Substudy 02A: Safety and Efficacy of Pembrolizumab in Combination With Investigational Agents in Participants With Programmed Cell-death 1 (PD-1) Refractory Melanoma (MK-3475-02A/KEYMAKER-U02)

NCT04305041 PHASE1, PHASE2 COMPLETED

Substudy 02A is part of a larger research study that is testing experimental treatments for melanoma, a type of skin cancer. The larger study is the umbrella study. The goal of substudy 02A is to evaluate the safety and efficacy of investigational treatment arms in participants with PD-1 refractory melanoma to identify the investigational agent(s) that, when used in combination, are superior to the current treatment options/historical control available. As of Amendment 4 (effective date: 05JAN2022), a third arm has been opened to participant enrollment, treatment with pembrolizumab and all-trans retinoic acid (ATRA). Enrollment into the first two arms, treatment with pembrolizumab + quavonlimab+ vibostolimab and treatment with pembrolizumab + quavonlimab + lenvatinib has been completed per protocol as of September 2021.

Details

Lead sponsor	Merck Sharp & Dohme LLC
Phase	PHASE1, PHASE2
Status	COMPLETED
Enrolment	100
Start date	Fri Jun 26 2020 00:00:00 GMT+0000 (Coordinated Universal Time)
Completion	Mon Aug 25 2025 00:00:00 GMT+0000 (Coordinated Universal Time)

Conditions

• Melanoma

Interventions

• Pembrolizumab
• Quavonlimab
• Vibostolimab
• Lenvatinib
• ATRA

Countries

France, Italy, South Africa, Israel, Switzerland, Australia, United States