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

Launched by SANOFI · Sep 21, 2021

Keywords

ClinConnect Summary

The duration of the study for an individual patient will start from the signature of the main informed consent and include:

* a screening period of up to 28 days
* a treatment period \[max 35 cycles {cohort A1 and B1} = 735 days or until PD {cohort B2}\]; max 35 cycles for SAR444245 and pembrolizumab\]
* an end-of-treatment visit at least approximately 30 days following the last administration of study drug (or until the patient receives another anticancer therapy, whichever is earlier)
* and a follow-up visits 3 months after treatment discontinuation and every 3 months thereafter followin...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • -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 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.
• Exclusion Criteria:
• • -Eastern Cooperative Oncology Group (ECOG) performance status of ≥2
• • Has 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 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.