[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"cutaneous-melanoma-stage-iii\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:cutaneous-melanoma-stage-iii":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,51,82,108],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100596730","the-multicentre-selective-lymphadenectomy-trial---3-100596730",false,"NCT07049276","The Multicentre Selective Lymphadenectomy Trial - 3","Randomized Controlled Trial of Selective Index Lymph Node Resection Versus Therapeutic Lymph Node Dissection After Neoadjuvant Immunotherapy for Stage IIIB-D Melanoma","MSLT-3","Inclusion Criteria:\n\n1. Male or female patients ≥ 18 years of age at the time of consent\n2. Written informed consent\n3. Cytologically or histologically confirmed, resectable pathological Stage IIIB, C or D (Any T, N1b, N2b, N2c, N3b, or N3c) cutaneous or unknown primary melanoma, with or without primary tumour in situ\n4. A minimum of one macroscopic lymph node, defined as:\n\n   * A palpable node, confirmed by pathology\n   * A non-palpable node, but enlarged per RECIST 1.1 criteria (≥ 15 mm in shortest diameter) and confirmed by pathology\n   * An ultrasound or PET\u002FCT scan positive lymph node of any size, confirmed by pathology.\n5. Up to 3 satellite (defined as any foci of clinically evident cutaneous and\u002For subcutaneous metastases occurring within 2 cm of but discontinuous from the primary melanoma) or in-transit metastases (defined as clinically evident cutaneous and\u002For subcutaneous metastases occurring \\>2 cm from the primary melanoma in the region between the primary and the regional lymph node basin) are permitted if they are completely resectable.\n6. Lymph node involvement in the groin (iliac, inguinal or both), axilla or neck only and may be unilateral or bilateral. Concurrent popliteal, epitrochlear or triangular intermuscular space (TIS) nodes permitted, as long as fully resectable.\n7. Tumour amenable to a newly obtained core biopsy of a lesion which has not been previously irradiated. Archival tissue from a past primary or nodal lesion (if applicable) or tissue taken for current diagnosis will also be collected if available.\n8. Systemic neoadjuvant immunotherapy is scheduled for administration with at least one PD-(L)-1 check point inhibitor (e.g. nivolumab, pembrolizumab, cemiplimab). The immunotherapy regimen may include other checkpoint inhibitors (e.g. ipilimumab, relatlimab, fianlimab). The patient should meet the fitness for treatment requirements as detailed in the relevant regulatory-approved Product Information or Summary of Product Characteristics.\n9. Neoadjuvant course of treatment to be no longer than 6 weeks (allows for a maximum of 3 cycles at weeks 0, 3 and 6).\n10. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.\n11. Anticipated life expectancy of \\> 5 years.\n\nExclusion Criteria:\n\n1. Uveal or mucosal melanoma.\n2. Isolated satellite or in-transit metastases only (without any cytological or histological proven lymph node involvement).\n3. Involvement of any lymph node basin other than groin, axilla or neck. Concurrent popliteal, epitrochlear or triangular intermuscular space (TIS) nodes permitted, as long as fully resectable.\n4. Clinical or radiographic evidence of distant metastasis (any AJCC 8th ed M Stage).\n5. Previous history of lymph node surgery to the same nodal basin, that was more extensive than a sentinel lymph node biopsy (SLNB).\n6. Previous radiotherapy to the same nodal basin.\n7. Any contraindication to the administration of nivolumab, ipilimumab, pembrolizumab or relatlimab per regulatory-approved product information and \u002F or medical oncologist.\n8. Prior anti-PD-1, CTLA-4, PDL-1 or LAG 3 antibody exposure, or an agent directed to another stimulatory or co-inhibitory T-cell receptor for any disease or any chemotherapy or experimental local or systemic drug treatment.\n9. A plan to administer targeted therapy or any non-checkpoint inhibitor immunotherapy, or any intralesional therapy for melanoma in the neoadjuvant setting.\n10. A plan to administer any experimental immunotherapy as part of a clinical trial in the neoadjuvant setting.\n11. Known additional malignancies (unless adequately treated) active within the previous 3 years, except for locally curable cancers that have been apparently cured. The following malignancies, if undergone successful definitive resection or curative treatment, are permitted:\n\n    * Basal cell carcinoma of the skin\n    * Squamous cell carcinoma of the skin\n    * Carcinoma in situ (e.g. breast carcinoma, cervical cancer in situ, but excluding carcinoma in situ of the bladder) that have undergone potentially curative therapy\n    * Prostatic intraepithelial neoplasia\n    * In situ melanoma\n    * Atypical melanocytic hyperplasia\n    * Stage I melanoma\n    * Other malignancies for which the patient has been disease free for 3 years, not requiring active anti-cancer therapy.