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.
Patients will undergo pre- and post-treatment thoracoscopies/biopsies.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
33
DCR
The number of patients that have CR or PR plus the number of patients that have SD, as a percentage of the total number of patients in the study.
Time frame: at 12 weeks
PFS
The time from the date of start of treatment to the date of the first documented tumor progression as determined by modified RECIST, or death due to any cause.
Time frame: Until progression, every 6 weeks up to 24 weeks.
OS
The time from date of start of treatment to the date of death
Time frame: every 8 weeks until death
TTP
The time from the date of start of treatment to the time of disease progression.
Time frame: Until progression, every 6 weeks up to 24 weeks.
ORR
The number of subjects whose best confirmed objective response is a CR or PR, divided by the number of treated subjects.
Time frame: Every 6 weeks up to 24 weeks.
Safety and tolerability (The incidence of (serious) adverse events)
The incidence of (serious) adverse events
Time frame: Participants will be followed fot the duration of the trial, an expected average of 6 weeks
DCR
The number of patients that have CR or PR plus the number of patients that have SD, as a percentage of the total number of patients in the study.
Time frame: At 6 months
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