TerminatedPhase 1/2

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

Stopped: lack of recruitment

Germany, Spain3 participantsStarted 2014-12

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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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.

What they're measuring

best objective response rate

Timeframe: 8 weeks

Trial details

NCT IDNCT02331875

SponsorInnate Pharma

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2016-12

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