Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

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/NCT03369223




Registration number
NCT03369223
Ethics application status
Date submitted
6/12/2017
Date registered
11/12/2017
Date last updated
4/10/2023

Titles & IDs
Public title
A Study of BMS-986249 Alone and in Combination With Nivolumab in Advanced Solid Tumors
Scientific title
A Phase 1/2 First-in-Human Study of BMS-986249 Alone and in Combination With Nivolumab in Advanced Solid Tumors
Secondary ID [1] 0 0
2018-000416-21
Secondary ID [2] 0 0
CA030-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced Cancer 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - BMS-986249
Treatment: Other - Nivolumab
Treatment: Other - Ipilimumab

Experimental: Part 1A: BMS-986249 -

Experimental: Part 1B: BMS-986249 + nivolumab (nivo) -

Experimental: Part 2A Arm C: BMS-986249 + nivo - Previously untreated unresectable stage III-IV melanoma

Experimental: Part 2A Arm D: ipilimumab + nivo then nivo - Previously untreated unresectable stage III-IV melanoma

Experimental: Part 2A Arm F: BMS-986249 + nivo - Previously untreated unresectable stage III-IV melanoma

Experimental: Part 2B Cohort 1: BMS-986249 + nivo - Advanced or intermediate hepatocellular carcinoma (HCC)

Experimental: Part 2B Cohort 2: BMS-986249 + nivo - Metastatic castration-resistant prostate cancer (CRPC)

Experimental: Part 2B Cohort 3: BMS-986249 + nivo - Unresectable locally advanced or metastatic triple-negative breast cancer (TNBC)

Experimental: Part 2A Arm A: BMS-986249 + nivo then nivo - * Previously untreated unresectable stage III-IV melanoma
* Enrollment is closed for this Arm

Experimental: Part 2A Arm B: BMS-986249 + nivo - * Previously untreated unresectable stage III-IV melanoma
* Enrollment is closed for this Arm

Experimental: Part 2A Arm E: Nivo - * Previously untreated unresectable stage III-IV melanoma
* Enrollment is closed for this Arm


Treatment: Other: BMS-986249
Specified dose on specified days

Treatment: Other: Nivolumab
Specified dose on specified days

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

Outcomes
Primary outcome [1] 0 0
Incidence of Adverse Events (AEs)
Timepoint [1] 0 0
Up to 2.5 years
Primary outcome [2] 0 0
Incidence of Serious Adverse Events (SAEs)
Timepoint [2] 0 0
Up to 2.5 years
Primary outcome [3] 0 0
Incidence of AEs meeting protocol-defined dose-limiting toxicity (DLT) criteria
Timepoint [3] 0 0
Up to 2.5 years
Primary outcome [4] 0 0
Incidence of AEs leading to discontinuation
Timepoint [4] 0 0
Up to 2.5 years
Primary outcome [5] 0 0
Incidence of death
Timepoint [5] 0 0
Up to 4 years
Primary outcome [6] 0 0
Number of participants with laboratory abnormalities
Timepoint [6] 0 0
Up to 2.5 years
Primary outcome [7] 0 0
Incidence of treatment-related Grade 3-5 AEs
Timepoint [7] 0 0
Within 24 weeks
Primary outcome [8] 0 0
Objective Response Rate (ORR) as assessed by investigator using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Timepoint [8] 0 0
Up to 2.5 years
Secondary outcome [1] 0 0
Cmax (Maximum observed serum concentration)
Timepoint [1] 0 0
Up to 2 years
Secondary outcome [2] 0 0
Tmax (Time of maximum observed concentration)
Timepoint [2] 0 0
Up to 2 years
Secondary outcome [3] 0 0
AUC(0-T) (Area under the serum concentration-time curve from time zero to time of last quantifiable concentration)
Timepoint [3] 0 0
Up to 2 years
Secondary outcome [4] 0 0
ORR as assessed by investigator using RECIST v1.1 or Prostate Cancer Working Group 3 (PCWG3) (for prostate cancer)
Timepoint [4] 0 0
Up to 4 years
Secondary outcome [5] 0 0
Duration of response (DOR) as assessed by investigator using RECIST v1.1 or PCWG3 (for prostate cancer)
Timepoint [5] 0 0
Up to 4 years
Secondary outcome [6] 0 0
Progression-Free survival (PFS) as assessed by investigator using RECIST v1.1 or PCWG3 (for prostate cancer)
Timepoint [6] 0 0
Up to 4 years
Secondary outcome [7] 0 0
Time to response (TTR) as assessed by investigator using RECIST v1.1 or PCWG3 (for prostate cancer)
Timepoint [7] 0 0
Up to 4 years
Secondary outcome [8] 0 0
Incidence of AEs in Part 2 of Study
Timepoint [8] 0 0
Up to 2.5 years
Secondary outcome [9] 0 0
Incidence of SAEs in Part 2 of Study
Timepoint [9] 0 0
Up to 2.5 years
Secondary outcome [10] 0 0
Incidence of AEs leading to discontinuation in Part 2 of study
Timepoint [10] 0 0
Up to 2.5 years
Secondary outcome [11] 0 0
Incidence of death in Part 2 of study
Timepoint [11] 0 0
Up to 4 years
Secondary outcome [12] 0 0
Number of participants with clinical laboratory abnormalities Part 2 of study
Timepoint [12] 0 0
Up to 2.5 years
Secondary outcome [13] 0 0
Time to Deterioration (TTD) in Part 2 of study
Timepoint [13] 0 0
Up to 4 Years