\n12. An active autoimmune disease or a requirement for chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 14 days prior to the first dose of study treatment. The following are permitted:\n\n    * Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc)\n    * Inhaled or intranasal corticosteroids (with minimal systemic absorption) may be continued if patient is on a stable dose\n    * Non-absorbed intra-articular steroid injections.\n13. Has had an allogenic tissue\u002Fsolid organ transplant.\n14. Active Hepatitis B (defined as Hepatitis B surface antigen \\[HBsAg\\] reactive) or Hepatitis C virus (defined as HCV RNA \\[qualitative\\] is detected) infection. Note: no testing for Hepatitis B and Hepatitis C is required unless mandated by local health authority.\n15. Has a known history of Human Immunodeficiency Virus (HIV). Note: no testing for HIV is required unless mandated by local health authority.\n16. Pregnant or breastfeeding females.\n17. Concurrent medical or social conditions that may prevent the patient from attending assessments or procedures per schedule.","ALL","18 Years",{"count":20,"type":21},1500,"ESTIMATED","INTERVENTIONAL",[24],"NA","The goal of this clinical trial is to demonstrate that there is no difference (non-inferiorty) in the 2 year recurrence-free survival (RFS) between 2 different surgical approaches for clinical Stage III melanoma. Following 6 weeks of standard neaodjuvant immunotherapy, patients will undergo either selective index lymph node resection (ILN) (identified at baseline as the largest affected lymph node) or the standard of care therapeutic lymph node dissection (TLND). The secondary aims are to assess if patients who are managed without TLND will have a reduction in surgical complications (less wound problems \\& lymphoedema), an improved quality of life, at a lower healthcare utilisation.",[27],"Cutaneous Melanoma, Stage III",[29,30,31,32,33,34,35,36,37],"Neoadjuvant","Non-inferiority","Randomised controlled trial","Adverse events","Quality of life","Healthcare economics","Index lymph node resection","Therapeutic lymph node dissection","Surgical morbidity","RECRUITING","2026-06-25",{"date":41,"type":42},"2026-06-29","ACTUAL",{"date":44,"type":42},"2025-10-01",{"date":46,"type":21},"2040-08",{"name":48,"class":49},"Melanoma Institute Australia","OTHER",8,{"id":52,"slug":53,"hasResults":11,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":57,"eligibilityCriteria":58,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":59,"targetDuration":4,"studyType":22,"phases":61,"briefSummary":63,"conditions":64,"keywords":66,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":81},"100610671","phase-2-neo-adjuvant-immunotherapy-in-patients-with-localized-melanoma-100610671","NCT07230613","Neo-adjuvant Immunotherapy in Patients With Localized Melanoma","Neo-adjuvant Intratumoral Anti-CTLA4 + Anti-PD1 in Patients With Localized Melanoma","NEOREM-NEO-1","In addition to NEOREM Master Protocol inclusion and exclusion criteria, the following inclusion and exclusion criteria must be verified before inclusion in the NEO-1 trial:\n\nInclusion Criteria:\n\n1. Patients ≥ 18 years old.\n2. Patients with resectable and measurable (according to RECIST v1.1 criteria) stage III cutaneous and mucosal melanoma.\n3. Patients who received anti-PD-1 and stopped treatment \\> 6 months prior to their inclusion in NEO-1 trial are eligible.\n4. Patients who received target therapy and stopped treatment \\> 3 months prior to their inclusion in NEO-1 trial are eligible.\n\nExclusion Criteria:\n\n1. Patients with clinically or radiologically detectable distant metastases.\n2. Patients with uveal melanoma.\n3. Patients with any hypersensitivity to the active ingredient or to any of the excipients of nivolumab and\u002F ipilimumab.\n4. Patients without pathological evaluable disease according to RECIST v1.1 criteria.",{"count":60,"type":21},50,[62],"PHASE2","The success of anti-PD-1 and anti-CTLA-4 therapies has initiated a paradigm shift in oncology, with drugs now targeting the immune system rather than cancer cells to stimulate the antitumor immune response. Intratumoral (IT) delivery of immunostimulating agents reduces the systemic toxicity associated with monoclonal antibodies (mAbs) targeting immune checkpoints. Notably, IT injections of immune checkpoint blockade (ICB) have been shown to induce immune-mediated tumor responses both at the injected site and at distant, non-injected tumor sites. While surgery has traditionally been the preferred treatment for stage III and IV melanoma patients, neoadjuvant therapy with anti-CTLA-4 and anti-PD-1 agents has shown promising efficacy.\n\nIn patients with localized melanoma, it is hypothesized that IT administration of ipilimumab (anti-CTLA-4 Ab) combined with nivolumab (anti-PD-1 Ab) will provide the most effective and safe treatment combination.\n\nThe NEO-1 study is a proof-of-concept clinical trial designed as a sub-protocol of NEOREM master protocol (NCT07262489) to validate the intratumoral immunotherapy approach, aiming to maximize the dose\u002Fefficacy ratio of combined ipilimumab and nivolumab treatment while minimizing systemic adverse events. This is an academic, open-label, multicentric, phase II clinical trial evaluating the efficacy and safety of intratumoral injections of ipilimumab and nivolumab combination as neoadjuvant treatment in localized stage III resectable cutaneous or mucosal melanoma patients.