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

Regeneron Pharmaceuticals

Status and phase: Not yet enrolling; Phase 2

Conditions: Head and Neck Squamous Cell Carcinoma (HNSCC)

Treatments: Drug: Cemiplimab; Drug: Placebo; Drug: FDC fianlimab+cemiplimab

Study type: Interventional

Funder types: Industry

Identifiers

NCT06769698

2024-517620-19-00 (Registry Identifier)

R3767-ONC-2431

Details and patient eligibility

About

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

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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120 participants in 2 patient groups

Cohort 1

Experimental group

Description:

Approximately 60 participants with HPV (human papillomavirus) positive HNSCC. Randomized 1:1 to Fianlimab + Cemiplmab Fixed Dose Combination (FDC) versus Cemiplimab + Placebo.

Treatment:

Drug: FDC fianlimab+cemiplimab

Drug: Placebo

Drug: Cemiplimab

Cohort 2

Experimental group

Description:

Approximately 60 participants with HPV negative HNSCC. Randomization is the same as in Cohort 1.

Treatment:

Drug: FDC fianlimab+cemiplimab

Drug: Placebo

Drug: Cemiplimab