RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Phase 2 Peri-operative Trial of Fianlimab and Cemiplimab Compared With Anti-PD1 Alone in Patients With Resectable Stage III and IV Melanoma

Quick Facts

Study Start:2024-09-18
Study Completion:2031-04-23
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06190951

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 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. 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. 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. 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. 5. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
  1. 1. Primary uveal melanoma
  2. 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. 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. 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.
  5. 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. 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.
  7. 7. Participants with a history of myocarditis.
  8. 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.

Contacts and Locations

Study Contact

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

Principal Investigator

Clinical Trial Management
STUDY_DIRECTOR
Regeneron Pharmaceuticals

Study Locations (Sites)

UC San Diego
La Jolla, California, 92093
United States
USC Norris Comprehensive Cancer Center
Los Angeles, California, 90033
United States
Hoag Family Cancer Institute
Newport Beach, California, 92663
United States
California Pacific Medical Center Research Institute
San Francisco, California, 94115
United States
University of California San Francisco (UCSF)
San Francisco, California, 94143
United States
St John's Cancer Institute
Santa Monica, California, 90404
United States
Hartford Hospital
Hartford, Connecticut, 06102
United States
Emory Healthcare, Emory Clinic
Atlanta, Georgia, 30322
United States
NorthShore University HealthSystem
Evanston, Illinois, 60201
United States
University of Massachusetts Chan Medical School
Worcester, Massachusetts, 01655
United States
Washington University School of Medicine
Saint Louis, Missouri, 63110
United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08901
United States
Northwell Health Cancer Institute
Lake Success, New York, 11040
United States
Duke Cancer Institute, University Hospital
Durham, North Carolina, 27710
United States
Seidman Cancer Center
Cleveland, Ohio, 44106
United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
United States
University of Tennessee Medical Center
Knoxville, Tennessee, 37920
United States
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
United States
University of Virginia
Charlottesville, Virginia, 22908
United States

Collaborators and Investigators

Sponsor: Regeneron Pharmaceuticals

  • Clinical Trial Management, STUDY_DIRECTOR, Regeneron Pharmaceuticals

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-09-18
Study Completion Date2031-04-23

Study Record Updates

Study Start Date2024-09-18
Study Completion Date2031-04-23

Terms related to this study

Keywords Provided by Researchers

  • Skin cancer
  • Fully resectable stage III melanoma
  • Fully resectable stage IV melanoma

Additional Relevant MeSH Terms

  • Melanoma