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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05169684




Registration number
NCT05169684
Ethics application status
Date submitted
10/12/2021
Date registered
27/12/2021
Date last updated
10/06/2025

Titles & IDs
Public title
A Study of BMS-986218 or BMS-986218 Plus Nivolumab in Combination With Docetaxel in Participants With Metastatic Castration-resistant Prostate Cancer
Scientific title
A Phase 2, Open-label, Randomized Controlled Trial of BMS-986218 or BMS-986218 Plus Nivolumab in Combination With Docetaxel in Participants With Metastatic Castration-resistant Prostate Cancer
Secondary ID [1] 0 0
2021-003990-74
Secondary ID [2] 0 0
CA022-009
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostatic Neoplasms, Castration-Resistant 0 0
Condition category
Condition code
Cancer 0 0 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - BMS-986218
Treatment: Drugs - Docetaxel
Treatment: Other - Nivolumab

Experimental: Arm 1A: Docetaxel + BMS-986218 -

Experimental: Arm 1B: Docetaxel + BMS-986218 + Nivolumab -

Experimental: Arm 2A: Docetaxel -

Experimental: Arm 2B: Docetaxel + BMS-986218 -

Experimental: Arm 2C: Docetaxel + BMS-986218 + Nivolumab -

Experimental: Arm 2D (Optional Crossover): BMS-986218 + Nivolumab -


Treatment: Other: BMS-986218
Specified dose on specified days

Treatment: Drugs: Docetaxel
Specified dose on specified days

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

Outcomes
Primary outcome [1] 0 0
Number of Participants With Treatment Related Adverse Events
Assessment method [1] 0 0
Adverse events will presented using National Cancer Institute Common Terminology Criteria for Adverse Events version 5 (NCI CTCAE v5).
Timepoint [1] 0 0
From first dose to 100 days follow up to last dose (Approximately 22 months)
Primary outcome [2] 0 0
Number of Participants With Treatment Related Serious Adverse Events
Assessment method [2] 0 0
Adverse events will presented using National Cancer Institute Common Terminology Criteria for Adverse Events version 5 (NCI CTCAE v5).
Timepoint [2] 0 0
From first dose to 100 days follow up to last dose (Approximately 22 months)
Primary outcome [3] 0 0
Number of Participants With Dose Limiting Toxicities
Assessment method [3] 0 0
DLTs will be defined as: Any treatment-related AEs for which a participant permanently discontinues a study treatment (other than daily prednisone) and that occurs during the first 2 cycles of treatment. Any death not clearly due to the underlying disease or extraneous causes and that occurs during the first 2 cycles of treatment Greater than or equal to Grade 2 pneumonitis lasting greater than 5 days despite appropriate medical therapy and that occurs during the first 2 cycles of treatment Any neutropenic fever as well as Grade 4 neutropenia or thrombocytopenia for \> 7 days that occurs during the first 2 cycles of treatment Any treatment-related AE that delays initiation of Cycle 2 or Cycle 3 of treatment by greater than 2 consecutive weeks.
Timepoint [3] 0 0
From first dose to 100 days follow up to last dose (Approximately 22 months)
Primary outcome [4] 0 0
Number of Participants With AEs Leading to Discontinuation
Assessment method [4] 0 0
Adverse events will presented using National Cancer Institute Common Terminology Criteria for Adverse Events version 5 (NCI CTCAE v5).
Timepoint [4] 0 0
From first dose to 100 days follow up to last dose (Approximately 22 months)
Primary outcome [5] 0 0
Number of Participants Who Died
Assessment method [5] 0 0
Number of participant deaths
Timepoint [5] 0 0
From first dose to 100 days follow up to last dose (Approximately 22 months)
Secondary outcome [1] 0 0
Prostate Specific Antigen Response Rate (PSA-RR)
Assessment method [1] 0 0
PSA-RR is the proportion of randomized participants with a 50% or greater decrease in PSA from baseline to any post-baseline PSA result. A second consecutive value obtained 3 or more weeks later is required to confirm the PSA response.
Timepoint [1] 0 0
From first dose to 100 days follow up to last dose (Approximately 22 months)
Secondary outcome [2] 0 0
Objective Response Rate
Assessment method [2] 0 0
Objective response rate per PCWG3 (ORR-PCWG3) is the proportion of participants who have a confirmed complete or partial best overall response (BOR) per PCWG3 among randomized participants who have measurable disease at baseline. The BOR is defined as the best response designation, as determined by the BICR, recorded between the date of randomization and the date of objectively documented radiographic progression, or last tumor measurement, whichever occurs first.
Timepoint [2] 0 0
From first dose to 100 days follow up to last dose (Approximately 22 months)
Secondary outcome [3] 0 0
Time to Response
Assessment method [3] 0 0
Time to response per PCWG3 (TTR-PCWG3) is the time from randomization date to the date of the first documented CR or PR per PCWG3, as determined by BICR.
Timepoint [3] 0 0
From first dose to 100 days follow up to last dose (Approximately 22 months)
Secondary outcome [4] 0 0
Duration of Response
Assessment method [4] 0 0
Duration of response per PCWG3 (DOR-PCWG3) is the time between the date of first response (CR/PR per PCWG3) to the date of first documented radiographic progression per PCWG3 (as determined by BICR), or death due to any cause.
Timepoint [4] 0 0
From first dose to 100 days follow up to last dose (Approximately 22 months)
Secondary outcome [5] 0 0
Overall Survival
Assessment method [5] 0 0
OS for all randomized participants is the time between randomization date and the date of death from any cause.
Timepoint [5] 0 0
From first dose to 100 days follow up to last dose (Approximately 22 months)

