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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT02754141
Registration number
NCT02754141
Ethics application status
Date submitted
22/04/2016
Date registered
28/04/2016
Date last updated
5/04/2023
Titles & IDs
Public title
An Investigational Immuno-therapy Study of Experimental Medication BMS-986179 Given Alone and in Combination With Nivolumab
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Scientific title
A Phase 1/2a Study of BMS-986179 Administered Alone and in Combination With Nivolumab (BMS-936558) in Subjects With Advanced Solid Tumors
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Secondary ID [1]
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2016-000603-91
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Secondary ID [2]
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CA013-004
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Malignant Solid Tumor
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Other - BMS-986179
Treatment: Other - Nivolumab
Treatment: Other - rHuPH20
Experimental: Arm A-Monotherapy - BMS-986179, dose as specified
Experimental: Arm B- Combination Therapy - BMS-986179 + nivolumab, dose as specified
Experimental: Arm C-Combination Therapy - BMS-986179 + rHuPH20, dose as specified
Treatment: Other: BMS-986179
Specified dose on specified days
Treatment: Other: Nivolumab
Specified dose on specified days
Treatment: Other: rHuPH20
Specified dose on specified days
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Intervention code [1]
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Treatment: Other
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of Participants With Drug Related AEs, SAEs, AEs Leading to Discontinuation and Deaths.
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Assessment method [1]
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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
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Timepoint [1]
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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.
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Secondary outcome [1]
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Number of Participants With a Best Overall Response (BOR) at Week 24
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Assessment method [1]
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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.
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Timepoint [1]
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from initial treatment to week 24
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Secondary outcome [2]
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Percentage of Participants With an Objective Response Rate (ORR) at Week 24
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Assessment method [2]
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ORR is defined as the percentage of all treated participants whose BOR is either a CR or PR.
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Timepoint [2]
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from initial treatment to week 24
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Secondary outcome [3]
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Progression Free Survival Rate (PFSR) at Week 24
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Assessment method [3]
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PFSR at 24 weeks is defined as the percentage of treated participants remaining progression free and surviving at 24 weeks.
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Timepoint [3]
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from initial treatment to week 24
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Secondary outcome [4]
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Median Duration of Response (DOR)
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Assessment method [4]
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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.
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Timepoint [4]
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from first measure response approximately up to 25 months
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Secondary outcome [5]
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Cmax
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Assessment method [5]
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Cmax is defined as maximum plasma concentration of the drug
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Timepoint [5]
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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
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Secondary outcome [6]
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Tmax
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Assessment method [6]
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Tmax is defined is the time to maximum plasma concentration
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Timepoint [6]
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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
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Secondary outcome [7]
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AUC (0-T)
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Assessment method [7]
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Area under the plasma concentration time-curve. AUC from time 0 to the last time of quantifiable concentration
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Timepoint [7]
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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
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Secondary outcome [8]
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AUC (Tau)
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Assessment method [8]
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Area under the plasma concentration time-curve. AUC over the dosing interval.
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Timepoint [8]
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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
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Secondary outcome [9]
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Ctau
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Assessment method [9]
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Ctau is defined as the concentration of study drug at the end of the dosing interval
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Timepoint [9]
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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
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Secondary outcome [10]
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Mean Change From Baseline in CD73 Assays
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Assessment method [10]
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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.
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Timepoint [10]
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approximately up to 95 weeks
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Secondary outcome [11]
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Number of Participants With a Positive Anti-drug Antibody (ADA) Test.
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Assessment method [11]
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A participant with at least one ADA-positive sample relative to baseline at any time after initiation of treatment with BMS-986179 and nivolumab.
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Timepoint [11]
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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
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Eligibility
Key inclusion criteria
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
* Solid cancers that are advanced or have spread (for which alternative therapies were deemed not effective)
* Eastern Cooperative Oncology Group (ECOG) 0-1
* Acceptable lab testing results
* Allow biopsies
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Central nervous system (CNS) tumors
* Uncontrolled or significant cardiovascular diseases
* Active or known autoimmune disease
* Organ transplant
Other protocol defined inclusion/exclusion criteria could apply
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
21/06/2016
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
12/10/2021
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Sample size
Target
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Accrual to date
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Final
235
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Recruitment in Australia
Recruitment state(s)
NSW,VIC
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Recruitment hospital [1]
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Local Institution - 0019 - Randwick
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Recruitment hospital [2]
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Local Institution - 0017 - Sydney
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Recruitment hospital [3]
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Local Institution - 0018 - Melbourne
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Recruitment postcode(s) [1]
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2031 - Randwick
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Recruitment postcode(s) [2]
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2010 - Sydney
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Recruitment postcode(s) [3]
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3004 - Melbourne
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Illinois
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Country [2]
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United States of America
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State/province [2]
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Maryland
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Country [3]
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United States of America
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State/province [3]
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Massachusetts
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Country [4]
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United States of America
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State/province [4]
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New York
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Country [5]
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United States of America
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State/province [5]
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Pennsylvania
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Country [6]
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United States of America
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State/province [6]
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Tennessee
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Country [7]
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United States of America
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State/province [7]
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Texas
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Country [8]
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Canada
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State/province [8]
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Ontario
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Country [9]
0
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Canada
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State/province [9]
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Quebec
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Country [10]
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France
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State/province [10]
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Marseille Cedex 5
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Country [11]
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France
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State/province [11]
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Marseille
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Country [12]
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France
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State/province [12]
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Toulouse Cedex 9
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Country [13]
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France
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State/province [13]
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Villejuif Cedex
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Country [14]
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Germany
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State/province [14]
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Freiburg
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Country [15]
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Germany
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State/province [15]
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Munich
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Country [16]
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Italy
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State/province [16]
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Napoli
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Country [17]
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Italy
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State/province [17]
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Padova
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Country [18]
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Netherlands
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State/province [18]
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Amsterdam
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Bristol-Myers Squibb
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT02754141
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Bristol-Myers Squibb
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Address
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Bristol-Myers Squibb
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
Study Protocol and Statistical Analysis Plan
https://cdn.clinicaltrials.gov/large-docs/41/NCT02754141/Prot_SAP_000.pdf
Statistical analysis plan
Study Protocol and Statistical Analysis Plan
https://cdn.clinicaltrials.gov/large-docs/41/NCT02754141/Prot_SAP_000.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT02754141
Download to PDF