Life sciences · Interventional Study
ClinicalTrials.gov · October 27, 2026
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Interventional Study.
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Registry record from ClinicalTrials.gov (NCT07689812). This is a study registration, not published results. Lead sponsor: Natera, Inc.. Recruitment status: NOT_YET_RECRUITING. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 920 participants (ESTIMATED). Conditions: 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. Interventions: DEVICE: Signatera Genome ultra-sensitive ctDNA blood test. Primary outcome measures: To demonstrate that ctDNA-guided intermittent ICI therapy results in at least 50% of patients who do not reinitiate systemic therapy prior to 6 months from randomization. , 6 months from randomization; To demonstrate that ctDNA-guided intermittent ICI therapy is non-inferior to SoC continuous ICI therapy as measured by 36 month OS in advanced/metastatic solid tumor patients. , 3 years from randomization to death from any cause. Brief summary: 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/metastatic non-small cell lung cancer (NSCLC), melanoma, microsatellite instability-high (MSI-High)/Deficient Mismatch Repair (dMMR) colorectal cancer (CRC), renal cell carcinoma (RCC) and other solid tumors. This study will be conducted in approximately to 100 sites.