M.D. Anderson Cancer Center
This is a phase II study testing the safety and preliminary efficacy of triplet ICB in treatment naïve patients with clinical stage III or oligometastatic stage IV melanoma with resectable disease.
Primary Objective: • Evaluate the safety of cemiplimab, fianlimab, and ipilimumab combination in resectable clinical stage III or oligometastatic stage IV melanoma patients in the neoadjuvant setting. Primary Endpoints • Incidence of grade 3 or higher toxicities by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 6 Secondary Objectives: * Estimation of MPRDetermination of pCR * Determination of objective response rate (ORR) to neoadjuvant therapy * Determination of EFS * Determination of RFS * Assess distant metastasis-free survival (DMFS) * Eva…
Inclusion Criteria: 1. At least 18 years of age on the date of providing informed consent 2. All patients must be either stage III (stage IIIB, IIIC, IIID) or stage IV (M1a, M1b, M1c) per ATJCC 8th edition and have histologically confirmed cutaneous melanoma (including acral melanoma) that is clinically detectable and deemed completely surgically resectable 1. Patients with stage IIIA and Stage IV M1d disease are excluded 2. Mucosal melanoma patients are allowed but capped at 10% of the total study population 3. Patients with melanoma of unknown primary are allowed, provided that co…
Given by IV
Given by IV
Given by IV
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