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)
- Conditions
- Melanoma
- Interventions
- Registration Number
- NCT06246916
- Lead Sponsor
- Regeneron Pharmaceuticals
- Brief 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)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 560
- Participants with histologically confirmed unresectable stage III and stage IV (metastatic) melanoma per American Joint Committee on Cancer (AJCC), eighth revised edition.
- Participants must not have received prior systemic therapy for unresectable or metastatic melanoma as described in the protocol.
- Measurable disease per RECIST version 1.1.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤1
- Adequate bone marrow, hepatic, and kidney function
- Known B-Rapidly Accelerated Fibrosarcoma protein (BRAF) V600 mutation status or submitted sample for BRAF V600 mutation assessment as described in the protocol
Key
Medical Conditions:
-
Uveal, acral or mucosal melanoma.
-
Ongoing or recent (within 2 years) evidence of an autoimmune disease that required systemic treatment with immunosuppressive agents as described in the protocol.
-
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:
-
Prior immune checkpoint inhibitor therapy other than anti-PD1/PD-L1 as described in the protocol
-
Systemic immune suppression as described in the protocol.
Other Comorbidities:
-
Participants with a history of myocarditis.
-
Troponin T (TnT) or troponin I (TnI) >2x institutional upper limit of normal (ULN).
-
Active or untreated brain metastases or spinal cord compression as described in the protocol.
Note: Other protocol-defined Inclusion/ Exclusion Criteria apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description relatlimab+nivolumab relatlimab+nivolumab Randomized 1:1 fianlimab+cemiplimab fianlimab Randomized 1:1 fianlimab+cemiplimab cemiplimab Randomized 1:1
- Primary Outcome Measures
Name Time Method Objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 based on blinded independent central review (BICR) Up to 72 months
- Secondary Outcome Measures
Name Time Method Titer of ADAs to fianlimab Up to 72 months Duration of Response (DOR) by BICR Up to 72 months DOR by investigator assessment Up to 72 months Disease control rate (DCR) by BICR Up to 72 months Death from any cause Up to 72 months Overall survival (OS) Up to 72 months PFS based on investigator assessment according to RECIST version 1.1 Up to 72 months Incidence of immune-mediated adverse events (imAEs) Up to 72 months Occurrence of interruption of study drug(s) due to AEs Up to 72 months Occurrence of discontinuation of study drug(s) due to AEs Up to 72 months Progression free survival (PFS) RECIST version 1.1 based on BICR Up to 72 months Incidence of treatment-emergent adverse events (TEAEs) Up to 72 months Incidence of laboratory abnormalities Up to 72 months Grade ≥3 per National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE v5.0) including standard hematology, chemistry, urinalysis, and other lab tests
Incidence of ADAs to cemiplimab Up to 72 months Titer of ADAs to cemiplimab Up to 72 months TEAEs leading to death Up to 72 months Incidence of NAbs to cemiplimab Up to 72 months ORR based on investigator assessment according to RECIST version 1.1 Up to 72 months Incidence of serious adverse events (SAEs) Up to 72 months Concentration of cemiplimab in serum Up to 72 months Incidence of anti-drug antibodies (ADAs) to fianlimab Up to 72 months Incidence of neutralizing antibodies (NAbs) to fianlimab Up to 72 months Concentration of fianlimab in serum Up to 72 months DCR by investigator assessment Up to 72 months
Trial Locations
- Locations (76)
Ironwood Cancer & Research Centers
🇺🇸Chandler, Arizona, United States
Banner MD Anderson Cancer Center
🇺🇸Gilbert, Arizona, United States
Arizona Oncology Associates
🇺🇸Tucson, Arizona, United States
Cancer and Blood Specialty Clinic
🇺🇸Los Alamitos, California, United States
UCLA
🇺🇸Los Angeles, California, United States
Eisenhower Medical Center
🇺🇸Rancho Mirage, California, United States
Sutter Health
🇺🇸Sacramento, California, United States
UCSF
🇺🇸San Francisco, California, United States
Sansum Clinic
🇺🇸Santa Barbara, California, United States
St John's Cancer Institute
🇺🇸Santa Monica, California, United States
Rocky Mountain Regional VA Medical Center
🇺🇸Aurora, Colorado, United States
University of Colorado Cancer Center
🇺🇸Aurora, Colorado, United States
The Melanoma And Skin Cancer Institute
🇺🇸Englewood, Colorado, United States
UCHealth
🇺🇸Fort Collins, Colorado, United States
Yale Cancer Center
🇺🇸New Haven, Connecticut, United States
Clermont Oncology Center
🇺🇸Clermont, Florida, United States
Cancer Specialist of North Florida
🇺🇸Jacksonville, Florida, United States
Boca Raton Clinical Research (BRCR) Global
🇺🇸Plantation, Florida, United States
H. Lee Moffitt Cancer Center
🇺🇸Tampa, Florida, United States
John B. Amos Cancer Center
🇺🇸Columbus, Georgia, United States
Beacon Clinic
🇺🇸Coeur d'Alene, Idaho, United States
Hope and Healing Cancer Services
🇺🇸Hinsdale, Illinois, United States
Advocate Lutheran General Hospital
🇺🇸Park Ridge, Illinois, United States
Illinois CancerCare
🇺🇸Peoria, Illinois, United States
Fort Wayne Medical Oncology and Hematology
🇺🇸Fort Wayne, Indiana, United States
The University of Kansas Cancer Center
🇺🇸Westwood, Kansas, United States
Markey Cancer Center Clinical Research Organization
🇺🇸Lexington, Kentucky, United States
Mary Bird Perkins Cancer Center
🇺🇸Baton Rouge, Louisiana, United States
Maryland Oncology Hematology, P.A.
