A Study of SAR444245 Combined With Other Anticancer Therapies for the Treatment of Participants With HNSCC (Master Protocol) (Pegathor Head and Neck 204)
Key facts
- Who runs it
- Sanofi
- Where
- Ann Arbor, Aurora, Duarte, Philadelphia, and Seattle, United StatesSee the 5 sitesAlso in 10 other countries, 22 sites
- Trial code
- NCT05061420
- EudraCT 2021-002105-99
- U1111-1251-5073
- Status
- Terminated
- Phase
- Phase 2
- People taking part
- 59 people enrolled
- Started
- 8 Oct 2021
- Ended
- 26 Nov 2024
- Type of study
- Interventional, 3 groups
- Treatments tested
- Pembrolizumab
- SAR444245 (Thor-707)
- Cetuximab
- Record updated
- 22 September 2025
- Why it stopped
- Early discontinuation based on strategic sponsor decision not driven by any safety concerns.
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
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Who can take part
- -Participants were ≥ 18 years of age inclusive, at the time of signing the informed consent
- Histologically or cytologically confirmed diagnosis of R/M HNSCC that was considered not amenable to further therapy with curative intent. The eligible primary tumor locations were oropharynx, oral cavity, hypopharynx, and larynx (nasopharynx is excluded)
- Measurable disease
- Baseline biopsy was submitted for all cohort A1 Core Phase participants
- Baseline biopsy was submitted for all cohort B1, B2 Expansion Phase participants
- Known HPV p16 status for oropharyngeal cancer
- Participant agreed to follow protocol-specified contraception guidelines
Who cannot take part
- Had 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)
- 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 were 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) were not excluded
- For participants in Cohort B2: Electrolytes (magnesium, calcium, potassium) outside the normal ranges
- -Eastern Cooperative Oncology Group (ECOG) performance status of ≥2
Where in United States
Also in 10 other countries, 22 sites
- University of Michigan- Site Number : 8400008Ann Arbor, United StatesNo longer taking part
- University of Colorado- Site Number : 8400004Aurora, United StatesNo longer taking part
- City of Hope Site Number : 8400007Duarte, United StatesNo longer taking part
- Thomas Jefferson University Hospital Site Number : 8400003Philadelphia, United StatesNo longer taking part
- Seattle Cancer Care Alliance Site Number : 8400006Seattle, United StatesNo longer taking part
About the trial
What the trial wants to find out
The study was 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 was structured as a master protocol for the investigation of SAR444245 with other anticancer therapies.
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Substudy 1-Cohort A1 aimed 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 were treatment-naïve for recurrent and/or metastatic (R/M) disease.
Substudy 4-Cohort B1 aimed 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 aimed 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.
The 3 groups in the trial
- Cohort A1 (sub study 01) treatment- naïveTreatment being tested
Participants with HNSCC, who were treatment-naïve for R/M disease and have a PD-L1 Combined Positive Score (CPS) ≥1, received pembrolizumab followed by SAR444245. Both drugs administered by intravenous (IV) infusion on Day 1 of each 21-day treatment cycle for up to 35 cycles.
Treatment: Pembrolizumab and SAR444245 (Thor-707)
- Cohort B1: (sub study 04) PD1/PD-L1 and platinum-based treatmentsTreatment being tested
Participants with HNSCC who received treatment with a PD1/PD-L1-based regimen \& platinum-based regimen and have failed no more than 2 regimens for R/M disease, received pembrolizumab followed by SAR444244. Both drugs administered IV infusion on Day 1 of each 21-day treatment cycle for up to 35 cycles
Treatment: Pembrolizumab and SAR444245 (Thor-707)
- Cohort B2: (sub study 05) cetuximab- naïveTreatment being tested
Participants with R/M HNSCC, who were cetuximab-naïve, have received treatment with a platinum-based regimen, and have failed no more than 2 regimens for R/M disease, received treatment with cetuximab followed by SAR444245. Cetuximab IV was given on days 1, 8, and 15 of each 21 day. SAR444245 was administered by IV infusion on Day 1 of each 21-day treatment cycle. Dosing of both drugs continued until disease progression, unacceptable toxicity, or withdrawal of consent.
Treatment: SAR444245 (Thor-707) and Cetuximab
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- 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)
- Record updated
- 22 September 2025