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Prostatic Neoplasms, Castration-ResistantPhase 2NCT05169684

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

A Phase 2 study testing BMS-986218, Docetaxel and Nivolumab in people with Prostatic Neoplasms, Castration-Resistant, run by Bristol-Myers Squibb at 31 sites in 3 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
BMS-986218, Docetaxel and Nivolumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
31 sitesin 3 countries
Study dates
14 Feb 2022to 6 Dec 2023
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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

Trial locations and contacts

31 sites in 3 countries.

31 sites in 3 countries

United States25 sites

  • The Winship Cancer Institute of Emory University

    Atlanta, Georgia, 30322-1013

  • The Johns Hopkins Hospital

    Baltimore, Maryland, 21287

  • Texas Oncology-Beaumont Mamie McFaddin Ward Cancer Center

    Beaumont, Texas, 77702

  • Texas Oncology

    Bedford, Texas, 76022-6920

  • The University of Chicago Medical Center - Duchossois Center for Advanced Medicine

    Chicago, Illinois, 60637-1426

  • Oncology Hematology Care, Inc. - Eastgate

    Cincinnati, Ohio, 45245-1995

  • Texas Oncology - Denton North

    Denton, Texas, 76201-4315

  • Duke Cancer Institute

    Durham, North Carolina, 27710

  • Willamette Valley Cancer Institute

    Eugene, Oregon, 97477

  • Texas Oncology

    Flower Mound, Texas, 75028

  • Texas Oncology - Fort Worth Cancer Center

    Fort Worth, Texas, 76104-2150

  • Local Institution - 0056

    Hampton, Virginia, 23666-5963

  • The University of Texas - MD Anderson Cancer Center - Genitourinary (GU) Cancer Center

    Houston, Texas, 77030-4004

  • University Of Iowa Hospitals And Clinics

    Iowa City, Iowa, 52242

  • Rocky Mountain Cancer Centers - Littleton

    Littleton, Colorado, 80120-4413

  • Kaiser Permanente Los Angeles Medical Center

    Los Angeles, California, 90027-5969

  • Local Institution - 0004

    Marietta, Georgia, 30060

  • Texas Oncology - McKinney

    McKinney, Texas, 75071-8106

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Yale School Of Medicine

    New Haven, Connecticut, 06510-3206

  • Local Institution - 0006

    New York, New York, 10032-3729

  • Medical Oncology Hematology Consultants - Newark

    Newark, Delaware, 19713-2055

  • Washington University School of Medicine in St. Louis

    St Louis, Missouri, 63110-1010

  • Arizona Oncology - Tucson - Wilmot Road Location

    Tucson, Arizona, 85711-2701

  • Texas Oncology- Tyler

    Tyler, Texas, 75702-8363

Other trials in United States

Italy5 sites

  • Local Institution - 0071

    Meldola, 47014

  • Local Institution - 0037

    Milan, MI, 20162

  • Local Institution - 0016

    Modena, 41124

  • Local Institution - 0029

    Pozzuoli, 80078

  • Local Institution - 0021

    Rozzano, MI, 20089

Other trials in Italy

France1 site

  • Local Institution - 0003

    Toulouse, 31100

Other trials in France

About this study

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

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.

Being tested
BMS-986218, Docetaxel, Nivolumab
Keywords
BMS-986218, BMS-936558, Docetaxel, Metastatic, MDX1106, Nivolumab, ONO-4538, TAXOTERE
Medical subject headings
Prostatic Neoplasms, Castration-Resistant, Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BMS-986218Biological

    Specified dose on specified days

  • DocetaxelDrug

    Also called TAXOTERE

    Specified dose on specified days

  • NivolumabBiological

    Also called BMS-936558, MDX1106, ONO-4538

    Specified dose on specified days

Study groups in NCT05169684
Study groupRoleWhat they receive
Arm 1A: Docetaxel + BMS-986218ExperimentalNot described
Receives: Biological: BMS-986218; Drug: Docetaxel
Arm 1B: Docetaxel + BMS-986218 + NivolumabExperimentalNot described
Receives: Biological: BMS-986218; Drug: Docetaxel; Biological: Nivolumab
Arm 2A: DocetaxelExperimentalNot described
Receives: Drug: Docetaxel
Arm 2B: Docetaxel + BMS-986218ExperimentalNot described
Receives: Biological: BMS-986218; Drug: Docetaxel
Arm 2C: Docetaxel + BMS-986218 + NivolumabExperimentalNot described
Receives: Biological: BMS-986218; Drug: Docetaxel; Biological: Nivolumab
Arm 2D (Optional Crossover): BMS-986218 + NivolumabExperimentalNot described
Receives: Biological: BMS-986218; Biological: Nivolumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With Treatment Related Adverse Events

    Adverse events will presented using National Cancer Institute Common Terminology Criteria for Adverse Events version 5 (NCI CTCAE v5).

