Efficacy Study of Pre-operative IPH2201 in Patients With Squamous Cell Carcinoma of the Oral Cavity

Phase 1

Terminated

• Conditions: Squamous Cell Carcinoma of the Oral Cavity
• Interventions: Drug: IPH2201; Procedure: Standard Surgery; Radiation: Postsurgical Adjuvant Therapy

• Registration Number: NCT02331875
• Lead Sponsor: Innate Pharma

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-12
• Study First Submitted: 2015-01-02
• Study First Submitted QC: 2015-01-02
• Study First Posted: 2015-01-06
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-02
• Last Update Posted: 2017-01-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 3

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
single arm	Postsurgical Adjuvant Therapy	IPH2201 followed by standard surgery and standard postsurgical adjuvant therapy
single arm	Standard Surgery	IPH2201 followed by standard surgery and standard postsurgical adjuvant therapy
single arm	IPH2201	IPH2201 followed by standard surgery and standard postsurgical adjuvant therapy

Primary Outcome Measures

Name	Time	Method
best objective response rate	8 weeks

Trial Locations

Locations (3)

Instituto Catalan de Oncologia - L'Hospitalet; 🇪🇸 L'Hospitalet de Llobregat Barcelona, Spain

Hospital Universitario La Paz; 🇪🇸 Madrid, Spain

Charité University Medicine Berlin; 🇩🇪 Berlin, Germany