A Phase 1/2 Open-Label Rolling-Arm Umbrella Platform Design of Investigational Agents With or Without Pembrolizumab or Pembrolizumab Alone in Participants With Melanoma (KEYMAKER-U02): Substudy 02D
Brief description of study
The Master Protocol is a Phase 1/2, rolling arm, multicenter, open-label, adaptive design study that will evaluate within this substudy protocol the efficacy of investigational agents with or without pembrolizumab for the treatment of PD-1 naïve or PD-1 exposed participants with MBM. Preliminary efficacy from this substudy protocol will be evaluated by using ORR per RECIST 1.1 as determined by BICR. In this substudy protocol, an investigational treatment arm refers to a unique investigational agent or a combination of investigational agents with or without pembrolizumab. Investigational agents will only be added to this substudy protocol after an initial evaluation of safety and tolerability when administered alone and in combination with pembrolizumab has been completed and a RP2D has been identified. Specific procedures to be performed during the study, including prescribed times and associated visit windows, are outlined in the SoA in Appendix 6, Section 10.6.2.1. Approximately 50 participants will be enrolled in each investigational treatment arm of this substudy protocol. Investigational treatment arm(s) within the PD-1 naïve cohort (Cohort 1) may be expanded to 100 participants based on the totality of evidence.
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