The Anti-CTLA-4 Monoclonal Antibody Tremelimumab in Malignant Mesothelioma
This study is currently recruiting participants.
Verified July 2012 by Azienda Ospedaliera Universitaria Senese
Sponsor:
Azienda Ospedaliera Universitaria Senese
Collaborator:
MedImmune LLC
Information provided by (Responsible Party):
Michele Maio, Azienda Ospedaliera Universitaria Senese
ClinicalTrials.gov Identifier:
NCT01655888
First received: July 31, 2012
Last updated: NA
Last verified: July 2012
History: No changes posted
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First Received Date ICMJE | July 31, 2012 | ||||||||
Last Updated Date | July 31, 2012 | ||||||||
Start Date ICMJE | July 2012 | ||||||||
Estimated Primary Completion Date | January 2014 (final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
To determine the objective response [ Time Frame: Weeks 24 ] [ Designated as safety issue: No ] The objective response is defined as a confirmed complete response (CR), or partial response (PR) according to the modified RECIST Criteria for pleural mesothelioma and the immune-related (ir) Response Criteria |
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Original Primary Outcome Measures ICMJE | Same as current | ||||||||
Change History | No Changes Posted | ||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
Current Other Outcome Measures ICMJE | |||||||||
Original Other Outcome Measures ICMJE | |||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | The Anti-CTLA-4 Monoclonal Antibody Tremelimumab in Malignant Mesothelioma | ||||||||
Official Title ICMJE | A SECOND-LINE, SINGLE ARM, PHASE II CLINICAL STUDY WITH TREMELIMUMAB, A FULLY HUMAN ANTI-CTLA-4 MONOCLONAL ANTIBODY, AS MONOTHERAPY IN PATIENTS WITH UNRESECTABLE MALIGNANT MESOTHELIOMA. The MESOT-TREM-2012 | ||||||||
Brief Summary | RATIONAL: Preliminary results fron the Study MESOT-TREM-2012 indicate a promising activity of tremelimumab in malignant mesothelioma (MM) patients. PURPOSE: The proposed study MESOT-TREM-2012 aims to explore the efficacy of a more intensive schedule of treatment with tremelimumab in 29 MM patients. Subjects will receive investigational product every 4 weeks (wks) for 6 doses, followed by doses every 12 wks until confirmed disease progression. |
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Detailed Description | Primary endpoint: 1) To assess the rate of objective clinical complete response (CR) or partial response (PR) Secondary endpoints:
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Study Type ICMJE | Interventional | ||||||||
Study Phase | Phase 2 | ||||||||
Study Design ICMJE | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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Condition ICMJE | Malignant Mesothelioma | ||||||||
Intervention ICMJE | Drug: Tremelimumab
Tremelimumab is administered as endovenous infusion
Other Name: CP-675,206 |
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Study Arm (s) | Experimental: single arm with Tremelimumab
Tremelimumab: 10mg/Kg ev day 1 every 4 weeks for 6 doses in induction phase, then every 12 weeks in maintenance phase until disease progression of severe toxicity
Intervention: Drug: Tremelimumab |
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Publications * | |||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status ICMJE | Recruiting | ||||||||
Estimated Enrollment ICMJE | 29 | ||||||||
Estimated Completion Date | January 2015 | ||||||||
Estimated Primary Completion Date | January 2014 (final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||||||
Ages | 18 Years and older | ||||||||
Accepts Healthy Volunteers | No | ||||||||
Contacts ICMJE |
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Location Countries ICMJE | Italy | ||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT01655888 | ||||||||
Other Study ID Numbers ICMJE | MESOT-TREM-2012, 2012-002762-12 | ||||||||
Has Data Monitoring Committee | Yes | ||||||||
Responsible Party | Michele Maio, Azienda Ospedaliera Universitaria Senese | ||||||||
Study Sponsor ICMJE | Azienda Ospedaliera Universitaria Senese | ||||||||
Collaborators ICMJE | MedImmune LLC | ||||||||
Investigators ICMJE |
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Information Provided By | Azienda Ospedaliera Universitaria Senese | ||||||||
Verification Date | July 2012 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |