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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
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
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
Intervention code [1] 0 0
Other interventions
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of participants with adverse events (AEs)
Timepoint [1] 0 0
Up to 2 years
Primary outcome [2] 0 0
Number of deaths
Timepoint [2] 0 0
Up to 2 years
Primary outcome [3] 0 0
Radiographic progression-free survival (rPFS) assessed by blinded independent central review (BICR) per Prostate Cancer Working Group 3 (PCWG3)
Timepoint [3] 0 0
Up to 4 years
Secondary outcome [1] 0 0
Objective response rate per Prostate Cancer Working Group 3 (ORR-PCWG3)
Timepoint [1] 0 0
Up to 4 years
Secondary outcome [2] 0 0
Time to response per Prostate Cancer Working Group 3 (TTR-PCWG3) as determined by BICR
Timepoint [2] 0 0
Up to 4 years
Secondary outcome [3] 0 0
Duration of response per Prostate Cancer Working Group 3 (DOR-PCWG3) as determined by BICR
Timepoint [3] 0 0
Up to 4 years
Secondary outcome [4] 0 0
Prostate-specific antigen response rate (PSA-RR)
Timepoint [4] 0 0
Up to 4 years
Secondary outcome [5] 0 0
Time to prostate-specific antigen progression (TTP-PSA) per PCWG3
Timepoint [5] 0 0
Up to 4 years
Secondary outcome [6] 0 0
Overall survival (OS)
Timepoint [6] 0 0
Up to 4 years
Secondary outcome [7] 0 0
Number of participants with adverse events (AEs)
Timepoint [7] 0 0
Up to 2 years
Secondary outcome [8] 0 0
Number of deaths
Timepoint [8] 0 0
Up to 2 years

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
Recruiting
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
6/12/2023
Actual
Sample size
Target
204
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Recruitment hospital [1] 0 0
Local Institution - 0019 - Darlinghurst
Recruitment hospital [2] 0 0
Local Institution - 0066 - Elizabeth Vale
Recruitment hospital [3] 0 0
Local Institution - 0078 - Heidelberg
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
5112 - Elizabeth Vale
Recruitment postcode(s) [3] 0 0
3084 - Heidelberg
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
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New York
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United States of America
State/province [12] 0 0
North Carolina
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United States of America
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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
Argentina
State/province [18] 0 0
B
Country [19] 0 0
Argentina
State/province [19] 0 0
C
Country [20] 0 0
Argentina
State/province [20] 0 0
T
Country [21] 0 0
Argentina
State/province [21] 0 0
Buenos Aires
Country [22] 0 0
Argentina
State/province [22] 0 0
MarDel Lata
Country [23] 0 0
Argentina
State/province [23] 0 0
San Juan
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
Angers
Country [27] 0 0
France
State/province [27] 0 0
Besancon
Country [28] 0 0
France
State/province [28] 0 0
Bordeaux
Country [29] 0 0
France
State/province [29] 0 0
Brest
Country [30] 0 0
France
State/province [30] 0 0
Clermont-Ferrand CEDEX 01
Country [31] 0 0
France
State/province [31] 0 0
Lyon
Country [32] 0 0
France
State/province [32] 0 0
Marseille
Country [33] 0 0
France
State/province [33] 0 0
Nice CEDEX 2
Country [34] 0 0
France
State/province [34] 0 0
St Quentin
Country [35] 0 0
France
State/province [35] 0 0
Toulouse
Country [36] 0 0
France
State/province [36] 0 0
Villejuif Cedex
Country [37] 0 0
Greece
State/province [37] 0 0
B
Country [38] 0 0
Greece
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I
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Greece
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Athens
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Greece
State/province [40] 0 0
Thessaloniki
Country [41] 0 0
Italy
State/province [41] 0 0
MI
Country [42] 0 0
Italy
State/province [42] 0 0
Meldola
Country [43] 0 0
Italy
State/province [43] 0 0
Modena
Country [44] 0 0
Italy
State/province [44] 0 0
Pozzuoli
Country [45] 0 0
Italy
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Roma
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Netherlands
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ZH
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Netherlands
State/province [47] 0 0
Rotterdam
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Spain
State/province [48] 0 0
M
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Spain
State/province [49] 0 0
Badajoz
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Spain
State/province [50] 0 0
Santander-Cantabria
Country [51] 0 0
United Kingdom
State/province [51] 0 0
BNH
Country [52] 0 0
United Kingdom
State/province [52] 0 0
BST
Country [53] 0 0
United Kingdom
State/province [53] 0 0
LAN
Country [54] 0 0
United Kingdom
State/province [54] 0 0
LND
Country [55] 0 0
United Kingdom
State/province [55] 0 0
SRY
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United Kingdom
State/province [56] 0 0
TOB
Country [57] 0 0
United Kingdom
State/province [57] 0 0
WLV
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United Kingdom
State/province [58] 0 0
Huddersfield
Country [59] 0 0
United Kingdom
State/province [59] 0 0
Sutton
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United Kingdom
State/province [60] 0 0
Truro

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 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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05169684
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
BMS Study Connect Contact Center www.BMSStudyConnect.com
Address 0 0
Country 0 0
Phone 0 0
855-907-3286
Fax 0 0
Email 0 0
Clinical.Trials@bms.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05169684