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 |
|---|---|---|---|---|---|---|---|
|
DREAM 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) |
Completed Met its primary endpoint with a 6-month PFS rate of 57% and a median OS of 18.4 months | [51] |
| 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 |
Interim The median OS at the time of report was 21.1 months. The 12 month OS rate was 70% | [52] |
|
Checkmate-743 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 |
Interim 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] |
|
DREAM3R 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 (CTG-IND-I227) | 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 |