Cancer Type: Cutaneous
Study Type: Treatment
Phase: Phase II
Principal Investigator: Tarhini, Ahmad
A Phase II, Open-Label, Multicenter, Randomized Study of Efficacy and Safety of RO7198457 in Combination with Pembrolizumab versus Pembrolizumab in Patients with Previously Untreated Advanced Melanoma
Objectives: This study will evaluate the efficacy, safety, pharmacokinetics, and patient-reported outcomes (PROs) of RO7198457 plus pembrolizumab compared with pembrolizumab alone in patients with previously untreated advanced melanoma. Specific objectives and corresponding endpoints for the study are outlined below. Primary Efficacy Objective The primary efficacy objective for this study is to evaluate the efficacy of RO7198457 plus pembrolizumab compared with pembrolizumab alone on the basis of the following endpoints: & 61623; PFS after randomization, defined as the time from randomization to the first occurrence of disease progression or death from any cause (whichever occurs first), as determined by the investigator according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)
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