NCT04305041

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)

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 02A

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Melanoma

Interventions

Type	Name	Description
BIOLOGICAL	Pembrolizumab	Administered via IV infusion at a specified dose on specified days
BIOLOGICAL	Quavonlimab	Administered via IV infusion at a specified dose on specified days
BIOLOGICAL	Vibostolimab	Administered via IV infusion at a specified dose on specified days
DRUG	Lenvatinib	Administered via oral capsules at a specified dose on specified days
DRUG	ATRA	Administered via oral capsules at a specified dose on specified days

Timeline

• Start date: 2020-06-26
• Primary completion: 2025-08-25
• Completion: 2025-08-25
• First posted: 2020-03-12
• Last updated: 2025-08-29

Locations

36 sites across 7 countries: United States, Australia, France, Israel, Italy, South Africa, Switzerland

Regulatory

• FDA-regulated drug study