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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 : April 18, 2023
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Description
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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.

Condition or disease Intervention/treatment Phase
Prostatic Neoplasms, Castration-Resistant Biological: BMS-986218 Drug: Docetaxel Biological: Nivolumab Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 204 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : February 14, 2022
Estimated Primary Completion Date : February 12, 2026
Estimated Study Completion Date : February 13, 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: Arm 1A: Docetaxel + BMS-986218 Biological: BMS-986218
Specified dose on specified days

Drug: Docetaxel
Specified dose on specified days
Other Name: TAXOTERE
Experimental: Arm 1B: Docetaxel + BMS-986218 + Nivolumab 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
Experimental: Arm 2A: Docetaxel Drug: Docetaxel
Specified dose on specified days
Other Name: TAXOTERE
Experimental: Arm 2B: Docetaxel + BMS-986218 Biological: BMS-986218
Specified dose on specified days

Drug: Docetaxel
Specified dose on specified days
Other Name: TAXOTERE
Experimental: Arm 2C: Docetaxel + BMS-986218 + Nivolumab 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
Experimental: Arm 2D (Optional Crossover): BMS-986218 + Nivolumab Biological: BMS-986218
Specified dose on specified days

Biological: Nivolumab
Specified dose on specified days
Other Name: BMS-936558, MDX1106, ONO-4538


Outcome Measures
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Primary Outcome Measures :
  1. Number of participants with adverse events (AEs) [ Time Frame: Up to 2 years ]
    Part 1

  2. Number of deaths [ Time Frame: Up to 2 years ]
    Part 1

  3. 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


Secondary Outcome Measures :
  1. Objective response rate per Prostate Cancer Working Group 3 (ORR-PCWG3) [ Time Frame: Up to 4 years ]
    Part 2

  2. Time to response per Prostate Cancer Working Group 3 (TTR-PCWG3) as determined by BICR [ Time Frame: Up to 4 years ]
    Part 2

  3. Duration of response per Prostate Cancer Working Group 3 (DOR-PCWG3) as determined by BICR [ Time Frame: Up to 4 years ]
    Part 2

  4. Prostate-specific antigen response rate (PSA-RR) [ Time Frame: Up to 4 years ]
    Part 2

  5. Time to prostate-specific antigen progression (TTP-PSA) per PCWG3 [ Time Frame: Up to 4 years ]
    Part 2

  6. Overall survival (OS) [ Time Frame: Up to 4 years ]
    Part 2

  7. Number of participants with adverse events (AEs) [ Time Frame: Up to 2 years ]
    Part 2

  8. Number of deaths [ Time Frame: Up to 2 years ]
    Part 2


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05169684


Contacts
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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 #.

Locations
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Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
More Information
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Additional Information:

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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT05169684    
Other Study ID Numbers: CA022-009
2021-003990-74 ( EudraCT Number )
U1111-1268-2566 ( Registry Identifier: WHO )
First Posted: December 27, 2021    Key Record Dates
Last Update Posted: April 18, 2023
Last Verified: April 2023

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bristol-Myers Squibb:
BMS-986218
BMS-936558
Docetaxel
Metastatic
 MDX1106
Nivolumab
ONO-4538
TAXOTERE
Additional relevant MeSH terms:
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Prostatic Neoplasms
Prostatic Neoplasms, Castration-Resistant
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Genital Diseases
Urogenital Diseases
Prostatic Diseases
 Male Urogenital Diseases
Docetaxel
Nivolumab
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological
Immune Checkpoint Inhibitors