Nivolumab Monotherapy or Nivolumab Plus Ipilimumab, for Unresectable Malignant Pleural Mesothelioma (MPM) Patients (MAPS2)
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ClinicalTrials.gov Identifier: NCT02716272 |
Recruitment Status :
Completed
First Posted : March 23, 2016
Last Update Posted : February 10, 2021
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Sponsor:
Intergroupe Francophone de Cancerologie Thoracique
Information provided by (Responsible Party):
Intergroupe Francophone de Cancerologie Thoracique
Tracking Information | |||||||
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First Submitted Date ICMJE | March 9, 2016 | ||||||
First Posted Date ICMJE | March 23, 2016 | ||||||
Last Update Posted Date | February 10, 2021 | ||||||
Actual Study Start Date ICMJE | March 24, 2016 | ||||||
Actual Primary Completion Date | February 2018 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
Disease Control rate assessed by CT scan [ Time Frame: 3-months ] Tumor assessment (modified RECIST1.0 for mesothelioma)
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Original Primary Outcome Measures ICMJE | Same as current | ||||||
Change History | |||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title ICMJE | Nivolumab Monotherapy or Nivolumab Plus Ipilimumab, for Unresectable Malignant Pleural Mesothelioma (MPM) Patients | ||||||
Official Title ICMJE | A Randomized Phase II Study Evaluating Efficacy and Safety of 2nd or 3rd Line Treatment by Nivolumab Monotherapy or Nivolumab Plus Ipilimumab, for Unresectable Malignant Pleural Mesothelioma (MPM) Patients | ||||||
Brief Summary | The sponsor raise the hypothesis that inhibition of immune PD-1+/- CTLA-4 check-point(s) would delay tumor progression in patients with unresectable MPM, experiencing disease progression after one or two lines of chemotherapy including at least first-line with pemetrexed and platinum, without altering significantly the quality of life of patients. | ||||||
Detailed Description | Not Provided | ||||||
Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Phase 2 | ||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Mesothelioma | ||||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Scherpereel A, Mazieres J, Greillier L, Lantuejoul S, Do P, Bylicki O, Monnet I, Corre R, Audigier-Valette C, Locatelli-Sanchez M, Molinier O, Guisier F, Urban T, Ligeza-Poisson C, Planchard D, Amour E, Morin F, Moro-Sibilot D, Zalcman G; French Cooperative Thoracic Intergroup. Nivolumab or nivolumab plus ipilimumab in patients with relapsed malignant pleural mesothelioma (IFCT-1501 MAPS2): a multicentre, open-label, randomised, non-comparative, phase 2 trial. Lancet Oncol. 2019 Feb;20(2):239-253. doi: 10.1016/S1470-2045(18)30765-4. Epub 2019 Jan 16. Erratum In: Lancet Oncol. 2019 Mar;20(3):e132. | ||||||
* 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 | Completed | ||||||
Actual Enrollment ICMJE |
125 | ||||||
Original Estimated Enrollment ICMJE |
114 | ||||||
Actual Study Completion Date ICMJE | June 22, 2019 | ||||||
Actual Primary Completion Date | February 2018 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | France | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT02716272 | ||||||
Other Study ID Numbers ICMJE | IFCT-1501 | ||||||
Has Data Monitoring Committee | No | ||||||
U.S. FDA-regulated Product | Not Provided | ||||||
IPD Sharing Statement ICMJE |
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Current Responsible Party | Intergroupe Francophone de Cancerologie Thoracique | ||||||
Original Responsible Party | Same as current | ||||||
Current Study Sponsor ICMJE | Intergroupe Francophone de Cancerologie Thoracique | ||||||
Original Study Sponsor ICMJE | Same as current | ||||||
Collaborators ICMJE | Not Provided | ||||||
Investigators ICMJE |
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PRS Account | Intergroupe Francophone de Cancerologie Thoracique | ||||||
Verification Date | February 2021 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |