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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


Active: Yes
Cancer Type: Melanoma NCT ID: NCT06190951
Trial Phases: Phase II
Phase III
Protocol IDs: R3767-ONC-2208 (primary)
NCI-2024-00872
2022-502825-17-00
Eligibility: 18 Years and older, Male and Female Study Type: Treatment
Study Sponsor: Regeneron Pharmaceuticals, Inc.
NCI Full Details: http://clinicaltrials.gov/show/NCT06190951

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 an approved
medication called pembrolizumab. These types of study drugs are collectively known as
immune checkpoint inhibitors. 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 pembrolizumab as peri-operative therapy in
participants with high-risk melanoma.

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.

Treatment Sites in Georgia

Winship Cancer Institute of Emory University
1365 Clifton Road NE
Building C
Atlanta, GA 30322
winshipcancer.emory.edu

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.