The purpose of this study is to assess the safety and tumor-shrinking ability of experimental medication BMS-986179 alone and when combined with Nivolumab, in patients with solid cancers that are advanced or have spread.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
235
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Local Institution - 0028
Chicago, Illinois, United States
Number of Participants With Drug Related AEs, SAEs, AEs Leading to Discontinuation and Deaths.
Number of participants with drug related adverse events (AE), drug related serious adverse events (SAE), drug related AEs Leading to discontinuation and drug related deaths
Time frame: From first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months.
Number of Participants With a Best Overall Response (BOR) at Week 24
Best overall response (BOR) is defined as the best response designation over the study as a whole, recorded between the dates of first dose until the last tumor assessment prior to subsequent therapy. CR or PR determinations included in the BOR assessment must be confirmed by a second scan performed no less than 4 weeks after the criteria for response are first met.
Time frame: from initial treatment to week 24
Percentage of Participants With an Objective Response Rate (ORR) at Week 24
ORR is defined as the percentage of all treated participants whose BOR is either a CR or PR.
Time frame: from initial treatment to week 24
Progression Free Survival Rate (PFSR) at Week 24
PFSR at 24 weeks is defined as the percentage of treated participants remaining progression free and surviving at 24 weeks.
Time frame: from initial treatment to week 24
Median Duration of Response (DOR)
DOR (computed for all treated subjects with a BOR of CR or PR) is defined as the time between the date of first response and the date of disease progression or death, whichever occurs first.
Time frame: from first measure response approximately up to 25 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Local Institution - 0001
Baltimore, Maryland, United States
Local Institution - 0022
Boston, Massachusetts, United States
Local Institution - 0023
Buffalo, New York, United States
Local Institution - 0005
New York, New York, United States
Local Institution - 0020
Pittsburgh, Pennsylvania, United States
Local Institution - 0004
Nashville, Tennessee, United States
Local Institution - 0009
Dallas, Texas, United States
Local Institution - 0019
Randwick, New South Wales, Australia
Local Institution - 0017
Sydney, New South Wales, Australia
...and 14 more locations
Cmax
Cmax is defined as maximum plasma concentration of the drug
Time frame: Part 1A Cycle 0 = 14 days Cycle 1 = 28 days Part 1B and Part 2 Q2W regimen Cycle 0 = 14 days Cycle 1 = 28 days Cycle 2 = 28 days Part 1B and 2 Q4W Regimen Cycle 1= 28 days Cycle 2 = 28 days Cycle 4 = 28 days
Tmax
Tmax is defined is the time to maximum plasma concentration
Time frame: Part 1A Cycle 0 = 14 days Cycle 1 = 28 days Part 1B and Part 2 Q2W regimen Cycle 0 = 14 days Cycle 1 = 28 days Cycle 2 = 28 days Part 1B and 2 Q4W Regimen Cycle 1= 28 days Cycle 2 = 28 days Cycle 4 = 28 days
AUC (0-T)
Area under the plasma concentration time-curve. AUC from time 0 to the last time of quantifiable concentration
Time frame: Part 1A Cycle 0 = 14 days Cycle 1 = 28 days Part 1B and Part 2 Q2W regimen Cycle 0 = 14 days Cycle 1 = 28 days Cycle 2 = 28 days Part 1B and 2 Q4W Regimen Cycle 1= 28 days Cycle 2 = 28 days Cycle 4 = 28 days
AUC (Tau)
Area under the plasma concentration time-curve. AUC over the dosing interval.
Time frame: Part 1A Cycle 0 = 14 days Cycle 1 = 28 days Part 1B and Part 2 Q2W regimen Cycle 0 = 14 days Cycle 1 = 28 days Cycle 2 = 28 days Part 1B and 2 Q4W Regimen Cycle 1= 28 days Cycle 2 = 28 days Cycle 4 = 28 days
Ctau
Ctau is defined as the concentration of study drug at the end of the dosing interval
Time frame: Part 1A Cycle 0 = 14 days Cycle 1 = 28 days Part 1B and Part 2 Q2W regimen Cycle 0 = 14 days Cycle 1 = 28 days Cycle 2 = 28 days Part 1B and 2 Q4W Regimen Cycle 1= 28 days Cycle 2 = 28 days Cycle 4 = 28 days
Mean Change From Baseline in CD73 Assays
Mean change from baseline in CD73 assays at the end of Part 1A treatment period Assays Measured: EHC CD73 H-score IHC CD73 Cytoplasm H-Score IHC CDS73 Membrane H-Score The H-score is given by the ratio of the weighted sum of the number of positive cells to the total number of detected cells. The H-score captures both the intensity and the proportion of the biomarker of interest from the IHC image and comprises values between 0 and 300. The lower the number equals a better prognosis.
Time frame: approximately up to 95 weeks
Number of Participants With a Positive Anti-drug Antibody (ADA) Test.
A participant with at least one ADA-positive sample relative to baseline at any time after initiation of treatment with BMS-986179 and nivolumab.
Time frame: From first dose to last dose: Part 1: up to 95 weeks, Part 2 SC: up to 62 weeks, RCC Mono: up to 108 weeks, Part 2: up to 104 weeks