OncoMatch/Clinical Trials/NCT06769698
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
Is NCT06769698 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including FDC fianlimab+cemiplimab and Cemiplimab for head and neck squamous cell carcinoma (hnscc).
Treatment: FDC fianlimab+cemiplimab · Cemiplimab — 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
Check if I qualifyExtracted eligibility criteria
Cancer type
Head and Neck Squamous Cell Carcinoma
Biomarker criteria
Required: PD-L1 (CD274) expression CPS ≥1 (CPS ≥1)
PD-L1 expression Combined Positive Score (CPS) ≥1 documented with a previously PD-L1 obtained Immunohistochemistry (IHC) result prior to screening
Required: HPV status established
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
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: systemic anticancer therapy
Lab requirements
Blood counts
adequate organ and bone marrow function as described in the protocol
Kidney function
adequate organ and bone marrow function as described in the protocol
Liver function
adequate organ and bone marrow function as described in the protocol
Adequate organ and bone marrow function as described in the protocol
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Oncology Hematology West P.C. dba Nebraska Cancer Specialists · Omaha, Nebraska
- Joe Arrington Cancer Research & Treatment Center · Lubbock, Texas
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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