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

Part of paid clinical trials in Orlando, Florida.

Sponsor
Regeneron Pharmaceuticals
Study ID
NCT06769698
Phase
PHASE2
Status
Recruiting
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Conditions

  • Head and Neck Squamous Cell Carcinoma (HNSCC)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • FDC fianlimab+cemiplimab — DRUG
    Fixed-Dose Combination (FDC) Administered per the protocol
  • Cemiplimab — DRUG
    Administered per the protocol
  • Placebo — DRUG
    Administered per the protocol

Study Details

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

Key Dates

Start date
Apr 14, 2026
Status verified
May 2026
Primary completion
Jun 4, 2028
Completion
Dec 28, 2030

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1
    Approximately 60 participants with HPV (human papillomavirus) positive HNSCC. Randomized 1:1 to Fianlimab + Cemiplmab Fixed Dose Combination (FDC) versus Cemiplimab + Placebo.
  • Experimental: Cohort 2
    Approximately 60 participants with HPV negative HNSCC. Randomization is the same as in Cohort 1.

Primary Outcome Measure

Overall Response Rate (ORR) [ Time Frame: Up to 90 days after last study treatment, approximately 58 months ]

Central Contacts

Locations (9)

FacilityCityStateZIPSite coordinators
Orlando HealthOrlandoFlorida32806-
Emory University School of MedicineAtlantaGeorgia30308-
St. Elizabeth HealthcareEdgewoodKentucky41017-
Norton Cancer InstituteLouisvilleKentucky40202-
Oncology Hematology West P.C. dba Nebraska Cancer SpecialistsOmahaNebraska68130-
Ohio State UniversityColumbusOhio43210-
Vanderbilt-Ingram Cancer CenterNashvilleTennessee37232-
Joe Arrington Cancer Research & Treatment CenterLubbockTexas79410-
Inova Schar Cancer InstituteFairfaxVirginia22031-

Find similar trials in Orlando, FL

By research site
Orlando Health· Orlando, FLEmory University School of Medicine· Atlanta, GASt. Elizabeth Healthcare· Edgewood, KYNorton Cancer Institute· Louisville, KYOncology Hematology West P.C. dba Nebraska Cancer Specialists· Omaha, NEOhio State University· Columbus, OH

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