NCT03048474

Ipilimumab and Nivolumab in the Treatment of Malignant Pleural Mesothelioma

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: The Netherlands Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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

Conditions

• Malignant Pleural Mesothelioma

Interventions

Type	Name	Description
DRUG	nivolumab and ipilimumab

Timeline

• Start date: 2016-09-01
• Primary completion: 2017-12-01
• Completion: 2019-12-01
• First posted: 2017-02-09
• Last updated: 2021-01-20

Locations

1 site across 1 country: Netherlands