The purpose of this study was to combine the PDR001 checkpoint inhibitor with several agents with immunomodulatory activity to identify the doses and schedule for combination therapy and to preliminarily assess the safety, tolerability, pharmacological and clinical activity of these combinations.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
298
UCLA Santa Monica Hematology / Oncology SC
Santa Monica, California, United States
Phase 1: Incidence of dose limiting toxicities (DLTs)
During the first two cycles Cycle = 28 days
Time frame: 5.5 years
Frequency of dose interruptions and reductions
Through study completion, an average of 6 months
Time frame: 5.5 years
Frequency and severity of treatment-emergent adverse events (AEs) and serious adverse events (SAEs)
Through study completion, an average of 6 months
Time frame: 6 years
Changes between baseline and post-baseline laboratory parameters and vital signs
Through study completion, an average of 6 months
Time frame: 6 years
Dose intensities
Through study completion, an average of 6 months
Time frame: 6 years
Changes from baseline in ECG parameters in patients recieving PDR001 in combination with Panobinostat
Baseline and end of treatment, an average of 6 months
Time frame: 6 years
Best overall response (BOR)
per RECIST v1.1
Time frame: 6 years
Time to reach max concentration (Tmax) for PDR001
Time frame: 6 years
Presence of anti-PDR001 antibodies
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Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
The Regents of the University of Michigan
Ann Arbor, Michigan, United States
Washington University Medical School SC
St Louis, Missouri, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, United States
UT Health San Antonio Mays Cancer Center
San Antonio, Texas, United States
Huntsman Cancer Institute
Salt Lake City, Utah, United States
Seattle Cancer Care Alliance
Seattle, Washington, United States
Novartis Investigative Site
Jena, Germany
...and 15 more locations
Time frame: 6 years
Progression free survival (PFS)
per RECIST v1.1
Time frame: 6 years
Treatment Free Survival (TFS)
Time frame: 6 years
Maximum and minimum plasma concentrations of LCL161 (Cmax and Cmin)
Cycle 1 through cycle 6 in treatment period 1, an average of 6 months
Time frame: 6 years
Maximum and minimum Plasma concentrations of everolimus (Cmax and Cmin)
Cycle 1 through cycle 6 in treatment period 1, an average of 6 months
Time frame: 6 years
Maximum and minimum plasma concentrations of panobinostat (Cmax and Cmin)
Cycle 1 through cycle 6 in treatment period 1, an average of 6 months
Time frame: 6 years
Concentration of anti-PDR001 antibodies
Cycle 1 through cycle 6 in treatment period 1 and 2, an average of 6 months
Time frame: 6 years
Maximum and minimum serum concentration of PDR001 (Cmax and Cmin)
Cycle 1 through cycle 6 in treatment period 1 and 2, an average of 6 months
Time frame: 6 years
Area under the concentration-time curve calculated to the last concentration point (AUClast) for PDR001, as applicable
Cycle 1 through cycle 6 in treatment period 1 and 2, an average of 6 months
Time frame: 6 years
Progression free survival (PFS) per irRC
Time frame: 6 years
Area under the concentration-time curve calculated to the last concentration point (AUClast) for LCL161, as applicable
Cycle 1 through cycle 6 in treatment period 1, an average of 6 months
Time frame: 6 years
Time to reach max concentration (Tmax) for LCL161
Cycle 1 through cycle 6 in treatment period 1, an average of 6 months
Time frame: 6 years
Time to reach max concentration (Tmax) for Everolimus
Cycle 1 through cycle 6 in treatment period 1, an average of 6 months
Time frame: 6 years
Time to reach max concentration (Tmax) for Panobinostat
Cycle 1 through cycle 6 in treatment period 1, an average of 6 months
Time frame: 6 years
Area under the concentration-time curve calculated to the last concentration point (AUClast) for Everolimus, as applicable
Cycle 1 through cycle 6 in treatment period 1, an average of 6 months
Time frame: 6 years
Area under the concentration-time curve calculated to the last concentration point (AUClast) for Panobinostat, as applicable
Cycle 1 through cycle 6 in treatment period 1, an average of 6 months
Time frame: 6 years
Maximum and minimum Plasma concentrations of QBM076 (Cmax and Cmin)
Cycle 1 through cycle 6 in treatment period 1, an average of 6 months
Time frame: 6 years
Maximum and minimum Plasma concentrations of HDM201 (Cmax and Cmin)
Cycle 1 through cycle 6 in treatment period 1, an average of 6 months
Time frame: 6 years
Time to reach max concentration (Tmax) for QBM076
Cycle 1 through cycle 6 in treatment period 1, an average of 6 months
Time frame: 6 years
Time to reach max concentration (Tmax) for HDM201
Cycle 1 through cycle 6 in treatment period 1, an average of 6 months
Time frame: 6 years
Area under the concentration-time curve calculated to the last concentration point (AUClast) for QBM076, as applicable
Cycle 1 through cycle 6 in treatment period 1, an average of 6 months
Time frame: 6 years
Area under the concentration-time curve calculated to the last concentration point (AUClast) for HDM201, as applicable
Cycle 1 through cycle 6 in treatment period 1, an average of 6 months
Time frame: 6 years