Nivolumab in Patients With Recurrent Malignant Mesothelioma

Sponsor
The Netherlands Cancer Institute
Study ID
NCT02497508
Phase
PHASE2
Status
Completed

Conditions

  • Malignant Pleural Mesothelioma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

This is a prospective, single arm, phase II trial in previously treated patients with MPM who are considered candidates for immunotherapy and repeat thoracoscopies/transthoracic biopsies. Nivolumab will be administered 3 mg/kg q2 weeks by intravenous injection. The administration of nivolumab as monotherapy will improve DCR form 20% to 40% at 12 weeks when compared to DCR of patients treated with best supportive care based on historical controls.

Key Dates

Start date
Jul 31, 2015
Status verified
Sep 2017
Primary completion
Jul 31, 2017
Completion
Jul 31, 2017

Study Design

Enrollment
33 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Nivolumab
    Nivolumab will be administered 2 weekly by intravenous infusion in a dose of 3 mg/kg

Primary Outcome Measure

DCR [ Time Frame: at 12 weeks ]

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