Study Stopped
lack of recruitment
Efficacy Study of Pre-operative IPH2201 in Patients With Squamous Cell Carcinoma of the Oral Cavity
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
2 other identifiers
interventional
3
2 countries
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Dec 2014
Typical duration for phase_1
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2014
CompletedFirst Submitted
Initial submission to the registry
January 2, 2015
CompletedFirst Posted
Study publicly available on registry
January 6, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedJanuary 4, 2017
January 1, 2017
2 years
January 2, 2015
January 2, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
best objective response rate
8 weeks
Study Arms (1)
single arm
EXPERIMENTALIPH2201 followed by standard surgery and standard postsurgical adjuvant therapy
Interventions
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.
After the end of treatment with IPH2201, according to standard recommendations in the relevant country .
After the standard surgery, according to standard recommendations in the relevant country
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Innate Pharmalead
Study Sites (3)
Charité University Medicine Berlin
Berlin, 13353, Germany
Instituto Catalan de Oncologia - L'Hospitalet
L'Hospitalet de Llobregat Barcelona, Spain, 08907, Spain
Hospital Universitario La Paz
Madrid, 28047, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 2, 2015
First Posted
January 6, 2015
Study Start
December 1, 2014
Primary Completion
December 1, 2016
Study Completion
December 1, 2016
Last Updated
January 4, 2017
Record last verified: 2017-01