A Clinical Trial Comparing an Antibody (INCA33890) Versus Pembrolizumab for Squamous Cell Carcinoma of the Head and Neck.

Study acronym: TRACE
StatusNot Yet Recruiting
PhasePhase 2
Started

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Record History

  1. Minor Study First Submitted
The objective of this research is to evaluate the efficacy of the new drug INCA33890 compared to the standard reference treatment, pembrolizumab. The study treatment is INCA33890. The reference treatment is pembrolizumab. Two-thirds of participants will receive INCA33890, and one-third will receive pembrolizumab. The details for the different treatment groups are as follows: * Group A: You will receive INCA33890 (900 mg) every two weeks for 3 cycles. * Group B: You will receive pembrolizumab (200 mg) every three weeks for 2 cycles. Following these treatments, you will undergo surgery. This surgical procedure will be performed in accordance with the hospital's standard care practices. After surgery, you will be offered one of the following standard additional treatments: * (Chemo)radiotherapy within 6 to 8 weeks after surgery. The adjuvant (chemo)radiotherapy will be tailored based on microscopic findings from the analysis of the resected tumor. * Immunotherapy: pembrolizumab (200 mg) administered intravenously every 3 weeks until disease progression or the occurrence of unacceptable toxicity.
Trial Details
NCT Number NCT07876414
Lead Sponsor Groupe Oncologie Radiotherapie Tete et Cou
Collaborators: Incyte Biosciences International Sàrl
Conditions
(from sponsor)
Resectable Locally Advanced Head and Neck Squamous Cell Carcinoma
Enrollment 78 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov