A Trial to See if the Combination of Fianlimab With Cemiplimab Works Better Than Pembrolizumab for Preventing or Delaying Melanoma From Coming Back After it Has Been Removed With Surgery

Conditions

• Melanoma

Eligibility Criteria

Sex

ALL

Age

12 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Fianlimab — DRUG
  Fianlimab will be administered by intravenous (IV) infusion every (Q) 3 weeks
• Cemiplimab — DRUG
  Cemiplimab will be administered by IV infusion Q 3 weeks
• Pembrolizumab — DRUG
  Pembrolizumab will be administered by IV infusion Q 3 weeks
• Placebo — DRUG
  Matching placebo co-infused with pembrolizumab IV, will be administered by IV infusion Q 3 weeks

Study Details

This study is researching an experimental drug called REGN3767, also known as fianlimab (R3767), when combined with another medication called cemiplimab (each individually called a "study drug" or called "study drugs" when combined) compared with an approved medication called pembrolizumab. The objective of this study is to see if the combination of fianlimab and cemiplimab is an effective treatment compared to pembrolizumab in patients that have had melanoma removal surgery but are still at high risk for the recurrence of the disease. Pembrolizumab is an approved treatment in some countries in this clinical setting. The study is looking at several other research questions, including: * What side effects may happen from receiving the study drugs. * How much study drug is in the blood at different times. * Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects). Antibodies are proteins that are naturally found in the blood stream that fight infections. * How administering the study drugs might improve quality of life.

Key Dates

Start date

Jan 16, 2023

Status verified

May 2025

Primary completion

May 16, 2028

Completion

Feb 15, 2030

Study Design

Enrollment

1,564 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Fianlimab HD + Cemiplimab
  Patients will be administered one combination dose of fianlimab high dose (HD) and cemiplimab
• Experimental: Fianlimab LD + Cemiplimab
  Patients will be administered one combination dose of fianlimab low dose (LD) and cemiplimab
• Active Comparator: Pembrolizumab
  Patients will be administered one dose of pembrolizumab co-infused with saline/dextrose placebo

Primary Outcome Measure

Relapse free survival (RSF) [ Time Frame: Up to 5 Years ]

Locations (28)

Find similar trials in La Jolla, CA

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