Trial Review

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/ct2/show/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
Other interventions - BMS-986249
Other interventions - Nivolumab
Other interventions - 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


Other interventions: BMS-986249
Specified dose on specified days

Other interventions: Nivolumab
Specified dose on specified days

Other interventions: Ipilimumab
Specified dose on specified days
Intervention code [1] 0 0
Other interventions
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/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
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
The purpose of this study is to determine whether BMS-986249 both by itself and in
combination with Nivolumab is safe and tolerable in the treatment of advanced solid tumors
Trial website
https://clinicaltrials.gov/ct2/show/NCT03369223
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/ct2/show/NCT03369223