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)
Public ClinicalTrials.gov record NCT04303169. 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 02C
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04303169
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 146 participants
Conditions and interventions
Conditions
Interventions
- Pembrolizumab Biological
- Vibostolimab Biological
- Gebasaxturev Biological
- MK-4830 Biological
- Favezelimab + Pembrolizumab Biological
- 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
- Sep 23, 2025
- Completion
- Sep 23, 2025
- Last update posted
- Aug 26, 2026
2020 – 2025
United States locations
- U.S. sites
- 11
- U.S. states
- 10
- U.S. cities
- 11
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| The Angeles Clinic and Research Institute ( Site 3009) | Los Angeles | California | 90025 | — |
| Providence Saint John's Health Center ( Site 3010) | Santa Monica | California | 90404 | — |
| University of Colorado, Anschutz Cancer Pavilion ( Site 3012) | Aurora | Colorado | 80045 | — |
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins ( Site 3022) | Baltimore | Maryland | 21287 | — |
| NYU Clinical Cancer Center ( Site 3002) | New York | New York | 10016 | — |
| Duke Cancer Institute ( Site 3005) | Durham | North Carolina | 27710 | — |
| Martha Morehouse Tower ( Site 3020) | Columbus | Ohio | 43221 | — |
| Oregon Health & Science University ( Site 3013) | Portland | Oregon | 97239 | — |
| University of Pennsylvania Abramson Cancer Center ( Site 3008) | Philadelphia | Pennsylvania | 19104 | — |
| West Cancer Center - East Campus ( Site 3014) | Germantown | Tennessee | 38138 | — |
| Inova Schar Cancer Institute ( Site 3011) | 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 18 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04303169, 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 26, 2026 · Synced Sep 6, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04303169 live on ClinicalTrials.gov.