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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)

Phase 3
Recruiting
Conditions
Melanoma
Interventions
Drug: relatlimab+nivolumab
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
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
relatlimab+nivolumabrelatlimab+nivolumabRandomized 1:1
fianlimab+cemiplimabfianlimabRandomized 1:1
fianlimab+cemiplimabcemiplimabRandomized 1:1
Primary Outcome Measures
NameTimeMethod
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
NameTimeMethod
Duration of Response (DOR) by BICRUp to 72 months
DOR by investigator assessmentUp to 72 months
Disease control rate (DCR) by BICRUp to 72 months
Death from any causeUp to 72 months
Overall survival (OS)Up to 72 months
PFS based on investigator assessment according to RECIST version 1.1Up to 72 months
Incidence of immune-mediated adverse events (imAEs)Up to 72 months
Occurrence of interruption of study drug(s) due to AEsUp to 72 months
Occurrence of discontinuation of study drug(s) due to AEsUp to 72 months
Progression free survival (PFS) RECIST version 1.1 based on BICRUp to 72 months
Incidence of treatment-emergent adverse events (TEAEs)Up to 72 months
Incidence of laboratory abnormalitiesUp 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 cemiplimabUp to 72 months
Titer of ADAs to cemiplimabUp to 72 months
TEAEs leading to deathUp to 72 months
Incidence of NAbs to cemiplimabUp to 72 months
ORR based on investigator assessment according to RECIST version 1.1Up to 72 months
Concentration of cemiplimab in serumUp to 72 months
Incidence of anti-drug antibodies (ADAs) to fianlimabUp to 72 months
Incidence of neutralizing antibodies (NAbs) to fianlimabUp to 72 months
Concentration of fianlimab in serumUp to 72 months
Titer of ADAs to fianlimabUp to 72 months
DCR by investigator assessmentUp to 72 months
Incidence of serious adverse events (SAEs)Up to 72 months

Trial Locations

Locations (84)

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

Cancer and Blood Specialty Clinic

🇺🇸

Los Alamitos, California, United States

University of California Los Angeles

🇺🇸

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

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Ironwood Cancer & Research Centers
🇺🇸Chandler, Arizona, United States

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