drugset / Trial / NCT03575793
A Phase I/II Study of Nivolumab, Ipilimumab and Plinabulin in Patients With Recurrent Small Cell Lung Cancer
Phase 1/2
Completed
39 enrolled
Salma Sabbour
BeyondSpring Pharmaceuticals Inc. · collabBristol-Myers Squibb · collabRutgers Cancer Institute of New Jersey · collab
Non-randomizedSingle-groupOpen-labelTreatment
Summary
This is an open-label Phase I/II study, with a dose escalation part (Phase I) and a single-arm part (Phase II), in patients with recurrent SCLC who progressed after first-line platinum-based chemotherapy and who are candidates for second line therapy. No PK evaluation is planned in this study as nivolumab and ipilimumab are unlikely to alter plinabulin's PK, since the route of excretion is different.
Timeline
- Start
- 2018-09-06
- Primary completion
- 2023-09-25
- Completion
- 2024-07-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ipilimumab | Monoclonal antibody | 3 mg/kg | Intravenous |
| Subject | Nivolumab | Monoclonal antibody | 240 mg | Intravenous |
| Subject | Plinabulin | Small molecule | 13.5 mg/m2 | Intravenous |
| Subject | Plinabulin | Small molecule | 20 mg/m2 | Intravenous |
| Subject | Plinabulin | Small molecule | 30 mg/m2 | Intravenous |