Clinical trial NCT02658890: An Investigational Immuno-therapy Study of BMS-986205 Given in Combination With Nivolumab and in Combination With Both Nivolumab and Ipilimumab in Cancers That Are Advanced or Have Spread
Official title: A Phase 1/2a Study of BMS-986205 Administered in Combination With Nivolumab (Anti-PD-1 Monoclonal Antibody) and in Combination With Both Nivolumab and Ipilimumab (Anti-CTLA-4 Monoclonal Antibody) in Advanced Malignant Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Advanced Cancer
Melanoma
Non-Small Cell Lung Cancer
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2016-01-20
Enrollment: 627
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to determine safety and effectiveness of experimental medication BMS-986205 when combined with Nivolumab and in combination with both Nivolumab and Ipilimumab in patients with cancers that are advanced or have spread. Pharmacokinetics and pharmacodynamics of BMS-986205 when combined with Nivolumab and in combination with Nivolumab and Ipilimumab in this patient population will also be assessed.


Eligibility criteria: For more information regarding Bristol-Myers Squibb (BMS) Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* During dose escalation, subjects with advanced solid tumors that have progressed following at least one standard regimen
* During cohort expansion, subjects with advanced cancer that either have received at least one prior therapy or are treatment naive, depending on the specified tumor type
* Subjects must have measurable disease
* Subject must consent to provide previously collected tumor tissue and a tumor biopsy during screening.
* At least 4 weeks since any previous treatment for cancer
* Must be able to swallow pills or capsules
* Eastern Cooperative Oncology Group(ECOG) Performance Status 0-1

Exclusion Criteria:

* Active or chronic autoimmune diseases
* Uncontrolled or significant cardiovascular disease
* History of any chronic Hepatitis, active Hepatitis B or C, human immunodeficiency virus (HIV), or acquired immune deficiency syndrome (AIDS)
* Chronic hepatitis: Positive test for Hepatitis B virus surface antigen or Hepatitis C antibody (except for subjects with hepatocellular carcinoma)
* Active central nervous system (CNS) metastases and CNS metastases as the only sites of disease
* Active infection

Other protocol defined inclusion/exclusion criteria could apply

Primary outcomes:
measure: Number of Participants With AEs, SAEs, AEs Leading to Discontinuation and Deaths
timeFrame: From first dose to 100 days after last dose (up to 15 months)
measure: Number of Treated Participant With Laboratory Abnormalities - Thyroid
timeFrame: From first dose to 100 days after last dose (up to 15 months)
measure: Number of Treated Participant With Laboratory Abnormalities - Liver
timeFrame: From first dose to 100 days after last dose (up to 15 months)
measure: Number of Participants With a Best Overall Response (BOR) - Parts 2 and 3
timeFrame: From first dose to the last tumor assessment prior to subsequent therapy (up to a maximum of 185 weeks)
measure: Percentage of Participants With an Objective Response Rate (ORR)- Parts 2 and 3
timeFrame: From first dose to the last tumor assessment prior to subsequent therapy (up to a maximum of 185 weeks)
measure: Median Duration of Response (DoR) - Parts 2 and 3
timeFrame: From first dose to the date of disease progression, death, or until participants withdraw from the study, whichever occurs first (up to a maximum of 185 weeks)
measure: Progression Free Survival Rate (PFSR) at 24 Weeks - Parts 2 and 3
timeFrame: At 24 weeks after first dose
measure: Progression Free Survival Rate (PFSR) at 1 Year - Parts 2 and 3
timeFrame: At 1 year
measure: Progression Free Survival Rate (PFSR) at 2 Years - Parts 2 and 3
timeFrame: At 2 years
Secondary outcomes:
measure: Cmax
timeFrame: At cycle 0 day 1 and day 14 [cycle 0= up to 2 weeks]
measure: Tmax
timeFrame: At cycle 0 day 1 and day 14 [cycle 0= up to 2 weeks]
measure: AUC(TAU)
timeFrame: Cycle 0 Day 1 (0, 1, 2, 3, 4, 6, 8, 24 hours post-dose), Cycle 0 Day 14 (0, 1, 2, 3, 4, 6, 8, 24 hours post-dose)
measure: Ctrough
timeFrame: At cycles 0 [up to 2 weeks] and at cycles 3, 5, 7, 10, 11, 13, 15 [each cycle is up to 4 weeks]
measure: CLT/F
timeFrame: At Cycle 0 Day 14 [cycle 0 = up to 2 weeks]
measure: Accumulation Index (AI) - AUC(TAU)
timeFrame: Cycle 0 Day 1 (0, 1, 2, 3, 4, 6, 8, 24 hours post-dose), Cycle 0 Day 14 (0, 1, 2, 3, 4, 6, 8, 24 hours post-dose)
measure: Accumulation Index (AI) - Cmax
timeFrame: At Cycle 0 Day 14 [cycle 0 = up to 2 weeks]
measure: Change From Baseline in Serum Kynurenine
timeFrame: At baseline (cycle 1, day 1) and at cycle 1, day 15 [cycle 1 = up to 4 weeks]
measure: Percent Change From Baseline in Serum Kynurenine
timeFrame: At baseline (cycle 1, day 1) and at cycle 1, day 15 [cycle 1 = up to 4 weeks]
measure: Number of Participants With a Best Overall Response (BOR) - Part 1 and Clinical Pharmacology Substudies
timeFrame: From first dose to the last tumor assessment prior to subsequent therapy (up to a maximum of 185 weeks)
measure: Percentage of Participants With an Objective Response Rate (ORR) - Part 1 and Clinical Pharmacology Substudies
timeFrame: From first dose to the last tumor assessment prior to subsequent therapy (up to a maximum of 185 weeks)
measure: Median Duration of Response (DoR) - Part 1 and Clinical Pharmacology Substudies
timeFrame: From first dose to the last tumor assessment prior to subsequent therapy (up to a maximum of 185 weeks)
measure: Progression Free Survival Rate (PFSR) at 24 Weeks - Part 1 and Clinical Pharmacology Substudies
timeFrame: At 24 weeks after first dose
measure: Progression Free Survival Rate (PFSR) at 1 Year - Part 1 and Clinical Pharmacology Substudies
timeFrame: At 1 year
measure: Progression Free Survival Rate (PFSR) at 2 Years - Part 1 and Clinical Pharmacology Substudies
timeFrame: At 2 years
measure: Number of Participants With a Positive Anti-Drug Antibody (ADA) Test
timeFrame: From first dose to last dose (up to approximately 48 weeks)
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Local Institution - 0028
state: Arizona
city: La Jolla
country: United States
facility: Local Institution - 0026
state: California
city: Tampa
country: United States
facility: Local Institution - 0035
state: Florida
city: Atlanta
country: United States
facility: Local Institution - 0005
state: Georgia
city: Atlanta
country: United States
facility: Local Institution - 0048
state: Georgia
city: Chicago
country: United States
facility: Local Institution - 0027
state: Illinois
city: Lutherville
country: United States
facility: Local Institution - 0051
state: Maryland
city: Detroit
country: United States
facility: Local Institution - 0049
state: Michigan
city: Saint Louis
country: United States
facility: Local Institution - 0006
state: Missouri
city: Hackensack
country: United States
facility: Local Institution - 0033
state: New Jersey
city: New York
country: United States
facility: Local Institution - 0041
state: New York
city: Cleveland
country: United States
facility: Local Institution - 0030
state: Ohio
city: Philadelphia
country: United States
facility: Local Institution - 0034
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Local Institution - 0057
state: Pennsylvania
city: Nashville
country: United States
facility: Local Institution - 0043
state: Tennessee
city: North Sydney
country: Australia
facility: Local Institution - 0045
state: New South Wales
city: Sydney
country: Australia
facility: Local Institution - 0029
state: New South Wales
city: Westmead
country: Australia
facility: Local Institution - 0046
state: New South Wales
city: Brisbane
country: Australia
facility: Local Institution - 0044
state: Queensland
city: Clayton
country: Australia
facility: Local Institution - 0008
state: Victoria
city: Melbourne
country: Australia
facility: Local Institution - 0004
state: Victoria
city: Nedlands
country: Australia
facility: Local Institution - 0047
state: Western Australia
city: Edmonton
country: Canada
facility: Local Institution - 0003
state: Alberta
city: Vancouver
country: Canada
facility: Local Institution - 0002
state: British Columbia
city: Toronto
country: Canada
facility: Local Institution - 0001
state: Ontario
city: Greenfield Park
country: Canada
facility: Local Institution
state: Quebec
city: Montreal
country: Canada
facility: Local Institution - 0036
state: Quebec
city: Helsinki
country: Finland
facility: Local Institution - 0059
city: Lille CEDEX
country: France
facility: Local Institution - 0040
city: Lyon Cedex 08
country: France
facility: Local Institution - 0024
city: Marseille Cedex 5
country: France
facility: Local Institution - 0053
city: Nantes Cedex 01
country: France
facility: Local Institution - 0052
city: Paris
country: France
facility: Local Institution - 0025
city: Toulouse
country: France
facility: Local Institution - 0023
city: Villejuif
country: France
facility: Local Institution - 0022
city: Essen
country: Germany
facility: Local Institution - 0019
city: Heilbronn
country: Germany
facility: Local Institution - 0013
city: Milano
country: Italy
facility: Local Institution - 0010
city: Milano
country: Italy
facility: Local Institution - 0011
city: Milano
country: Italy
facility: Local Institution - 0012
city: Rozzano MI
country: Italy
facility: Local Institution - 0009
city: Oslo
country: Norway
facility: Local Institution - 0054
city: Warszawa
country: Poland
facility: Local Institution - 0042
state: Mazowieckie
city: Barcelona
country: Spain
facility: Local Institution - 0017
city: Madrid
country: Spain
facility: Local Institution - 0016
city: Madrid
country: Spain
facility: Local Institution - 0018
city: Solna
country: Sweden
facility: Local Institution - 0055
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: