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NCT Number: NCT06246916

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)

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)

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Cross Cancer Institute, Edmonton, Alberta, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key 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.

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.

Treatment and study plan

Fianlimab

Drug

Intravenous (IV) administration every 3 weeks (Q3W) in combination with cemiplimab

Other names: REGN3767

cemiplimab

Drug

IV administration Q3W in combination with fianlimab

Other names: REGN2810, LIBTAYO®

relatlimab+nivolumab

Drug

IV administration every 4 weeks (Q4W)

Other names: Opdualag™

Primary outcomes

  1. Objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 based on blinded independent central review (BICR)

    Time frame: Up to 72 months

Secondary outcomes

  1. Progression free survival (PFS) RECIST version 1.1 based on BICR

    Time frame: Up to 72 months

  2. Death from any cause

    Time frame: Up to 72 months

  3. Overall survival (OS)

    Time frame: Up to 72 months

  4. Duration of Response (DOR) by BICR

    Time frame: Up to 72 months

  5. DOR by investigator assessment

    Time frame: Up to 72 months

  6. Disease control rate (DCR) by BICR

    Time frame: Up to 72 months

  7. DCR by investigator assessment

    Time frame: Up to 72 months

  8. ORR based on investigator assessment according to RECIST version 1.1

    Time frame: Up to 72 months

  9. PFS based on investigator assessment according to RECIST version 1.1

    Time frame: Up to 72 months

  10. Incidence of treatment-emergent adverse events (TEAEs)

    Time frame: Up to 72 months

  11. Incidence of serious adverse events (SAEs)

    Time frame: Up to 72 months

  12. Incidence of immune-mediated adverse events (imAEs)

    Time frame: Up to 72 months

  13. Occurrence of interruption of study drug(s) due to AEs

    Time frame: Up to 72 months

  14. Occurrence of discontinuation of study drug(s) due to AEs

    Time frame: Up to 72 months

  15. TEAEs leading to death

    Time frame: Up to 72 months

  16. Incidence of laboratory abnormalities

    Time frame: 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

  17. Concentration of fianlimab in serum

    Time frame: Up to 72 months

  18. Concentration of cemiplimab in serum

    Time frame: Up to 72 months

  19. Incidence of anti-drug antibodies (ADAs) to fianlimab

    Time frame: Up to 72 months

  20. Titer of ADAs to fianlimab

    Time frame: Up to 72 months

  21. Incidence of ADAs to cemiplimab

    Time frame: Up to 72 months

  22. Titer of ADAs to cemiplimab

    Time frame: Up to 72 months

  23. Incidence of neutralizing antibodies (NAbs) to fianlimab

    Time frame: Up to 72 months

  24. Incidence of NAbs to cemiplimab

    Time frame: Up to 72 months

Study contacts

Contact information is provided by the study sponsor or research team.

Clinical Trials Administrator

CONTACT

[email protected]

844-734-6643

Sponsors and collaborators

Lead sponsor

Regeneron Pharmaceuticals

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2027
Study completion
2033
First posted
Feb 7, 2024
Registry last updated
Jul 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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