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NCT04303169 · ClinicalTrials.gov registry record · Phase 1
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)
A Phase 1 study, sponsored by Merck Sharp & Dohme.
- Completed
- Registry status
- Phase 1
- Development phase
- 146
- Enrollment target
NCT04303169 is a Phase 1 study that has completed, run by Merck Sharp & Dohme. The registered enrollment target is 146 participants.
The verdict
NCT04303169, a Phase 1 study, has completed, sponsored by Merck Sharp & Dohme.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 146 participants
- Enrollment target
Study Summary
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.
Interventions
- BIOLOGICAL Pembrolizumab
- BIOLOGICAL MK-4830
- BIOLOGICAL Vibostolimab
- BIOLOGICAL Gebasaxturev
- BIOLOGICAL Favezelimab + Pembrolizumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 146 participants |
| Start Date | 2020-06-26 |
| Est. Completion | 2025-09-24 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04303169
The ClinicalTrials.gov registry entry for NCT04303169 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 146 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 5 interventions - of which Pembrolizumab is the first listed.
NCT04303169 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04303169 about?
NCT04303169 is a clinical study titled "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)". 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 melan...
What is the current status of trial NCT04303169?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 146 participants. The study started on 2020-06-26. Estimated completion is 2025-09-24.
What interventions are being tested in trial NCT04303169?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL), MK-4830 (BIOLOGICAL), Vibostolimab (BIOLOGICAL), Gebasaxturev (BIOLOGICAL), Favezelimab + Pembrolizumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT04303169?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
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