    Measured: From first dose to 100 days follow up to last dose (Approximately 22 months)

  2. Number of Participants With Treatment Related Serious Adverse Events

    Adverse events will presented using National Cancer Institute Common Terminology Criteria for Adverse Events version 5 (NCI CTCAE v5).

    Measured: From first dose to 100 days follow up to last dose (Approximately 22 months)

  3. Number of Participants With Dose Limiting Toxicities

    DLTs will be defined as:

    Any treatment-related AEs for which a participant permanently discontinues a study treatment (other than daily prednisone) and that occurs during the first 2 cycles of treatment.

    Any death not clearly due to the underlying disease or extraneous causes and that occurs during the first 2 cycles of treatment Greater than or equal to Grade 2 pneumonitis lasting greater than 5 days despite appropriate medical therapy and that occurs during the first 2 cycles of treatment Any neutropenic fever as well as Grade 4 neutropenia or thrombocytopenia for > 7 days that occurs during the first 2 cycles of treatment Any treatment-related AE that delays initiation of Cycle 2 or Cycle 3 of treatment by greater than 2 consecutive weeks.

    Measured: From first dose to 100 days follow up to last dose (Approximately 22 months)

  4. Number of Participants With AEs Leading to Discontinuation

    Adverse events will presented using National Cancer Institute Common Terminology Criteria for Adverse Events version 5 (NCI CTCAE v5).

    Measured: From first dose to 100 days follow up to last dose (Approximately 22 months)

  5. Number of Participants Who Died

    Number of participant deaths

    Measured: From first dose to 100 days follow up to last dose (Approximately 22 months)

Secondary outcomes (5)

  1. Prostate Specific Antigen Response Rate (PSA-RR)

    PSA-RR is the proportion of randomized participants with a 50% or greater decrease in PSA from baseline to any post-baseline PSA result. A second consecutive value obtained 3 or more weeks later is required to confirm the PSA response.

    Measured: From first dose to 100 days follow up to last dose (Approximately 22 months)

  2. Objective Response Rate

    Objective response rate per PCWG3 (ORR-PCWG3) is the proportion of participants who have a confirmed complete or partial best overall response (BOR) per PCWG3 among randomized participants who have measurable disease at baseline. The BOR is defined as the best response designation, as determined by the BICR, recorded between the date of randomization and the date of objectively documented radiographic progression, or last tumor measurement, whichever occurs first.

    Measured: From first dose to 100 days follow up to last dose (Approximately 22 months)

  3. Time to Response

    Time to response per PCWG3 (TTR-PCWG3) is the time from randomization date to the date of the first documented CR or PR per PCWG3, as determined by BICR.

    Measured: From first dose to 100 days follow up to last dose (Approximately 22 months)

  4. Duration of Response

    Duration of response per PCWG3 (DOR-PCWG3) is the time between the date of first response (CR/PR per PCWG3) to the date of first documented radiographic progression per PCWG3 (as determined by BICR), or death due to any cause.

    Measured: From first dose to 100 days follow up to last dose (Approximately 22 months)

  5. Overall Survival

    OS for all randomized participants is the time between randomization date and the date of death from any cause.

    Measured: From first dose to 100 days follow up to last dose (Approximately 22 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Dec 2021
  2. Study start14 Feb 2022
  3. Primary completion6 Dec 2023
  4. Study completion6 Dec 2023

Why it stopped: Business objectives have changed

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05169684
Sponsor's protocol ID
CA022-009
Other IDs
2021-003990-74, U1111-1268-2566
Status last verified
May 2025
First submitted
10 Dec 2021
Last updated
10 Jun 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BMS-986218, Docetaxel and Nivolumab in people with Prostatic Neoplasms, Castration-Resistant, run by Bristol-Myers Squibb at 31 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 10 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 31 sites in United States, Italy, France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Treatment Related Adverse Events (time frame: From first dose to 100 days follow up to last dose (Approximately 22 months)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05169684.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2025.

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