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
NCT ID: NCT06190951
Last Updated: 2025-11-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
150 participants
INTERVENTIONAL
2024-09-18
2031-04-23
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Arm A
As described in the protocol
cemiplimab
Administered per the protocol
Placebo
Administered per the protocol
Arm B
As described in the protocol
Fixed Dose Combination (FDC) cemiplimab+fianlimab
Or coadministration, depending on availability.
Arm C
As described in the protocol
Fixed Dose Combination (FDC) cemiplimab+fianlimab
Or coadministration, depending on availability.
Interventions
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cemiplimab
Administered per the protocol
Fixed Dose Combination (FDC) cemiplimab+fianlimab
Or coadministration, depending on availability.
Placebo
Administered per the protocol
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Regeneron Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trial Management
Role: STUDY_DIRECTOR
Regeneron Pharmaceuticals
Locations
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UC San Diego
La Jolla, California, United States
USC Norris Comprehensive Cancer Center
Los Angeles, California, United States
Hoag Family Cancer Institute
Newport Beach, California, United States
California Pacific Medical Center Research Institute
San Francisco, California, United States
University of California San Francisco (UCSF)
San Francisco, California, United States
St John's Cancer Institute
Santa Monica, California, United States
Hartford Hospital
Hartford, Connecticut, United States
Emory Healthcare, Emory Clinic
Atlanta, Georgia, United States
NorthShore University HealthSystem
Evanston, Illinois, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Dana Farber Cancer Institute Brookline Avenue
Boston, Massachusetts, United States
University of Massachusetts Chan Medical School
Worcester, Massachusetts, United States
Washington University School of Medicine
St Louis, Missouri, United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
Northwell Health Cancer Institute
Lake Success, New York, United States
Duke Cancer Institute, University Hospital
Durham, North Carolina, United States
Seidman Cancer Center
Cleveland, Ohio, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
University of Tennessee Medical Center
Knoxville, Tennessee, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, United States
University of Virginia
Charlottesville, Virginia, United States
Lismore Base Hospital
Lismore, New South Wales, Australia
Westmead Hospital
Westmead, New South Wales, Australia
Melanoma Institute of Australia
Wollstonecraft, New South Wales, Australia
Hervey Bay Hospital
Hervey Bay, Queensland, Australia
The Queen Elizabeth Hospital
Woodville, South Australia, Australia
Eastern Health
Box Hill, Victoria, Australia
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia
One Clinical Research at Hollywood Private Hospital
Nedlands, Western Australia, Australia
Princess Margaret Cancer Centre
Toronto, Ontario, Canada
Centre Hospitalier de l'Universite de Montreal (CHUM)
Montreal, Quebec, Canada
CHU de Quebec - Universite Laval
Québec, , Canada
CHU-Dijon
Dijon, Burgundy, France
CHRU de Tours
Tours, Centre-Val de Loire, France
Chu De Bordeaux
Bordeaux, Gironde, France
Centre Francois Baclesse
Caen, Normandy, France
Hopital Ambroise Pare
Boulogne, , France
CHU Estaing
Clermont-Ferrand, , France
Regional University Hospital of Lille 2208
Lille, , France
Hopital Timone
Marseille, , France
Centre Hospitalier Universitaire De Nice Hopital De L Archet
Nice, , France
Saint Louis Hospital
Paris, Île-de-France Region, France
Gustave Roussy
Villejuif, Île-de-France Region, France
University Hospital Giessen
Giessen, Hesse, Germany
Universitatsklinikum Leipzig, AoR
Leipzig, Saxony, Germany
Charite University Medicine
Berlin, , Germany
Azienda Ospedaliero-Universitaria Ferrara
Ferrara, , Italy
U.O. Oncologia Medica 2 Universitaria, Azienda Ospedaliero Universitaria Pisana
Pisa, , Italy
Instituto Oncologico Dr Rosell
Barcelona, Catalonia, Spain
Vall d'Hebron Hospital
Barcelona, , Spain
Hospital Clinic de Barcelona
Barcelona, , Spain
Hospital Clinico Universitario de Salamanca
Salamanca, , Spain
Countries
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Central Contacts
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Other Identifiers
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2022-502825-17-00
Identifier Type: CTIS
Identifier Source: secondary_id
R3767-ONC-2208
Identifier Type: -
Identifier Source: org_study_id
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