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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06764485




Registration number
NCT06764485
Ethics application status
Date submitted
17/12/2024
Date registered
8/01/2025
Date last updated
13/01/2025

Titles & IDs
Public title
A Study to Compare the Efficacy and Safety of BMS-986365 Versus the Investigator's Choice of Therapy in Participants With Metastatic Castration-resistant Prostate Cancer
Scientific title
A Phase 3, Two-part, Randomized, Open-label, Adaptive Study Comparing BMS-986365 Versus Investigator's Choice of Therapy Comprising Either Docetaxel or Second Androgen Receptor Pathway Inhibitor (ARPI), in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) - rechARge
Secondary ID [1] 0 0
CA071-1000
Universal Trial Number (UTN)
Trial acronym
rechARge
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metastatic Castration-resistant Prostate Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - BMS-986365
Treatment: Drugs - Enzalutamide
Treatment: Drugs - Abiraterone
Treatment: Drugs - Docetaxel
Treatment: Drugs - Predinsone/Prednisolone

Experimental: Part 1: Dose 1 -

Experimental: Part 1: Dose 2 -

Active comparator: Part 1: Comparator 1 - Enzalutamide or Abiraterone Acetate + Prednisone/Prednisolone

Active comparator: Part 1: Comparator 2 -

Experimental: Part 2: Dose Selected -

Active comparator: Part 2: Comparator 1 - Enzalutamide or Abiraterone Acetate + Prednisone/Prednisolone

Active comparator: Part 2: Comparator 2 -


Treatment: Drugs: BMS-986365
Specified dose on specified days

Treatment: Drugs: Enzalutamide
Specified dose on specified days

Treatment: Drugs: Abiraterone
Specified dose on specified days

Treatment: Drugs: Docetaxel
Specified dose on specified days

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

Outcomes
Primary outcome [1] 0 0
Radiographic progression-free survival (rPFS) by blinded independent central review (BICR) using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 (soft tissue) and Prostate Cancer Clinical Trials Working Group 3 (PCWG3) (bone) criteria
Timepoint [1] 0 0
Up to 4 years
Secondary outcome [1] 0 0
Overall Survival (OS)
Timepoint [1] 0 0
Up to 4 years
Secondary outcome [2] 0 0
Recommended dose of BMS-986365 for Part 2
Timepoint [2] 0 0
Up to approximately 1.5 years
Secondary outcome [3] 0 0
Progression-free survival (PFS)
Timepoint [3] 0 0
Up to 4 years
Secondary outcome [4] 0 0
Confirmed overall response rate (ORR) by BICR assessment in participants with measurable disease using RECIST 1.1 (soft tissue) and PCWG3 (bone) criteria
Timepoint [4] 0 0
Up to 4 years
Secondary outcome [5] 0 0
Time to pain progression (TTPP)
Timepoint [5] 0 0
Up to 4 years
Secondary outcome [6] 0 0
Time to symptomatic progression (TTSP)
Timepoint [6] 0 0
Up to 4 years
Secondary outcome [7] 0 0
Time to initiation of the first subsequent systemic therapy (TFST)
Timepoint [7] 0 0
Up to 4 years
Secondary outcome [8] 0 0
Prostate-specific antigen (PSA) response rate
Timepoint [8] 0 0
Up to 4 years
Secondary outcome [9] 0 0
Change from baseline in Functional Assessment of Cancer Therapy - Prostate Cancer (FACT-P) total scores
Timepoint [9] 0 0
Up to 4 years
Secondary outcome [10] 0 0
Change from baseline in Prostate Cancer Subscale (PCS) scores
Timepoint [10] 0 0
Up to 4 years
Secondary outcome [11] 0 0
Change from baseline in trial outcome index (TOI)
Timepoint [11] 0 0
Up to 4 years
Secondary outcome [12] 0 0
Change from baseline in Brief Pain Inventory - Short Form (BPI-SF) worst pain (item #3) intensity
Timepoint [12] 0 0
Up to 4 years
Secondary outcome [13] 0 0
Incidence of adverse events (AEs)
Timepoint [13] 0 0
Up to 4 years
Secondary outcome [14] 0 0
Incidence of serious adverse events (SAEs)
Timepoint [14] 0 0
Up to 4 years
Secondary outcome [15] 0 0
Incidence of AEs leading to dose modifications
Timepoint [15] 0 0
Up to 4 years
Secondary outcome [16] 0 0
Incidence of AEs leading to interruptions
Timepoint [16] 0 0
Up to 4 years
Secondary outcome [17] 0 0
Incidence of AEs leading to discontinuation
Timepoint [17] 0 0
Up to 4 years
Secondary outcome [18] 0 0
Electrocardiogram (ECG) findings
Timepoint [18] 0 0
Up to 4 years
Secondary outcome [19] 0 0
Incidence of laboratory abnormalities
Timepoint [19] 0 0
Up to 4 years

