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.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
16
Copanlisib: lyophilisate for reconstitution and further dilution for infusion
Nivolumab: concentrate for solution for infusion
Tower Hematology/Oncology Medical Group
Beverly Hills, California, United States
Orthopaedic Institute for Children
Los Angeles, California, United States
Rocky Mountain Cancer Centers / Denver, CO
Denver, Colorado, United States
Gabrail Cancer Center
Canton, Ohio, United States
Phase 1b: Frequency of dose limiting toxicities (DLT) at each dose level associated with administration of copanlisib and nivolumab
Time frame: At the end of Cycle 2 of a 28-day cycle
Phase 2: Overall response rate (ORR) as per RECIST v 1.1 (Response evaluation criteria in solid tumors, v 1.1) (by local investigator
Time frame: Up to 26 months
Phase 1b: Overall response rate (ORR) as per RECIST v 1.1 (by local investigator assessment)
Time frame: Up to 26 months
Phase 1b and 2:Maximum drug concentration in plasma (Cmax) of copanlisib
Time frame: At cycle1 day15, cycle2 day15, cycle 6 day15
Phase 1b and 2:Area under the curve (AUC) of copanlisib
Time frame: At cycle1 day15, cycle2 day15,cycle 6 day15
Phase 1b and 2: Cmax for nivolumab
Time frame: At cycle1 day15, cycle2 day15,cycle 6 day15
Phase 1b and 2: Minimum plasma drug concentration (Cmin) for nivolumab
Time frame: At cycle1 day15, cycle2 day15,cycle 6 day15
Phase 1b and 2: Overall survival (OS)
Time frame: Up to 26 months
Phase 1b and 2: Progression-free survival (PFS)
Time frame: Up to 26 months
Phase 1b and 2: Disease control rate (DCR)
Time frame: Up to 26 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Rhode Island Hospital
Providence, Rhode Island, United States
Princess Margaret Cancer Centre
Toronto, Ontario, Canada
Phase 1b and 2: Duration of stable disease (DSD)
Time frame: Up to 26 months
Phase 1b and 2: Time to response (TTR)
Time frame: Up to 26 months
Phase 1b and 2: Time to progression (TTP)
Time frame: Up to 26 months
Phase 1b and 2: Duration of response (DOR)
Time frame: Up to 26 months
Phase 1b and 2:Number of participants with Adverse events (AE) and Serious AEs (SAE)
Time frame: Up to 26 months
Phase 1b and 2:Number of participants with clinically significantly abnormal changes in electrocardiograms (ECG) including heart rate and measures PR, QRS, QT, and QTc intervals
Time frame: Up to 26 months
Phase 1b and 2:Number of participants with changes in dose including interruptions, reductions and dose intensity
Time frame: Up to 26 months