A study of SAR444245 combined with other anticancer therapies for the treatment of participants with HNSCC (Master Protocol)
- Conditions
- Squamous cell carcinoma of head and neckMedDRA version: 21.0Level: PTClassification code 10060121Term: Squamous cell carcinoma of head and neckSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2021-002105-99-NL
- Lead Sponsor
- Sanofi-Aventis Recherche & Développement
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 228
- 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To determine the antitumor activity of SAR444245 in combination with other anti-cancer therapies in patients with HNSCC;Secondary Objective: - To assess the safety profile of SAR444245 when combined with other anti-cancer therapies<br>- To assess other indicators of antitumor activity<br>- To assess the concentrations of SAR444245<br>- To assess the immunogenicity of SAR444245<br>- To confirm the dose of SAR444245 when combined with cetuximab and pembrolizumab (Substudy 02 Cohort A2)<br>- To assess the concentrations of cetuximab (Substudy 02 - Cohort A2 and Substudy 05 - Cohort B2);Primary end point(s): Objective response rate (ORR);Timepoint(s) of evaluation of this end point: Baseline to the date of first documented progression or initiation of subsequent anticancer therapy or approximately 9 months after the last participant receive first dose
- Secondary Outcome Measures
Name Time Method