A Phase 2 Peri-operative Trial of Fianlimab and Cemiplimab Compared With Anti-PD1 Alone in Patients With Resectable Stage III and IV Melanoma
Status: Recruiting
Location: See all (54) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
• 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.
• 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.
• 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).
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
Locations
United States
California
UC San Diego
RECRUITING
La Jolla
Usc Norris Comprehensive Cancer Center
RECRUITING
Los Angeles
Hoag Family Cancer Institute
RECRUITING
Newport Beach
California Pacific Medical Center Research Institute
RECRUITING
San Francisco
University of California San Francisco (UCSF)
RECRUITING
San Francisco
St John's Cancer Institute
RECRUITING
Santa Monica
Connecticut
Hartford Hospital
RECRUITING
Hartford
Georgia
Emory Healthcare, Emory Clinic
RECRUITING
Atlanta
Illinois
NorthShore University HealthSystem
RECRUITING
Evanston
Massachusetts
Dana Farber Cancer Institute Brookline Avenue
RECRUITING
Boston
Massachusetts General Hospital
RECRUITING
Boston
University of Massachusetts Chan Medical School
RECRUITING
Worcester
Missouri
Washington University School of Medicine
RECRUITING
St Louis
North Carolina
Duke Cancer Institute, University Hospital
RECRUITING
Durham
New Jersey
Rutgers Cancer Institute of New Jersey
RECRUITING
New Brunswick
New York
Northwell Health Cancer Institute
RECRUITING
Lake Success
Ohio
Cleveland Clinic Foundation
RECRUITING
Cleveland
Seidman Cancer Center
RECRUITING
Cleveland
Pennsylvania
Thomas Jefferson University Hospital
RECRUITING
Philadelphia
University of Pittsburgh
RECRUITING
Pittsburgh
Tennessee
University of Tennessee Medical Center
RECRUITING
Knoxville
Texas
University of Texas MD Anderson Cancer Center
RECRUITING
Houston
Virginia
University of Virginia
RECRUITING
Charlottesville
Other Locations
Australia
Eastern Health
RECRUITING
Box Hill
Hervey Bay Hospital
RECRUITING
Hervey Bay
Lismore Base Hospital
RECRUITING
Lismore
Peter MacCallum Cancer Centre
RECRUITING
Melbourne
One Clinical Research at Hollywood Private Hospital
RECRUITING
Nedlands
Westmead Hospital
RECRUITING
Westmead
Melanoma Institute of Australia
RECRUITING
Wollstonecraft
The Queen Elizabeth Hospital
RECRUITING
Woodville
Canada
Centre Hospitalier de l'Universite de Montreal (CHUM)
RECRUITING
Montreal
CHU de Quebec - Universite Laval
RECRUITING
Québec
Princess Margaret Cancer Centre
RECRUITING
Toronto
France
Chu De Bordeaux
RECRUITING
Bordeaux
Hopital Ambroise Pare
RECRUITING
Boulogne
Centre Francois Baclesse
RECRUITING
Caen
CHU Estaing
RECRUITING
Clermont-ferrand
CHU-Dijon
RECRUITING
Dijon
Regional University Hospital of Lille 2208
RECRUITING
Lille
Hopital Timone
RECRUITING
Marseille
Centre Hospitalier Universitaire De Nice Hopital De L Archet