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Ipilimumab and Nivolumab in the Treatment of Malignant Pleural Mesothelioma

NCT03048474 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2021-01-20

No results posted yet for this study

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.

Conditions

  • Malignant Pleural Mesothelioma

Interventions

DRUG

nivolumab and ipilimumab

Sponsors & Collaborators

Principal Investigators

  • Paul Baas, MD, PhD · The Netherlands Cancer Institute-Antoni van Leeuwenhoek Ziekenhuis

  • Maria Disselhorst, MD · The Netherlands Cancer Institute-Antoni van Leeuwenhoek Ziekenhuis

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-09-30
Primary Completion
2017-12-31
Completion
2019-12-31

Countries

  • Netherlands

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03048474 on ClinicalTrials.gov