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)
Public ClinicalTrials.gov record NCT04305041. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04305041
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 100 participants
Conditions and interventions
Conditions
Interventions
- Pembrolizumab Biological
- Quavonlimab Biological
- Vibostolimab Biological
- Lenvatinib Drug
- ATRA Drug
Biological · Drug
Eligibility (public fields only)
- Age range
- 18 Years to 120 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 25, 2020
- Primary completion
- Aug 24, 2025
- Completion
- Aug 24, 2025
- Last update posted
- Aug 31, 2026
2020 – 2025
United States locations
- U.S. sites
- 13
- U.S. states
- 11
- U.S. cities
- 12
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| The Angeles Clinic and Research Institute ( Site 1009) | Los Angeles | California | 90025 | — |
| UCLA Hematology & Oncology ( Site 1004) | Los Angeles | California | 90095 | — |
| Providence Saint John's Health Center ( Site 1010) | Santa Monica | California | 90404 | — |
| University of Colorado, Anschutz Cancer Pavilion ( Site 1012) | Aurora | Colorado | 80045 | — |
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins ( Site 1022) | Baltimore | Maryland | 21287 | — |
| NYU Clinical Cancer Center ( Site 1002) | New York | New York | 10016 | — |
| Duke Cancer Institute ( Site 1005) | Durham | North Carolina | 27710 | — |
| Martha Morehouse Tower ( Site 1020) | Columbus | Ohio | 43221 | — |
| Oregon Health & Science University ( Site 1013) | Portland | Oregon | 97239 | — |
| University of Pennsylvania Abramson Cancer Center ( Site 1008) | Philadelphia | Pennsylvania | 19104 | — |
| West Cancer Center - East Campus ( Site 1014) | Germantown | Tennessee | 38138 | — |
| University of Texas MD Anderson Cancer Center ( Site 1006) | Houston | Texas | 77030 | — |
| Inova Schar Cancer Institute ( Site 1011) | Fairfax | Virginia | 22031 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 23 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04305041, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 31, 2026 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04305041 live on ClinicalTrials.gov.