Study to evaluate the IPH2201 treatment in the head or neck cancer before surgery

Phase 1

• Conditions: ocally advanced resectable squamous cell carcinoma of the oral cavity; MedDRA version: 18.1Level: PTClassification code 10071536Term: Head and neck cancer stage IVSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 18.1Level: PTClassification code 10071537Term: Head and neck cancer stage IIISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 18.1Level: PTClassification code 10071538Term: Head and neck cancer stage IISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2014-002135-34-DE
• Lead Sponsor: Innate Pharma

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-08-15
• Last Update Posted: 3 April 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 43

Inclusion Criteria

Patients must meet all of the following criteria for inclusion into the study:
- Age = 18 years
- Histologically confirmed HPV positive or negative, primary, previously untreated, resectable squamous cell carcinoma of the oral cavity considered clinically and radiologically as intermediate or high-risk, i.e. classified according to the AJCC classification as:
o Stage II with large (= 3 cm and = 4cm) cT2cN0cM0 tumors or any cT2cN0cM0 tumor invading neighboring structures
o Stage III:
cT1cN1cM0
cT2cN1cM0
cT3cN0cM0 or cT3cN1cM0
o Stage IVa:
cT1cN2cM0
cT2cN2cM0
cT3cN2cM0
cT4acN0cM0 or cT4acN1cM0 or cT4acN2cM0
o Stage IV with a primary tumor (cT) of any stage and an adenopathy assessed as cN3 considered as resectable by the investigator surgeon and no clinically or radiologically detectable metastasis
- Good probability to achieve a R0 resection and to perform an adequate functional reconstruction
- Measurable lesion of the primary tumor and, if any, of lymph node metastasis
- ECOG 0-1
- Adequate bone marrow function
- Adequate liver function
- Adequate renal function
- Patients (male or female) who accept and are able to use recognized highly effective contraception methods throughout the study and up to 5 months after last dose of study drug
- Signed informed consent prior to any protocol-specific procédures

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 19
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 24

Exclusion Criteria

Patients will not be eligible for the study if they fulfil one or more of the following exclusion criteria:
- Squamous cell carcinoma of the oral cavity considered clinically and radiologically as stage I according to the AJCC classification
- Other ongoing malignancy including another location of squamous cell cancer outside the oral cavity
- History of previous malignancies corresponding to the following:
o any other head and neck cancer treated by radiotherapy;
o any other squamous cell carcinoma of the oral cavity;
o any other malignancy for which treatment has not allowed to achieve a complete remission, or for which complete remission was achieved less than 1 year before enrollment
o any other malignancy, even in complete remission, which treatment by chemo- and /or radiotherapy has been completed for less than one year
- Life expectancy <3 months
- Abnormal cardiac status
- Patients who are currently receiving medication with a known risk to prolong the QT interval or inducing Torsades de Pointes
- Current active or chronic infectious diseases, including positive serology for HIV, and/or HCV with detectable viremia and/ or HBV with positive Hbs Antigen and/or negative anti-Hbs Antibody; active infection by mycobacterium tuberculosis; latent infection by mycobacterium tuberculosis with positive interferon gamma release assay irrespective of history of Bacillus Calmette Guérin (BCG) vaccination
- History of severe allergic, anaphylactic, or other hypersensitivity reaction to therapeutic antibodies, Chinese hamster ovary cell products or any of the constituents of IPH2201
- Administration of a live, attenuated vaccine, within 4 weeks prior to randomisation and for at least 5 half-lives after the last dose of study drug.
- Auto-immune disease, which currently or previously required systemic immunosuppressive or immunomodulatory therapy
- Serious concurrent uncontrolled medical disorder
- History of allogeneic stem cell or solid organ transplantation
- Intermittent or continuous renal replacement therapy
- Pregnant or lactating women
- Any medical, psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
- Any medical, psychological or other condition that restricts the reconnaissance or consent of the patient to voluntarily participate in this examination
- Persons who are housed in an institution due to governmental or judicial authorities
- Use of any investigational agent within 3 months prior to the first dosing
- Systemic treatment with corticosteroids or other immunosuppressive agents within 30 days prior to IPH2201 first administration

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified