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

Part of paid clinical trials in Duarte, California.

Sponsor
Sanofi
Study ID
NCT05061420
Phase
PHASE2
Status
Terminated

Conditions

  • Squamous Cell Carcinoma of Head and Neck

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Pembrolizumab — DRUG
    Pharmaceutical Form: Concentration for solution for infusion Route of Administration: Intravenous Infusion
  • SAR444245 (Thor-707) — DRUG
    Pharmaceutical Form: Concentrate for solution for infusion Route of Administration: Intravenous Infusion
  • Cetuximab — DRUG
    Pharmaceutical Form: Solution for infusion Route of Administration: Intravenous Infusion

Study Details

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. 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.

Key Dates

Start date
Oct 8, 2021
Status verified
Aug 2025
Primary completion
Jul 21, 2023
Completion
Nov 26, 2024

Study Design

Enrollment
59 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort A1 (sub study 01) treatment- naïve
    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.
  • Experimental: Cohort B1: (sub study 04) PD1/PD-L1 and platinum-based treatments
    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
  • Experimental: Cohort B2: (sub study 05) cetuximab- naïve
    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.

Primary Outcome Measure

Cohort A1: Objective Response Rate (ORR) [ Time Frame: From first dose of study treatment administration (Day 1) up to approximately 21 months ]

Locations (5)

FacilityCityStateZIPSite coordinators
City of Hope- Site Number : 8400007DuarteCalifornia91010-
University of Colorado- Site Number : 8400004AuroraColorado80045-
University of Michigan- Site Number : 8400008Ann ArborMichigan48109-
Thomas Jefferson University Hospital Site Number : 8400003PhiladelphiaPennsylvania19107-
Seattle Cancer Care Alliance Site Number : 8400006SeattleWashington98115-

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By research site
City of Hope· Duarte, CAUniversity of Colorado· Aurora, COUniversity of Michigan· Ann Arbor, MIThomas Jefferson University Hospital· Philadelphia, PASeattle Cancer Care Alliance· Seattle, WA

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