drugset / Trial / NCT03735628

An Study to Evaluate the Safety and Efficacy of Copanlisib in Combination With Nivolumab in Patients With Advanced Solid Tumors

NCT03735628

Phase 1 Completed 16 enrolled Bayer
Non-randomizedSequentialOpen-labelTreatment

Summary

The purpose of the dose escalation part of this study is to determine the feasibility of using the combination of copanlisib and nivolumab in subjects with advanced solid tumors, and to determine the maximum tolerated dose of copanlisib in combination with nivolumab. The maximum tolerated dose will then be used in Phase 2 (dose expansion) of the study.

Timeline

Start
2018-10-17
Primary completion
2022-10-13
Completion
2022-10-13

Drugs

EvaluationDrugModalityDoseRoute
Subject Copanlisib Small molecule 45 mg
Subject Copanlisib Small molecule 60 mg
Subject Nivolumab Monoclonal antibody 240 mg