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
Head and Neck Cancer
Unknown Primary
18 Years and older, Male and Female
R3767-ONC-2431 (primary)
NCI-2025-02677
2024-517620-19-00
Summary
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
Eligibility
- 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
Treatment Sites in Georgia
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