[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100640202":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":25,"locations":25,"responsibleParty":29,"collaborators":33,"id":37,"slug":38,"hasResults":39,"nctId":40,"briefTitle":41,"officialTitle":42,"acronym":43,"eligibilityCriteria":44,"healthyVolunteers":39,"sex":45,"minAge":46,"maxAge":25,"enrollmentInfo":47,"targetDuration":25,"studyType":50,"phases":51,"briefSummary":54,"conditions":55,"keywords":25,"overallStatus":57,"whyStopped":25,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":25},{"fullName":5,"class":6},"Amsterdam UMC, location VUmc","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Group 1 - Intradermal ipilimumab","EXPERIMENTAL","Patients with advanced\u002Fmetastatic melanoma who are eligible for standard of care i.v nivolumab will be treated by a single local i.d. injection of 20 mg ipilimumab around (the exci sion site of the) primary tumour or around a skin metastasis, in combination with treatment with i.v. nivolumab continuous.",[13],"Drug: Group 1 - Intradermal ipilimumab",{"label":15,"type":16,"description":17,"interventionNames":18},"Group 2 - Conventional treatment","ACTIVE_COMPARATOR","Patients with advanced advanced\u002Fmetastatic melanoma who are eligible for standard for standard of care i.v. ipilimumab (4 cycles) combined with i.v. nivolumab (continuous) will be treated accordingly.",[19],"Drug: Group 2 - Conventional treatment",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Patients will be treated once by local i.d. injection of 20 mg ipilimumab around (the excision site of the) primary tumour or around a skin metastasis, in combination with i.v. nivolumab according to standard of care (continuous).",[9],null,{"type":22,"name":15,"description":27,"armGroupLabels":28,"otherNames":25},"Patients will be treated according to standard of care with i.v. ipilimumab (4 cycles) combined with i.v. nivolumab (continuous).",[15],{"type":30,"investigatorFullName":31,"investigatorTitle":32,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"PRINCIPAL_INVESTIGATOR","C. Menke- van der Houven van Oordt","Full Professor, Medical Oncology, Medical Specialist, Internal Medicine",[34],{"name":35,"class":36},"GE Healthcare","INDUSTRY","100640202","phase-1-comparing-intravenous-or-intradermal-administration-of-anti-ctla-4-in-combination-with-anti-pd1-treatment-in-patients-with-melanoma-100640202",false,"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.","ALL","18 Years",{"count":48,"type":49},18,"ESTIMATED","INTERVENTIONAL",[52,53],"PHASE1","PHASE2","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.",[56],"Melanoma (Skin Cancer)","NOT_YET_RECRUITING","2026-05-22",{"date":60,"type":61},"2026-05-29","ACTUAL",{"date":63,"type":49},"2026-07",{"date":65,"type":49},"2029-07",{"name":5,"class":6}]