🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in the USA / NCT06246916
Recruiting 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)

NCT06246916 · tracked via the Priya Life Science USA tracker
Sponsor
Regeneron Pharmaceuticals
Phase
Phase 3
Started
2024-09-09
Last updated
2026-08-19

Condition(s) studied

Melanoma

Investigational drug(s) / intervention(s)

fianlimabcemiplimabrelatlimab+nivolumab

fianlimab: Intravenous (IV) administration every 3 weeks (Q3W) in combination with cemiplimab

cemiplimab: IV administration Q3W in combination with fianlimab

relatlimab+nivolumab: IV administration every 4 weeks (Q4W)

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)

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Key Inclusion Criteria: 1. Participants with histologically confirmed unresectable stage III and stage IV (metastatic) melanoma per American Joint Committee on Cancer (AJCC), eighth revised edition. 2. Participants must not have received prior systemic therapy for unresectable or metastatic melanoma as described in the protocol. 3. Measurable disease per RECIST version 1.1. 4. Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤1 5. Adequate bone marrow, hepatic, and kidney function 6. Known B-Rapidly Accelerated Fibrosarcoma protein (BRAF) V600 mutation status or submitted sample for BRAF V600 mutation assessment as described in the protocol Key Exclusion Criteria: Medical Conditions: 1. Uveal, acral or mucosal melanoma. 2. Ongoing or recent (within 2 years) evidence of an autoimmune disease that required systemic treatment with immunosuppressive agents as described in the protocol. 3. Uncontrolled infection with human immunodeficiency virus (HIV), hepatitis B (HBV), or hepatitis C virus (HCV) infection; or diagnosis of immunodeficiency that is related to, or results in chronic infection. Mild cancer-related immunodeficiency (such as immunodeficiency treated with gamma globulin and without chronic or recurrent infection) is allowed. Prior/Concomitant Therapy: 4. Prior immune checkpoint inhibitor therapy other than anti-PD1/PD-L1 as described in the protocol 5. Systemic immune suppression as described in the protocol. Other Comorbidities: 6. Participants with a history of myocarditis. 7. Troponin T (TnT) or troponin I (TnI) \>2x institutional upper limit of normal (ULN). 8. Active or untreated brain metastases or spinal cord compression as described in the protocol. Note: Other protocol-defined Inclusion/ Exclusion Criteria apply.

Primary outcome measure(s)

Trial sites (111)

FacilityCityRegionStatus
Ironwood Cancer & Research Centers Chandler Arizona Recruiting
Banner MD Anderson Cancer Center Gilbert Arizona Recruiting
Arizona Oncology Associates Tucson Arizona Withdrawn
University of Arkansas for Medical Sciences Little Rock Arkansas Recruiting
Providence Medical Foundation Fullerton California Recruiting
Cancer and Blood Specialty Clinic Los Alamitos California Recruiting
University of California Los Angeles Los Angeles California Recruiting
St. Joseph Hospital Orange Orange California Recruiting
University of California Irvine, UCI Medical Center Orange California Recruiting
Eisenhower Medical Center Rancho Mirage California Withdrawn
Emad Ibrahim, MD, Inc. Redlands California Recruiting
Sutter Health Sacramento California Recruiting
University of California San Francisco (UCSF) San Francisco California Recruiting
Sansum Clinic Santa Barbara California Withdrawn
St John's Cancer Institute Santa Monica California Recruiting
Rocky Mountain Regional VA Medical Center Aurora Colorado Recruiting
University of Colorado Cancer Center Aurora Colorado Recruiting
The Melanoma And Skin Cancer Institute Englewood Colorado Recruiting
UCHealth Fort Collins Colorado Withdrawn
Yale Cancer Center New Haven Connecticut Recruiting
Clermont Oncology Center Clermont Florida Withdrawn
Mayo Clinic Florida Jacksonville Florida Recruiting
Cancer Specialist of North Florida Jacksonville Florida Withdrawn
Boca Raton Clinical Research (BRCR) Global Tamarac Florida Recruiting
H. Lee Moffitt Cancer Center Tampa Florida Recruiting
University Cancer & Blood Center Athens Georgia Recruiting
John B. Amos Cancer Center Columbus Georgia Withdrawn
Beacon Clinic Coeur d'Alene Idaho Recruiting
Hope and Healing Cancer Services Hinsdale Illinois Recruiting
Advocate Lutheran General Hospital Park Ridge Illinois Recruiting
Illinois CancerCare Peoria Illinois Recruiting
Fort Wayne Medical Oncology and Hematology Fort Wayne Indiana Recruiting
The University of Kansas Cancer Center Westwood Kansas Recruiting
Markey Cancer Center Clinical Research Organization Lexington Kentucky Recruiting
Mary Bird Perkins Cancer Center Baton Rouge Louisiana Recruiting
Maryland Oncology Hematology, P.A. Columbia Maryland Recruiting
University of Michigan Ann Arbor Michigan Recruiting
Karmanos Cancer Institute Detroit Michigan Withdrawn
Henry Ford Cancer Institute/Henry Ford Health System Detroit Michigan Recruiting
Minnesota Oncology Hematology, P.A Fridley Minnesota Recruiting

+ 71 more sites — see the full list on the official registry below.

On this site

📄 Libtayo (cemiplimab) drug profile →

More Regeneron Pharmaceuticals trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06246916 on ClinicalTrials.gov ↗ ← All trials in the USA