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Sponsor: Sanofi
Conditions: Squamous Cell Carcinoma of Head and Neck
Interventions: Pembrolizumab, SAR444245 (Thor-707), Cetuximab
Countries: United States, Argentina, Canada, Chile, France, Germany, Italy, Netherlands
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.
Sex: ALL
Age: 18 Years to —
Healthy volunteers: No
Study type: INTERVENTIONAL
Inclusion Criteria: -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. Exclusion Criteria: -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.
- Duarte, California, United States
- Aurora, Colorado, United States
- Ann Arbor, Michigan, United States
- Philadelphia, Pennsylvania, United States
- Seattle, Washington, United States
- Buenos Aires, Argentina
- Montreal, Quebec, Canada
- Santiago, Reg Metropolitana de Santiago, Chile
- Santiago, Reg Metropolitana de Santiago, Chile
- Viña del Mar, Valparaiso, Chile
- Temuco, Chile
- Bordeaux, France
- Lyon, France
- Paris, France
- Strasbourg, France
- Villejuif, France
- Berlin, Germany
- Brescia, Italy
- Amsterdam, Netherlands
- Nijmegen, Netherlands
- Seoul, Seoul-teukbyeolsi, South Korea
- Seoul, Seoul-teukbyeolsi, South Korea
- Barcelona, Barcelona [Barcelona], Spain
- Barcelona, Barcelona [Barcelona], Spain
- Madrid, Madrid, Comunidad de, Spain
- Madrid, Madrid, Comunidad de, Spain
- Tainan, Taiwan