Nivolumab in Patients With Recurrent Malignant Mesothelioma (NivoMes)
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|ClinicalTrials.gov Identifier: NCT02497508|
Recruitment Status : Completed
First Posted : July 14, 2015
Last Update Posted : September 14, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Malignant Pleural Mesothelioma||Drug: nivolumab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||33 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Single Arm Phase II Study of Nivolumab in Patients With Recurrent Malignant Pleural Mesothelioma: Interim Biopsy Analysis to Determine Efficacy. Acronym: NivoMes Study|
|Study Start Date :||July 2015|
|Actual Primary Completion Date :||July 2017|
|Actual Study Completion Date :||July 2017|
Nivolumab will be administered 2 weekly by intravenous infusion in a dose of 3 mg/kg
Other Name: BMS-936558
- DCR [ Time Frame: at 12 weeks ]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.
- PFS [ Time Frame: Until progression, every 6 weeks up to 24 weeks. ]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.
- OS [ Time Frame: every 8 weeks until death ]The time from date of start of treatment to the date of death
- TTP [ Time Frame: Until progression, every 6 weeks up to 24 weeks. ]The time from the date of start of treatment to the time of disease progression.
- ORR [ Time Frame: Every 6 weeks up to 24 weeks. ]The number of subjects whose best confirmed objective response is a CR or PR, divided by the number of treated subjects.
- Safety and tolerability (The incidence of (serious) adverse events) [ Time Frame: Participants will be followed fot the duration of the trial, an expected average of 6 weeks ]The incidence of (serious) adverse events
- DCR [ Time Frame: At 6 months ]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.
- Exploratory [ Time Frame: At screening and after cycle 3 (day 35-50) ]The effects of nivolumab on tissue samples with respect to influx of immuno-modulating cells and the PD-L1 status of tumors and other possible biomarkers and explore correlations between biomarkers and anti-tumor activity.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02497508
|Principal Investigator:||Paul Baas, MD, PhD||The Netherlands Cancer Institute|
|Principal Investigator:||Josine Quispel-Janssen, MD||The Netherlands Cancer Institute|