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

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

48

Participants

Timeline

Start Date

January 17, 2019

Primary Completion Date

June 14, 2022

Study Completion Date

June 30, 2025

Conditions
Unresectable or Metastatic Microsatellite Stable (MSS) Solid TumorMicrosatellite Stable (MSS) Colon Cancer
Interventions
DRUG

Copanlisib

"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"

DRUG

Nivolumab

"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"

Trial Locations (1)

21231

Sidney Kimmel Comprehensive Cancer Center, Baltimore

Sponsors

Collaborators (2)

All Listed Sponsors
collaborator

Bayer

INDUSTRY

collaborator

Bristol-Myers Squibb

INDUSTRY

lead

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

OTHER