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RecruitingLast updated: 15 May 2026

Testing whether combining fianlimab with cemiplimab works better and is as safe as cemiplimab alone as a first treatment for people with recurrent or metastatic head and neck cancerPhase II Randomized Study of Fianlimab Plus Cemiplimab Versus Cemiplimab Plus Placebo in First-Line Treatment of Participants With Recurrent or Metastatic (R/M) Head and Neck Squamous Cell Carcinoma (HNSCC) That Is Positive for PD-L1 Expression

Trial purpose

Medical clipboardCancer treatment

Tumor type

Multi-Cancer Multi-Cancer

Age

People18+

Clinical summary

Summary

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

The study is focused on people 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 (called recurrent or metastatic, or R/M) head and neck squaumous cell carcinoma (HNSCC).

You may be eligible for this study if you have recurrent or metastatic HNSCC. Your primary tumour location should be in the oral cavity, oropharynx, larynx, or hypopharynx. You should have a PD-L1 score of at or above 1.

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

Study participants will be randomly allocated (by chance) to receive one of two treatments:

  • fianlimab + cemiplimab
  • cemiplimab + placebo

Participants will be grouped in two cohorts based on whether they are positive or negative to the human papillomavirus (HPV). Treatment and randomisation will be the same within each cohort.

 

Conditions

This trial is treating people with head and neck squamous cell cancer

Eligibility

Inclusion

  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
  5. At least 1 lesion that is measurable by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as described in the protocol
  6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  7. Adequate organ and bone marrow function as described in the protocol

Exclusion

Medical Conditions

  1. Participants who have Progressive Disease (PD) within 6 months of completion of curatively intended systemic treatment for locoregionally advanced HNSCC as described in the protocol
  2. Participants who have a primary tumor site of nasopharynx, paranasal sinus or salivary gland (any histology)
  3. Head and neck SCC with unknown primary site as described in the protocol
  4. Participants with active, known, or suspected autoimmune disease that has required systemic therapy within 5 years of the projected enrollment date as described in the protocol
  5. History of interstitial lung disease (eg, idiopathic pulmonary fibrosis, organizing pneumonia) or active, noninfectious pneumonitis that required immune-suppressive doses of glucocorticoids to assist with management

  6. History or current evidence of significant cardiovascular disease including, myocarditis, congestive heart failure (as defined by New York Heart Association Functional Classification III and IV), unstable angina, serious uncontrolled arrhythmia, and myocardial infarction 6 months prior to study enrollment.

    Prior/Concomitant Therapy

  7. Participants who have received prior systemic anticancer therapy in the R/M HNSCC setting as described in the protocol
  8. Participants with a condition requiring corticosteroid therapy (>10 mg prednisone/prednisolone/day or equivalent) within 14 days of the first dose of study drug as described in the protocol

Note: Other protocol defined Inclusion/ Exclusion Criteria apply

Inclusion

  • You have had treatment, but your cancer has come back (relapsed or recurrent).
  • Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

Participating hospitals

Recruiting hospitals

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More information

Trial Identifiers

Information on this page is partially produced from ClinicalTrials.gov, EU Clinical Trials Register *. View further details about this trial on the registry via the links below:

Trial sponsor

Regeneron Pharmaceuticals

Scientific Title

Phase II Randomized Study of Fianlimab Plus Cemiplimab Versus Cemiplimab Plus Placebo in First-Line Treatment of Participants With Recurrent or Metastatic (R/M) Head and Neck Squamous Cell Carcinoma (HNSCC) That Is Positive for PD-L1 Expression

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