drugset / Trial / NCT03138889
Bempegaldesleukin and Pembrolizumab With or Without Chemotherapy in Locally Advanced or Metastatic Solid Tumors
Non-randomizedParallel-groupOpen-labelTreatment
Summary
This study is to assess the safety and tolerability, and to assess the preliminary clinical benefit of NKTR-214 when combined with pembrolizumab (KEYTRUDA®) with or without chemotherapy. The study is comprised of two groups; dose optimization and dose expansion cohorts. Dose Optimization included first-line and second-line advanced or metastatic solid tumors including non-small cell lung cancer (NSCLC) The dose expansion cohort will include first-line NSCLC patients.
Timeline
- Start
- 2017-06-09
- Primary completion
- 2022-07-05
- Completion
- 2022-08-24
Outcome
Outcome not reported
Stopped (Business): “Sponsor decision”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Atezolizumab | Monoclonal antibody | — | — |
| Subject | Bempegaldesleukin | Protein / enzyme biologic | 0.006 mg/kg | Intravenous |
| Subject | Bempegaldesleukin | Protein / enzyme biologic | 0.008 mg/kg | Intravenous |
| Subject | Bempegaldesleukin | Protein / enzyme biologic | 0.01 mg/kg | Intravenous |
| Subject | Bempegaldesleukin | Protein / enzyme biologic | 0.012 mg/kg | Intravenous |
| Subject | Pembrolizumab | Monoclonal antibody | 200 mg | — |
| Background | Carboplatin | Small molecule | — | — |
| Background | Cisplatin | Other / unclassified | — | — |
| Background | Nab-paclitaxel | Small molecule | — | — |
| Background | Paclitaxel | Small molecule | — | — |
| Background | Pemetrexed | Small molecule | — | — |