What is the Purpose of this Study?
The purpose of this study is to evaluate an experimental drug called fianlimab (REGN3767) alone or in combination with another drug called cemiplimab in people who have recurrent or metastatic head and neck cancer squamous cell carcinoma (HNSCC). The study focuses on patients who have not been previously treated for head and neck cancer that has come back or spread to other parts of the body. Fianlimab and cemiplimab are monoclonal antibodies. A monoclonal antibody is a type of antibody that is manufactured as a medication to target a specific protein in the body that may be involved in cancer. Fianlimab blocks the action of a protein called LAG-3, and cemiplimab blocks PD-1, a cell receptor on white blood cells (immune cells). Blocking LAG-3 and/or PD-1 may help immune cells destroy the cancer cells. Participants will be randomly assigned to receive either fianlimab in combination with cemiplimab, or cemiplimab with a placebo (inactive substance). The use of fianlimab in combination with cemiplimab is considered experimental.
Eligibility
- 1. Have histologically confirmed (by local pathology) R/M HNSCC that is considered incurable by local therapies
- 2. Primary tumor location of oral cavity, oropharynx, larynx, or hypopharynx (patients with cervical neck node SCC with occult primary as described in the protocol
- 3. PD-L1 expression Combined Positive Score (CPS) ≥1 documented with a previously PD-L1 obtained Immunohistochemistry (IHC) result prior to screening, as described in protocol
- 4. Oropharynx cancer participants only: HPV status, based on a previously documented result prior to screening, must have been established in a surgical biopsy specimen or a core biopsy specimen as described in the protocol
Where can I participate?
- CS Cancer at Beverly Hills : Maria Tarallo
- CS Cancer at Cedars-Sinai Medical Center : Maria Tarallo
- CS Cancer at The Angeles Clinic and Research Institute : Maria Tarallo
More about this Clinical Trial
What is the full name of this clinical trial?
R3767-ONC-2431: A Phase II, Randomized Study of Fianlimab Plus Cemiplimab Versus Cemiplimab Plus Placebo in First-Line Treatment of Participants with Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma That is Positive for PD-L1 Expression