Safety and Efficacy of Copanlisib in Combination with Nivolumab: A Phase Ib Study in Patients with Advanced Solid Tumors.

ABSTRACT:

Purpose

Copanlisib in combination with immune checkpoint inhibitors demonstrated synergy and favorable antitumor immune responses in preclinical models. This study evaluated copanlisib plus nivolumab in adults with advanced solid tumors.

Patients and methods

In this phase Ib, nonrandomized, open-label, dose-escalation study, patients received intravenous nivolumab 240 mg (day 15 of cycle 1 and days 1 and 15 of subsequent cycles) plus intravenous copanlisib (45 or 60 mg on days 1, 8, and 15 of each cycle) in 28-day cycles. The primary objective was to determine the MTD and/or recommended phase II dose of copanlisib plus nivolumab. Secondary objectives were safety, tolerability, and efficacy. Exploratory objectives included evaluation of potentially predictive biomarkers.

R

SUBMITTER: Carneiro BA 

PROVIDER: S-EPMC11907410 | biostudies-literature | 2025 Mar

REPOSITORIES: biostudies-literature