Adding fianlimab to cemiplimab versus cemiplimab alone for recurrent or metastatic head and neck squamous cell carcinoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized Phase 2 trial compares the combination of fianlimab (REGN3767) plus cemiplimab to cemiplimab plus placebo in people with recurrent or metastatic head and neck squamous cell carcinoma who have not received prior systemic therapy for their recurrent/metastatic disease. Participants must have PD-L1 expression (CPS ≥1), measurable disease, and good performance status, and are treated at participating US sites. The study will measure anti-tumor activity as well as monitor safety, blood levels of the drugs, and whether patients develop antibodies to the study drugs. Additional translational research samples may be collected to better understand how the drugs work and tumor biology.

Why it matters

Who can join: the full rules

Key Inclusion Criteria:

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

Key Exclusion Criteria:

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

Where it's running

• University of California Los Angeles
  Los Angeles, California, United States Recruiting
• Samuel Oschin Cancer Center
  Los Angeles, California, United States Recruiting
• Orlando Health
  Orlando, Florida, United States Recruiting
• Emory University School of Medicine
  Atlanta, Georgia, United States Recruiting
• Northwestern University
  Evanston, Illinois, United States Recruiting
• St. Elizabeth Healthcare
  Edgewood, Kentucky, United States Recruiting

Study contacts

• Study coordinator: Clinical Trials Administrator
• Email: clinicaltrials@regeneron.com
• Phone: 844-734-6643

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Capecitabine/Oxaliplatin chemo with cemiplimab with or without fianlimab or REGN7075 for locally advanced rectal cancer

  This trial tests whether adding cemiplimab, cemiplimab with fianlimab, or cemiplimab with REGN7075 to CAPOX can help people with MSS locally advanced rectal cancer before surgery.

  Recruiting Phase 2 Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Baltimore, Maryland · NCT07281768

• Cemiplimab alone or with fianlimab after stereotactic body radiation for oligometastatic clear cell kidney cancer

  This trial will test whether giving cemiplimab alone or with fianlimab after stereotactic body radiation helps people with oligometastatic clear cell kidney cancer stay free of recurrence longer.

  Recruiting Phase 2 University of Oklahoma · Oklahoma City, Oklahoma · NCT07223541

• Comparing two immunotherapy combinations and their immune effects in unresectable or metastatic melanoma

  This will test whether two different first-line immunotherapy combinations produce different immune responses in tumors and blood of people with unresectable or metastatic melanoma.

  Recruiting University of Pittsburgh · Pittsburgh, Pennsylvania · NCT07223411

• First-line immune-checkpoint antibody combinations for advanced clear cell kidney cancer

  This trial tests whether combining fianlimab and cemiplimab, with or without ipilimumab, works better than the standard ipilimumab plus nivolumab as first treatment for people with advanced clear cell kidney cancer.

  Recruiting at 5 sites Phase 2 Hoosier Cancer Research Network · Washington D.C., District of Columbia and 4 other locations · NCT07188896

• Two immunotherapies after treatment for HPV-positive head and neck cancer

  This study tests whether adding fianlimab to cemiplimab helps prevent recurrence in adults with HPV-positive head and neck cancer who have detectable residual disease after initial therapy.

  Recruiting Phase 2 University of Chicago · Chicago, Illinois · NCT07179315

• Cemiplimab alone or with Fianlimab or REGN7075 after surgery and chemo in colorectal cancer with minimal residual disease

  This study tests whether cemiplimab alone or in combination with fianlimab or REGN7075 can help prevent colorectal cancer from returning in adults who are ctDNA-positive after standard treatment.

  Recruiting at 13 sites Phase 2 NSABP Foundation Inc · Gainesville, Florida and 12 other locations · NCT07058012

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.