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Ipilimumab and Nivolumab in the Treatment of Malignant Pleural Mesothelioma — INITIATE  

Malignant Pleural Mesothelioma Clinical Trial

Official title:
Ipilimumab and Nivolumab in the Treatment of Malignant Pleural Mesothelioma: a Phase II Study. Acronym: INITIATE

Clinical Trial Summary

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.

Clinical Trial Description

Patients will undergo pre- and post-treatment thoracoscopies/biopsies. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03048474
Study type Interventional
Source The Netherlands Cancer Institute
Contact
Status Completed
Phase Phase 2
Start date September 2016
Completion date December 2019
View Details
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