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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 is a Phase 1 study that has completed, run by Merck Sharp & Dohme. The registered enrollment target is 56 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04700072
The ClinicalTrials.gov registry entry for NCT04700072 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 56 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Merck Sharp & Dohme, which has 558 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Pembrolizumab is the first listed.
NCT04700072 reports 0 study locations.
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.
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