An Investigational Immuno-therapy Study of Experimental Medication BMS-986179 Given Alone and in Combination With Nivolumab
A Phase 1/2a Study of BMS-986179 Administered Alone and in Combination With Nivolumab (BMS-936558) in Subjects With Advanced Solid Tumors
2 other identifiers
interventional
235
7 countries
24
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 Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jun 2016
Longer than P75 for phase_1
24 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 22, 2016
CompletedFirst Posted
Study publicly available on registry
April 28, 2016
CompletedStudy Start
First participant enrolled
June 21, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 12, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
October 12, 2021
CompletedResults Posted
Study results publicly available
April 5, 2023
CompletedApril 5, 2023
March 1, 2023
5.3 years
April 22, 2016
October 12, 2022
March 10, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (11)
Number of Participants With a Best Overall Response (BOR) at Week 24
from initial treatment to week 24
Percentage of Participants With an Objective Response Rate (ORR) at Week 24
from initial treatment to week 24
Progression Free Survival Rate (PFSR) at Week 24
from initial treatment to week 24
Median Duration of Response (DOR)
from first measure response approximately up to 25 months
Cmax
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
- +6 more secondary outcomes
Study Arms (3)
Arm A-Monotherapy
EXPERIMENTALBMS-986179, dose as specified
Arm B- Combination Therapy
EXPERIMENTALBMS-986179 + nivolumab, dose as specified
Arm C-Combination Therapy
EXPERIMENTALBMS-986179 + rHuPH20, dose as specified
Interventions
Specified dose on specified days
Specified dose on specified days
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Central nervous system (CNS) tumors
- Uncontrolled or significant cardiovascular diseases
- Active or known autoimmune disease
- Organ transplant
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (24)
Local Institution - 0028
Chicago, Illinois, 60611, United States
Local Institution - 0001
Baltimore, Maryland, 21287, United States
Local Institution - 0022
Boston, Massachusetts, 02215, United States
Local Institution - 0023
Buffalo, New York, 14263, United States
Local Institution - 0005
New York, New York, 10032, United States
Local Institution - 0020
Pittsburgh, Pennsylvania, 15232, United States
Local Institution - 0004
Nashville, Tennessee, 37203, United States
Local Institution - 0009
Dallas, Texas, 75230, United States
Local Institution - 0019
Randwick, New South Wales, 2031, Australia
Local Institution - 0017
Sydney, New South Wales, 2010, Australia
Local Institution - 0018
Melbourne, Victoria, 3004, Australia
Local Institution - 0003
Ottawa, Ontario, K1H 8L6, Canada
Local Institution - 0002
Toronto, Ontario, M5G 1Z5, Canada
Local Institution - 0024
Montreal, Quebec, H2X 3E4, Canada
Local Institution - 0014
Montreal, Quebec, H3T 1E2, Canada
Local Institution - 0033
Marseille, 13273, France
Local Institution - 0021
Marseille, 13385, France
Local Institution - 0008
Toulouse, 31059, France
Local Institution - 0007
Villejuif, 94805, France
Local Institution - 0016
Freiburg im Breisgau, 79106, Germany
Local Institution - 0015
Munich, 81675, Germany
Local Institution - 0012
Napoli, 80131, Italy
Local Institution - 0013
Padua, Padova, Italy
Local Institution - 0006
Amsterdam, 1066 CX, Netherlands
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Bristol-Myers Squibb Study Director
- Organization
- Bristol-Myers Squibb
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 22, 2016
First Posted
April 28, 2016
Study Start
June 21, 2016
Primary Completion
October 12, 2021
Study Completion
October 12, 2021
Last Updated
April 5, 2023
Results First Posted
April 5, 2023
Record last verified: 2023-03