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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 |
| Clinicaltrials.gov identifier | recruitment status | First Posted | Last update posted |
| NCT05169684 | Recruiting | December 27, 2021 | August 3, 2022 |
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| study description |
| Brief Summary |
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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: | Prostatic Neoplasms, Castration-Resistant |
| Intervention/treatment: |
Biological: BMS-986218 Drug: Docetaxel Biological: Nivolumab |
| Phase: | Phase 2 |
| Detailed Description |
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N/A |
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| study design | ||||||||||||||||||||||
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| Arms and interventions |
| Arm | Intervention/treatment |
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Experimental: Arm 1A: Docetaxel + BMS-986218 |
Biological: BMS-986218 Specified dose on specified days Drug: Docetaxel Specified dose on specified days |
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Experimental: Arm 1B: Docetaxel + BMS-986218 + Nivolumab |
Biological: BMS-986218 Specified dose on specified days Drug: Docetaxel Specified dose on specified days Biological: Nivolumab Specified dose on specified days |
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Experimental: Arm 2B: Docetaxel + BMS-986218 |
Biological: BMS-986218 Specified dose on specified days Drug: Docetaxel Specified dose on specified days |
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Experimental: Arm 2C: Docetaxel + BMS-986218 + Nivolumab |
Biological: BMS-986218 Specified dose on specified days Drug: Docetaxel Specified dose on specified days Biological: Nivolumab Specified dose on specified days |
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Experimental: Arm 2D (Optional Crossover): BMS-986218 + Nivolumab |
Biological: BMS-986218 Specified dose on specified days Biological: Nivolumab Specified dose on specified days |
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Experimental: Arm 2A: Docetaxel |
Drug: Docetaxel Specified dose on specified days |
| outcome measures |
| Primary Outcome Measures: |
1. Number of participants with adverse events (AEs) [ Time Frame: Up to 2 years ] Part 1 |
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2. Number of deaths [ Time Frame: Up to 2 years ] Part 1 |
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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 |
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| Secondary Outcome Measures: |
1. Objective response rate per Prostate Cancer Working Group 3 (ORR-PCWG3) [ Time Frame: Up to 4 years ] Part 2 |
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2. Time to response per Prostate Cancer Working Group 3 (TTR-PCWG3) as determined by BICR [ Time Frame: Up to 4 years ] Part 2 |
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3. Duration of response per Prostate Cancer Working Group 3 (DOR-PCWG3) as determined by BICR [ Time Frame: Up to 4 years ] Part 2 |
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4. Prostate-specific antigen response rate (PSA-RR) [ Time Frame: Up to 4 years ] Part 2 |
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5. Time to prostate-specific antigen progression (TTP-PSA) per PCWG3 [ Time Frame: Up to 4 years ] Part 2 |
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6. Overall survival (OS) [ Time Frame: Up to 4 years ] Part 2 |
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7. Number of participants with adverse events (AEs) [ Time Frame: Up to 2 years ] Part 2 |
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8. Number of deaths [ Time Frame: Up to 2 years ] Part 2 |
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| Eligibility Criteria |
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
| Criteria |
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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 |
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| Contacts and Locations |
| 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 |
| United States, Arizona | Arizona Oncology - Tucson - Wilmot Road Location | Tucson |
| United States, California | Local Institution | Los Angeles |
| United States, Colorado | Rocky Mountain Cancer Centers (Littleton) - USOR | Littleton |
| United States, Connecticut | Local Institution | New Haven |
| United States, Delaware | Medical oncology Hematology Consultants PA, Helen F Graham Cancer Center | Newark |
| United States, Florida | Florida Urology Partners, LLP - Tampa | Tampa |
