Fianlimab with cemiplimab for newly treated recurrent or metastatic head and neck cancer
Tests fianlimab plus cemiplimab against cemiplimab alone in adults with head and neck cancer.
Plain-language title generated from the registry record
Registry title: 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
Key facts
- Where
- A Coruña, Barcelona, Madrid, Pamplona, Seville, and Zaragoza, SpainSee the 8 sites
- Phase
- Phase 2
Where in Spain
- Centro Oncologico de GaliciaA Coruña, SpainTaking people
- Complejo Hospitalario Universitario de A CoruñaA Coruña, SpainTaking people
- Hospital ClinicBarcelona, SpainTaking people
- University Hospital Vall d'HebronBarcelona, SpainTaking people
- Hospital Universitario La PazMadrid, SpainTaking people
- Hospital Universitario de NavarraPamplona, SpainTaking people
- Hospital Universitario Virgen del RocioSeville, SpainTaking people
- Hospital Universitario Miguel ServetZaragoza, SpainTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Regeneron Pharmaceuticals
- Trial code
- NCT06769698EU 2024-517620-19-00
- Record updated
- 22 October 2026
- Original description
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.Read full original descriptionShow less
Phase II Randomized Study of Fianlimab Plus Cemiplimab Versus Cemiplimab Plus Placebo in First-Line Treatment of Participants With Recurrent or Metastatic (R/M) Head and Neck Squamous Cell Carcinoma (HNSCC) That Is Positive for PD-L1 Expression
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
Inclusion: 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 (patients with cervical neck node SCC with occult primary as described in the protocol; 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; 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; At least 1 lesion that is measurable by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as described in the protocol; Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; Adequate organ and bone marrow function as described in the protocol.
Exclusion: 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; Participants who have received prior systemic anticancer therapy in the R/M HNSCC setting as described in the protocol; Medical Conditions; 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; 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; 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; 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; Participants who have a primary tumor site of nasopharynx, paranasal sinus or salivary gland (any histology); Head and neck SCC with unknown primary site as described in the protocol.