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)

Conditions

• Melanoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• fianlimab — DRUG
  Intravenous (IV) administration every 3 weeks (Q3W) in combination with cemiplimab
• cemiplimab — DRUG
  IV administration Q3W in combination with fianlimab
• relatlimab+nivolumab — DRUG
  IV administration every 4 weeks (Q4W)

Study Details

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)

Key Dates

Start date

Sep 9, 2024

Status verified

May 2026

Primary completion

Mar 22, 2027

Completion

Jul 10, 2033

Study Design

Enrollment

560 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: fianlimab+cemiplimab
  Randomized 1:1
• Active Comparator: relatlimab+nivolumab
  Randomized 1:1

Primary Outcome Measure

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 ]

Central Contacts

• Clinical Trials Administrator
  844-734-6643
  [email protected]

Locations (104)

Find similar trials in Chandler, AZ

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