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NCT07876414
A Clinical Trial Comparing an Antibody (INCA33890) Versus Pembrolizumab for Squamous Cell Carcinoma of the Head and Neck.
Conditions: Resectable Locally Advanced Head and Neck Squamous Cell Carcinoma
Sex: All
Ages: 18 Years – 75 Years
Healthy volunteers: No
Phase: PHASE2
Enrollment: 78
Sponsor: Groupe Oncologie Radiotherapie Tete et Cou
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.
Eligibility Criteria
Inclusion Criteria:
Patients with confirmed diagnosis in previously untreated LA-SCCHN patients suitable for definitive surgery 18-75 years with (CPS) ≥1
Exclusion Criteria:
Prior treatment for H\&N cancer, metastatic disease, cardiovascular disease, pulmonary comorbidities, central nervous system disorders, corticoids treatment, active uncontrolled inflammatory disease, history of organ transplant or active autoimmune disease.
Source: ClinicalTrials.gov (NCT07876414). StuddyBuddy aggregates publicly available trial information.