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)
Public ClinicalTrials.gov record NCT04700072. 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 02D
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04700072
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 56 participants
Conditions and interventions
Conditions
Interventions
- Pembrolizumab Biological
- Pembrolizumab/Quavonlimab Biological
- Lenvatinib 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
- May 3, 2021 (Actual)
- Primary completion
- Oct 17, 2025 (Actual)
- Completion
- Oct 17, 2025 (Actual)
- Last update posted
- Oct 28, 2025
2021 – 2025
United States locations
- U.S. sites
- 9
- U.S. states
- 7
- U.S. cities
- 8
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| The Angeles Clinic and Research Institute ( Site 4009) | Los Angeles | California | 90025 | — |
| UCLA Hematology & Oncology ( Site 4004) | Los Angeles | California | 90095 | — |
| Providence Saint John's Health Center ( Site 4010) | Santa Monica | California | 90404 | — |
| University of Colorado, Anschutz Cancer Pavilion ( Site 4012) | Aurora | Colorado | 80045 | — |
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins ( Site 4022) | Baltimore | Maryland | 21287 | — |
| NYU Clinical Cancer Center ( Site 4002) | New York | New York | 10016 | — |
| Duke Cancer Institute ( Site 4005) | Durham | North Carolina | 27710 | — |
| Martha Morehouse Tower ( Site 4020) | Columbus | Ohio | 43221 | — |
| Inova Schar Cancer Institute ( Site 4011) | 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 27 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04700072, 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 Oct 28, 2025 · Synced Oct 26, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04700072 live on ClinicalTrials.gov.