Eligibility
Key inclusion criteria
* Histologic or cytologic confirmation of a solid tumor that is advanced (metastatic, recurrent, and/or unresectable) with measurable disease or metastatic disease documented by either bone lesions on radionuclide bone scan and/or soft tissue lesions on CT/MRI for prostate cancer and have at least 1 lesion accessible for biopsy. For Part 2B participants with HCC, intermediate disease is allowed.
* Eastern Cooperative Oncology Group Performance Status of 0 or 1
* Must have received, and then progressed, relapsed, or been intolerant to, at least 1 standard treatment regimen in the advanced or metastatic setting according to tumor type, if such a therapy exists
* Prior anti-cancer treatments such as chemotherapy, radiotherapy, or hormonal are permitted for some participants
* Willing and able to comply with all study procedures
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Primary central nervous system (CNS) malignancies, tumors with CNS metastases as the only site of disease or active brain metastases will be excluded
* Other active malignancy requiring concurrent intervention
* Prior organ allograft
* Active, known, or suspected autoimmune disease

Other protocol-defined inclusion/exclusion criteria 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
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
6/12/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
19/09/2024
Actual
Sample size
Target
425
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Recruitment hospital [1] 0 0
Local Institution - 0015 - North Sydney
Recruitment hospital [2] 0 0
Local Institution - 0014 - Adelaide
Recruitment hospital [3] 0 0
Local Institution - Frankston
Recruitment hospital [4] 0 0
Local Institution - 0047 - Heidelberg
Recruitment postcode(s) [1] 0 0
2060 - North Sydney
Recruitment postcode(s) [2] 0 0
5000 - Adelaide
Recruitment postcode(s) [3] 0 0
3199 - Frankston
Recruitment postcode(s) [4] 0 0
3084 - Heidelberg
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Colorado
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Maryland
Country [4] 0 0
United States of America
State/province [4] 0 0
New Jersey
Country [5] 0 0
United States of America
State/province [5] 0 0
New York
Country [6] 0 0
United States of America
State/province [6] 0 0
Ohio
Country [7] 0 0
United States of America
State/province [7] 0 0
Oregon
Country [8] 0 0
United States of America
State/province [8] 0 0
Pennsylvania
Country [9] 0 0
United States of America
State/province [9] 0 0
South Carolina
Country [10] 0 0
United States of America
State/province [10] 0 0
Texas
Country [11] 0 0
United States of America
State/province [11] 0 0
Virginia
Country [12] 0 0
United States of America
State/province [12] 0 0
Washington
Country [13] 0 0
Argentina
State/province [13] 0 0
Distrito Federal
Country [14] 0 0
Argentina
State/province [14] 0 0
Buenos Aires
Country [15] 0 0
Canada
State/province [15] 0 0
Alberta
Country [16] 0 0
Chile
State/province [16] 0 0
Metropolitana
Country [17] 0 0
Finland
State/province [17] 0 0
Helsinki
Country [18] 0 0
Germany
State/province [18] 0 0
Essen
Country [19] 0 0
Germany
State/province [19] 0 0
Hamburg
Country [20] 0 0
Germany
State/province [20] 0 0
Heidelberg
Country [21] 0 0
Italy
State/province [21] 0 0
Milan
Country [22] 0 0
Italy
State/province [22] 0 0
Napoli
Country [23] 0 0
Italy
State/province [23] 0 0
Siena
Country [24] 0 0
Poland
State/province [24] 0 0
Warszawa
Country [25] 0 0
Romania
State/province [25] 0 0
Bucharest
Country [26] 0 0
Romania
State/province [26] 0 0
Craiova
Country [27] 0 0
Spain
State/province [27] 0 0
Barcelona [Barcelona]
Country [28] 0 0
Spain
State/province [28] 0 0
Madrid, Comunidad De
Country [29] 0 0
Spain
State/province [29] 0 0
Barcelona
Country [30] 0 0
Spain
State/province [30] 0 0
Madrid
Country [31] 0 0
Spain
State/province [31] 0 0
Malaga

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Bristol-Myers Squibb
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT03369223