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Table 4 Clinical trials in MPM of combined checkpoint inhibitors within the second-line (salvage) setting

From: Emerging avenues in immunotherapy for the management of malignant pleural mesothelioma

Trial acronym or title Trial identifier Treatment Phase Primary objective(s) Completion date Report status References
MAPS2 NCT02716272 Monotherapy vs Combination Therapy
Nivolumab 3 mg/kg every 2 weeks vs Nivolumab as above plus Ipilimumab 1 mg/Kg every 6 weeks
II DCR assessed by CT scan [Time Frame: 3-months]
Tumor assessment (modified RECIST1.0 for mesothelioma)
Secondary outcomes included OS, PFS
Estimated Study Completion Date:
April 2020
Completed
Median OS data observed was 11.9 months for the single therapy and 15.9 months for the combination
[70]
NIBIT-Meso-1 NCT02588131 Single arm Tremelimumab 1 mg/kg plus Durvalumab 20 mg/kg every four weeks for 4 doses, then Durvalumab 20 mg/kg every four weeks for an additional 9 doses II immune related ORR
Secondary objectives included OS, PFS and DCR
Estimated Study Completion Date:
March 2018
Completed
median OS for the study was 16·6 months
[71]
INITIATE NCT03048474 Nivolumab (240 mg flat dose every 2 weeks) plus Ipilimumab (1 mg/kg every 6 weeks up to four times) II Disease Control Rate (DCR) at 12 weeks
Secondary Outcomes included PFS, OS, ORR
Actual Study Completion Date:
December 2019
Completed
Median overall survival was not reached
(estimated to exceed
12·7 months)
[72,73,74]
A Phase 2 Study of Durvalumab in Combination With Tremelimumab in Malignant Pleural Mesothelioma NCT03075527 Single arm Durvalumab plus Tremelimumab once per day for every 28 day cycles (+ 7 days). Participants will receive tremelimumab for up to 4 cycles (4 doses). Beginning with cycle 5 day 1, subjects will continue to receive durvalumab alone, until clinical or radiological progression II   Actual Primary Completion Date:
June 7, 2019
Estimated Study Completion Date: September 30, 2024
Suspended
At a median follow-up of 7.1 months, the median PFS was 2.8 months, and the median OS was 7.8 months
[75]