drugset / Trial / NCT05535569

Phase Ib/II Study to Evaluate the Safety and Efficacy of Nivolumab in Combination With Paclitaxel in Epstein-Barr Virus(EBV)-Related, or Microsatellite Instability-High (MSI-H), or Programmed Cell Death Ligand 1 (PD-L1) Positive Advanced Gastric Cancer

NCT05535569 ↗

Phase 1/2 Completed 50 enrolled Yonsei University
NaSingle-groupOpen-labelTreatment

Summary

This is a Phase Ib/II study to identify the recommended dose of paclitaxel and nivolumab for further study, and to assess the safety and clinical efficacy of this combined treatment in EBV-related, MSI-high, or PD-L1 positive advanced gastric cancer after first line treatment.

Timeline

Start
2017-07-17
Primary completion
2021-11-22
Completion
2021-11-22

Drugs

EvaluationDrugModalityDoseRoute
Subject Nivolumab Monoclonal antibody 3 mg/kg —
Subject Paclitaxel Small molecule 70 mg/m2 —
Subject Paclitaxel Small molecule 80 mg/m2 —

Indications

No indication recorded.