drugset / Trial / NCT03123055

A Study of B-701 in Combination With Pembrolizumab in Treatment of Locally Advanced or Metastatic Urothelial Cell Carcinoma

NCT03123055

Phase 1/2 Terminated 28 enrolled Rainier Therapeutics
Non-randomizedParallel-groupOpen-labelTreatment

Summary

This is a Phase 1b/2 multi-center, open-label study to establish the initial safety and to determine a recommended Phase 2 dose of B-701 in combination with pembrolizumab, and to determine safety, tolerability and efficacy of B-701 (vofatamab) plus pembrolizumab in the treatment of subjects with locally advanced or metastatic UCC, who have progressed following platinum-based chemotherapy and who have not received prior immune checkpoint inhibitor therapy.

Timeline

Start
2017-04-20
Primary completion
2019-12-01
Completion
2019-12-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Pembrolizumab Monoclonal antibody 200 mg Intravenous
Subject Vofatamab Monoclonal antibody 25 mg/kg Intravenous