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NCT04700072 · ClinicalTrials.gov registry record · Phase 1
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 study, sponsored by Merck Sharp & Dohme.
- Completed
- Registry status
- Phase 1
- Development phase
- 56
- Enrollment target
NCT04700072: Completed Phase 1 study, sponsored by Merck Sharp & Dohme.
NCT04700072 is a Phase 1 study that has completed, run by Merck Sharp & Dohme. The registered enrollment target is 56 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04700072, a Phase 1 study, has completed, sponsored by Merck Sharp & Dohme.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 56 participants
- Enrollment target
Study 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.
Primary Outcome
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants who experience an AE will be reported.
Interventions
- BIOLOGICAL Pembrolizumab
- DRUG Lenvatinib
- BIOLOGICAL Pembrolizumab/Quavonlimab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 56 participants |
| Start Date | 2021-05-03 |
| Est. Completion | 2025-10-17 |
| Phase | Phase 1 |
What the finished NCT04700072 record still lists
NCT04700072 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 56 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 3 interventions - of which Pembrolizumab is the first listed.
NCT04700072 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04700072 about?
NCT04700072 is a clinical study titled "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)". 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) na...
What is the current status of trial NCT04700072?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 56 participants. The study started on 2021-05-03. Estimated completion is 2025-10-17.
What interventions are being tested in trial NCT04700072?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Lenvatinib (DRUG), Pembrolizumab/Quavonlimab (BIOLOGICAL).
Who is sponsoring clinical trial NCT04700072?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04700072's enrollment target sits among peer trials
56 902nd of 2000 higher than 1,083 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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