NCT04305054

Substudy 02B: Safety and Efficacy of Pembrolizumab in Combination With Investigational Agents or Pembrolizumab Alone in Participants With First Line (1L) Advanced Melanoma (MK-3475-02B/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 02B

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 315 (estimated)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

Summary

Substudy 02B is part of a larger research study where researchers are looking for new ways to treat advanced melanoma that has not been treated before. The larger study is the umbrella study. Researchers want to know if adding other treatments to pembrolizumab can treat advanced melanoma. The goals of this study are to learn: * About the safety and how well people tolerate pembrolizumab given with other treatments * How many people have melanoma that responds (gets smaller or goes away) to treatment

Detailed description

With Amendment 6, all arms are closed to enrollment. Participants in arms 2 (pembrolizumab), 3 (coformulation pembrolizumab/quavonlimab), and 4 (coformulation pembrolizumab/quavonlimab + lenvatinib) who complete study treatment or otherwise meet end of treatment (EOT) criteria will be discontinued from the study after completing the EOT visit and any required safety follow-up visits. Participants in arm 6 (coformulation favezelimab/pembrolizumab + All-trans Retinoic Acid \[ATRA\]) will discontinue ATRA and participants in arms 5 and 6 can continue on coformulation favezelimab/pembrolizumab or pembrolizumab.

Conditions

• Melanoma

Interventions

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

Timeline

• Start date: 2020-07-01
• Primary completion: 2026-05-20
• Completion: 2026-05-20
• First posted: 2020-03-12
• Last updated: 2026-04-08

Locations

60 sites across 14 countries: United States, Argentina, Australia, Chile, Colombia, France, Greece, Hungary, Israel, Italy, Poland, South Africa, Spain, Switzerland

Regulatory

• FDA-regulated drug study