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

NCT02331875 — Phase 1 / Phase 2, Terminated, 3 participants, Innate Pharma

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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

Registry	NCT02331875
Status	Terminated - lack of recruitment
Phase	Phase 1 / Phase 2
Study type	Interventional; na, single group, masking: none, treatment
Enrollment	3 (Actual)
Sponsor	Innate Pharma (Industry)
Conditions	Squamous Cell Carcinoma of the Oral Cavity
Interventions	IPH2201, Standard Surgery, Postsurgical Adjuvant Therapy (Drug, procedure, radiation)
Dates	start 2014-12-01, primary completion 2016-12-01, completion 2016-12-01, first posted 2015-01-06, last updated 2017-01-04
Locations	3 sites in Germany, Spain

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
single arm	Experimental	Drug: IPH2201; Procedure: Standard Surgery; Radiation: Postsurgical Adjuvant Therapy	IPH2201 followed by standard surgery and standard postsurgical adjuvant therapy

IPH2201 (Drug): 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.
Standard Surgery (Procedure): After the end of treatment with IPH2201, according to standard recommendations in the relevant country .
Postsurgical Adjuvant Therapy (Radiation): After the standard surgery, according to standard recommendations in the relevant country

+Outcome measures

Primary outcomes

best objective response rate [8 weeks]

+Eligibility

Sex: All, ages: 18 Years to any

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.

+Locations (3)

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

+Funding

NIH grants: 2014