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NCT04305041 · ClinicalTrials.gov registry record · Phase 1
Substudy 02A: Safety and Efficacy of Pembrolizumab in Combination With Investigational Agents in Participants With Programmed Cell-death 1 (PD-1) Refractory Melanoma (MK-3475-02A/KEYMAKER-U02)
A Phase 1 study of Melanoma, sponsored by Merck Sharp & Dohme.
- Completed
- Registry status
- Phase 1
- Development phase
- 100
- Enrollment target
- 20
- Study locations
NCT04305041 is a Phase 1 study of Melanoma that has completed, run by Merck Sharp & Dohme. The registered enrollment target is 100 participants, below the 706-participant average among 266 other Melanoma trials with a reported enrollment target (86% lower). The trial reports 20 study locations across 17 states.
The verdict
NCT04305041, a Phase 1 study of Melanoma, has completed, sponsored by Merck Sharp & Dohme.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 100 participants
- Enrollment target
- 20
- Study locations
Study Summary
Substudy 02A 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 02A is to evaluate the safety and efficacy of investigational treatment arms in participants with PD-1 refractory melanoma to identify the investigational agent(s) that, when used in combination, are superior to the current treatment options/historical control available. As of Amendment 4 (effective date: 05JAN2022), a third arm has been opened to participant enrollment, treatment with pembrolizumab and all-trans retinoic acid (ATRA). Enrollment into the first two arms, treatment with pembrolizumab + quavonlimab+ vibostolimab and treatment with pembrolizumab + quavonlimab + lenvatinib has been completed per protocol as of September 2021.
Conditions Studied
Interventions
- BIOLOGICAL Pembrolizumab
- DRUG ATRA
- DRUG Lenvatinib
- BIOLOGICAL Vibostolimab
- BIOLOGICAL Quavonlimab
Study Locations (20)
California
- The Angeles Clinic and Research Institute ( Site 1009) - Los Angeles
- UCLA Hematology & Oncology ( Site 1004) - Los Angeles
- Providence Saint John's Health Center ( Site 1010) - Santa Monica
New South Wales
- Calvary Mater Newcastle-Medical Oncology ( Site 1404) - Waratah
- Melanoma Institute Australia ( Site 1402) - Wollstonecraft
Colorado
- University of Colorado, Anschutz Cancer Pavilion ( Site 1012) - Aurora
Maryland
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins ( Site 1022) - Baltimore
New York
- NYU Clinical Cancer Center ( Site 1002) - New York
North Carolina
- Duke Cancer Institute ( Site 1005) - Durham
Ohio
- Martha Morehouse Tower ( Site 1020) - Columbus
Oregon
- Oregon Health & Science University ( Site 1013) - Portland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2020-06-26 |
| Est. Completion | 2025-08-25 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04305041
The ClinicalTrials.gov registry entry for NCT04305041 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 706-participant average among 266 other Melanoma trials with a reported enrollment target (86% lower). The listed sponsor is Merck Sharp & Dohme, which has 558 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Melanoma appearing as the primary indexed condition, and to 5 interventions - of which Pembrolizumab is the first listed.
NCT04305041 reports 20 study locations spanning 17 distinct geographic areas - top geographies include California, New South Wales, Colorado.
Frequently Asked Questions
What is clinical trial NCT04305041 about?
NCT04305041 is a clinical study titled "Substudy 02A: Safety and Efficacy of Pembrolizumab in Combination With Investigational Agents in Participants With Programmed Cell-death 1 (PD-1) Refractory Melanoma (MK-3475-02A/KEYMAKER-U02)". Substudy 02A 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 02A is to evaluate the safety and efficacy of investigational treatment arms in participants with PD-1 refractory...
What is the current status of trial NCT04305041?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 100 participants. The study started on 2020-06-26. Estimated completion is 2025-08-25.
What conditions does trial NCT04305041 study?
This clinical trial studies the following conditions: Melanoma.
What interventions are being tested in trial NCT04305041?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL), ATRA (DRUG), Lenvatinib (DRUG), Vibostolimab (BIOLOGICAL), Quavonlimab (BIOLOGICAL).
Who is sponsoring clinical trial NCT04305041?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04305041 being conducted?
This trial has 20 study locations across California, Colorado, Maryland, New York, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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