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

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02331875
• Other study ID #: IPH2201-201
• Secondary ID: 2014-002135-34
• Status: Terminated
• Phase: Phase 1/Phase 2
• First received: January 2, 2015
• Last updated: January 2, 2017
• Start date: December 2014
• Est. completion date: December 2016

Study information

• Verified date: January 2017
• Source: Innate Pharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Paul-Ehrlich-InstitutSpain: Agencia Española de Medicamentos y Productos Sanitarios
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

• Histologically confirmed, primary, previously untreated, resectable squamous cell carcinoma of the oral cavity considered clinically and radiologically as intermediate or high risk, classified II ( with large (= 3 cm and = 4cm) cT2cN0cM0 tumors or any cT2cN0cM0 tumor invading neighboring structures) III or IVa according to the American Joint Committee on Cancer

• Adequate liver and renal function

Exclusion criteria:

• Other malignancy

• Abnormal cardiac status

• Autoimmune disease

• Serious concurrent uncontrolled medical disorder

• Systemic treatment with corticosteroids or other immunosuppressive agents within 30 days prior to IPH2201 first administration.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Squamous Cell Carcinoma of the Oral Cavity

Intervention

Drug:
• IPH2201
The first 6 patients will receive IPH2201, IV, 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.

Procedure:
• Standard Surgery
After the end of treatment with IPH2201, according to standard recommendations in the relevant country .

Radiation:
• Postsurgical Adjuvant Therapy
After the standard surgery, according to standard recommendations in the relevant country

Locations

Country	Name	City	State
Germany	Charité University Medicine Berlin	Berlin
Spain	Instituto Catalan de Oncologia - L'Hospitalet	L'Hospitalet de Llobregat Barcelona
Spain	Hospital Universitario La Paz	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Innate Pharma

Countries where clinical trial is conducted

Germany,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	best objective response rate		8 weeks	No