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Clinical Trials in Canada / NCT06190951
Active, not recruiting Phase 2

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

NCT06190951 · tracked via the Priya Life Science Canada tracker
Phase
Phase 2
Started
2024-09-18
Last updated
2026-02-10

Condition(s) studied

Melanoma

Investigational drug(s) / intervention(s)

cemiplimab →Fixed Dose Combination (FDC) cemiplimab+fianlimab →Placebo

cemiplimab: Administered per the protocol

Fixed Dose Combination (FDC) cemiplimab+fianlimab: Or coadministration, depending on availability.

Placebo: Administered per the protocol

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Key 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 Key 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

Primary outcome measure(s)

Trial sites (104)

FacilityCityRegionStatus
UC San Diego La Jolla California
USC Norris Comprehensive Cancer Center Los Angeles California
Hoag Family Cancer Institute Newport Beach California
California Pacific Medical Center Research Institute San Francisco California
University of California San Francisco (UCSF) San Francisco California
St John's Cancer Institute Santa Monica California
University of Colorado Cancer Center Aurora Colorado
Hartford Hospital Hartford Connecticut
Yale University Cancer Center New Haven Connecticut
Emory Healthcare, Emory Clinic Atlanta Georgia
NorthShore University HealthSystem Evanston Illinois
Massachusetts General Hospital Boston Massachusetts
Dana Farber Cancer Institute Brookline Avenue Boston Massachusetts
University of Massachusetts Chan Medical School Worcester Massachusetts
Washington University School of Medicine St Louis Missouri
Rutgers Cancer Institute of New Jersey New Brunswick New Jersey
Northwell Health Cancer Institute Lake Success New York
Duke Cancer Institute, University Hospital Durham North Carolina
Seidman Cancer Center Cleveland Ohio
Cleveland Clinic Foundation Cleveland Ohio
The Ohio State University James Comprehensive Cancer Center Columbus Ohio
Thomas Jefferson University Hospital Philadelphia Pennsylvania
University of Pittsburgh Pittsburgh Pennsylvania
University of Tennessee Medical Center Knoxville Tennessee
UT Southwestern/Simmons Comprehensive Cancer Center Dallas Texas
University of Texas MD Anderson Cancer Center Houston Texas
University of Virginia Charlottesville Virginia
Inova Schar Cancer Institute Fairfax Virginia
Lismore Base Hospital Lismore New South Wales
Westmead Hospital Westmead New South Wales
Melanoma Institute of Australia Wollstonecraft New South Wales
The Townsville Hospital Douglas Queensland
Hervey Bay Hospital Hervey Bay Queensland
Flinders Medical Centre Bedford Park South Australia
The Queen Elizabeth Hospital Woodville South Australia
Icon Cancer Centre Hobart Hobart Tasmania
Eastern Health Box Hill Victoria
Peter MacCallum Cancer Centre Melbourne Victoria
One Clinical Research at Hollywood Private Hospital Nedlands Western Australia
University Hospital Saint Poelten Sankt Pölten Lower Austria

+ 64 more sites — see the full list on the official registry below.

On this site

📄 Libtayo (cemiplimab) drug profile →

More Regeneron Pharmaceuticals trials in Canada

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06190951 on ClinicalTrials.gov ↗ ← All trials in Canada