cemiplimab: Administered per the protocol
Fixed Dose Combination (FDC) cemiplimab+fianlimab: Or coadministration, depending on availability.
Placebo: Administered per the protocol
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.
| Facility | City | Region | Status |
|---|---|---|---|
| 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.
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