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)
- Conditions
- cancer10027655head and neck
- Registration Number
- NL-OMON52068
- Lead Sponsor
- Genzyme Europe BV
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 7
- 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
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>•To determine the antitumor activity of SAR444245 in combination with other<br /><br>anti-cancer therapies in patients with HNSCC</p><br>
- Secondary Outcome Measures
Name Time Method <p>•To assess the safety profile of SAR444245 when combined with other anti-cancer<br /><br>therapies<br /><br>• To assess other indicators of antitumor activity.<br /><br>• To assess the concentrations of SAR444245.<br /><br>• To assess the immunogenicity of SAR444245.<br /><br>• To confirm the dose of SAR444245 when combined with cetuximab and<br /><br>pembrolizumab<br /><br>(Substudy -2 Cohort A2)<br /><br>• To assess the concentrations of cetuximab (Substudy 2- Cohort A2 and Substudy<br /><br>5- Cohort B2)</p><br>