Locally advanced resectable squamous cell carcinoma of the oral cavity MedDRA version: 18.1 Level: PT Classification code 10071536 Term: Head and neck cancer stage IV System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 18.1 Level: PT Classification code 10071537 Term: Head and neck cancer stage III System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 18.1 Level: PT Clas
Conditions
Interventions
Product Code: IPH2201
Pharmaceutical Form: Powder for solution for injection
Other descriptive name: IPH2201
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration n
Sponsors
Innate Pharma
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the antitumor activity of pre-operative IPH2201 in patients with operable squamous cell carcinoma of the oral cavity;Secondary Objective: To assess the safety of IPH2201, the pharmacokinetics, the immunogenicity and the pharmacodynamics including intra-tumoral biomarkers;Primary end point(s): Best objective response rate before surgery documented by imaging, and confirmed by independent radiologists, on the basis of RECIST 1.1 criteria;Timepoint(s) of evaluation of this end point: week 4, week 8 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Pathologic complete response rate assessed in patients undergoing surgical removal of the tumor - Separate assessment of the objective response rate, based on the RECIST criteria and documented by imaging in the primary tumor and in invaded lymph nodes, if any - Progression-Free Survival (PFS) rate and Overall Survival (OS) rates - Safety of IPH2201 - Documentation of the surgical delay due to adverse events. - Assessment of the quality of life of the patients using the EORTC QLQ H&N35 questionnaire, at screening and end of treatment visits. - Pharmacokinetic endpoints - Pharmacodynamic endpoints - Immunogenicity: occurrence of HAHA ;Timepoint(s) of evaluation of this end point: - Tumor response assessments at weeks 4, 8, 20, 32, 44, 52 - PFS rate and OS rate 12 months after the first administration (then 2 additional years within the scope of a post study follow up) - QoL: week 8 - Safety/PK/PD: each study visit | — |
Countries
Germany, Italy, Spain
Contacts
Public ContactRegulatory Submissions
Medpace Germany GmbH
Outcome results
None listed