Spots Global Cancer Trial Database for Ipilimumab and Nivolumab in the Treatment of Malignant Pleural Mesothelioma
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Trial Identification
Brief Title: Ipilimumab and Nivolumab in the Treatment of Malignant Pleural Mesothelioma
Official Title: Ipilimumab and Nivolumab in the Treatment of Malignant Pleural Mesothelioma: a Phase II Study. Acronym: INITIATE
Study ID: NCT03048474
Conditions
Interventions
Study Description
Brief 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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Netherlands Cancer Institute-Antoni van Leeuwenhoek Ziekenhuis, Amsterdam, North-Holland, Netherlands
Contact Details
Name: Paul Baas, MD, PhD
Affiliation: The Netherlands Cancer Institute-Antoni van Leeuwenhoek Ziekenhuis
Role: PRINCIPAL_INVESTIGATOR
Name: Maria Disselhorst, MD
Affiliation: The Netherlands Cancer Institute-Antoni van Leeuwenhoek Ziekenhuis
Role: PRINCIPAL_INVESTIGATOR
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