check_circleStudy Completed
Non-small cell lung cancer (NSCLC), Head and neck squamous cell carcinoma (HNSCC), Hepatocellular carcinoma (HCC)
Bayer Identifier:
19769
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
An study to evaluate the safety and efficacy of copanlisib in combination with nivolumab in patients with advanced solid tumors
Trial purpose
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.
Key Participants Requirements
Sex
AllAge
18 - N/ATrial summary
Enrollment Goal
16Trial Dates
October 2018 - October 2022Phase
Phase 1Could I Receive a placebo
NoProducts
Aliqopa (Copanlisib, BAY80-6946)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Rhode Island Hospital | Providence, 20903, United States |
Completed | Orthopaedic Institute for Children | Los Angeles, 90001, United States |
Completed | Gabrail Cancer Center | Canton, 44718, United States |
Completed | Princess Margaret Cancer Centre | Toronto, M5G 1Z5, Canada |
Completed | Rocky Mountain Cancer Centers / Denver, CO | Denver, 80218, United States |
Completed | Tower Hematology/Oncology Medical Group | Beverly Hills, 90211-1850, United States |
Withdrawn | Charleston Hematology & Oncology Associates, PA | Charleston, 29414, United States |
Withdrawn | University of Toledo Medical Center | Toledo, 43614, United States |
Withdrawn | Texas Oncology-Fort Worth | Fort Worth, 76104, United States |
Withdrawn | Willamette Valley Cancer Institute and Research Center | Eugene, 97401, United States |
Withdrawn | Beverly Hills Cancer Center | Beverly Hills, 92663, United States |
Primary Outcome
- Phase 1b: Frequency of dose limiting toxicities (DLT) at each dose level associated with administration of copanlisib and nivolumabdate_rangeTime 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 investigatordate_rangeTime Frame:Up to 26 months
Secondary Outcome
- Phase 1b: Overall response rate (ORR) as per RECIST v 1.1 (by local investigator assessment)date_rangeTime Frame:Up to 26 months
- Phase 1b and 2:Maximum drug concentration in plasma (Cmax) of copanlisibdate_rangeTime Frame:At cycle1 day15, cycle2 day15, cycle 6 day15
- Phase 1b and 2:Area under the curve (AUC) of copanlisibdate_rangeTime Frame:At cycle1 day15, cycle2 day15,cycle 6 day15
- Phase 1b and 2: Cmax for nivolumabdate_rangeTime Frame:At cycle1 day15, cycle2 day15,cycle 6 day15
- Phase 1b and 2: Minimum plasma drug concentration (Cmin) for nivolumabdate_rangeTime Frame:At cycle1 day15, cycle2 day15,cycle 6 day15
- Phase 1b and 2: Overall survival (OS)date_rangeTime Frame:Up to 26 months
- Phase 1b and 2: Progression-free survival (PFS)date_rangeTime Frame:Up to 26 months
- Phase 1b and 2: Disease control rate (DCR)date_rangeTime Frame:Up to 26 months
- Phase 1b and 2: Duration of stable disease (DSD)date_rangeTime Frame:Up to 26 months
- Phase 1b and 2: Time to response (TTR)date_rangeTime Frame:Up to 26 months
- Phase 1b and 2: Time to progression (TTP)date_rangeTime Frame:Up to 26 months
- Phase 1b and 2: Duration of response (DOR)date_rangeTime Frame:Up to 26 months
- Phase 1b and 2:Number of participants with Adverse events (AE) and Serious AEs (SAE)date_rangeTime 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 intervalsdate_rangeTime Frame:Up to 26 months
- Phase 1b and 2:Number of participants with changes in dose including interruptions, reductions and dose intensitydate_rangeTime Frame:Up to 26 months
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
Non-randomizedBlinding
N/AAssignment
Sequential AssignmentTrial Arms
2