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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02754141




Registration number
NCT02754141
Ethics application status
Date submitted
22/04/2016
Date registered
28/04/2016
Date last updated
24/03/2020

Titles & IDs
Public title
An Investigational Immuno-therapy Study of Experimental Medication BMS-986179 Given Alone and in Combination With Nivolumab
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
Secondary ID [1] 0 0
2016-000603-91
Secondary ID [2] 0 0
CA013-004
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Malignant Solid Tumor 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - BMS-986179
Other interventions - Nivolumab
Other interventions - 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


Other interventions: BMS-986179
Specified dose on specified days

Other interventions: Nivolumab
Specified dose on specified days

Other interventions: rHuPH20
Specified dose on specified days

Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of adverse events (AE), serious adverse events (SAE), AEs leading to discontinuation, and deaths
Timepoint [1] 0 0
Up to 100 days after the last dose of study drug
Secondary outcome [1] 0 0
The effect of BMS-986179 on CD73 enzymatic activity in pre- and on-treatment biopsies
Timepoint [1] 0 0
Approximately 63 days
Secondary outcome [2] 0 0
The effect of BMS-986179 on CD73 protein expression in pre- and on-treatment biopsies
Timepoint [2] 0 0
Approximately 63 days
Secondary outcome [3] 0 0
Objective response rate (ORR)
Timepoint [3] 0 0
Approximately 2 years
Secondary outcome [4] 0 0
Duration of response (DOR)
Timepoint [4] 0 0
Approximately 2 years
Secondary outcome [5] 0 0
Progression free survival rate (PFSR)
Timepoint [5] 0 0
Approximately 2 years
Secondary outcome [6] 0 0
Maximum observed serum concentration (Cmax)
Timepoint [6] 0 0
Up to 100 days after the last dose of study drug
Secondary outcome [7] 0 0
Time of maximum observed serum concentration (Tmax)
Timepoint [7] 0 0
Up to 100 days after the last dose of study drug
Secondary outcome [8] 0 0
Area under the serum concentration-time curve from time zero to time of the last quantifiable concentration [AUC(0-T)]
Timepoint [8] 0 0
Up to 100 days after the last dose of study drug
Secondary outcome [9] 0 0
Area under the serum concentration-time curve in 1 dosing interval [AUC(TAU)]
Timepoint [9] 0 0
Up to 100 days after the last dose of study drug
Secondary outcome [10] 0 0
Apparent terminal half-life (T-HALF)
Timepoint [10] 0 0
Up to 100 days after the last dose of study drug
Secondary outcome [11] 0 0
Area under the serum concentration-time curve from time zero extrapolated to infinite time [AUC(INF)]
Timepoint [11] 0 0
Up to 100 days after the last dose of study drug
Secondary outcome [12] 0 0
Effective elimination half-life (T-HALFeff)
Timepoint [12] 0 0
Up to 100 days after the last dose of study drug
Secondary outcome [13] 0 0
Concentration at the end of the dosing interval (Ctau)
Timepoint [13] 0 0
Up to 100 days after the last dose of study drug
Secondary outcome [14] 0 0
Trough observed serum concentration at the end of the dosing interval (Ctrough)
Timepoint [14] 0 0
Up to 100 days after the last dose of study drug
Secondary outcome [15] 0 0
Total body clearance (CLT)
Timepoint [15] 0 0
Up to 100 days after the last dose of study drug
Secondary outcome [16] 0 0
Volume of distribution at steady state (Vss)
Timepoint [16] 0 0
Up to 100 days after the last dose of study drug
Secondary outcome [17] 0 0
Accumulation index (AI)
Timepoint [17] 0 0
Up to 100 days after the last dose of study drug
Secondary outcome [18] 0 0
Apparent volume of distribution of terminal phase (Vz)
Timepoint [18] 0 0
Up to 100 days after the last dose of study drug
Secondary outcome [19] 0 0
Degree of fluctuation or fluctuation index (DF)
Timepoint [19] 0 0
Up to 100 days after the last dose of study drug
Secondary outcome [20] 0 0
Frequency of positive anti-drug antibody (ADA) to BMS-986179
Timepoint [20] 0 0
Up to 100 days after the last dose of study drug
Secondary outcome [21] 0 0
Frequency of positive anti-drug antibody (ADA) to nivolumab
Timepoint [21] 0 0
Up to 100 days after the last dose of study drug

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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1/Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
The Kinghorn Cancer Centre - Darlinghurst
Recruitment hospital [2] 0 0
Scientia Clinical Research Limited - Randwick
Recruitment hospital [3] 0 0
Local Institution - Melbourne
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
2031 - Randwick
Recruitment postcode(s) [3] 0 0
3004 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Connecticut
Country [2] 0 0
United States of America
State/province [2] 0 0
Illinois
Country [3] 0 0
United States of America
State/province [3] 0 0
Maryland
Country [4] 0 0
United States of America
State/province [4] 0 0
Massachusetts
Country [5] 0 0
United States of America
State/province [5] 0 0
New York
Country [6] 0 0
United States of America
State/province [6] 0 0
Oklahoma
Country [7] 0 0
United States of America
State/province [7] 0 0
Pennsylvania
Country [8] 0 0
United States of America
State/province [8] 0 0
Tennessee
Country [9] 0 0
United States of America
State/province [9] 0 0
Texas
Country [10] 0 0
Canada
State/province [10] 0 0
Ontario
Country [11] 0 0
Canada
State/province [11] 0 0
Quebec
Country [12] 0 0
France
State/province [12] 0 0
Marseille Cedex 5
Country [13] 0 0
France
State/province [13] 0 0
Toulouse Cedex 9
Country [14] 0 0
France
State/province [14] 0 0
Villejuif Cedex
Country [15] 0 0
Germany
State/province [15] 0 0
Freiburg
Country [16] 0 0
Germany
State/province [16] 0 0
Munich
Country [17] 0 0
Italy
State/province [17] 0 0
Napoli
Country [18] 0 0
Italy
State/province [18] 0 0
Padova
Country [19] 0 0
Netherlands
State/province [19] 0 0
Amsterdam

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Bristol-Myers Squibb
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/show/NCT02754141
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bristol-Myers Squibb
Address 0 0
Bristol-Myers Squibb
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email:
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Clinical.Trials@bms.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT02754141