Table 4.

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

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)	[72–74]
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]