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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02754141
Other study ID # CA013-004
Secondary ID 2016-000603-91
Status Completed
Phase Phase 1/Phase 2
First received
Last updated
Start date June 21, 2016
Est. completion date October 12, 2021

Study information

Verified date March 2023
Source Bristol-Myers Squibb
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 235
Est. completion date October 12, 2021
Est. primary completion date October 12, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: - 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 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


Related Conditions & MeSH terms


Intervention

Biological:
BMS-986179
Specified dose on specified days
Nivolumab
Specified dose on specified days
rHuPH20
Specified dose on specified days

Locations

Country Name City State
Australia Local Institution - 0018 Melbourne Victoria
Australia Local Institution - 0019 Randwick New South Wales
Australia Local Institution - 0017 Sydney New South Wales
Canada Local Institution - 0014 Montreal Quebec
Canada Local Institution - 0024 Montreal Quebec
Canada Local Institution - 0003 Ottawa Ontario
Canada Local Institution - 0002 Toronto Ontario
France Local Institution - 0033 Marseille
France Local Institution - 0021 Marseille Cedex 5
France Local Institution - 0008 Toulouse Cedex 9
France Local Institution - 0007 Villejuif Cedex
Germany Local Institution - 0016 Freiburg
Germany Local Institution - 0015 Munich
Italy Local Institution - 0012 Napoli
Italy Local Institution - 0013 Padova
Netherlands Local Institution - 0006 Amsterdam
United States Local Institution - 0001 Baltimore Maryland
United States Local Institution - 0022 Boston Massachusetts
United States Local Institution - 0023 Buffalo New York
United States Local Institution - 0028 Chicago Illinois
United States Local Institution - 0009 Dallas Texas
United States Local Institution - 0004 Nashville Tennessee
United States Local Institution - 0005 New York New York
United States Local Institution - 0020 Pittsburgh Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Australia,  Canada,  France,  Germany,  Italy,  Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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 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. from initial treatment to week 24
Secondary 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. from initial treatment to week 24
Secondary 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. from initial treatment to week 24
Secondary 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. from first measure response approximately up to 25 months
Secondary Cmax Cmax is defined as maximum plasma concentration of the drug 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 Tmax Tmax is defined is the time to maximum plasma concentration 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 AUC (0-T) Area under the plasma concentration time-curve. AUC from time 0 to the last time of quantifiable concentration 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 AUC (Tau) Area under the plasma concentration time-curve. AUC over the dosing interval. 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 Ctau Ctau is defined as the concentration of study drug at the end of the dosing interval 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 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.
approximately up to 95 weeks
Secondary 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. 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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