A Study of SAR444245 Combined With Other Anticancer Therapies for the Treatment of Participants With HNSCC (Master Protocol) (Pegathor Head and Neck 204)

Stopped early · Phase 2

Conditions studied: Squamous Cell Carcinoma of Head and Neck

In brief

The study was a phase 2 multi-cohort, non-randomized, open-label, multi-center study assessing the clinical benefit of SAR444245 combined with other anticancer therapies for the treatment of participants aged 18 years and older with HNSCC. This study was structured as a master protocol for the investigation of SAR444245 with other anticancer therapies. Substudy 1-Cohort A1 aimed to establish proof-of-concept that SAR444245 combined with the anti-PD1 antibody pembrolizumab, will result in a significant increase in the observed number of objective responses in trial participants with HNSCC who were treatment-naïve for recurrent and/or metastatic (R/M) disease. Substudy 4-Cohort B1 aimed to establish proof-of-concept that SAR444245 combined with the anti-PD1 antibody pembrolizumab, will result in a significant increase in the observed number of objective responses in trial participants with HNSCC who have received treatment with PD1/PD-L1 and platinum-based regimen. Substudy 5-Cohort B2 aimed to establish proof-of-concept that SAR444245 combined with cetuximab will result in a significant increase in the observed number of objective responses in trial participants with HNSCC previously treated with platinum-based regimen \& cetuximab-naive after failure of no more than 2 regimens for recurrent and/or metastatic (R/M) disease.

Key facts

Study ID

NCT05061420

Run by

Sanofi

People needed

59

Starts

2021-10-08

Expected to finish

2024-11-26

Last updated by the study team

2025-09-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participants were ≥ 18 years of age inclusive, at the time of signing the informed consent
• Histologically or cytologically confirmed diagnosis of R/M HNSCC that was considered not amenable to further therapy with curative intent. The eligible primary tumor locations were oropharynx, oral cavity, hypopharynx, and larynx (nasopharynx is excluded).
• Measurable disease.
• Baseline biopsy was submitted for all cohort A1 Core Phase participants.
• Baseline biopsy was submitted for all cohort B1, B2 Expansion Phase participants.
• Known HPV p16 status for oropharyngeal cancer.
• Participant agreed to follow protocol-specified contraception guidelines.

You may not qualify if…

• Eastern Cooperative Oncology Group (ECOG) performance status of ≥2
• Had received prior IL2-based anticancer treatment. -For participants in Cohort A1: Prior treatment with an agent (approved or investigational) that blocks the PD-1/PD-L1 pathway (participants who joined a study with an anti-PD-1/PD-L1 in the experimental arm but have written confirmation they have not received anti-PD-1/PD-L1 are allowed).
• For participants in Cohort B2: Prior treatment with cetuximab (prior cetuximab allowed if used for the treatment of locally advanced disease, with no progressive disease for at least 4 months from completion of prior cetuximab therapy).
• For participants in Cohort B2: Electrolytes (magnesium, calcium, potassium) outside the normal ranges.
• Participants under anti-hypertensive treatment who cannot temporarily (for at least 36 hours) withhold antihypertensive medications prior to each IMP dosing.
• Participants with baseline SpO2 ≤92% (without oxygen therapy).
• Comorbidity requiring corticosteroid therapy (>10 mg prednisone/day or equivalent) within 2 weeks of IMP initiation. Inhaled or topical steroids are permitted, provided that they were not for treatment of an autoimmune disorder. Participants who require a brief course of steroids (eg, as prophylaxis for imaging studies due to hypersensitivity to contrast agents) were not excluded.

Where it is running

• City of Hope- Site Number : 8400007 — Duarte, California, United States
• University of Colorado- Site Number : 8400004 — Aurora, Colorado, United States
• University of Michigan- Site Number : 8400008 — Ann Arbor, Michigan, United States
• Thomas Jefferson University Hospital Site Number : 8400003 — Philadelphia, Pennsylvania, United States
• Seattle Cancer Care Alliance Site Number : 8400006 — Seattle, Washington, United States
• Investigational Site Number : 0320001 — Buenos Aires, Argentina
• Investigational Site Number : 1240001 — Montreal, Quebec, Canada
• Investigational Site Number : 1520003 — Santiago, Reg Metropolitana de Santiago, Chile
• Investigational Site Number : 1520001 — Santiago, Reg Metropolitana de Santiago, Chile
• Investigational Site Number : 1520004 — Viña del Mar, Valparaiso, Chile
• Investigational Site Number : 1520002 — Temuco, Chile
• Investigational Site Number : 2500003 — Bordeaux, France
• Investigational Site Number : 2500008 — Lyon, France
• Investigational Site Number : 2500006 — Paris, France
• Investigational Site Number : 2500002 — Strasbourg, France
• Investigational Site Number : 2500001 — Villejuif, France
• Investigational Site Number : 2760004 — Berlin, Germany
• Investigational Site Number : 3800003 — Brescia, Italy
• Investigational Site Number : 5280002 — Amsterdam, Netherlands
• Investigational Site Number : 5280001 — Nijmegen, Netherlands
• Investigational Site Number : 4100002 — Seoul, Seoul-teukbyeolsi, South Korea
• Investigational Site Number : 4100001 — Seoul, Seoul-teukbyeolsi, South Korea
• Investigational Site Number : 7240001 — Barcelona, Barcelona [Barcelona], Spain
• Investigational Site Number : 7240004 — Barcelona, Barcelona [Barcelona], Spain
• Investigational Site Number : 7240005 — Madrid, Madrid, Comunidad de, Spain

Full record on ClinicalTrials.gov

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