Trial Review

Did you know?

The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02658890




Registration number
NCT02658890
Ethics application status
Date submitted
14/01/2016
Date registered
20/01/2016
Date last updated
28/08/2023

Titles & IDs
Public title
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
Scientific 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
Secondary ID [1] 0 0
2015-004914-79
Secondary ID [2] 0 0
CA017-003
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced Cancer 0 0
Melanoma 0 0
Non-Small Cell Lung Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Non small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Experimental: Combination Therapy (Dose Escalation) - BMS 986205 + Nivolumab specified dose at specified intervals.

Experimental: Combination Therapy (Dose Expansion) - BMS 986205 + Nivolumab specified dose at specified intervals.

Experimental: Combination Therapy 2 (Dose Expansion) - BMS 986205 + both Nivolumab and ipilimumab specified dose at specified intervals
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With AEs, SAEs, AEs Leading to Discontinuation and Deaths
Timepoint [1] 0 0
From first dose to 100 days after last dose (up to 15 months)
Primary outcome [2] 0 0
Number of Treated Participant With Laboratory Abnormalities - Thyroid
Timepoint [2] 0 0
From first dose to 100 days after last dose (up to 15 months)
Primary outcome [3] 0 0
Number of Treated Participant With Laboratory Abnormalities - Liver
Timepoint [3] 0 0
From first dose to 100 days after last dose (up to 15 months)
Primary outcome [4] 0 0
Number of Participants With a Best Overall Response (BOR) - Parts 2 and 3
Timepoint [4] 0 0
From first dose to the last tumor assessment prior to subsequent therapy (up to a maximum of 185 weeks)
Primary outcome [5] 0 0
Percentage of Participants With an Objective Response Rate (ORR)- Parts 2 and 3
Timepoint [5] 0 0
From first dose to the last tumor assessment prior to subsequent therapy (up to a maximum of 185 weeks)
Primary outcome [6] 0 0
Median Duration of Response (DoR) - Parts 2 and 3
Timepoint [6] 0 0
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)
Primary outcome [7] 0 0
Progression Free Survival Rate (PFSR) at 24 Weeks - Parts 2 and 3
Timepoint [7] 0 0
At 24 weeks after first dose
Primary outcome [8] 0 0
Progression Free Survival Rate (PFSR) at 1 Year - Parts 2 and 3
Timepoint [8] 0 0
At 1 year
Primary outcome [9] 0 0
Progression Free Survival Rate (PFSR) at 2 Years - Parts 2 and 3
Timepoint [9] 0 0
At 2 years
Secondary outcome [1] 0 0
Cmax
Timepoint [1] 0 0
At cycle 0 day 1 and day 14 [cycle 0= up to 2 weeks]
Secondary outcome [2] 0 0
Tmax
Timepoint [2] 0 0
At cycle 0 day 1 and day 14 [cycle 0= up to 2 weeks]
Secondary outcome [3] 0 0
AUC(TAU)
Timepoint [3] 0 0
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)
Secondary outcome [4] 0 0
Ctrough
Timepoint [4] 0 0
At cycles 0 [up to 2 weeks] and at cycles 3, 5, 7, 10, 11, 13, 15 [each cycle is up to 4 weeks]
Secondary outcome [5] 0 0
CLT/F
Timepoint [5] 0 0
At Cycle 0 Day 14 [cycle 0 = up to 2 weeks]
Secondary outcome [6] 0 0
Accumulation Index (AI) - AUC(TAU)
Timepoint [6] 0 0
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)
Secondary outcome [7] 0 0
Accumulation Index (AI) - Cmax
Timepoint [7] 0 0
At Cycle 0 Day 14 [cycle 0 = up to 2 weeks]
Secondary outcome [8] 0 0
Change From Baseline in Serum Kynurenine
Timepoint [8] 0 0
At baseline (cycle 1, day 1) and at cycle 1, day 15 [cycle 1 = up to 4 weeks]
Secondary outcome [9] 0 0
Percent Change From Baseline in Serum Kynurenine
Timepoint [9] 0 0
At baseline (cycle 1, day 1) and at cycle 1, day 15 [cycle 1 = up to 4 weeks]
Secondary outcome [10] 0 0
Number of Participants With a Best Overall Response (BOR) - Part 1 and Clinical Pharmacology Substudies
Timepoint [10] 0 0
From first dose to the last tumor assessment prior to subsequent therapy (up to a maximum of 185 weeks)
Secondary outcome [11] 0 0
Percentage of Participants With an Objective Response Rate (ORR) - Part 1 and Clinical Pharmacology Substudies
Timepoint [11] 0 0
From first dose to the last tumor assessment prior to subsequent therapy (up to a maximum of 185 weeks)
Secondary outcome [12] 0 0
Median Duration of Response (DoR) - Part 1 and Clinical Pharmacology Substudies
Timepoint [12] 0 0
From first dose to the last tumor assessment prior to subsequent therapy (up to a maximum of 185 weeks)
Secondary outcome [13] 0 0
Progression Free Survival Rate (PFSR) at 24 Weeks - Part 1 and Clinical Pharmacology Substudies
Timepoint [13] 0 0
At 24 weeks after first dose
Secondary outcome [14] 0 0
Progression Free Survival Rate (PFSR) at 1 Year - Part 1 and Clinical Pharmacology Substudies
Timepoint [14] 0 0
At 1 year
Secondary outcome [15] 0 0
Progression Free Survival Rate (PFSR) at 2 Years - Part 1 and Clinical Pharmacology Substudies
Timepoint [15] 0 0
At 2 years
Secondary outcome [16] 0 0
Number of Participants With a Positive Anti-Drug Antibody (ADA) Test
Timepoint [16] 0 0
From first dose to last dose (up to approximately 48 weeks)