Eligibility
Key inclusion criteria
* Histologic confirmation of carcinoma of the prostate without small cell features
* Documented prostate cancer progression by Prostate Cancer Working Group 3 (PCWG3) criteria while castrate
* Evidence of metastatic disease documented by either bone lesions on radionuclide bone scan and/or soft tissue lesions on computed tomography (CT)/magnetic resonance imaging (MRI)
* Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1
* Ongoing androgen deprivation therapy (ADT) with a gonadotropin-releasing hormone (GnRH) agonist/antagonist or bilateral orchiectomy (i.e., surgical or medical castration) confirmed by testosterone level = 1.73 nmol/L (50 ng/dL) at the screening visit
* Chemotherapy-naive for metastatic castration-resistant prostate cancer (mCRPC) and have received at least one novel antiandrogen therapy (NAT)
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
* Concurrent malignancy (present during screening) requiring treatment or history of prior malignancy active within 2 years prior to treatment assignment in Part 1 or randomization in Part 2
* Untreated central nervous system (CNS) metastases
* Leptomeningeal metastases
* 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
Other
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
14/02/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
6/12/2023
Sample size
Target
Accrual to date
Final
10
Recruitment in Australia
Recruitment state(s)
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
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Connecticut
Country [5] 0 0
United States of America
State/province [5] 0 0
Delaware
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Illinois
Country [8] 0 0
United States of America
State/province [8] 0 0
Iowa
Country [9] 0 0
United States of America
State/province [9] 0 0
Maryland
Country [10] 0 0
United States of America
State/province [10] 0 0
Missouri
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
North Carolina
Country [13] 0 0
United States of America
State/province [13] 0 0
Ohio
Country [14] 0 0
United States of America
State/province [14] 0 0
Oregon
Country [15] 0 0
United States of America
State/province [15] 0 0
Texas
Country [16] 0 0
United States of America
State/province [16] 0 0
Virginia
Country [17] 0 0
United States of America
State/province [17] 0 0
Wisconsin
Country [18] 0 0
France
State/province [18] 0 0
Toulouse
Country [19] 0 0
Italy
State/province [19] 0 0
MI
Country [20] 0 0
Italy
State/province [20] 0 0
Meldola
Country [21] 0 0
Italy
State/province [21] 0 0
Modena
Country [22] 0 0
Italy
State/province [22] 0 0
Pozzuoli

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 0 0
Bristol-Myers Squibb
Address 0 0
Bristol-Myers Squibb
Country 0 0
Phone 0 0
Email 0 0
Contact person for public queries
Name 0 0
BMS Study Connect Contact Center www.BMSStudyConnect.com
Address 0 0
Country 0 0
Phone 0 0
855-907-3286
Email 0 0
Clinical.Trials@bms.com
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT05169684