NCT03735628

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

An Open-label, Multi-center, Phase 1b/2 Study to Evaluate the Safety and Efficacy of Copanlisib in Combination With Nivolumab in Patients With Advanced Solid Tumors.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Bayer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Study was originally designed with both Phase I and Phase II part, but sponsor decided not to conduct Phase 2 part due to strategic portfolio re-prioritization.

Conditions

• Non-small Cell Lung Cancer (NSCLC)
• Head and Neck Squamous Cell Carcinoma (HNSCC)
• Hepatocellular Carcinoma (HCC)

Interventions

Type	Name	Description
DRUG	Copanlisib	Copanlisib: lyophilisate for reconstitution and further dilution for infusion
DRUG	Nivolumab	Nivolumab: concentrate for solution for infusion

Timeline

• Start date: 2018-10-17
• Primary completion: 2022-10-13
• Completion: 2022-10-13
• First posted: 2018-11-08
• Last updated: 2023-10-06

Locations

6 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study