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)
Recruiting · NCT06246916 · Interventional (participants receive a specific treatment) · Lead sponsor: Regeneron Pharmaceuticals
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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)
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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
Exclusion criteria
- 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.
- ther 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.
Where it is running
60 locations listed across 37 US states.
- Ironwood Cancer & Research Centers - Chandler, Arizona, United States
- Banner MD Anderson Cancer Center - Gilbert, Arizona, United States
- Arizona Oncology Associates - Tucson, Arizona, United States
- University of Arkansas for Medical Sciences - Little Rock, Arkansas, United States
- Providence Medical Foundation - Fullerton, California, United States
- Cancer and Blood Specialty Clinic - Los Alamitos, California, United States
- University of California Los Angeles - Los Angeles, California, United States
- St. Joseph Hospital Orange - Orange, California, United States
- University of California Irvine, UCI Medical Center - Orange, California, United States
- Eisenhower Medical Center - Rancho Mirage, California, United States
- Emad Ibrahim, MD, Inc. - Redlands, California, United States
- Sutter Health - Sacramento, California, United States
- University of California San Francisco (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
- Mayo Clinic Florida - Jacksonville, Florida, United States
- Cancer Specialist of North Florida - Jacksonville, Florida, United States
- Boca Raton Clinical Research (BRCR) Global - Tamarac, Florida, United States
- H. Lee Moffitt Cancer Center - Tampa, Florida, United States
- University Cancer & Blood Center - Athens, Georgia, 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
- University of Michigan - Ann Arbor, Michigan, United States
- Karmanos Cancer Institute - Detroit, Michigan, United States
- Henry Ford Cancer Institute/Henry Ford Health System - 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 - St Louis, Missouri, United States
- Washington University School of Medicine - St Louis, Missouri, United States
- Mercy South - St 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
- Dartmouth Hitchcock Medical Center - Lebanon, New Hampshire, United States
- John Theurer Cancer Center - Hackensack, New Jersey, United States
- Rutgers Cancer Institute of New Jersey - New Brunswick, New Jersey, United States
- The Valley Hospital Inc. - Paramus, 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
- Novant Health Cancer Institute - Charlotte, North Carolina, United States
- Novant Health Weisiger Cancer Institute - Charlotte - Charlotte, North Carolina, United States
- Duke Health System - Durham, North Carolina, United States
- Novant Health Zimmer Cancer Institute - Wilmington - Wilmington, North Carolina, United States
- Oncology Hematology Care Clinical Trials - Cincinnati, Ohio, United States
- Seidman Cancer Center - Cleveland, Ohio, United States
Showing 60 of 111 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →