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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT02658890
Ethics application status
Date submitted
14/01/2016
Date registered
20/01/2016
Date last updated
15/07/2019

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
Safety and tolerability of BMS-986205 as measured by a composite of the incidence of adverse events (AEs), serious adverse events (SAEs), AEs leading to discontinuation, deaths, and clinical laboratory test abnormalities. - measured by incidence
Timepoint [1] 0 0
100 days after the last dose of study therapy
Primary outcome [2] 0 0
Safety of BMS-986205 plus nivolumab as measured by a composite of the incidence of adverse events (AEs), serious adverse events (SAEs), AEs leading to discontinuation, deaths, and clinical laboratory test abnormalities. - measured by incidence
Timepoint [2] 0 0
100 days after the last dose of study therapy
Primary outcome [3] 0 0
Safety of BMS-986205 plus both nivolumab and ipilimumab as measured by incidence of adverse events (AEs), serious adverse events (SAEs), AEs leading to discontinuation, deaths, and clinical laboratory test abnormalities. - measured by incidence
Timepoint [3] 0 0
100 days after the last dose of study therapy
Primary outcome [4] 0 0
Anti-tumor activity of BMS 986205 administered in combination with nivolumab as measured by the best overall response (BOR) - measured by CT scan
Timepoint [4] 0 0
Approximately 3 years
Primary outcome [5] 0 0
Anti-tumor activity of BMS 986205 administered in combination with nivolumab as measured by the duration of response (DOR) - measured by CT scan
Timepoint [5] 0 0
Approximately 3 years
Primary outcome [6] 0 0
Anti-tumor activity of BMS 986205 administered in combination with nivolumab as measured by progression-free survival rates (PFSRs) - measured by CT scan
Timepoint [6] 0 0
Approximately 3 years
Primary outcome [7] 0 0
Anti-tumor activity of BMS 986205 administered in combination with both nivolumab and ipilimumab as measured by the best overall response (BOR) - measured by CT scan
Timepoint [7] 0 0
Approximately 3 years
Primary outcome [8] 0 0
Anti-tumor activity of BMS 986205 administered in combination with both nivolumab and ipilimumab as measured by the duration of response (DOR) - measured by CT scan
Timepoint [8] 0 0
Approximately 3 years
Primary outcome [9] 0 0
Anti-tumor activity of BMS 986205 administered in combination with both nivolumab and ipilimumab as measured by progression-free survival rates (PFSRs) - measured by CT scan
Timepoint [9] 0 0
Approximately 3 years
Secondary outcome [1] 0 0
Maximum observed plasma concentration (Cmax) of BMS-986205 - measured by plasma concentration
Timepoint [1] 0 0
Approximately 3 years
Secondary outcome [2] 0 0
Time of maximum observed plasma concentration (Tmax) of BMS-986205 - measured by plasma concentration
Timepoint [2] 0 0
Approximately 3 years
Secondary outcome [3] 0 0
Area under the concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of BMS-986205 - measured by plasma concentration
Timepoint [3] 0 0
Approximately 3 years
Secondary outcome [4] 0 0
Area under the concentration-time curve from time zero to the time of the last quantifiable concentration [AUC(0-T)] of BMS-986205 - measured by plasma concentration
Timepoint [4] 0 0
Approximately 3 years
Secondary outcome [5] 0 0
Area under the concentration-time curve in 1 dosing interval [AUC(TAU)] of BMS-986205 - measured by plasma concentration
Timepoint [5] 0 0
Approximately 3 years
Secondary outcome [6] 0 0
Trough observed plasma concentration at the end of the dosing interval (Ctrough) of BMS-986205 - measured by plasma concentration
Timepoint [6] 0 0
Approximately 3 years
Secondary outcome [7] 0 0
Observed plasma concentration at 24 hours (C24) of BMS-986205 - measured by plasma concentration
Timepoint [7] 0 0
Approximately 3 years
Secondary outcome [8] 0 0
Apparent terminal phase half-life (T-HALF) of BMS-986205 - measured by plasma concentration
Timepoint [8] 0 0
Approximately 3 years
Secondary outcome [9] 0 0
Apparent total body clearance (CLT/F) of BMS-986205 - measured by plasma concentration
Timepoint [9] 0 0
Approximately 3 years
Secondary outcome [10] 0 0
Apparent renal clearance (CLR/F) of BMS-986205 - measured by plasma concentration
Timepoint [10] 0 0
Approximately 3 years
Secondary outcome [11] 0 0
Volume of distribution of terminal phase (Vz/F) of BMS-986205 - measured by plasma concentration
Timepoint [11] 0 0
Approximately 3 years
Secondary outcome [12] 0 0
Apparent volume of distribution at steady state (Vss/F) of BMS-986205 - measured by plasma concentration
