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A Study to See if Giving Fianlimab and Cemiplimab Together is Better Than Cemiplimab Alone at Treating Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma


Active: Yes
Cancer Type: Head and Neck Cancer
Unknown Primary
NCT ID: NCT06769698
Trial Phases: Phase II Protocol IDs: R3767-ONC-2431 (primary)
NCI-2025-02677
2024-517620-19-00
Eligibility: 18 Years and older, Male and Female Study Type: Treatment
Study Sponsor: Regeneron Pharmaceuticals, Inc.
NCI Full Details: http://clinicaltrials.gov/show/NCT06769698

Summary

This study is researching an experimental drug called fianlimab (also called REGN3767),
combined with a medication called cemiplimab compared against cemiplimab combined with
placebo (a placebo looks like a treatment but does not contain any real medicine),
collectively called "study drugs" in this form.

The study is focused on participants with head and neck cancers who have not been
previously treated for head and neck cancer that has come back or spread to other parts
of the body, referred to as recurrent or metastatic (R/M) head and neck squamous cell
carcinoma (HNSCC).

The study is looking at several other research questions, including:

- What side effects may happen from taking the study drugs

- How much of each study drug is in the blood at different times

- Whether the body makes antibodies against the study drug(s) individually (which
could make the study drugs less effective or could lead to side effects)

- Compatible research to better understand the study drugs and HNSCC

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.