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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/NCT03400332




Registration number
NCT03400332
Ethics application status
Date submitted
12/01/2018
Date registered
17/01/2018
Date last updated
21/05/2024

Titles & IDs
Public title
A Study of BMS-986253 in Combination With Nivolumab or Nivolumab Plus Ipilimumab in Advanced Cancers
Scientific title
A Phase 1/2 Study of BMS-986253 in Combination With Nivolumab or Nivolumab Plus Ipilimumab in Advanced Cancers
Secondary ID [1] 0 0
2018-000340-26
Secondary ID [2] 0 0
CA027-002
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer 0 0
Melanoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Malignant melanoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - BMS-986253
Other interventions - Nivolumab
Other interventions - Ipilimumab
Other interventions - Placebo

Experimental: Part 1A: BMS-986253 + nivolumab -

Experimental: Part 1B: BMS-986253 + nivolumab -

Experimental: Part 1C: BMS-986253 + nivolumab + ipilimumab -

Experimental: Part 2A: BMS-986253 + nivolumab + ipilimumab -

Placebo Comparator: Part 2B: Placebo + nivolumab + ipilimumab -


Treatment: Drugs: BMS-986253
Specified dose on specified days

Other interventions: Nivolumab
Specified dose on specified days

Other interventions: Ipilimumab
Specified dose on specified days

Other interventions: Placebo
Specified dose on specified days
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of adverse events (AE)
Timepoint [1] 0 0
Approximately 5 years
Primary outcome [2] 0 0
Incidence of serious adverse events (SAE)
Timepoint [2] 0 0
Approximately 5 years
Primary outcome [3] 0 0
Incidence of AEs meeting protocol-defined dose limiting toxicities (DLT) criteria
Timepoint [3] 0 0
Approximately 5 years
Primary outcome [4] 0 0
Incidence of AEs leading to discontinuation
Timepoint [4] 0 0
Approximately 5 years
Primary outcome [5] 0 0
Incidence of deaths
Timepoint [5] 0 0
Approximately 5 years
Primary outcome [6] 0 0
Incidence of clinically significant changes in clinical laboratory results: Hematology tests
Timepoint [6] 0 0
Approximately 5 years
Primary outcome [7] 0 0
Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests
Timepoint [7] 0 0
Approximately 5 years
Primary outcome [8] 0 0
Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests
Timepoint [8] 0 0
Approximately 5 years
Primary outcome [9] 0 0
Progression-free survival (PFS) hazard ratio based on Blinded independent central review (BICR) assessments per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Timepoint [9] 0 0
Approximately 5 years
Secondary outcome [1] 0 0
Objective response rate (ORR) based on Blinded independent central review (BICR) assessments per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Timepoint [1] 0 0
Approximately 5 years
Secondary outcome [2] 0 0
Median duration of response (mDOR) per response evaluation criteria in solid tumors (RECIST) v1.1
Timepoint [2] 0 0
Approximately 5 years
Secondary outcome [3] 0 0
Incidence of anti-drug antibody (ADA) to BMS-986253
Timepoint [3] 0 0
Approximately 5 years
Secondary outcome [4] 0 0
Serum biomarker concentration
Timepoint [4] 0 0
Approximately 5 years
Secondary outcome [5] 0 0
Maximum observed serum concentration (Cmax)
Timepoint [5] 0 0
Approximately 5 years
Secondary outcome [6] 0 0
Time of maximum observed serum concentration (Tmax)
Timepoint [6] 0 0
Approximately 5 years
Secondary outcome [7] 0 0
Area under the serum concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)]
Timepoint [7] 0 0
Approximately 5 years
Secondary outcome [8] 0 0
Area under the serum concentration-time curve in 1 dosing interval [AUC(TAU)]
Timepoint [8] 0 0
Approximately 5 years
Secondary outcome [9] 0 0
Observed serum concentration at the end of a dosing interval (CTAU)
Timepoint [9] 0 0
Approximately 5 years
Secondary outcome [10] 0 0
Trough observed serum concentration at the end of the dosing interval (CTROUGH)
Timepoint [10] 0 0
Approximately 5 years
Secondary outcome [11] 0 0
Progression-free survival (PFS) hazard ratio based on Blinded independent central review (BICR) assessments per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Timepoint [11] 0 0
Approximately 5 years
Secondary outcome [12] 0 0
Overall Survival (OS)
Timepoint [12] 0 0
Approximately 5 years
Secondary outcome [13] 0 0
Incidence of AEs
Timepoint [13] 0 0
Approximately 5 years
Secondary outcome [14] 0 0
Incidence of SAEs
Timepoint [14] 0 0
Approximately 5 years
Secondary outcome [15] 0 0
Incidence of AEs leading to discontinuation
Timepoint [15] 0 0
Approximately 5 years
Secondary outcome [16] 0 0
Incidence of death
Timepoint [16] 0 0
Approximately 5 years
Secondary outcome [17] 0 0
Incidence of clinically significant changes in clinical laboratory results: Hematology tests
Timepoint [17] 0 0
Approximately 5 years
Secondary outcome [18] 0 0
Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests
Timepoint [18] 0 0
Approximately 5 years
Secondary outcome [19] 0 0
Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests
Timepoint [19] 0 0
Approximately 5 years

Eligibility
Key inclusion criteria
- Histologic or cytologic confirmation of a solid tumor that is advanced (metastatic,
recurrent and/or unresectable) with measurable disease per RECIST v1.1

