Prostatic Neoplasms, Castration-Resistant Clinical Trial
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
| Verified date | December 2023 |
| Source | Bristol-Myers Squibb |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 10 |
| Est. completion date | December 6, 2023 |
| Est. primary completion date | December 6, 2023 |
| Accepts healthy volunteers | No |
| Gender | Male |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Argentina | Local Institution - 0039 | Buenos Aires | |
| Argentina | Local Institution - 0046 | Buenos Aires | |
| Argentina | Local Institution - 0055 | Buenos Aires | C |
| Argentina | Local Institution - 0041 | MarDel Lata | |
| Argentina | Local Institution - 0070 | Pergamino | B |
| Argentina | Local Institution - 0062 | San Juan | |
| Argentina | Local Institution - 0025 | San Miguel De Tocuman | T |
| Canada | Local Institution - 0067 | Hamilton | Ontario |
| Canada | Local Institution - 0083 | Ottawa | Ontario |
| Canada | Local Institution - 0015 | Québec | Quebec |
| Canada | Local Institution - 0028 | Toronto | Ontario |
| France | Local Institution - 0086 | Angers | |
| France | Local Institution - 0011 | Besancon | |
| France | Local Institution - 0080 | Bordeaux | |
| France | Local Institution - 0031 | Brest | |
| France | Local Institution - 0023 | Clermont-Ferrand CEDEX 01 | |
| France | Local Institution - 0008 | Lyon | |
| France | Local Institution - 0076 | Marseille | |
| France | Local Institution - 0012 | Nice CEDEX 2 | |
| France | Local Institution - 0049 | St Quentin | |
| France | Local Institution - 0003 | Toulouse | |
| France | Local Institution - 0014 | Villejuif Cedex | |
| Greece | Local Institution - 0010 | Athens | I |
| Greece | Local Institution - 0077 | Athens | |
| Greece | Local Institution - 0007 | Athina | I |
| Greece | Local Institution - 0027 | Athina | I |
| Greece | Local Institution - 0054 | Marousi | I |
| Greece | Local Institution - 0032 | Peiraias | I |
| Greece | Local Institution - 0069 | Thessaloniki | |
| Greece | Local Institution - 0081 | Thessaloniki | B |
| Italy | Local Institution - 0071 | Meldola | |
| Italy | Local Institution - 0037 | Milano | MI |
| Italy | Local Institution - 0016 | Modena | |
| Italy | Local Institution - 0029 | Pozzuoli | |
| Italy | Local Institution - 0021 | Rozzano | MI |
| Netherlands | Local Institution - 0074 | Dordrecht | ZH |
| United Kingdom | Local Institution - 0064 | Blackburn | LAN |
| United Kingdom | Local Institution - 0075 | Brighton | BNH |
| United Kingdom | Local Institution - 0053 | Guildford | SRY |
| United Kingdom | Local Institution - 0048 | London | LND |
| United Kingdom | Local Institution - 0030 | Preston | LAN |
| United Kingdom | Local Institution - 0035 | Sutton | |
| United Kingdom | Local Institution - 0051 | Torquay | TOB |
| United Kingdom | Local Institution - 0063 | Truro | |
| United Kingdom | Local Institution - 0073 | West Midlands | WLV |
| United States | The Winship Cancer Institute of Emory University | Atlanta | Georgia |
| United States | The Johns Hopkins Hospital | Baltimore | Maryland |
| United States | Texas Oncology-Beaumont Mamie McFaddin Ward Cancer Center | Beaumont | Texas |
| United States | Texas Oncology | Bedford | Texas |
| United States | The University of Chicago Medical Center - Duchossois Center for Advanced Medicine | Chicago | Illinois |
| United States | Oncology Hematology Care, Inc. - Eastgate | Cincinnati | Ohio |
| United States | Texas Oncology - Denton North | Denton | Texas |
| United States | Duke Cancer Institute | Durham | North Carolina |
| United States | Willamette Valley Cancer Institute | Eugene | Oregon |
| United States | Texas Oncology | Flower Mound | Texas |
| United States | Texas Oncology - Fort Worth Cancer Center | Fort Worth | Texas |
| United States | Virginia Oncology Associates - Hampton | Hampton | Virginia |
| United States | The University of Texas - MD Anderson Cancer Center - Genitourinary (GU) Cancer Center | Houston | Texas |
| United States | University Of Iowa Hospitals And Clinics | Iowa City | Iowa |
| United States | Rocky Mountain Cancer Centers - Littleton | Littleton | Colorado |
| United States | Kaiser Permanente Los Angeles Medical Center | Los Angeles | California |
| United States | Northwest Georgia Oncology Centers, P.C. | Marietta | Georgia |
| United States | Texas Oncology - McKinney | McKinney | Texas |
| United States | Medical College of Wisconsin | Milwaukee | Wisconsin |
| United States | Yale School Of Medicine | New Haven | Connecticut |
| United States | Columbia University Medical Center - Herbert Irving Pavilion Location | New York | New York |
| United States | Medical Oncology Hematology Consultants - Newark | Newark | Delaware |
| United States | Washington University School of Medicine in St. Louis | Saint Louis | Missouri |
| United States | Arizona Oncology - Tucson - Wilmot Road Location | Tucson | Arizona |
| United States | Texas Oncology- Tyler | Tyler | Texas |
| Lead Sponsor | Collaborator |
|---|---|
| Bristol-Myers Squibb |
United States, Argentina, Canada, France, Greece, Italy, Netherlands, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of participants with adverse events (AEs) | Part 1 | Up to 2 years | |
| Primary | Number of deaths | Part 1 | Up to 2 years | |
| Primary | Radiographic progression-free survival (rPFS) assessed by blinded independent central review (BICR) per Prostate Cancer Working Group 3 (PCWG3) | Part 2 | Up to 4 years | |
| Secondary | Objective response rate per Prostate Cancer Working Group 3 (ORR-PCWG3) | Part 2 | Up to 4 years | |
| Secondary | Time to response per Prostate Cancer Working Group 3 (TTR-PCWG3) as determined by BICR | Part 2 | Up to 4 years | |
| Secondary | Duration of response per Prostate Cancer Working Group 3 (DOR-PCWG3) as determined by BICR | Part 2 | Up to 4 years | |
| Secondary | Prostate-specific antigen response rate (PSA-RR) | Part 2 | Up to 4 years | |
| Secondary | Time to prostate-specific antigen progression (TTP-PSA) per PCWG3 | Part 2 | Up to 4 years | |
| Secondary | Overall survival (OS) | Part 2 | Up to 4 years | |
| Secondary | Number of participants with adverse events (AEs) | Part 2 | Up to 2 years | |
| Secondary | Number of deaths | Part 2 | Up to 2 years |
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