drugset / Trial / NCT03387111
QUILT-3.090: NANT Squamous Cell Carcinoma (SCC) Vaccine: Subjects With SCC Who Have Progressed
NaSingle-groupOpen-labelTreatment
Summary
This is a phase 1b/2 study to evaluate the safety and efficacy of metronomic combination therapy in subjects with SCC who have progressed on or after previous platinum-based chemotherapy and anti-PD-1/PD-L1 therapy. Phase 2 will be based on Simon's two-stage optimal design.
Timeline
- Start
- 2018-01-09
- Primary completion
- 2019-04-17
- Completion
- 2021-01-11
Outcome
Outcome not reported
Stopped: “Study halted prematurely and will not resume; participants are no longer being examined or receiving intervention”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Aldoxorubicin | Small molecule | — | — |
| Subject | Avelumab | Monoclonal antibody | — | — |
| Subject | Bevacizumab | Monoclonal antibody | — | — |
| Subject | Capecitabine | Small molecule | — | — |
| Subject | Cetuximab | Monoclonal antibody | — | — |
| Subject | Cisplatin | Other / unclassified | — | — |
| Subject | Cyclophosphamide | Other / unclassified | — | — |
| Subject | ETBX-011 | Vaccine | — | — |
| Subject | ETBX-021 | Vaccine | — | — |
| Subject | ETBX-051 | Vaccine | — | — |
| Subject | ETBX-061 | Vaccine | — | — |
| Subject | GI-4000 | Vaccine | — | — |
| Subject | GI-6207 | Vaccine | — | — |
| Subject | GI-6301 | Vaccine | — | — |
| Subject | Leucovorin | Small molecule | — | — |
| Subject | N-803 | Protein / enzyme biologic | — | — |
| Subject | Nab-paclitaxel | Small molecule | — | — |
| Subject | Necitumumab | Monoclonal antibody | — | — |
| Subject | fluorouracil | Small molecule | — | — |
| Subject | haNK | Cell therapy | — | — |