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NCT06246916 · ClinicalTrials.gov registry record · Phase 3
A Study With Combinations of Anti-LAG-3 and Anti-PD-1 Antibodies in Adult Participants With Advanced or Metastatic Melanoma (Harmony Head-to-Head)
A Phase 3 study of Melanoma, sponsored by Regeneron Pharmaceuticals.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 560
- Enrollment target
- 20
- Study locations
NCT06246916: Recruiting Phase 3 study of Melanoma, sponsored by Regeneron Pharmaceuticals.
NCT06246916 is a Phase 3 study of Melanoma that is actively recruiting participants, run by Regeneron Pharmaceuticals. The registered enrollment target is 560 participants, below the 704-participant average among 266 other Melanoma trials with a reported enrollment target (20% lower). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06246916, a Phase 3 study of Melanoma, is actively recruiting participants, sponsored by Regeneron Pharmaceuticals.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 560 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study is researching an experimental drug called fianlimab (also known as REGN3767), combined with another medication called cemiplimab (also known as REGN2810), called "study drugs". The study is focused on patients with a type of skin cancer known as melanoma. The aim of the study is to see how safe and effective the combination of fianlimab and cemiplimab is in treating melanoma, in comparison with the combination of two medications, relatlimab and nivolumab, commercialized under the brand name Opdualag™ and approved for the treatment of melanoma in adults and children. The study is looking at several other research questions, including: * What side effects may happen from taking the study drugs. * How much study drug is in the blood at different times. * Whether the body makes antibodies against the study drugs (which could make the drug less effective or could lead to side effects)
Conditions Studied
Interventions
- DRUG fianlimab
- DRUG cemiplimab
- DRUG relatlimab+nivolumab
Study Locations (20)
California
- Providence Medical Foundation - Fullerton
- Cancer and Blood Specialty Clinic - Los Alamitos
- University of California Los Angeles - Los Angeles
- St. Joseph Hospital Orange - Orange
- Eisenhower Medical Center - Rancho Mirage
- Emad Ibrahim, MD, Inc. - Redlands
- Sutter Health - Sacramento
- University of California San Francisco (UCSF) - San Francisco
- Sansum Clinic - Santa Barbara
- St John's Cancer Institute - Santa Monica
Colorado
- Rocky Mountain Regional VA Medical Center - Aurora
- University of Colorado Cancer Center - Aurora
- The Melanoma And Skin Cancer Institute - Englewood
- UCHealth - Fort Collins
Arizona
- Ironwood Cancer & Research Centers - Chandler
- Banner MD Anderson Cancer Center - Gilbert
- Arizona Oncology Associates - Tucson
Arkansas
- University of Arkansas for Medical Sciences - Little Rock
Connecticut
- Yale Cancer Center - New Haven
Florida
- Clermont Oncology Center - Clermont
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 560 participants |
| Start Date | 2024-09-09 |
| Est. Completion | 2033-07-10 |
| Phase | Phase 3 |
What NCT06246916 shows while recruiting
NCT06246916 is an interventional study that assigns participants to a tested intervention. The registered 560 participants enrollment target is mid-sized for trials with a published cap, below the 704-participant average among 266 other Melanoma trials with a reported enrollment target (20% lower).
The record links to 1 condition, with Melanoma appearing as the primary indexed condition, and to 3 interventions - of which fianlimab is the first listed.
NCT06246916 names 20 study sites across 6 states, led by California, Colorado, Arizona.
Frequently Asked Questions
What is clinical trial NCT06246916 about?
NCT06246916 is a clinical study titled "A Study With Combinations of Anti-LAG-3 and Anti-PD-1 Antibodies in Adult Participants With Advanced or Metastatic Melanoma (Harmony Head-to-Head)". This study is researching an experimental drug called fianlimab (also known as REGN3767), combined with another medication called cemiplimab (also known as REGN2810), called "study drugs". The study is focused on patients with a type of skin cancer known as melanoma. The aim of the study is to see h...
What is the current status of trial NCT06246916?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 560 participants. The study started on 2024-09-09. Estimated completion is 2033-07-10.
What conditions does trial NCT06246916 study?
This clinical trial studies the following conditions: Melanoma.
What interventions are being tested in trial NCT06246916?
The interventions under investigation include: fianlimab (DRUG), cemiplimab (DRUG), relatlimab+nivolumab (DRUG).
Who is sponsoring clinical trial NCT06246916?
This trial is sponsored by Regeneron Pharmaceuticals, which has 280 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06246916 being conducted?
This trial has 20 study locations across Arizona, Arkansas, California, Colorado, Connecticut. 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 NCT06246916's enrollment target sits among peer trials
560 35th of 266 higher than 232 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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