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

Study Overview

The is 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 is structured as a master protocol for the investigation of SAR444245 with other anticancer therapies.

Substudy 1-Cohort A1 aims 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 are treatment-naïve for recurrent and/or metastatic (R/M) disease.

Substudy 4-Cohort B1 aims 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 aims 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.

Study details

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 following, until disease progression, or initiation of another antitumor treatment, or death, whichever is earlier

Eligibility Criteria

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Squamous Cell Carcinoma of Head and Neck
  • Age: 18 Years
  • Gender: All

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.

Updated on 04 Apr 2024. Study ID: NCT05061420