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. 2021 May 5;21:148. doi: 10.1186/s12890-021-01513-7

Table 7.

Additional clinical trials in MPM utilizing checkpoint inhibitors

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 1000 mg/m2 on day 1 and day 8 of each cycle (every 3 weeks) and with atezolizumab 1200 mg on day 1 of each cycle (every 3 weeks)

II ORR

Estimated Primary Completion Date:

April 2025

Estimated Study Completion Date: December 2025

Not yet recruiting