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

Phase 2

Not yet recruiting

• Conditions: Recurrent or Metastatic (R/M) Head and Neck Squamous Cell Carcinoma (HNSCC)

• Registration Number: 2024-517620-19-00
• Lead Sponsor: Regeneron Pharmaceuticals Inc.

Brief Summary

To evaluate investigator-assessed Overall Response Rate (ORR) with combination therapy (fianlimab + cemiplimab) vs cemiplimab monotherapy (cemiplimab + placebo) in participants with HNSCC

Detailed Description

Not available

Study Timeline

• Study First Posted: 2025-06-05
• Last Update Posted: 2025-06-16

Recruitment & Eligibility

• Status: Authorised, recruitment pending
• Sex: Not specified
• Target Recruitment: 68

Inclusion Criteria

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

Other protocol defined Inclusion Criteria apply

Exclusion Criteria

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 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

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

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.

Participants who have received prior systemic anticancer therapy in the R/M HNSCC setting as described in the protocol

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

Other protocol defined Exclusion Criteria apply

Study & Design

• Study Type: Not specified
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall Response Rate (ORR)		Overall Response Rate (ORR)

Secondary Outcome Measures

Name	Time	Method
Incidence of Adverse Events (AEs)		Incidence of Adverse Events (AEs)
Severity of AEs		Severity of AEs
Incidence of Treatment Emergent Adverse Events (TEAEs)		Incidence of Treatment Emergent Adverse Events (TEAEs)
Incidence of immune-mediated Adverse Events (imAEs)		Incidence of immune-mediated Adverse Events (imAEs)
Incidence of treatment-related AEs		Incidence of treatment-related AEs
Incidence of Adverse Events of Special Interest (AESIs)		Incidence of Adverse Events of Special Interest (AESIs)
Incidence of Serious Adverse Events (SAEs)		Incidence of Serious Adverse Events (SAEs)
Incidence of AEs leading to discontinuation		Incidence of AEs leading to discontinuation
Incidence of AEs leading to death		Incidence of AEs leading to death
Incidence of laboratory abnormalities		Incidence of laboratory abnormalities
DCR per investigator assessment		DCR per investigator assessment
DOR per investigator assessment or death, whichever occurs first		DOR per investigator assessment or death, whichever occurs first
PFS per investigator assessment or death, whichever occurs first		PFS per investigator assessment or death, whichever occurs first
Concentrations of cemiplimab in serum		Concentrations of cemiplimab in serum
Concentrations of fianlimab in serum		Concentrations of fianlimab in serum
Incidence of Anti-Drug Antibody (ADA) to fianlimab		Incidence of Anti-Drug Antibody (ADA) to fianlimab
Titer of ADA to fianlimab		Titer of ADA to fianlimab

Trial Locations

Locations (25)

Centre Hospitalier Regional De Marseille; 🇫🇷 Marseille, France

Centre Jean Perrin; 🇫🇷 Clermont-Ferrand, France

Assistance Publique Hopitaux De Paris; 🇫🇷 Paris, France

Centre Oscar Lambret; 🇫🇷 Lille, France

Ospedale San Raffaele S.r.l.; 🇮🇹 Milan, Italy

IRCCS Istituto Nazionale Tumori Fondazione Pascale; 🇮🇹 Naples, Italy

Istituto Europeo Di Oncologia S.r.l.; 🇮🇹 Milan, Italy

Azienda Ospedaliero Universitaria Di Modena; 🇮🇹 Modena, Italy

Humanitas Mirasole S.p.A.; 🇮🇹 Rozzano, Italy

Fondazione IRCCS Istituto Nazionale Dei Tumori; 🇮🇹 Milan, Italy

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Centre Hospitalier Regional De Marseille

🇫🇷Marseille, France

Sébastien Salas

Site contact

+330491385708

sebastien.salas@ap-hm.fr