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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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
Treatment: Drugs - BMS-986205
Treatment: Drugs - Nivolumab
Treatment: Drugs - Ipilimumab

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


Treatment: Drugs: BMS-986205


Treatment: Drugs: Nivolumab


Treatment: Drugs: Ipilimumab
Intervention code [1] 0 0
Treatment: Drugs
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/Phase 2
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/ct2/show/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