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

study description
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: Prostatic Neoplasms, Castration-Resistant
Intervention/treatment: Biological: BMS-986218
Drug: Docetaxel
Biological: Nivolumab
Phase: Phase 2
Detailed Description

N/A


study design
Study Type: Interventional
Estimated Enrollment : 204 participants
Allocation : Randomized
Intervention Model : Sequential Assignment
Masking: None (Open Label) ()
Primary Purpose: Treatment
Official Title: A Study 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 2022
Estimated Primary Completion Date: February 2026
Estimated Study Completion Date: February 2026

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

Drug: Docetaxel
Specified dose on specified days
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
Experimental: Arm 2B: Docetaxel + BMS-986218
Biological: BMS-986218
Specified dose on specified days

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

Biological: Nivolumab
Specified dose on specified days
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
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
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
Contacts

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
Additional relevant MeSH terms :
Prostatic Neoplasms
Prostatic Neoplasms, Castration-Resistant
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases