A Phase 2 non-randomized, open-label, multi-cohort, multi-center study assessing the clinical benefit of SAR444245 (THOR-707) combined with other anticancer therapies for the treatment of participants with head and neck squamous cell carcinoma (HNSCC) (Pegasus Head and Neck 204)

Sanofi-Aventis Recherche & Développement0 个研究点目标入组 228 人开始时间: 2021年11月26日最近更新: 2024年7月8日

适应症

试验速览

暂无简介。

•- Participants must be = 18 years of age inclusive, at the time of signing the informed consent
•- Histologically or cytologically confirmed diagnosis of R/M HNSCC that is considered not amenable to further therapy with curative intent. The eligible primary tumor locations are oropharynx, oral cavity, hypopharynx, and larynx (nasopharynx is excluded)
•- Measurable disease
•- Baseline biopsy must be submitted for all cohort A1, A2 Core Phase participants
•- Baseline biopsy must be submitted for all cohort B1, B2 Expansion Phase participants
•- Known HPV p16 status for oropharyngeal cancer
•- Participant agrees to follow protocol-specified contraception guidelines
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 90
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 138

•Participants are excluded from the study if any of the following criteria apply:
•- Eastern Cooperative Oncology Group (ECOG) performance status of =2
•- Has received prior IL2-based anticancer treatment
•- For participants in Cohorts A1, A2: 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 Cohorts A2, 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 Cohorts A2, 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 are 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) are not excluded.

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