NCT04317105View on ClinicalTrials.gov

Testing the Addition of an Anti-cancer Drug, Copanlisib, to the Usual Immunotherapy (Nivolumab With or Without Ipilimumab) in Patients With Advanced Solid Cancers That Have Changes in the Following Genes: PIK3CA and PTEN

PHASE1/PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

102

Participants

Timeline

Start Date

July 17, 2020

Primary Completion Date

December 31, 2025

Study Completion Date

December 31, 2025

Conditions
Advanced Malignant Solid NeoplasmMetastatic Malignant Solid NeoplasmUnresectable Malignant Solid Neoplasm
Interventions
PROCEDURE

Biopsy Procedure

Undergo a tumor biopsy

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

PROCEDURE

Computed Tomography

Undergo a CT scan

DRUG

Copanlisib Hydrochloride

Given IV

PROCEDURE

Echocardiography Test

Undergo ECHO

BIOLOGICAL

Ipilimumab

Given IV

BIOLOGICAL

Nivolumab

Given IV

PROCEDURE

X-Ray Imaging

Undergo an x-ray

Trial Locations (6)

23298

VCU Massey Comprehensive Cancer Center, Richmond

77030

M D Anderson Cancer Center, Houston

78712

University of Texas at Austin, Austin

02215

Dana-Farber Cancer Institute, Boston

77555-0565

University of Texas Medical Branch, Galveston

M5G 2M9

University Health Network-Princess Margaret Hospital, Toronto

All Listed Sponsors
lead

National Cancer Institute (NCI)

NIH