A Trial to Learn if Fianlimab and Cemiplimab Are Safe and Work Better Than Anti-PD1 Alone in Adult Participants With Resectable Stage 3 or 4 Melanoma

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 cemiplimab alone. These types of immunotherapy study drugs are collectively known as immune checkpoint inhibitors. Immunotherapies are treatments that use the immune system to recognize and kill cancer cells. The study is focused on participants with a type of skin cancer known as melanoma. The objective of this study is to see if the combination of fianlimab and cemiplimab is an effective treatment compared to cemiplimab in participants with high-risk, resectable melanoma. Participants will receive treatment before surgery, undergo resection, and then will have the option to continue treatment after resection. The study is looking at several other research questions, including: - What side effects may happen from receiving the study drug(s). - How much study drug(s) is in the blood at different times. - Whether the body makes antibodies against the study drug(s) (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.

Condition

  • Melanoma

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  1. All patients must be either stage III (IIIB, IIIC, IIID) or stage IV (M1a, M1b, M1c) per American Joint Committee on Cancer (AJCC) 8th edition (Amin 2017) and have histologically confirmed cutaneous melanoma that is deemed completely surgically resectable in order to be eligible as described in the protocol. 2. Patients with stage III melanoma must have clinically detectable disease that is confirmed as malignant on the pathology report. The pathology report must be reviewed, signed and dated by the investigator; this process will be confirmed during the interactive voice response system (IVRS) process as described in the protocol. 3. Patients must be candidates for full resection with curative intent and must be able to be surgically rendered free of disease with negative margins on resected specimens at surgery. The treatment plan including date of surgery must be documented by the investigator prior to randomization. 4. All patients must undergo full disease staging through a complete physical examination and imaging studies within 4 weeks prior to randomization. Imaging must include a computer tomography (CT) scan of the chest, abdomen, pelvis (if the primary tumor is on the head/neck then include a CT scan of head/neck), and all known sites of previously resected disease (if applicable) and brain magnetic resonance imaging (MRI) (or brain CT with contrast allowed if MRI is contraindicated). 5. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1

Exclusion Criteria

Medical conditions: 1. Primary uveal melanoma 2. Ongoing or recent (within 2 years) evidence of an autoimmune disease that required systemic treatment with immunosuppressive agents. The following are non-exclusionary: vitiligo, childhood asthma that has resolved, residual hypothyroidism that requires only hormone replacement, psoriasis not requiring systemic treatment. 3. Patients must not have received any prior systemic anti-cancer therapy for melanoma. Prior radiotherapy for melanoma is allowed if not given to a target lesion or, if given to a target lesion, there is pathological evidence of disease progression in the same lesion. 4. 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 as described in the protocol. Prior/concomitant therapy: 5. Use of immunosuppressive doses of corticosteroids (≥10mg of prednisone per day or equivalent) within 14 days of the first dose of study medication as described in the protocol. 6. Treatment with any anti-cancer therapy for malignancies other than melanoma, including immuno- therapy, chemotherapy, radiotherapy, or biological therapy in the 5 years prior to randomization as described in the protocol. Other comorbidities: 7. Participants with a history of myocarditis. 8. History or current evidence of significant (CTCAE grade ≥2) local or systemic infection (e. g., cellulitis, pneumonia, septicemia) requiring systemic antibiotic treatment within 2 weeks prior to the first dose of trial medication. Note: Other protocol-defined inclusion/ exclusion criteria apply

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Triple (Participant, Care Provider, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
Arm A
As described in the protocol
  • Drug: cemiplimab
    Administered per the protocol
    Other names:
    • REGN2810
    • Libtayo
  • Drug: Placebo
    Administered per the protocol
Experimental
Arm B
As described in the protocol
  • Drug: Fixed Dose Combination (FDC) cemiplimab+fianlimab
    Or coadministration, depending on availability.
    Other names:
    • REGN2810
    • Libtayo
    • REGN3767
Experimental
Arm C
As described in the protocol
  • Drug: Fixed Dose Combination (FDC) cemiplimab+fianlimab
    Or coadministration, depending on availability.
    Other names:
    • REGN2810
    • Libtayo
    • REGN3767

Recruiting Locations

UC San Diego
La Jolla 5363943, California 5332921 92093

Usc Norris Comprehensive Cancer Center
Los Angeles 5368361, California 5332921 90033

Hoag Family Cancer Institute
Newport Beach 5376890, California 5332921 92663

California Pacific Medical Center Research Institute
San Francisco 5391959, California 5332921 94115

University of California San Francisco (UCSF)
San Francisco 5391959, California 5332921 94143

St John's Cancer Institute
Santa Monica 5393212, California 5332921 90404

Hartford Hospital
Hartford 4835797, Connecticut 4831725 06102

Emory Healthcare, Emory Clinic
Atlanta 4180439, Georgia 4197000 30322

NorthShore University HealthSystem
Evanston 4891382, Illinois 4896861 60201

University of Massachusetts Chan Medical School
Worcester 4956184, Massachusetts 6254926 01655

Washington University School of Medicine
St Louis 4407066, Missouri 4398678 63110

Rutgers Cancer Institute of New Jersey
New Brunswick 5101717, New Jersey 5101760 08901

Northwell Health Cancer Institute
Lake Success 5123853, New York 5128638 11040

Duke Cancer Institute, University Hospital
Durham 4464368, North Carolina 4482348 27710

Seidman Cancer Center
Cleveland 5150529, Ohio 5165418 44106

Cleveland Clinic Foundation
Cleveland 5150529, Ohio 5165418 44195

Thomas Jefferson University Hospital
Philadelphia 4560349, Pennsylvania 6254927 19107

University of Pittsburgh
Pittsburgh 5206379, Pennsylvania 6254927 15213

University of Tennessee Medical Center
Knoxville 4634946, Tennessee 4662168 37920

University of Texas MD Anderson Cancer Center
Houston 4699066, Texas 4736286 77030

University of Virginia
Charlottesville 4752031, Virginia 6254928 22908

More Details

NCT ID
NCT06190951
Status
Recruiting
Sponsor
Regeneron Pharmaceuticals

Study Contact

Clinical Trials Administrator
844-734-6643
clinicaltrials@regeneron.com