Squamous Cell Carcinoma of the Oral Cavity Clinical Trial
Official title:
Open Label Single Arm Phase Ib-II Study of Pre-operative IPH2201 in Patients With Locally Advanced Resectable Squamous Cell Carcinoma of the Oral Cavity
The primary objective of this open label Phase Ib/II trial is to evaluate the clinical and
pharmacological activity of IPH2201 as a single-agent in treatment-naïve pre-operative
patients with operable Squamous Cell Carcinoma of the Oral Cavity .
43 patients are planned to be enrolled. The first 6 patients will receive IPH2201 at a dose
of 4 mg/kg q2w x 4. Subsequent patients will be treated at a dose of 10 mg/kg q2w x 4.
Standard loco-regional treatment with surgery followed by adjuvant therapy will be initiated
after the last administration of IPH2201.
n/a
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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