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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)

NCT04305054 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 315

Last updated 2026-04-08

No results posted yet for this study

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

Conditions

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
120 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-01
Primary Completion
2026-05-20
Completion
2026-05-20
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Chile
  • Colombia
  • France
  • Greece
  • Hungary
  • Israel
  • Italy
  • Poland
  • South Africa
  • Spain
  • Switzerland

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04305054 on ClinicalTrials.gov