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Table 2 Clinical trials in MPM of checkpoint inhibitors within the front-line (first-line) 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
A phase 2 trial of durvalumab with first line chemotherapy in mesothelioma with a safety run in
ACTRN12616001170415 To investigate the effectiveness of durvalumab in combination with standard chemotherapy for mesothelioma I/II PFS at 6 months (PFS6) according to mRECIST for MPM 27/09/2019
(Date of last data collection)
Met its primary endpoint with a 6-month PFS rate of 57% and a median OS of 18.4 months
PrE0505 NCT02899195 A single arm, open label phase II study of durvalumab, in combination with standard chemotherapy II OS assessed in accordance with RECIST 1.1
Time Frame: 72 months
Actual Primary Completion Date:
February 16, 2020
Estimated Study Completion Date:
June 2023
The median OS at the time of report was 21.1 months. The 12 month OS rate was 70%
A Phase III, Randomized, Open Label Trial of Nivolumab in Combination With Ipilimumab Versus Pemetrexed With Cisplatin or Carboplatin as First Line Therapy in Unresectable Pleural Mesothelioma
NCT02899299 Nivolumab and Ipilimumab vs Pemetrexed and Cisplatin/Carboplatin III OS
Time Frame: 4.5 years
Actual Primary Completion Date March 25, 2020
Estimated Study Completion Date: April 15, 2022
Significant improvement in OS versus platinum-based standard chemotherapy (HR, 0.74; 95% CI, 0.61–0.89; P = .002). At 22.1 months of follow-up, the median OS was 18.1 months with the combination (95% CI, 16.8- 21.5) versus 14.1 months with chemotherapy (95% CI, 12.5 -16.2). The 2-year OS rates were 41% and 27%, respectively
[53, 54]
DuRvalumab With chEmotherapy as First Line treAtment in Advanced Pleural Mesothelioma
NCT04334759 First-line cisplatin plus pemetrexed with or without durvalumab III OS
Time Frame: Minimum follow-up is 24 months after randomisation
Estimated Primary Completion Date: April 2025
Estimated Study Completion Date: December 2025
Not yet reported  
A Phase II/III Randomized Study of Pembrolizumab in Patients with Advanced Malignant Pleural Mesothelioma NCT02784171
Cisplatin/Pemetrexed vs Cisplatin/Pemetrexed + Pembrolizumab vs Pembrolizumab (Phase II only) II/III Phase II:
PFS measured as time from randomization to first observation of objective disease relapse or progression [Time Frame: 32 months]
Phase III:
OS defined as time from randomization to the date of death from any cause [Time Frame: 32 months]
Estimated Primary Completion Date:
July 31, 2022
Estimated Study Completion Date: December 31, 2022
Not yet reported