🇺🇸Columbia, Maryland, United States
Karmanos Cancer Institute
🇺🇸Detroit, Michigan, United States
Minnesota Oncology Hematology, P.A
🇺🇸Fridley, Minnesota, United States
Allina Health Cancer Institute
🇺🇸Minneapolis, Minnesota, United States
VA St. Louis Healthcare System
🇺🇸Saint Louis, Missouri, United States
Washington University
🇺🇸Saint Louis, Missouri, United States
Mercy South
🇺🇸Saint Louis, Missouri, United States
St. Vincent Healthcare
🇺🇸Billings, Montana, United States
Oncology Hematology West P.C. dba Nebraska Cancer Specialists
🇺🇸Omaha, Nebraska, United States
Comprehensive Cancer Centers of Nevada
🇺🇸Las Vegas, Nevada, United States
John Theurer Cancer Center
🇺🇸Hackensack, New Jersey, United States
Rutgers Cancer Institute of New Jersey
🇺🇸New Brunswick, New Jersey, United States
New York Oncology Hematology
🇺🇸Albany, New York, United States
Messino Cancer Center
🇺🇸Asheville, North Carolina, United States
Levine Cancer Institute
🇺🇸Charlotte, North Carolina, United States
Oncology Hematology Care Clinical Trials
🇺🇸Cincinnati, Ohio, United States
Seidman Cancer Center
🇺🇸Cleveland, Ohio, United States
Oklahoma Cancer Specialists and Research Institute, LLC
🇺🇸Tulsa, Oklahoma, United States
Kaiser Foundation Hospitals
🇺🇸Portland, Oregon, United States
St. Luke's University Health Network
🇺🇸Easton, Pennsylvania, United States
Fox Chase Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center (UPMC) Hillman Cancer Center
🇺🇸Pittsburgh, Pennsylvania, United States
Lifespan Cancer Institute
🇺🇸Providence, Rhode Island, United States
Saint Francis Cancer Center
🇺🇸Greenville, South Carolina, United States
Tennessee Oncology - Chattanooga
🇺🇸Chattanooga, Tennessee, United States
University of Tennessee Medical Center
🇺🇸Knoxville, Tennessee, United States
Sunnybrook Health Sciences Centre
🇨🇦Toronto, Ontario, Canada
Princess Margaret Cancer Centre
🇨🇦Toronto, Ontario, Canada
Sarah Cannon Research Institute (SCRI) Oncology Partners
🇺🇸Nashville, Tennessee, United States
Tennessee Oncology
🇺🇸Nashville, Tennessee, United States
Texas Oncology - Austin Central, Central Austin Cancer Center
🇺🇸Austin, Texas, United States
Center For Disease And Blood Disorder
🇺🇸Fort Worth, Texas, United States
Centre Hospitalier Universitaire de Quebec (CHUQ) - Centre Hospitalier de l'Universite Laval (CHUL)
🇨🇦Quebec, Canada
The University of Texas MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
Joe Arrington Cancer Research & Treatment Center
🇺🇸Lubbock, Texas, United States
The University of Texas Health Science Center at Tyler D/B/A UT Health East Texas HOPE Cancer Center
🇺🇸Tyler, Texas, United States
Texas Oncology-Tyler, Northeast Texas Cancer Institute
🇺🇸Tyler, Texas, United States
University of Virginia
🇺🇸Charlottesville, Virginia, United States
Virginia Cancer Specialists, PC
🇺🇸Fairfax, Virginia, United States
Virginia Oncology Associates
🇺🇸Norfolk, Virginia, United States
Virginia Commonwealth University Massey Cancer Center
🇺🇸Richmond, Virginia, United States
Oncology & Hematology Associates of Southwest Virginia, Inc.
🇺🇸Roanoke, Virginia, United States
Swedish Cancer Institute - Edmonds Campus
🇺🇸Edmonds, Washington, United States
Swedish Cancer Institute - Issaquah Campus
🇺🇸Issaquah, Washington, United States
Swedish Cancer Institute
🇺🇸Seattle, Washington, United States
West Virginia University
🇺🇸Morgantown, West Virginia, United States
University of Wisconsin Carbone Cancer Center
🇺🇸Madison, Wisconsin, United States
London Regional Cancer Centre
🇨🇦London, Ontario, Canada