Timepoint [12] 0 0
Approximately 3 years
Secondary outcome [13] 0 0
Accumulation index (AI) of BMS-986205 - measured by plasma concentration
Timepoint [13] 0 0
Approximately 3 years
Secondary outcome [14] 0 0
Percent urinary recovery (%UR) of BMS-986205 - measured by urine concentration
Timepoint [14] 0 0
Approximately 3 years
Secondary outcome [15] 0 0
Percent urinary recovery over 24 hours(%UR24) of BMS-986205 - measured by urine concentration
Timepoint [15] 0 0
Approximately 3 years
Secondary outcome [16] 0 0
Ratio of metabolite Cmax to parent Cmax, corrected for molecular weight (MR_Cmax) of BMS-986205 - measured by plasma concentration
Timepoint [16] 0 0
Approximately 3 years
Secondary outcome [17] 0 0
Ratio of metabolite AUC(0-T) to parent AUC(0-T), corrected for molecular weight (single dose in clinical pharmacology substudy only) [MR_AUC(0-T)] of BMS-986205 - measured by plasma concentration
Timepoint [17] 0 0
Approximately 3 years
Secondary outcome [18] 0 0
Ratio of metabolite AUC(TAU) to parent AUC(TAU), corrected for molecular weight [MR_AUC(TAU)] of BMS-986205 - measured by plasma concentration
Timepoint [18] 0 0
Approximately 3 years
Secondary outcome [19] 0 0
Ratio of metabolite AUC(INF) to parent AUC(INF), corrected for molecular weight (single dose in clinical pharmacology substudy only) [MR_AUC(INF)] of BMS-986205 - measured by plasma concentration
Timepoint [19] 0 0
Approximately 3 years
Secondary outcome [20] 0 0
Anti-drug antibody (ADA) response to Nivolumab in combination with BMS-986205 - measured by immunoassay and liquid chromatography- mass spectrometry
Timepoint [20] 0 0
Approximately 3 years
Secondary outcome [21] 0 0
Anti-drug antibody (ADA) response to Ipilimumab in combination with BMS-986205 - measured by immunoassay and liquid chromatography- mass spectrometry
Timepoint [21] 0 0
Approximately 3 years

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
Gender
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
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
The Kinghorn Cancer Centre - Darlinghurst
Recruitment hospital [2] 0 0
Melanoma Institute Australia - North Sydney
Recruitment hospital [3] 0 0
Local Institution - Westmead
Recruitment hospital [4] 0 0
Princess Alexandra Hospital - Brisbane
Recruitment hospital [5] 0 0
Local Institution - Clayton
Recruitment hospital [6] 0 0
Royal Melbourne Hospital - Melbourne
Recruitment hospital [7] 0 0
Linear Clinical Research Ltd - Nedlands
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
2146 - North 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
Minnesota
Country [9] 0 0
United States of America
State/province [9] 0 0
Missouri
Country [10] 0 0
United States of America
State/province [10] 0 0
New Jersey
Country [11] 0 0
United States of America
State/province [11] 0 0
New York
Country [12] 0 0
United States of America
State/province [12] 0 0
Ohio
Country [13] 0 0
United States of America
State/province [13] 0 0
Pennsylvania
Country [14] 0 0
United States of America
State/province [14] 0 0
Tennessee
Country [15] 0 0
Canada
State/province [15] 0 0
Alberta
Country [16] 0 0
Canada
State/province [16] 0 0
British Columbia
Country [17] 0 0
Canada
State/province [17] 0 0
Ontario
Country [18] 0 0
Canada
State/province [18] 0 0
Quebec
Country [19] 0 0
Finland
State/province [19] 0 0
Helsinki
Country [20] 0 0
France
State/province [20] 0 0
Lille CEDEX
Country [21] 0 0
France
State/province [21] 0 0
Lyon Cedex 08
Country [22] 0 0
France
State/province [22] 0 0
Marseille Cedex 5
Country [23] 0 0
France
State/province [23] 0 0
Nantes Cedex 01
Country [24] 0 0
France
State/province [24] 0 0
Paris
Country [25] 0 0
France
State/province [25] 0 0
Toulouse
Country [26] 0 0
France
State/province [26] 0 0
Villejuif
Country [27] 0 0
Germany
State/province [27] 0 0
Essen
Country [28] 0 0
Germany
State/province [28] 0 0
Heilbronn
Country [29] 0 0
Italy
State/province [29] 0 0
Milano
Country [30] 0 0
Italy
State/province [30] 0 0
Rozzano MI
Country [31] 0 0
Norway
State/province [31] 0 0
Oslo
Country [32] 0 0
Poland
State/province [32] 0 0
Mazowieckie
Country [33] 0 0
Poland
State/province [33] 0 0
Gdansk
Country [34] 0 0
Spain
State/province [34] 0 0
Barcelona
Country [35] 0 0
Spain
State/province [35] 0 0
Madrid
Country [36] 0 0
Sweden
State/province [36] 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/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
Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email:
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Clinical.Trials@bms.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT02658890