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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 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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06246916
The ClinicalTrials.gov registry entry for NCT06246916 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 560 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 704-participant average among 266 other Melanoma trials with a reported enrollment target (20% lower). The listed sponsor is Regeneron Pharmaceuticals, which has 280 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 6 distinct geographic areas - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
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