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NCT04305054 · ClinicalTrials.gov registry record · Phase 1
Substudy 02B: Safety and Efficacy of Pembrolizumab in Combination With Investigational Agents or Pembrolizumab Alone in Participants With First Line (1L) Advanced Melanoma (MK-3475-02B/KEYMAKER-U02)
A Phase 1 study of Melanoma, sponsored by Merck Sharp & Dohme.
- Active
- Registry status
- Phase 1
- Development phase
- 315
- Enrollment target
- 20
- Study locations
NCT04305054: Active Phase 1 study of Melanoma, sponsored by Merck Sharp & Dohme.
NCT04305054 is a Phase 1 study of Melanoma that is active but no longer recruiting, run by Merck Sharp & Dohme. The registered enrollment target is 315 participants, below the 705-participant average among 266 other Melanoma trials with a reported enrollment target (55% lower). The trial reports 20 study locations across 16 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04305054, a Phase 1 study of Melanoma, is active but no longer recruiting, sponsored by Merck Sharp & Dohme.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 315 participants
- Enrollment target
- 20
- Study locations
Study Summary
Substudy 02B is part of a larger research study where researchers are looking for new ways to treat advanced melanoma that has not been treated before. The larger study is the umbrella study. Researchers want to know if adding other treatments to pembrolizumab can treat advanced melanoma. The goals of this study are to learn: * About the safety and how well people tolerate pembrolizumab given with other treatments * How many people have melanoma that responds (gets smaller or goes away) to treatment
Primary Outcome
The percentage of participants who experience 1 or more protocol-defined DLTs during the safety lead-in period will be reported.
Conditions Studied
Interventions
- BIOLOGICAL Pembrolizumab
- DRUG Lenvatinib
- BIOLOGICAL Vibostolimab
- BIOLOGICAL Pembrolizumab/Quavonlimab
- BIOLOGICAL Favezelimab/Pembrolizumab
Study Locations (20)
California
- The Angeles Clinic and Research Institute ( Site 2009) - Los Angeles
- UCLA Hematology & Oncology ( Site 2004) - Los Angeles
- Providence Saint John's Health Center ( Site 2010) - Santa Monica
New York
- R.J. Zuckerberg Cancer Center ( Site 2032) - Lake Success
- NYU Clinical Cancer Center ( Site 2002) - New York
New South Wales
- Calvary Mater Newcastle-Medical Oncology ( Site 2404) - Waratah
- Melanoma Institute Australia ( Site 2402) - Wollstonecraft
Colorado
- University of Colorado, Anschutz Cancer Pavilion ( Site 2012) - Aurora
Florida
- University of Florida College of Medicine-UF Health Cancer Center/Clinical Trials Office ( Site 2026) - Gainesville
Maryland
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins ( Site 2022) - Baltimore
North Carolina
- Duke Cancer Institute ( Site 2005) - Durham
Ohio
- Martha Morehouse Tower ( Site 2020) - Columbus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 315 participants |
| Start Date | 2020-07-01 |
| Est. Completion | 2026-04-20 |
| Phase | Phase 1 |
What the registry record for NCT04305054 still lists
NCT04305054 is an interventional study that assigns participants to a tested intervention. The registered 315 participants enrollment target is mid-sized for trials with a published cap, below the 705-participant average among 266 other Melanoma trials with a reported enrollment target (55% lower).
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.
NCT04305054 names 20 study sites across 16 states, led by California, New York, New South Wales.
Frequently Asked Questions
What is clinical trial NCT04305054 about?
NCT04305054 is a clinical study titled "Substudy 02B: Safety and Efficacy of Pembrolizumab in Combination With Investigational Agents or Pembrolizumab Alone in Participants With First Line (1L) Advanced Melanoma (MK-3475-02B/KEYMAKER-U02)". Substudy 02B is part of a larger research study where researchers are looking for new ways to treat advanced melanoma that has not been treated before. The larger study is the umbrella study. Researchers want to know if adding other treatments to pembrolizumab can treat advanced melanoma. The goals ...
What is the current status of trial NCT04305054?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 315 participants. The study started on 2020-07-01. Estimated completion is 2026-04-20.
What conditions does trial NCT04305054 study?
This clinical trial studies the following conditions: Melanoma.
What interventions are being tested in trial NCT04305054?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Lenvatinib (DRUG), Vibostolimab (BIOLOGICAL), Pembrolizumab/Quavonlimab (BIOLOGICAL), Favezelimab/Pembrolizumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT04305054?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04305054 being conducted?
This trial has 20 study locations across California, Colorado, Florida, Maryland, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Melanoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04305054's enrollment target sits among peer trials
315 54th of 266 higher than 213 of 266 other Melanoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Melanoma 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.
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