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



* 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
Minimum age
18 Years
Maximum age
100 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled 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
14/04/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
26/10/2021
Sample size
Target
Accrual to date
Final
627
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
Local Institution - 0045 - North Sydney
Recruitment hospital [2] 0 0
Local Institution - 0029 - Sydney
Recruitment hospital [3] 0 0
Local Institution - 0046 - Westmead
Recruitment hospital [4] 0 0
Local Institution - 0044 - Brisbane
Recruitment hospital [5] 0 0
Local Institution - 0008 - Clayton
Recruitment hospital [6] 0 0
Local Institution - 0004 - Melbourne
Recruitment hospital [7] 0 0
Local Institution - 0047 - Nedlands
Recruitment postcode(s) [1] 0 0
2146 - North Sydney
Recruitment postcode(s) [2] 0 0
2010 - Sydney
Recruitment postcode(s) [3] 0 0
2145 - Westmead
Recruitment postcode(s) [4] 0 0
4102 - Brisbane
Recruitment postcode(s) [5] 0 0
3168 - Clayton
Recruitment postcode(s) [6] 0 0
3000 - Melbourne
Recruitment postcode(s) [7] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Georgia
Country [5] 0 0
United States of America
State/province [5] 0 0
Illinois
Country [6] 0 0
United States of America
State/province [6] 0 0
Maryland
Country [7] 0 0
United States of America
State/province [7] 0 0
Michigan
Country [8] 0 0
United States of America
State/province [8] 0 0
Missouri
Country [9] 0 0
United States of America
State/province [9] 0 0
New Jersey
Country [10] 0 0
United States of America
State/province [10] 0 0
New York
Country [11] 0 0
United States of America
State/province [11] 0 0
Ohio
Country [12] 0 0
United States of America
State/province [12] 0 0
Pennsylvania
Country [13] 0 0
United States of America
State/province [13] 0 0
Tennessee
Country [14] 0 0
Canada
State/province [14] 0 0
Alberta
Country [15] 0 0
Canada
State/province [15] 0 0
British Columbia
Country [16] 0 0
Canada
State/province [16] 0 0
Ontario
Country [17] 0 0
Canada
State/province [17] 0 0
Quebec
Country [18] 0 0
Finland
State/province [18] 0 0
Helsinki
Country [19] 0 0
France
State/province [19] 0 0
Lille CEDEX
Country [20] 0 0
France
State/province [20] 0 0
Lyon Cedex 08
Country [21] 0 0
France
State/province [21] 0 0
Marseille Cedex 5
Country [22] 0 0
France
State/province [22] 0 0
Nantes Cedex 01
Country [23] 0 0
France
State/province [23] 0 0
Paris
Country [24] 0 0
France
State/province [24] 0 0
Toulouse
Country [25] 0 0
France
State/province [25] 0 0
Villejuif
Country [26] 0 0
Germany
State/province [26] 0 0
Essen
Country [27] 0 0
Germany
State/province [27] 0 0
Heilbronn
Country [28] 0 0
Italy
State/province [28] 0 0
Milano
Country [29] 0 0
Italy
State/province [29] 0 0
Rozzano MI
Country [30] 0 0
Norway
State/province [30] 0 0
Oslo
Country [31] 0 0
Poland
State/province [31] 0 0
Mazowieckie
Country [32] 0 0
Spain
State/province [32] 0 0
Barcelona
Country [33] 0 0
Spain
State/province [33] 0 0
Madrid
Country [34] 0 0
Sweden
State/province [34] 0 0
Solna

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 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.
Trial website
https://clinicaltrials.gov/study/NCT02658890
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/NCT02658890