RECRUITING

A Study With Combinations of Anti-LAG-3 and Anti-PD-1 Antibodies in Adult Participants With Advanced or Metastatic Melanoma

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Conditions

MelanomaUnresectable MelanomaMetastatic MelanomaAdvanced MelanomaStage IIIStage IV

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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)

Official Title

A Phase 3 Study of Fixed Dose Combinations of Fianlimab and Cemiplimab Versus Relatlimab and Nivolumab in Participants With Unresectable or Metastatic Melanoma

Quick Facts

Study Start:2024-09-09
Study Completion:2033-06-26
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06246916

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Participants with histologically confirmed unresectable stage III and stage IV (metastatic) melanoma per American Joint Committee on Cancer (AJCC), eighth revised edition.
  2. 2. Participants must not have received prior systemic therapy for unresectable or metastatic melanoma as described in the protocol.
  3. 3. Measurable disease per RECIST version 1.1.
  4. 4. Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤1.
  5. 5. Adequate bone marrow, hepatic, and kidney function.
  1. 1. Uveal, acral or mucosal melanoma.
  2. 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. 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.
  4. 4. Unknown v-Raf murine sarcoma viral oncogene homolog B1 (BRAF) V600 mutation status as described in the protocol.
  5. 5. Prior immune checkpoint inhibitor therapy other than anti-PD1/PD-L1 as described in the protocol
  6. 6. Systemic immune suppression as described in the protocol.
  7. 7. Participants with a history of myocarditis.
  8. 8. Troponin T (TnT) or troponin I (TnI) \>2x institutional upper limit of normal (ULN).
  9. 9. Active or untreated brain metastases or spinal cord compression as described in the protocol.

Contacts and Locations

Study Contact

Clinical Trials Administrator
CONTACT
844-734-6643
clinicaltrials@regeneron.com

Principal Investigator

Clinical Trial Management
STUDY_DIRECTOR
Regeneron Pharmaceuticals

Study Locations (Sites)

Eisenhower Medical Center
Rancho Mirage, California, 92270
United States
UCHealth
Fort Collins, Colorado, 80528
United States
Clermont Oncology Center
Clermont, Florida, 34711
United States
Boca Raton Clinical Research (BRCR) Global
Plantation, Florida, 33322
United States
John B. Amos Cancer Center
Columbus, Georgia, 31904
United States
Illinois CancerCare
Peoria, Illinois, 61615
United States
Karmanos Cancer Institute
Detroit, Michigan, 48201
United States
Allina Health Cancer Institute
Minneapolis, Minnesota, 55407
United States
Oncology Hematology West P.C. dba Nebraska Cancer Specialists
Omaha, Nebraska, 68130
United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, 89148
United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903
United States
New York Oncology Hematology
Albany, New York, 12206
United States
Kaiser Foundation Hospitals
Portland, Oregon, 97227
United States
University of Tennessee Medical Center
Knoxville, Tennessee, 37920
United States
The University of Texas Health Science Center at Tyler D/B/A UT Health East Texas HOPE Cancer Center
Tyler, Texas, 75701
United States
West Virginia University (Please Use)
Morgantown, West Virginia, 26506
United States
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, 53792
United States

Collaborators and Investigators

Sponsor: Regeneron Pharmaceuticals

  • Clinical Trial Management, STUDY_DIRECTOR, Regeneron Pharmaceuticals

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-09-09
Study Completion Date2033-06-26

Study Record Updates

Study Start Date2024-09-09
Study Completion Date2033-06-26

Terms related to this study

Keywords Provided by Researchers

  • Unresectable Melanoma
  • Metastatic Melanoma
  • Advanced Melanoma
  • Stage III
  • Stage IV

Additional Relevant MeSH Terms

  • Melanoma