Head and Neck Squamous Cell Carcinoma (HNSCC)
Conditions
Keywords
Recurrent or Metastatic (R/M), Positive for Programmed Death Ligand 1 (PD-L1) Expression, Human Papillomavirus (HPV)
Brief 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
Interventions
DRUGFDC fianlimab+cemiplimab
Fixed-Dose Combination (FDC) Administered per the protocol
DRUGCemiplimab
Administered per the protocol
DRUGPlacebo
Administered per the protocol
Sponsors
Regeneron Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Response Rate (ORR) | Up to 90 days after last study treatment, approximately 58 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Adverse Events (AEs) | Up to 90 days after last study treatment, approximately 58 months | — |
| Severity of AEs | Up to 90 days after last study treatment, approximately 58 months | — |
| Incidence of Treatment Emergent Adverse Events (TEAEs) | Up to 90 days after last study treatment, approximately 58 months | — |
| Incidence of immune-mediated Adverse Events (imAEs) | Up to 90 days after last study treatment, approximately 58 months | — |
| Incidence of treatment-related AEs | Up to 90 days after last study treatment, approximately 58 months | — |
| Incidence of Adverse Events of Special Interest (AESIs) | Up to 90 days after last study treatment, approximately 58 months | — |
| Incidence of Serious Adverse Events (SAEs) | Up to 90 days after last study treatment, approximately 58 months | — |
| Incidence of AEs leading to discontinuation | Up to 90 days after last study treatment, approximately 58 months | — |
| Incidence of AEs leading to death | Up to 90 days after last study treatment, approximately 58 months | — |
| Incidence of laboratory abnormalities | Up to 90 days after last study treatment, approximately 58 months | Per National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0 |
| Disease Control Rate (DCR) per investigator assessment | Up to 90 days after last study treatment, approximately 58 months | — |
| Duration of Response (DOR) per investigator assessment or death, whichever occurs first | Up to 90 days after last study treatment, approximately 58 months | — |
| Progression-Free Survival (PFS) per investigator assessment or death, whichever occurs first | Up to 90 days after last study treatment, approximately 58 months | — |
| Concentrations of cemiplimab in serum | Up to 90 days after last study treatment, approximately 58 months | — |
| Concentrations of fianlimab in serum | Up to 90 days after last study treatment, approximately 58 months | — |
| Incidence of Anti-Drug Antibody (ADA) to fianlimab | Up to 90 days after last study treatment, approximately 58 months | — |
| Titer of ADA to fianlimab | Up to 90 days after last study treatment, approximately 58 months | — |
Countries
Australia, France, Italy, Spain, United States
Contacts
CONTACTClinical Trials Administrator
STUDY_DIRECTORClinical Trial Management
Regeneron Pharmaceuticals
Outcome results
None listed