drugset / Trial / NCT04069273
Novel SEQUEnced Immunotherapy With Anti-angiogenesis and Chemotherapy in Advanced gastroesophageaL Adenocarcinoma
RandomizedSequentialOpen-labelTreatment
Summary
Cohort 1 \[CLOSED\] Study treatment involves two segments: (1) Induction Immunotherapy segment with pembrolizumab monotherapy every 3 weeks until irRECIST PD and (2) Combination Therapy segment. Nab-paclitaxel may be utilized in place of paclitaxel at investigator's discretion for subjects with paclitaxel reactions. Cohort 2 Patients are randomized to Arm A or B. Treatment in both arms includes pembrolizumab + RAM + paclitaxel.
Timeline
- Start
- 2020-12-01
- Primary completion
- 2026-06-11
- Completion
- 2026-12-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Paclitaxel | Small molecule | 90 mg/m2 | Intravenous |
| Subject | Pembrolizumab | Monoclonal antibody | 200 mg | Intravenous |
| Subject | Ramucirumab | Monoclonal antibody | 10 mg/kg | Intravenous |