NCT04303169

Substudy 02C: Safety and Efficacy of Pembrolizumab in Combination With Investigational Agents or Pembrolizumab Alone in Participants With Stage III Melanoma Who Are Candidates for Neoadjuvant Therapy (MK-3475-02C/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 02C

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 146 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

Summary

Substudy 02C 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 02C is to evaluate the safety and efficacy of investigational treatment arms in participants with Stage III melanoma who are candidates for neoadjuvant therapy to identify the investigational agent(s) that, when used in combination, are superior to the current treatment options/historical control available. Arm 1: Pembrolizumab + Vibostolimab, Arm 2: Pembrolizumab + Gebasaxturev, and Arm 3: Pembrolizumab were added in the base protocol on 13-Nov-2019, and enrollment into those arms has been completed. Arm 4: Pembrolizumab + MK-4830 was added in Amendment 04 on 20-Dec-2021, and enrollment into that arm has been completed. Arm 5: Favezelimab + Pembrolizumab and Arm 6: Pembrolizumab + all-trans retinoic acid (ATRA) were added in Amendment 06 on 25-Jun-2022, and enrollment is ongoing.

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	Gebasaxturev	Administered via IT injection at a specified dose on specified days
BIOLOGICAL	MK-4830	Administered via IV infusion 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 capsules at a specified dose on specified days

Timeline

• Start date: 2020-06-26
• Primary completion: 2025-09-24
• Completion: 2025-09-24
• First posted: 2020-03-10
• Last updated: 2025-10-27

Locations

29 sites across 6 countries: United States, Australia, France, Israel, Italy, Switzerland

Regulatory

• FDA-regulated drug study