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

Outcomes
Primary outcome [1] 0 0
Number of Participants With Drug Related AEs, SAEs, AEs Leading to Discontinuation and Deaths.
Timepoint [1] 0 0
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.
Secondary outcome [1] 0 0
Number of Participants With a Best Overall Response (BOR) at Week 24
Timepoint [1] 0 0
from initial treatment to week 24
Secondary outcome [2] 0 0
Percentage of Participants With an Objective Response Rate (ORR) at Week 24
Timepoint [2] 0 0
from initial treatment to week 24
Secondary outcome [3] 0 0
Progression Free Survival Rate (PFSR) at Week 24
Timepoint [3] 0 0
from initial treatment to week 24
Secondary outcome [4] 0 0
Median Duration of Response (DOR)
Timepoint [4] 0 0
from first measure response approximately up to 25 months
Secondary outcome [5] 0 0
Cmax
Timepoint [5] 0 0
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
Secondary outcome [6] 0 0
Tmax
Timepoint [6] 0 0
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
Secondary outcome [7] 0 0
AUC (0-T)
Timepoint [7] 0 0
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
Secondary outcome [8] 0 0
AUC (Tau)
Timepoint [8] 0 0
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
Secondary outcome [9] 0 0
Ctau
Timepoint [9] 0 0
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
Secondary outcome [10] 0 0
Mean Change From Baseline in CD73 Assays
Timepoint [10] 0 0
approximately up to 95 weeks
Secondary outcome [11] 0 0
Number of Participants With a Positive Anti-drug Antibody (ADA) Test.
Timepoint [11] 0 0
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

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
Sex
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
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
21/06/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
12/10/2021
Sample size
Target
Accrual to date
Final
235
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Local Institution - 0019 - Randwick
Recruitment hospital [2] 0 0
Local Institution - 0017 - Sydney
Recruitment hospital [3] 0 0
Local Institution - 0018 - Melbourne
Recruitment postcode(s) [1] 0 0
2031 - Randwick
Recruitment postcode(s) [2] 0 0
2010 - Sydney
Recruitment postcode(s) [3] 0 0
3004 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Illinois
Country [2] 0 0
United States of America
State/province [2] 0 0
Maryland
Country [3] 0 0
United States of America
State/province [3] 0 0
Massachusetts
Country [4] 0 0
United States of America
State/province [4] 0 0
New York
Country [5] 0 0
United States of America
State/province [5] 0 0
Pennsylvania
Country [6] 0 0
United States of America
State/province [6] 0 0
Tennessee
Country [7] 0 0
United States of America
State/province [7] 0 0
Texas
Country [8] 0 0
Canada
State/province [8] 0 0
Ontario
Country [9] 0 0
Canada
State/province [9] 0 0
Quebec
Country [10] 0 0
France
State/province [10] 0 0
Marseille Cedex 5
Country [11] 0 0
France
State/province [11] 0 0
Marseille
Country [12] 0 0
France
State/province [12] 0 0
Toulouse Cedex 9
Country [13] 0 0
France
State/province [13] 0 0
Villejuif Cedex
Country [14] 0 0
Germany
State/province [14] 0 0
Freiburg
Country [15] 0 0
Germany
State/province [15] 0 0
Munich
Country [16] 0 0
Italy
State/province [16] 0 0
Napoli
Country [17] 0 0
Italy
State/province [17] 0 0
Padova
Country [18] 0 0
Netherlands
State/province [18] 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/study/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
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

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