Eligibility
Key inclusion criteria
Inclusion Criteria

* Participants must have histologic or cytologic confirmation of adenocarcinoma of the prostate without small cell or neuro-endocrine features.
* Participants must have current evidence of metastatic disease documented by either bone lesions on radionuclide bone scan and/or soft tissue lesions on computed tomography/magnetic resonance imaging (CT/MRI).
* Participants must be asymptomatic or mildly symptomatic from prostate cancer with score on Brief Pain Inventory - Short Form (BPI-SF) that must be < 4.
* Participants must have had previous treatment with an androgen receptor pathway inhibitor (abiraterone, enzalutamide, apalutamide, or darolutamide).
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria

* Participants must not have impaired cardiac function or clinically significant cardiac disease.
* Participants must not have any brain metastasis.
* Participants must not have any liver metastasis.
* Participants with superscan on technetium-99m (Tc-99m) radionuclide bone scans.
* 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 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
11/03/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
19/01/2029
Actual
Sample size
Target
960
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,TAS,VIC,WA
Recruitment hospital [1] 0 0
Local Institution - 0366 - Campbelltown
Recruitment hospital [2] 0 0
Local Institution - 0359 - Darlinghurst
Recruitment hospital [3] 0 0
Local Institution - 0356 - Macquarie University
Recruitment hospital [4] 0 0
Local Institution - 0360 - Port Macquarie
Recruitment hospital [5] 0 0
Local Institution - 0355 - Wahroonga
Recruitment hospital [6] 0 0
Local Institution - 0347 - Greenslopes
Recruitment hospital [7] 0 0
Local Institution - 0351 - Southport
Recruitment hospital [8] 0 0
Local Institution - 0362 - Adelaide
Recruitment hospital [9] 0 0
Local Institution - 0358 - Elizabeth Vale
Recruitment hospital [10] 0 0
Local Institution - 0352 - Kurralta Park
Recruitment hospital [11] 0 0
Local Institution - 0354 - Hobart
Recruitment hospital [12] 0 0
Local Institution - 0363 - Heidelberg
Recruitment hospital [13] 0 0
Local Institution - 0353 - Malvern
Recruitment hospital [14] 0 0
Local Institution - 0348 - Melbourne
Recruitment hospital [15] 0 0
Local Institution - 0361 - Melbourne
Recruitment hospital [16] 0 0
Local Institution - 0357 - Murdoch
Recruitment postcode(s) [1] 0 0
2560 - Campbelltown
Recruitment postcode(s) [2] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [3] 0 0
2109 - Macquarie University
Recruitment postcode(s) [4] 0 0
2444 - Port Macquarie
Recruitment postcode(s) [5] 0 0
2076 - Wahroonga
Recruitment postcode(s) [6] 0 0
4120 - Greenslopes
Recruitment postcode(s) [7] 0 0
4215 - Southport
Recruitment postcode(s) [8] 0 0
5000 - Adelaide
Recruitment postcode(s) [9] 0 0
5112 - Elizabeth Vale
Recruitment postcode(s) [10] 0 0
5037 - Kurralta Park
Recruitment postcode(s) [11] 0 0
7000 - Hobart
Recruitment postcode(s) [12] 0 0
3084 - Heidelberg
Recruitment postcode(s) [13] 0 0
3144 - Malvern
Recruitment postcode(s) [14] 0 0
3000 - Melbourne
Recruitment postcode(s) [15] 0 0
3004 - Melbourne
Recruitment postcode(s) [16] 0 0
6150 - Murdoch
Recruitment outside Australia
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Lugo [Lugo]
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Spain
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Madrid, Comunidad De
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Navarra
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Badajoz
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Málaga
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Sevilla
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València
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Sweden
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Skåne Län [se-12]
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Sweden
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Stockholms Län [se-01]
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Sweden
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Uppsala Län [se-03]
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Istanbul
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United Kingdom
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Hillingdon
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Sutton
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United Kingdom
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Manchester

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Celgene
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to compare the efficacy and safety of BMS-986365 versus the investigator's choice of therapy in participants with Metastatic Castration-resistant Prostate Cancer.
Trial website
https://clinicaltrials.gov/study/NCT06764485
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 Clinical Trials Contact Center www.BMSClinicalTrials.com
Address 0 0
Country 0 0
Phone 0 0
855-907-3286
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06764485