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

Ki vehet részt

• -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

Ki nem vehet részt

• 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)
• 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
• For participants in Cohort B2: Electrolytes (magnesium, calcium, potassium) outside the normal ranges
• -Eastern Cooperative Oncology Group (ECOG) performance status of ≥2