drugset / Trial / NCT04390399
Combination Immunotherapy Plus Standard-of-Care Chemotherapy Versus Standard-of-Care Chemotherapy for the Treatment of Locally Advanced or Metastatic Pancreatic Cancer
RandomizedParallel-groupOpen-labelTreatment
Summary
This is a phase 2, three-cohort (2 randomized and 1 single-arm), open-label study to evaluate the comparative efficacy and overall safety of standard-of-care chemotherapy versus standard-of-care chemotherapy in combination with aldoxorubicin HCl, N-803, and PD-L1 t-haNK in subjects with locally advanced or metastatic pancreatic cancer. Each treatment setting (ie, first line maintenance, second line, or third line or greater) will be evaluated independently as a separate cohort.
Timeline
- Start
- 2020-07-21
- Primary completion
- 2025-10-13
- Completion
- 2026-05-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Aldoxorubicin | Small molecule | — | — |
| Subject | Cyclophosphamide | Other / unclassified | — | — |
| Subject | Gemcitabine | Small molecule | — | — |
| Comparator | Irinotecan | Small molecule | — | — |
| Comparator | Leucovorin | Small molecule | — | — |
| Subject | N-803 | Protein / enzyme biologic | — | — |
| Subject | PD-L1 t-haNK | Cell therapy | — | — |
| Subject | Paclitaxel | Small molecule | — | — |
| Comparator | fluorouracil | Small molecule | — | — |