Clinical trial NCT02754141: An Investigational Immuno-therapy Study of Experimental Medication BMS-986179 Given Alone and in Combination With Nivolumab
Official title: A Phase 1/2a Study of BMS-986179 Administered Alone and in Combination With Nivolumab (BMS-936558) in Subjects With Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Malignant Solid Tumor
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2016-04-28
Enrollment: 235
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With Drug Related AEs, SAEs, AEs Leading to Discontinuation and Deaths.
timeFrame: 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:
measure: Number of Participants With a Best Overall Response (BOR) at Week 24
timeFrame: from initial treatment to week 24
measure: Percentage of Participants With an Objective Response Rate (ORR) at Week 24
timeFrame: from initial treatment to week 24
measure: Progression Free Survival Rate (PFSR) at Week 24
timeFrame: from initial treatment to week 24
measure: Median Duration of Response (DOR)
timeFrame: from first measure response approximately up to 25 months
measure: Cmax
timeFrame: 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
measure: Tmax
timeFrame: 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
measure: AUC (0-T)
timeFrame: 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
measure: AUC (Tau)
timeFrame: 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
measure: Ctau
timeFrame: 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
measure: Mean Change From Baseline in CD73 Assays
timeFrame: approximately up to 95 weeks
measure: Number of Participants With a Positive Anti-drug Antibody (ADA) Test.
timeFrame: 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
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Local Institution - 0028
state: Illinois
city: Baltimore
country: United States
facility: Local Institution - 0001
state: Maryland
city: Boston
country: United States
facility: Local Institution - 0022
state: Massachusetts
city: Buffalo
country: United States
facility: Local Institution - 0023
state: New York
city: New York
country: United States
facility: Local Institution - 0005
state: New York
city: Pittsburgh
country: United States
facility: Local Institution - 0020
state: Pennsylvania
city: Nashville
country: United States
facility: Local Institution - 0004
state: Tennessee
city: Dallas
country: United States
facility: Local Institution - 0009
state: Texas
city: Randwick
country: Australia
facility: Local Institution - 0019
state: New South Wales
city: Sydney
country: Australia
facility: Local Institution - 0017
state: New South Wales
city: Melbourne
country: Australia
facility: Local Institution - 0018
state: Victoria
city: Ottawa
country: Canada
facility: Local Institution - 0003
state: Ontario
city: Toronto
country: Canada
facility: Local Institution - 0002
state: Ontario
city: Montreal
country: Canada
facility: Local Institution - 0024
state: Quebec
city: Montreal
country: Canada
facility: Local Institution - 0014
state: Quebec
city: Marseille Cedex 5
country: France
facility: Local Institution - 0021
city: Marseille
country: France
facility: Local Institution - 0033
city: Toulouse Cedex 9
country: France
facility: Local Institution - 0008
city: Villejuif Cedex
country: France
facility: Local Institution - 0007
city: Freiburg
country: Germany
facility: Local Institution - 0016
city: Munich
country: Germany
facility: Local Institution - 0015
city: Napoli
country: Italy
facility: Local Institution - 0012
city: Padova
country: Italy
facility: Local Institution - 0013
city: Amsterdam
country: Netherlands
facility: Local Institution - 0006
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: