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

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)

Conditions

Melanoma

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Study Overview

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Study Details

Study overview

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)

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

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

Condition
Melanoma
Intervention / Treatment

-

Contacts and Locations

Rancho Mirage

Eisenhower Medical Center, Rancho Mirage, California, United States, 92270

Fort Collins

UCHealth, Fort Collins, Colorado, United States, 80528

Clermont

Clermont Oncology Center, Clermont, Florida, United States, 34711

Plantation

Boca Raton Clinical Research (BRCR) Global, Plantation, Florida, United States, 33322

Columbus

John B. Amos Cancer Center, Columbus, Georgia, United States, 31904

Peoria

Illinois CancerCare, Peoria, Illinois, United States, 61615

Detroit

Karmanos Cancer Institute, Detroit, Michigan, United States, 48201

Minneapolis

Allina Health Cancer Institute, Minneapolis, Minnesota, United States, 55407

Omaha

Oncology Hematology West P.C. dba Nebraska Cancer Specialists, Omaha, Nebraska, United States, 68130

Las Vegas

Comprehensive Cancer Centers of Nevada, Las Vegas, Nevada, United States, 89148

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • 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.
  • 4. Unknown v-Raf murine sarcoma viral oncogene homolog B1 (BRAF) V600 mutation status as described in the protocol.
  • 5. Prior immune checkpoint inhibitor therapy other than anti-PD1/PD-L1 as described in the protocol
  • 6. Systemic immune suppression as described in the protocol.
  • 7. Participants with a history of myocarditis.
  • 8. Troponin T (TnT) or troponin I (TnI) \>2x institutional upper limit of normal (ULN).
  • 9. Active or untreated brain metastases or spinal cord compression as described in the protocol.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Regeneron Pharmaceuticals,

Clinical Trial Management, STUDY_DIRECTOR, Regeneron Pharmaceuticals

Study Record Dates

2033-06-26