Table 7.
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 |