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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/NCT05169684
Registration number
NCT05169684
Ethics application status
Date submitted
10/12/2021
Date registered
27/12/2021
Date last updated
6/12/2023
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
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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
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Secondary ID [1]
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2021-003990-74
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Secondary ID [2]
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CA022-009
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Prostatic Neoplasms, Castration-Resistant
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Condition category
Condition code
Cancer
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Prostate
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - BMS-986218
Treatment: Drugs - Docetaxel
Other interventions - 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 -
Other interventions: BMS-986218
Specified dose on specified days
Treatment: Drugs: Docetaxel
Specified dose on specified days
Other interventions: Nivolumab
Specified dose on specified days
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Intervention code [1]
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Other interventions
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Intervention code [2]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of participants with adverse events (AEs)
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Assessment method [1]
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Part 1
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Timepoint [1]
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Up to 2 years
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Primary outcome [2]
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Number of deaths
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Assessment method [2]
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Part 1
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Timepoint [2]
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Up to 2 years
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Primary outcome [3]
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Radiographic progression-free survival (rPFS) assessed by blinded independent central review (BICR) per Prostate Cancer Working Group 3 (PCWG3)
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Assessment method [3]
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Part 2
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Timepoint [3]
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Up to 4 years
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Secondary outcome [1]
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Objective response rate per Prostate Cancer Working Group 3 (ORR-PCWG3)
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Assessment method [1]
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Part 2
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Timepoint [1]
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Up to 4 years
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Secondary outcome [2]
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Time to response per Prostate Cancer Working Group 3 (TTR-PCWG3) as determined by BICR
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Assessment method [2]
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Part 2
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Timepoint [2]
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Up to 4 years
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Secondary outcome [3]
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Duration of response per Prostate Cancer Working Group 3 (DOR-PCWG3) as determined by BICR
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Assessment method [3]
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Part 2
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Timepoint [3]
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Up to 4 years
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Secondary outcome [4]
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Prostate-specific antigen response rate (PSA-RR)
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Assessment method [4]
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Part 2
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Timepoint [4]
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Up to 4 years
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Secondary outcome [5]
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Time to prostate-specific antigen progression (TTP-PSA) per PCWG3
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Assessment method [5]
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Part 2
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Timepoint [5]
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Up to 4 years
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Secondary outcome [6]
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Overall survival (OS)
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Assessment method [6]
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Part 2
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Timepoint [6]
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Up to 4 years
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Secondary outcome [7]
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Number of participants with adverse events (AEs)
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Assessment method [7]
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Part 2
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Timepoint [7]
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Up to 2 years
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Secondary outcome [8]
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Number of deaths
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Assessment method [8]
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Part 2
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Timepoint [8]
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Up to 2 years
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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)
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Males
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Other
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
14/02/2022
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
6/12/2023
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Actual
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Sample size
Target
204
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
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Recruitment hospital [1]
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Local Institution - 0019 - Darlinghurst
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Recruitment hospital [2]
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Local Institution - 0066 - Elizabeth Vale
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Recruitment hospital [3]
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Local Institution - 0078 - Heidelberg
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Recruitment postcode(s) [1]
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2010 - Darlinghurst
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Recruitment postcode(s) [2]
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5112 - Elizabeth Vale
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Recruitment postcode(s) [3]
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3084 - Heidelberg
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Recruitment outside Australia
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Arizona
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Truro
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Bristol-Myers Squibb
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to assess the safety, efficacy, tolerability, and toxicity of
docetaxel alone, in combination with BMS-986218, or in combination with nivolumab plus
BMS-986218 in men who have metastatic castration-resistant prostate cancer (mCRPC) that
progressed after novel antiandrogen therapy and have not received chemotherapy for mCRPC.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05169684
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Bristol-Myers Squibb
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Address
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Bristol-Myers Squibb
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Phone
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Fax
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Email
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Contact person for public queries
Name
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BMS Study Connect Contact Center www.BMSStudyConnect.com
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Address
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Phone
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855-907-3286
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05169684
Download to PDF