| United States, Georgia | Local Institution | Atlanta |
| United States, Georgia | Northwest Georgia Oncology Centers PC | Marietta |
| United States, Illinois | Local Institution | Chicago |
| United States, Maryland | Local Institution | Baltimore |
| United States, Maryland | Maryland Oncology Hematology, P.A. | Columbia |
| United States, Missouri | Local Institution | Saint Louis |
| United States, New York | Columbia University Medical Center Herbert Irving Pavilion | New York |
| United States, North Carolina | Local Institution | Cary |
| United States, Ohio | Oncology Hematology Care Incorporated | Cincinnati |
| United States, Oregon | Willamette Valley Cancer Institute And Research Center | Eugene |
| United States, Pennsylvania | Thomas Jefferson University Hospital | Philadelphia |
| United States, Texas | Texas Oncology-Beaumont | Beaumont |
| United States, Texas | Texas Oncology | Bedford |
| United States, Texas | Texas Oncology - Denton North | Denton |
| United States, Texas | Texas Oncology | Flower Mound |
| United States, Texas | Texas Oncology - Fort Worth Cancer Center | Fort Worth |
| United States, Texas | University of Texas MD Anderson Cancer Center | Houston |
| United States, Texas | Local Institution | McKinney |
| United States, Texas | Texas Oncology-Tyler | Tyler |
| United States, Virginia | Local Institution | Hampton |
| United States, Wisconsin | Local Institution | Milwaukee |
| Argentina, Buenos Aires | Local Institution | Ciudad de Buenos Aires |
| Argentina, Buenos Aires | Local Institution | Mar Del Plata |
| Argentina, Buenos Aires | Local Institution | Pergamino |
| Argentina | Local Institution | Buenos Aires |
| Argentina | Local Institution - 0018 | Buenos Aires |
| Argentina | Local Institution | Buenos Aires |
| Argentina | Local Institution | Tucuman |
| Australia, New South Wales | Local Institution | Darlinghurst |
| Australia, South Australia | Local Institution | Elizabeth Vale |
| Australia, Victoria | Local Institution | Heidleberg |
| Canada, Ontario | Local Institution | Hamilton |
| Canada, Ontario | Local Institution | Toronto |
| Canada | Local Institution | Quebec |
| France, Paca | Local Institution | Nice |
| France | Local Institution | Besançon |
| France | Local Institution | Bordeaux |
| France | Local Institution | Brest |
| France | Local Institution | Clermont-Ferrand |
| France | Local Institution | Lyon |
| France | Local Institution | Marseille |
| France | Local Institution | Saint-Quentin |
| France | Local Institution | Toulouse |
| France | Local Institution | Villejuif Cedex |
| Greece | Local Institution | Athens |
| Greece | Local Institution | Athens |
| Greece | Local Institution | Athens |
| Greece | Local Institution | Athens |
| Greece | Local Institution | Marousi |
| Greece | Local Institution | Pylaia-Chortiatis |
| Greece | Local Institution | Thessaloniki |
| Greece | Local Institution | Thessaloniki |
| Italy | Local Institution | Meldola |
| Italy | Local Institution | Milano |
| Italy | Local Institution | Modena |
| Italy | Local Institution | Pozzuoli |
| Italy | Local Institution | Roma |
| Italy | Local Institution | Rozzano |
| Netherlands | Local Institution | Dordrecht |
| Netherlands | Local Institution | Rotterdam |
| Netherlands | Local Institution | Rotterdam |
| Spain | Local Institution | Badajoz |
| Spain | Local Institution | Madrid |
| Spain | Local Institution | Santander |
| United Kingdom | Local Institution | Blackburn |
| United Kingdom | Local Institution | Brighton |
| United Kingdom | Local Institution - 0065 | Bristol |
| United Kingdom | Local Institution | Guildford |
| United Kingdom | Local Institution | Huddersfield |
| United Kingdom | Local Institution | London |
| United Kingdom | Local Institution | London |
| United Kingdom | Local Institution | Preston |
| United Kingdom | Local Institution | Torquay |
| United Kingdom | Local Institution | Truro |
| United Kingdom | Local Institution | Wolverhampton |
| Sponsors and Collaborators |
| Bristol-Myers Squibb |
| Investigator | ||
| Study Director : | Bristol-Myers Squibb | Bristol-Myers Squibb |
| More Information | ||||||||||
| Responsible Party : | Bristol-Myers Squibb | |||||||||
| ClinicalTrials.gov Identifier : | NCT05169684 | |||||||||
| Other Study ID Numbers : | CA022-009, 2021-003990-74, U1111-1268-2566 | |||||||||
| First Posted : | December 27, 2021 | |||||||||
| Last Update Posted : | August 3, 2022 | |||||||||
| Last Verified : | August 2022 | |||||||||
| 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 |
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| Additional relevant MeSH terms : |
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