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NOT YET RECRUITING
NCT07876414
PHASE2

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

Sponsor: Groupe Oncologie Radiotherapie Tete et Cou

View on ClinicalTrials.gov

Summary

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.

Official title: A Randomized Phase 2 Trial of Anti Bispecific Antibody (INCA33890) Versus Pembrolizumab for Resectable Locally Advanced Squamous Cell Carcinoma of the Head and Neck (TRACE)

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

78

Start Date

2027-02

Completion Date

2030-12

Last Updated

2026-10-15

Healthy Volunteers

No

Interventions

DRUG

INCA33890

INCA33890 is administered IV Q2W on Day 1 of each cycle. INCA33890 is given at a fixed dose of 900 mg (9 vials of 100 mg) IV, q2w for 3 cycles. The dose formulation and concentration is a solution of 20mg/ml or 50mg/ml.

DRUG

Pembrolizumab

Pembrolizumab (Keytruda®) is an antineoplastic agent for the treatment of patients with SCCHN