- At least 1 lesion accessible for biopsy

- Eastern Cooperative Oncology Group Performance Status of 0 or 1
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Participants with CNS metastases as the only site of active disease (Participants with
controlled brain metastases; however, will be allowed to enroll)

- Participants with active, known or suspected autoimmune disease

- Participants with conditions requiring systemic treatment with either corticosteroids
(> 10mg prednisone equivalents) or other immunosuppressive medications within 14 days
of study treatment administration

- Participants with a known history of testing positive for Human Immunodeficiency Virus
(HIV) or known Acquired Immunodeficiency Syndrome (AIDS)

- Cytotoxic agents, unless at least 4 weeks have elapsed from last dose of prior
anti-cancer therapy and initiation of study therapy

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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1/Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
12/02/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/11/2025
Actual
Sample size
Target
Accrual to date
Final
281
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC,WA
Recruitment hospital [1] 0 0
Local Institution - 0088 - Wollstonecraft
Recruitment hospital [2] 0 0
Local Institution - 0096 - Adelaide
Recruitment hospital [3] 0 0
Local Institution - 0090 - Melbourne
Recruitment hospital [4] 0 0
Local Institution - 0095 - Melbourne
Recruitment hospital [5] 0 0
Local Institution - 0097 - Perth
Recruitment hospital [6] 0 0
Local Institution - 0091 - Ballarat Central
Recruitment postcode(s) [1] 0 0
2065 - Wollstonecraft
Recruitment postcode(s) [2] 0 0
5000 - Adelaide
Recruitment postcode(s) [3] 0 0
3000 - Melbourne
Recruitment postcode(s) [4] 0 0
3004 - Melbourne
Recruitment postcode(s) [5] 0 0
6009 - Perth
Recruitment postcode(s) [6] 0 0
VIC 3350 - Ballarat Central
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arkansas
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
Colorado
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
Maryland
Country [6] 0 0
United States of America
State/province [6] 0 0
Massachusetts
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
Nebraska
Country [9] 0 0
United States of America
State/province [9] 0 0
Nevada
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
Oklahoma
Country [13] 0 0
United States of America
State/province [13] 0 0
Oregon
Country [14] 0 0
United States of America
State/province [14] 0 0
Pennsylvania
Country [15] 0 0
United States of America
State/province [15] 0 0
South Carolina
Country [16] 0 0
United States of America
State/province [16] 0 0
Texas
Country [17] 0 0
United States of America
State/province [17] 0 0
Utah
Country [18] 0 0
United States of America
State/province [18] 0 0
Virginia
Country [19] 0 0
Belgium
State/province [19] 0 0
Bruxelles
Country [20] 0 0
Belgium
State/province [20] 0 0
Gent
Country [21] 0 0
Belgium
State/province [21] 0 0
Kortrijk
Country [22] 0 0
Canada
State/province [22] 0 0
Alberta
Country [23] 0 0
Canada
State/province [23] 0 0
British Columbia
Country [24] 0 0
Canada
State/province [24] 0 0
Ontario
Country [25] 0 0
Canada
State/province [25] 0 0
Quebec
Country [26] 0 0
France
State/province [26] 0 0
Bouches-du-Rhône
Country [27] 0 0
France
State/province [27] 0 0
Nantes
Country [28] 0 0
France
State/province [28] 0 0
Paris
Country [29] 0 0
France
State/province [29] 0 0
Toulouse
Country [30] 0 0
France
State/province [30] 0 0
Villejuif
Country [31] 0 0
Germany
State/province [31] 0 0
Baden-Württemberg
Country [32] 0 0
Germany
State/province [32] 0 0
Rheinland-Pfalz
Country [33] 0 0
Germany
State/province [33] 0 0
Berlin
Country [34] 0 0
Germany
State/province [34] 0 0
Hamburg
Country [35] 0 0
Italy
State/province [35] 0 0
Forlì
Country [36] 0 0
Italy
State/province [36] 0 0
Milano
Country [37] 0 0
Italy
State/province [37] 0 0
Napoli
Country [38] 0 0
Italy
State/province [38] 0 0
Rozzano-milano
Country [39] 0 0
Poland
State/province [39] 0 0
Krakow
Country [40] 0 0
Poland
State/province [40] 0 0
Warszawa
Country [41] 0 0
Spain
State/province [41] 0 0
Madrid
Country [42] 0 0
Spain
State/province [42] 0 0
Malaga
Country [43] 0 0
Spain
State/province [43] 0 0
Pamplona
Country [44] 0 0
Spain
State/province [44] 0 0
Santiago de Compostela
Country [45] 0 0
Sweden
State/province [45] 0 0
Lund
Country [46] 0 0
Switzerland
State/province [46] 0 0
Lausanne
Country [47] 0 0
Switzerland
State/province [47] 0 0
St.Gallen
Country [48] 0 0
Switzerland
State/province [48] 0 0
Zuerich
Country [49] 0 0
United Kingdom
State/province [49] 0 0
Greater Manchester
Country [50] 0 0
United Kingdom
State/province [50] 0 0
Lanarkshire
Country [51] 0 0
United Kingdom
State/province [51] 0 0
West Midlands

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 this study is to investigate experimental medication BMS-986253 in combination
with Nivolumab or Nivolumab plus Ipilimumab in participants with advanced cancers.
Trial website
https://clinicaltrials.gov/ct2/show/NCT03400332
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