M.D. Anderson Cancer Center
To determine the recommended Phase IIa dose (RP2D) of the triplet combination. To determine the safety and efficacy of the combination at the RP2D.
Primary Objectives: Phase I: Primary Objective of the Phase I portion is to determine the recommended Phase IIa dose (RP2D) of ipilimumab in combination with nivolumab and relatlimab in the first line treatment of patients with metastatic melanoma. Phase IIa: Primary Objective of the Phase IIa portion is to determine the preliminary clinical efficacy of ipilimumab at the RP2D in combination with nivolumab and relatlimab in the first line treatment of patients with metastatic melanoma as determined by overall response rate (ORR) according to RECIST 1.1. Secondary Objectives: 1. Phase I: T…
Inclusion Criteria: 1. Age ≥ 18 years old. 2. ECOG performance status 0-1 3. Subjects must have signed and dated an IRB/IEC approved written informed consent form in accordance with regulatory and institutional guidelines. This must be obtained before the performance of any protocol-related procedures that are not part of normal subject care. • Subjects must be willing and able to comply with scheduled visits, treatment schedule, laboratory testing, and other requirements of the study. 4. Histologically confirmed unresectable stage III or stage IV malignant melanoma (Stage IV). 5. At leas…
Given by IV
Given by IV
Given by IV
Arctuva estimate
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