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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	12 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Key

Inclusion Criteria:

1. All patients must be either stage IIB, IIC, III, or stage IV per American Joint Committee on Cancer (AJCC) 8th edition and have histologically confirmed melanoma that is completely surgically resected in order to be eligible as defined by the protocol. 2. Complete surgical resection must be performed within 12 weeks prior to randomization, and enrollment may occur only after satisfactory wound healing from the surgery. 3. All patients must have disease-free status documented by a complete physical examination and imaging studies within 4 weeks prior to randomization, as described in the protocol. Key

Exclusion Criteria:

1. Uveal melanoma. 2. Any evidence of residual disease after surgery by imaging, pathology, or cytology. 3. Ongoing or recent (within 2 years) evidence of clinically significant autoimmune disease that required treatment. 4. Uncontrolled infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C (HCV) infection; or diagnosis of immunodeficiency that is related to, or results in chronic infection, as described in the protocol. 5. Another malignancy that is currently progressing or that required active treatment in the past 5 years, as described in the protocol. 6. Participants with a history of myocarditis. 7. Adolescent patients (≥12 to <18 years old) with body weight <40 kg. Note: Other Protocol Defined Inclusion/ Exclusion Criteria Apply

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05608291
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 3
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Regeneron Pharmaceuticals
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Clinical Trial Management
Principal Investigator Affiliation	Regeneron Pharmaceuticals
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	Argentina, Australia, Belgium, Brazil, Canada, Chile, Czechia, France, Georgia, Germany, Greece, Ireland, Israel, Italy, Mexico, Poland, Romania, South Africa, Spain, Turkey, United Kingdom, United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Melanoma
Study Website:	View Trial Website

Arms & Interventions

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

Interventions

Drug: - Fianlimab

Fianlimab will be administered by intravenous (IV) infusion every (Q) 3 weeks

Drug: - Cemiplimab

Cemiplimab will be administered by IV infusion Q 3 weeks

Drug: - Pembrolizumab

Pembrolizumab will be administered by IV infusion Q 3 weeks

Drug: - Placebo

Matching placebo co-infused with pembrolizumab IV, will be administered by IV infusion Q 3 weeks

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

University of California San Diego, La Jolla, California

Status

Recruiting

Address

University of California San Diego

La Jolla, California, 92093

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