with-cutaneous-melanoma-a-randomized-phase-iii-multi-center-non--inferiority-trial-magmen-ii-100635431","NCT07552597","Superparamagnetic Iron Oxide for Sentinel Lymph Node Localization in Patients With Cutaneous Melanoma, a Randomized Phase III Multi-center Non- Inferiority Trial: MagMen-II","MagMen-II","Inclusion criteria:\n\n1. Male or female aged above 18 years\n2. Signed and dated written informed consent before the start of specific protocol procedures\n3. Histologically confirmed melanoma planned for wide local excision and sentinel lymph node biopsy\n\nExclusion Criteria:\n\n1. Pregnant or breast-feeding\n2. Inability to undergo any of the study procedures\n3. Iron overload disease\n4. Known hypersensitivity to iron or dextran compounds",{"count":727,"type":21},254,[729],"PHASE3","A randomized, international, phase III, multi-center, non- inferiority trial assessing the safety and efficacy of Magtrace® (superparamagnetic iron oxide, SPIO) in identification of lymph nodes in patients with cutaneous melanoma undergoing a sentinel lymph node biopsy (SLNB). Participants will be injected with both tracer methods Technetium (Tc99) plus Blue Dye (BD) and Magtrace®). They will undergo both a lymphoscintigraphy and a Magnetic Resonance Imaging (MRI) of the SLN basins. Before surgery, the participants will be randomly assigned on a 1:1 basis to either start the SLNB procedure using Tc99\u002FBD and gamma-probe followed by Magtrace® and magnetic probe, or SLNB using Magtrace® followed by Tc99\u002FBD. Randomization will be stratified by study site using permuted variable block sizes.",[30],[261,733,734,735],"sentinel node biopsy","magnetic tracer","Magtrace","2026-04-20",{"date":738,"type":36},"2026-04-27",{"date":710,"type":21},{"date":741,"type":21},"2029-12-31",{"name":743,"class":544},"Vastra Gotaland Region"]