Squamous cell carcinoma of head and neck MedDRA version: 21.0 Level: PT Classification code 10060121 Term: Squamous cell carcinoma of head and neck System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Sponsors
Sanofi-Aventis Recherche & Développement
Eligibility
Sex/Gender
All
Inclusion 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, 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
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 - To assess other indicators of antitumor activity - To assess the concentrations of SAR444245 - To assess the immunogenicity of SAR444245 - To confirm the dose of SAR444245 when combined with cetuximab and pembrolizumab (Substudy 02 Cohort A2) - 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
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1 - To assess the safety profile of SAR444245 when combined with other anti-cancer therapies (TEAEs) 2 - To assess the safety profile of SAR444245 when combined with other anti-cancer therapies (SAEs) 3 - Time to response 4 - Duration of response (DoR) 5 - Clinical benefit rate (CBR) 6 - Progression free survival (PFS) 7 - To assess the concentrations of SAR444245 8 - To assess the immunogenicity of SAR444245;Timepoint(s) of evaluation of this end point: 1-From first IMP dose up to 30 days after the last dose of IMP 2-From first IMP dose up to 90 days after the last dose of IMP 3,4,6-From the date of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months 5-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 7-At Day 1 and Day 15 of Cycle 1, at Day 1 of Cycle 2-4-7-10 + every 5th cycle (each cycle is 21 days), maximum is up to approximately 24 months 8-At Day 1 and Day 15 of Cycle 1, at Day 1 of Cycle 2-4-7-10 + every 5th cycle (each cycle is 21 days) and 30 days after last IMP administration, maximum is up to approximately 24 months | — |
Countries
Canada, France, Germany, Italy, Korea, Republic of, Netherlands, Poland, Spain, Taiwan, United States
Contacts
Public ContactUnidad de Estudios Clínicos
Sanofi-Aventis, S.A
Outcome results
None listed