Ipilimumab and Nivolumab in the Treatment of Malignant Pleural Mesothelioma (INITIATE)
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|ClinicalTrials.gov Identifier: NCT03048474|
Recruitment Status : Completed
First Posted : February 9, 2017
Last Update Posted : January 20, 2021
This is a prospective, monocenter, single arm, phase II trial in 33 patients with unresectable MPM, who experience disease progression or recurrence after at least one previous line of platinum-based systemic treatment.
Nivolumab will be administered at a fixed dose of 240 mg every 2 week. Nivolumab will be given in combination with ipilimumab on week 1, 7, 13 and 19 and will be administered prior to the infusion of ipilimumab. Ipilimumab will be administered at the dose of 1 mg/Kg.The patients will receive nivolumab monotherapy on week 3, 5, 9, 11, 15 and 17. From week 21 thereafter, Nivolumab will be then administered every 2 weeks for a maximum period of 2 years or until disease progression or unacceptable toxicity occurs.
|Condition or disease||Intervention/treatment||Phase|
|Malignant Pleural Mesothelioma||Drug: nivolumab and ipilimumab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||36 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Ipilimumab and Nivolumab in the Treatment of Malignant Pleural Mesothelioma: a Phase II Study. Acronym: INITIATE|
|Study Start Date :||September 2016|
|Actual Primary Completion Date :||December 2017|
|Actual Study Completion Date :||December 2019|
Experimental: Nivolumab and Ipilimumab
Nivolumab will be administered at a fixed dose of 240 mg every 2 weeks for a maximum period of 2 years. Nivolumab will be given in combination with ipilimumab on week 1, 7, 13 and 19. Ipilimumab will be administered at the dose of 1 mg/Kg.
Drug: nivolumab and ipilimumab
Other Name: BMS-936558 and L01XC11
- Disease Controle Rate (DCR) at 12 weeks [ Time Frame: at 12 weeks ]The number of patients that have CR or PR plus the number of patients with stable disease as a percentage of the total number of patients in the study.
- Safety: the incidence of adverse events, serious adverse events, deaths and laboratory abnormalities. [ Time Frame: Participants will be followed for the duration of the trial, an expected average of 6 weeks ]Incidence of (serious) adverse events, serious adverse events, deaths and laboratory abnormalities.
- Disease Controle Rate (DCR) at 6 months [ Time Frame: at 6 months ]The number of patients that have CR or PR plus the number of patients with stable disease as a percentage of the total number of patients in the study.
- Progression Free Survival (PFS) [ Time Frame: Until progression, every 6 weeks up to 48 weeks ]The time from the date of start treatment to the date of the first documented tumor progression as determined by modified RECIST, or death due to any cause
- Overall Survival (OS) [ Time Frame: every 6 weeks up to 48 weeks, thereafter every 12 weeks up to 36 months. ]The time from date of start of treatment to the date of death from any cause, every 6 weeks up to 48 weeks, thereafter every 12 weeks up to 36 months
- Overall Response Rate (ORR) [ Time Frame: Every 6 weeks up to 48 weeks ]The number of subjects whose best confirmed objective response is a CR or PR, divided by the number of treated subjects
- Exploratory in blood and tumor biopsies [ Time Frame: At screening and after 6 weeks of treatment (day 56-70) ]The research will focus on re-activation and expansion of tumor-specific T cells. Multimer pMCH technology will be used to examine the quantitative changes in T cell responses and transcriptomic analysis of tumor infiltrating T-cells in biopsies taken before and after 6 weeks of treatment.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03048474
|Netherlands Cancer Institute-Antoni van Leeuwenhoek Ziekenhuis|
|Amsterdam, North-Holland, Netherlands, 1066CX|
|Principal Investigator:||Paul Baas, MD, PhD||The Netherlands Cancer Institute-Antoni van Leeuwenhoek Ziekenhuis|
|Principal Investigator:||Maria Disselhorst, MD||The Netherlands Cancer Institute-Antoni van Leeuwenhoek Ziekenhuis|