General Information

Age Group

Adults

Status

Recruiting

Protocol Number

NCT06769698

Background Information

The purpose of this study is to investigate cemiplimab with or without fianlimab with the hypothesis that the combination will have additive or synergistic effects that may provide clinical benefit in participants with head and neck cancers.

Enrolled study participants will be randomized 1:1 to fianlimab + cemiplimab or cemiplimab + placebo. 

This study is comprised of a Screening period, Treatment period, and Follow-up period. 

In addition, the participants will be contacted by phone every quarter for survival follow-up.

Offered At

Inova Schar Cancer
8081 Innovation Park Drive,
Fairfax, VA 22031
Principal Investigator

John Deeken, MD

Eligibility Information

  • Have histologically confirmed (by local pathology) R/M HNSCC that is considered incurable by local therapies.
  • Primary tumor location of oral cavity, oropharynx, larynx, or hypopharynx.
  • PD-L1 expression CPS ≥1 documented with a previously PD-L1 obtained IHC result prior to screening, based on a surgical specimen or a core biopsy specimen from any site of HNSCC.
  • Oropharynx cancer participants only: HPV status, based on a previously documented result prior to screening, must have been established in a surgical specimen or a core biopsy specimen from any site of OPSCC.
  • At least 1 lesion that is measurable by Response Evaluation Criteria in Solid Tumors (RECIST v1.1).
  • ECOG performance status of 0 or 1

Ineligibility Information

  • Participants who have Progressive Disease (PD) within 6 months of completion of curatively intended systemic
    treatment for locoregionally advanced HNSCC.
  • Participants who have a primary tumor site of nasopharynx, paranasal sinus or salivary gland (any histology).
  • Head and neck SCC with unknown primary site (unless documented to have HPV positive oropharynx cancer based on HPV ISH in cervical node.
  • Participants with active, known, or suspected autoimmune disease that has required systemic therapy within 5 years of the projected enrollment date.
  • Has known active CNS metastases and/or carcinomatous meningitis.
  • 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.