We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study of BMS-986218 or BMS-986218 Plus Nivolumab in Combination With Docetaxel in Participants With Metastatic Castration-resistant Prostate Cancer

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 evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05169684
Recruitment Status : Recruiting
First Posted : December 27, 2021
Last Update Posted : August 3, 2022
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Tracking Information
First Submitted Date  ICMJE December 10, 2021
First Posted Date  ICMJE December 27, 2021
Last Update Posted Date August 3, 2022
Actual Study Start Date  ICMJE February 14, 2022
Estimated Primary Completion Date February 12, 2026   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 12, 2022)
  • Number of participants with adverse events (AEs) [ Time Frame: Up to 2 years ]
    Part 1
  • Number of deaths [ Time Frame: Up to 2 years ]
    Part 1
  • Radiographic progression-free survival (rPFS) assessed by blinded independent central review (BICR) per Prostate Cancer Working Group 3 (PCWG3) [ Time Frame: Up to 4 years ]
    Part 2
Original Primary Outcome Measures  ICMJE
 (submitted: December 10, 2021)
  • Incidence of adverse events (AEs) [ Time Frame: Up to 2 years ]
    Part 1
  • Incidence of serious adverse events (SAEs) [ Time Frame: Up to 2 years ]
    Part 1
  • Incidence of AEs meeting protocol-defined (dose-limiting toxicity) DLT criteria [ Time Frame: Up to 2 years ]
    Part 1
  • Incidence of treatment-related adverse event (TRAEs) [ Time Frame: Up to 2 years ]
    Part 1
  • Incidence of AEs leading to discontinuation [ Time Frame: Up to 2 years ]
    Part 1
  • Incidence of death [ Time Frame: Up to 2 years ]
    Part 1
  • Progression-free survival (PFS) [ Time Frame: Up to 4 years ]
    Part 2
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 12, 2022)
  • Objective response rate per Prostate Cancer Working Group 3 (ORR-PCWG3) [ Time Frame: Up to 4 years ]
    Part 2
  • Time to response per Prostate Cancer Working Group 3 (TTR-PCWG3) as determined by BICR [ Time Frame: Up to 4 years ]
    Part 2
  • Duration of response per Prostate Cancer Working Group 3 (DOR-PCWG3) as determined by BICR [ Time Frame: Up to 4 years ]
    Part 2
  • Prostate-specific antigen response rate (PSA-RR) [ Time Frame: Up to 4 years ]
    Part 2
  • Time to prostate-specific antigen progression (TTP-PSA) per PCWG3 [ Time Frame: Up to 4 years ]
    Part 2
  • Overall survival (OS) [ Time Frame: Up to 4 years ]
    Part 2
  • Number of participants with adverse events (AEs) [ Time Frame: Up to 2 years ]
    Part 2
  • Number of deaths [ Time Frame: Up to 2 years ]
    Part 2
Original Secondary Outcome Measures  ICMJE
 (submitted: December 10, 2021)
  • Objective response rate per Prostate Cancer Working Group 3 (ORR-PCWG3) [ Time Frame: Up to 4 years ]
    Part 2
  • Time to response per Prostate Cancer Working Group 3 (TTR-PCWG3) [ Time Frame: Up to 4 years ]
    Part 2
  • Duration of response per Prostate Cancer Working Group 3 (DOR-PCWG3) [ Time Frame: Up to 4 years ]
    Part 2
  • Prostate-specific antigen response rate (PSA-RR) [ Time Frame: Up to 4 years ]
    Part 2
  • Time to prostate-specific antigen progression (TTP-PSA) per PCWG3 [ Time Frame: Up to 4 years ]
    Part 2
  • Overall survival (OS) [ Time Frame: Up to 4 years ]
    Part 2
  • Incidence of AEs [ Time Frame: Up to 2 years ]
    Part 2
  • Incidence of TRAEs [ Time Frame: Up to 2 years ]
    Part 2
  • Incidence of SAEs [ Time Frame: Up to 2 years ]
    Part 2
  • Incidence of AEs leading to discontinuation [ Time Frame: Up to 2 years ]
    Part 2
  • Incidence of death [ Time Frame: Up to 2 years ]
    Part 2
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of BMS-986218 or BMS-986218 Plus Nivolumab in Combination With Docetaxel in Participants With Metastatic Castration-resistant Prostate Cancer
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Prostatic Neoplasms, Castration-Resistant
Intervention  ICMJE
  • Biological: BMS-986218
    Specified dose on specified days
  • Drug: Docetaxel
    Specified dose on specified days
    Other Name: TAXOTERE
  • Biological: Nivolumab
    Specified dose on specified days
    Other Name: BMS-936558, MDX1106, ONO-4538
Study Arms  ICMJE
  • Experimental: Arm 1A: Docetaxel + BMS-986218
    Interventions:
    • Biological: BMS-986218
    • Drug: Docetaxel
  • Experimental: Arm 1B: Docetaxel + BMS-986218 + Nivolumab
    Interventions:
    • Biological: BMS-986218
    • Drug: Docetaxel
    • Biological: Nivolumab
  • Experimental: Arm 2A: Docetaxel
    Intervention: Drug: Docetaxel
  • Experimental: Arm 2B: Docetaxel + BMS-986218
    Interventions:
    • Biological: BMS-986218
    • Drug: Docetaxel
  • Experimental: Arm 2C: Docetaxel + BMS-986218 + Nivolumab
    Interventions:
    • Biological: BMS-986218
    • Drug: Docetaxel
    • Biological: Nivolumab
  • Experimental: Arm 2D (Optional Crossover): BMS-986218 + Nivolumab
    Interventions:
    • Biological: BMS-986218
    • Biological: Nivolumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 10, 2021)		 204
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 13, 2026
Estimated Primary Completion Date February 12, 2026   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: BMS Study Connect Contact Center www.BMSStudyConnect.com 855-907-3286 Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT # and Site #.
Listed Location Countries  ICMJE Argentina,   Australia,   Canada,   France,   Greece,   Italy,   Netherlands,   Spain,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05169684
Other Study ID Numbers  ICMJE CA022-009
2021-003990-74 ( EudraCT Number )
U1111-1268-2566 ( Registry Identifier: WHO )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Bristol-Myers Squibb
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Bristol-Myers Squibb
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
PRS Account Bristol-Myers Squibb
Verification Date August 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP