Melanoma Clinical Trial

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

Summary

The primary objective of the study is To demonstrate superiority of fianlimab + cemiplimab compared to pembrolizumab, as measured by relapse free survival (RFS)

The secondary objectives of the study are:

To demonstrate superiority of fianlimab + cemiplimab compared to pembrolizumab, as measured by overall survival (OS)
To demonstrate superiority of fianlimab + cemiplimab compared to pembrolizumab, as measured by melanoma specific survival (MSS)
To evaluate whether post-operative adjuvant therapy improves distant metastasis-free survival (DMFS), in stage IIC or III patients receiving fianlimab + cemiplimab compared to pembrolizumab
To assess impact of fianlimab + cemiplimab on quality of life as compared to pembrolizumab in adults
To assess safety and tolerability of fianlimab + cemiplimab compared to pembrolizumab
To characterize pharmacokinetics (PK) of fianlimab + cemiplimab using sparse PK sampling in patients 12 years of age and older
To assess immunogenicity of fianlimab and against cemiplimab

View Eligibility Criteria

Eligibility Criteria

Key Inclusion Criteria:

All patients must be either stage 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
Complete surgical resection must be performed within 12 weeks prior to randomization, and enrollment may occur only after satisfactory wound healing from the surgery
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:

Uveal melanoma
Any evidence of residual disease after surgery by imaging, pathology, or cytology.
Ongoing or recent (within 2 years) evidence of clinically significant autoimmune disease that required systemic treatment with immunosuppressive agents
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
Another malignancy that is currently progressing or that required active treatment in the past 5 years, as described in the protocol
Adolescent patients (≥12 to <18 years old) with body weight <40 kg

Note: Other Protocol Defined Inclusion/ Exclusion Criteria Apply

Study is for people with:

Melanoma

Phase:

Phase 3

Estimated Enrollment:

1530

Study ID:

NCT05608291

Recruitment Status:

Recruiting

Sponsor:

Regeneron Pharmaceuticals

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There are 30 Locations for this study

See Locations Near You

University of California San Diego
La Jolla California, 92093, United States
University of California, San Francisco
San Francisco California, 94158, United States
John Wayne Cancer Institute - Saint John's Health Center
Santa Monica California, 90404, United States
The Melanoma And Skin Cancer Institute
Englewood Colorado, 80113, United States
Miami Cancer Institute
Miami Florida, 33176, United States
Orlando Health Cancer Institute
Orlando Florida, 32806, United States
Massachusetts General Cancer Center
Boston Massachusetts, 02114, United States
Rutgers Cancer Institute of New Jersey
New Brunswick New Jersey, 08901, United States
NYU Langone Health
New York New York, 10016, United States
Columbia University Medical Center
New York New York, 10032, United States
Lineberger Comprehensive Cancer Center
Chapel Hill North Carolina, 27599, United States
Duke University Medical Center
Durham North Carolina, 27710, United States
Cleveland Clinic Foundation
Cleveland Ohio, 44195, United States
St. Luke's Hematology
Easton Pennsylvania, 18045, United States
Thomas Jefferson University Hospital
Philadelphia Pennsylvania, 19107, United States
University of Tennessee Medical Center
Knoxville Tennessee, 37920, United States
Tennessee Oncology
Nashville Tennessee, 37203, United States
University of Virginia Health System
Charlottesville Virginia, 22908, United States
Virginia Cancer Specialist Research Institute
Fairfax Virginia, 22031, United States
Dr. Everett Chalmers Hospital
Fredericton New Brunswick, E3B5N, Canada
Royal Victoria Regional Health Centre
Barrie Ontario, L4M 6, Canada
LTD Cancer Center of Adjara Autonomic Republic
Batumi Adjara, 6000, Georgia
Israeli Georgian medical research clinic Helsicore
T'bilisi , 0112, Georgia
LTD Research Institute of Clinical Medicine (LLC Todua Clinic)
T'bilisi , 0112, Georgia
LTD New Hospitals
T'bilisi , 0114, Georgia
High Technology Medical Center, University Clinic Tbilisi
T'bilisi , 0144, Georgia
Tbilisi Institute of Medicine (TIM)
T'bilisi , 0168, Georgia
Hospital Universitario Quiron Dexeus Barcelona
Barcelona , 08028, Spain
Hospital Universitario HM Sanchinarro
Madrid , 28050, Spain
Kocaeli University Hospital
Umuttepe Kocaeli, 41380, Turkey
Ankara Memorial Hospital
Ankara , 06520, Turkey

How clear is this clinincal trial information?

Study is for people with:

Melanoma

Phase:

Phase 3

Estimated Enrollment:

1530

Study ID:

NCT05608291

Recruitment Status:

Recruiting

Sponsor:


Regeneron Pharmaceuticals

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.