\n\nBaseline and on-treatment PORTRAIT profiling, as described in the NEOREM Master Protocol (NCT07262489), will be performed using fresh blood and tumor samples. This profiling will reveal the immune status of patients and support biomarker-driven preselection for future trials.",[27,65],"Mucosal Melanoma",[67,68,69,70,71],"Neo-adjuvant Immunotherapy","Localized Cancers","Intra-tumoral treatment","Melanoma","Immune-checkpoint blockade","2026-02-06",{"date":74,"type":42},"2026-02-11",{"date":76,"type":42},"2026-01-12",{"date":78,"type":21},"2033-12",{"name":80,"class":49},"UNICANCER",1,{"id":83,"slug":84,"hasResults":11,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":4,"eligibilityCriteria":88,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":89,"targetDuration":4,"studyType":91,"phases":4,"briefSummary":92,"conditions":93,"keywords":97,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":81},"100604340","symptoms-of-immune-checkpoint-inhibitor-therapy-in-cutaneous-melanoma-100604340","NCT07148245","Symptoms of Immune Checkpoint Inhibitor Therapy in Cutaneous Melanoma","Characterization of the Symptom Experience of Patients With Cutaneous Melanoma Receiving Immune Checkpoint Inhibitor Therapy","Inclusion Criteria:\n\n* Adults ≥18 years of age\n* Able to speak and read English\n* Diagnosed with stage IIB, III, or IV cutaneous melanoma\n* Participants who are scheduled to receive \\>=1 immune checkpoint inhibitor at University of California San Francisco medical center locations. Participants on targeted therapies (e.g., BRAF or mitogen-activated extracellular signal-regulated kinase (MEK) inhibitors) will be eligible.\n* Provide written informed consent to participate in this study.\n* Participants with stage IIB or higher cutaneous melanoma\n\nExclusion Criteria:\n\n* Participants will be excluded if they are unable to complete study requirements.",{"count":90,"type":21},300,"OBSERVATIONAL","The introduction of immune checkpoint inhibitors (ICIs) for the treatment of patients with stages IIB to IV cutaneous melanoma resulted in dramatic improvements in mortality rates for this common form of cancer. With this rapid shift in treatment, significant gaps in knowledge exist regarding the impact of ICIs on patients' symptom experiences. An in-depth characterization of inter-individual differences in patients' symptom experiences will fill this knowledge gap and assist with the early detection of ICI toxicity; guide symptom management; inform treatment decision making; and refine ICI-symptom instrument development. Furthermore, given the limited knowledge in this area, the identification of demographic, clinical, environmental, and molecular risk factors associated with a worse symptom experience is warranted. This is a longitudinal, prospective study evaluating the symptoms that immune checkpoint inhibitors may cause in patients with cutaneous melanoma.",[94,27,95,96],"Cutaneous Melanoma","Cutaneous Melanoma by AJCC V7 Stage","Cutaneous Melanoma, Stage IV",[98],"Toxicity","2025-11-05",{"date":101,"type":42},"2025-11-10",{"date":103,"type":42},"2025-10-13",{"date":105,"type":21},"2027-06-30",{"name":107,"class":49},"University of California, San Francisco",{"id":109,"slug":110,"hasResults":11,"nctId":111,"briefTitle":112,"officialTitle":112,"acronym":4,"eligibilityCriteria":113,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":4,"targetDuration":4,"studyType":114,"phases":4,"briefSummary":115,"conditions":116,"keywords":119,"overallStatus":132,"whyStopped":4,"lastUpdateSubmitDate":133,"lastUpdatePostDateStruct":134,"startDateStruct":4,"completionDateStruct":4,"leadSponsor":136,"locationsCount":4},"100428020","ifx-hu20-expanded-access-program-100428020","NCT04853602","IFx-Hu2.0 Expanded Access Program","Inclusion Criteria:\n\n* To request more information use Responsible Party contact information provided in this record\n\nExclusion Criteria:\n\n* To request more information use Responsible Party contact information provided in this record","EXPANDED_ACCESS","Expanded access requests for IFx-Hu2.0 may be considered for the treatment of adult patients (greater than or equal to 18 years of age) with stage III through IV cutaneous melanoma, advanced Merkel cell carcinoma (MCC), or advanced cutaneous squamous cell carcinoma (cSCC) who have failed all available treatment options.\n\nTo request access, use Responsible Party contact information provided in this record..",[27,96,117,118],"Merkel Cell Carcinoma","Cutaneous Squamous Cell Carcinoma",[120,121,122,123,124,125,126,127,128,129,130,131],"CM","MCC","cSCC","pDNA","plasmid DNA","pAc\u002Femm55","IFx-Hu.20","Immunotherapy","Gene Therapy","Immunology","Oncology","Immuno-Oncology","AVAILABLE","2024-08-08",{"date":135,"type":42},"2024-08-12",{"name":137,"class":138},"TuHURA Biosciences, Inc.","INDUSTRY"]