CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 48 enrolled
Drug / intervention
Copanlisib +1 moredrug
Likely dose
Copanlisib 45 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03711058
NCT03711058Phase 2Completed

A Phase I/II Study of PI3Kinase Inhibition (Copanlisib) and Anti-PD-1 Antibody Nivolumab in Relapsed/Refractory Solid Tumors With Expansions in Mismatch-repair Proficient (MSS) Colorectal Cancer

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins·interventional·Posted Oct 18, 2018·Updated Sep 16, 2025

In Brief

A Phase 2 clinical trial evaluating Copanlisib and Nivolumab for Unresectable or Metastatic Microsatellite Stable (MSS) Solid Tumor and Microsatellite Stable (MSS) Colon Cancer. Completed, enrolled 48 participants across 1 site.

Detailed Summary

A phase I/II study of PI3Kinase inhibition (copanlisib) and anti-PD-1 antibody nivolumab in relapsed/refractory solid tumors with expansions in mismatch-repair proficient (MSS) colorectal cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
20192020202120222023202420252026
First PostedOct 18, 2018
Enrollment StartJan 17, 2019
Primary CompletionJun 14, 2022
Study CompletionJun 30, 2025
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 7.7 years ago

Interventions

Copanlisibdrug

Copanlisib will be administered as a 60 minute IV infusion (-5min/+10min) at a dose of 45 mg - 60 mg IV. Copanlisib will be administered once a week (days 1, 8, and 15 or Day 1 and Day 15 of each 28 day cycle). Drug: 45 or 60 mg IV

Nivolumabdrug

Nivolumab 480 mg will be administered as a 30 minute IV infusion (-5min/+10min) on Day 1 of each 28 day cycle. Drug: 480 mg IV