[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"melanoma-skin-stage-iv\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:melanoma-skin-stage-iv":32},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,73],{"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":42,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"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",false,"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.","ALL","18 Years",{"count":20,"type":21},920,"ESTIMATED","INTERVENTIONAL",[24],"NA","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.",[27,28,29,30,31,32,33,34,35,36,37,38,39,40,41],"NSCLC (Advanced Non-small Cell Lung Cancer)","NSCLC (Non-small Cell Lung Cancer)","NSCLC (Non-small Cell Lung Carcinoma)","NSCLC","Melanoma (Skin Cancer)","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",[43,44,45,46,47,30,48,49,50,51,33,52,37,53,54,55,56,57,58,59,60],"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","NOT_YET_RECRUITING","2026-07-31",{"date":64,"type":65},"2026-08-04","ACTUAL",{"date":67,"type":21},"2026-12",{"date":69,"type":21},"2034-03",{"name":71,"class":72},"Natera, Inc.","INDUSTRY",{"id":74,"slug":75,"hasResults":11,"nctId":76,"briefTitle":77,"officialTitle":77,"acronym":78,"eligibilityCriteria":79,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":80,"targetDuration":4,"studyType":22,"phases":82,"briefSummary":84,"conditions":85,"keywords":88,"overallStatus":93,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":97,"completionDateStruct":98,"leadSponsor":100,"locationsCount":5},"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":81,"type":21},70,[83],"PHASE2","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.",[32,31,86,87,48],"Melanoma Metastatic","Melanoma Advanced",[89,90,91,92],"microbiota","gut microbiota","dietary fiber","life-style","RECRUITING","2026-07-24",{"date":96,"type":65},"2026-07-27",{"date":62,"type":21},{"date":99,"type":21},"2029-04-30",{"name":101,"class":102},"Radboud University Medical Center","OTHER"]