Clinical Trial 21344

Study Title

A Phase Ib/II, Open-Label, Multicenter, Randomized Umbrella Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients with Melanoma (Morpheus-Melanoma)

Summary

This study will evaluate the efficacy, safety, and pharmacokinetics of treatment combinations in cancer immunotherapy (CIT)-naive participants with resectable Stage III melanoma (Cohort 1) and in participants with Stage IV melanoma (Cohort 2). The study is designed with the flexibility to open new treatment arms as new treatments become available, close existing treatment arms that demonstrate minimal clinical activity or unacceptable toxicity, and modify the participant population.

Objective

pRR (defined as the proportion of patients with pCR, pnCR, and pPR) at time of surgery, as determined by independent pathologic review. 2. pRR (defined as the proportion of patients with pCR, pnCR, and pPR) at time of surgery, as determined by local pathologic assessment 3. EFS, defined as the time from randomization to any of the following events (whichever occurs first): Disease progression that precludes surgery, as assessed by the investigator according to RECIST v1.1; local, regional or distant disease recurrence; or death from any cause 4.RFS, defined as the time from surgery to the first documented recurrence of disease or death from any cause 5.OS, defined as the time from randomization to death from any cause 6. ORR, defined as the proportion of patients with a CR or PR as determined by the investigator according to RECIST v1.1, prior to surgery