Table 7 Additional clinical trials in MPM utilizing checkpoint inhibitors
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 |
|---|---|---|---|---|---|---|---|
Phase I/II Evaluation of Oral Decitabine/Tetrahydrouridine as Epigenetic Priming for Pembrolizumab Immune Checkpoint Blockade in Inoperable Locally Advanced or Metastatic Non-Small Cell Lung Cancers, and Esophageal Carcinomas, or Pleural Mesotheliomas | NCT03233724 | Experimental: 1 (Dose Escalation) Decitabine (DAC) –Tetrahydrouridine (THU) + pembrolizumab at escalating doses Experimental: 2 Dose Expansion DAC-THU + pembrolizumab at the dose established in Arm 1 | I/II | Maximum Tolerated Dose (MTD) ORR – to determine if the combination is associated with an ORR which exceeds that of Pembrolizumab alone in patients who have PD-L1 expression of at least 50% and those who do not | Estimated Study Completion Date: December 31, 2026 | Running no interim results as yet |  |
ORIGIN Overcoming Resistance to Immunotherapy Combining Gemcitabine With Atezolizumab in Advanced NSCLC and Mesothelioma Progressing Under Immune-checkpoint Inhibitors or Gemcitabine. A Multicenter, Single-arm, Open Label Phase II Trial With Two Cohorts | NCT04480372 | Cohort 1. NSCLC Cohort 2. Inoperable MPM gemcitabine 1000Â mg/m2 on day 1 and day 8 of each cycle (every 3Â weeks) and with atezolizumab 1200Â mg on day 1 of each cycle (every 3Â weeks) | II | ORR | Estimated Primary Completion Date: April 2025 Estimated Study Completion Date: December 2025 | Not yet recruiting | Â |