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

Primary Purpose

Squamous Cell Carcinoma of the Oral Cavity

Status

Terminated

Phase

Phase 1

Locations

International

Study Type

Interventional

Intervention

IPH2201

Standard Surgery

Postsurgical Adjuvant Therapy

About this trial

This is an interventional treatment trial for Squamous Cell Carcinoma of the Oral Cavity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Charité University Medicine Berlin
Instituto Catalan de Oncologia - L'Hospitalet
Hospital Universitario La Paz

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

single arm

Arm Description

IPH2201 followed by standard surgery and standard postsurgical adjuvant therapy

Outcomes

Primary Outcome Measures

best objective response rate

Secondary Outcome Measures

Full Information

NCT ID

NCT02331875

First Posted

January 2, 2015

Last Updated

January 2, 2017

Sponsor

Innate Pharma

1. Study Identification

Unique Protocol Identification Number

NCT02331875

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2017

Overall Recruitment Status

Terminated

Why Stopped

lack of recruitment

Study Start Date

December 2014 (undefined)

Primary Completion Date

December 2016 (Actual)

Study Completion Date

December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Innate Pharma

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Squamous Cell Carcinoma of the Oral Cavity

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

3 (Actual)

8. Arms, Groups, and Interventions

Arm Title

single arm

Arm Type

Experimental

Arm Description

IPH2201 followed by standard surgery and standard postsurgical adjuvant therapy

Intervention Type

Drug

Intervention Name(s)

IPH2201

Intervention Description

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.

Intervention Type

Procedure

Intervention Name(s)

Standard Surgery

Intervention Description

After the end of treatment with IPH2201, according to standard recommendations in the relevant country .

Intervention Type

Radiation

Intervention Name(s)

Postsurgical Adjuvant Therapy

Intervention Description

After the standard surgery, according to standard recommendations in the relevant country

Primary Outcome Measure Information:

Title

best objective response rate

Time Frame

8 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Facility Information:

Facility Name

Charité University Medicine Berlin

City

Berlin

ZIP/Postal Code

13353

Country

Germany

Facility Name

Instituto Catalan de Oncologia - L'Hospitalet

City

L'Hospitalet de Llobregat Barcelona

ZIP/Postal Code

08907

Country

Spain

Facility Name

Hospital Universitario La Paz

City

Madrid

ZIP/Postal Code

28047

Country

Spain

12. IPD Sharing Statement

Learn more about this trial

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

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