NCT04700072

Substudy 02D: Safety and Efficacy of Pembrolizumab in Combination With Investigational Agents or Pembrolizumab Alone in Participants With Melanoma Brain Metastasis (MK-3475-02D/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 02D

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

Summary

Substudy 02D 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 02D is to evaluate the safety and efficacy of investigational treatment arms in programmed cell-death 1 (PD-1) naïve or PD-1 exposed participants with melanoma brain metastasis (MBM) and to identify the investigational agent(s) that, when used in combination, are superior to the current treatment options/historical control available. As of amendment 2 (effective 01DEC2022) enrollment into the treatment arm of pembrolizumab and lenvatinib has been discontinued.

Conditions

• Melanoma

Interventions

Type	Name	Description
BIOLOGICAL	Pembrolizumab	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

Timeline

• Start date: 2021-05-03
• Primary completion: 2025-10-17
• Completion: 2025-10-17
• First posted: 2021-01-07
• Last updated: 2025-10-28

Locations

36 sites across 8 countries: United States, Australia, France, Israel, Italy, South Africa, Spain, Switzerland

Regulatory

• FDA-regulated drug study