Clinical trial NCT05169684: A Study of BMS-986218 or BMS-986218 Plus Nivolumab in Combination With Docetaxel in Participants With Metastatic Castration-resistant Prostate Cancer
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Prostatic Neoplasms, Castration-Resistant
Keywords: BMS-986218
BMS-936558
Docetaxel
Metastatic
MDX1106
Nivolumab
ONO-4538
TAXOTERE
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2021-12-27
Enrollment: 10
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Number of Participants With Treatment Related Adverse Events
timeFrame: From first dose to 100 days follow up to last dose (Approximately 22 months)
measure: Number of Participants With Treatment Related Serious Adverse Events
timeFrame: From first dose to 100 days follow up to last dose (Approximately 22 months)
measure: Number of Participants With Dose Limiting Toxicities
timeFrame: From first dose to 100 days follow up to last dose (Approximately 22 months)
measure: Number of Participants With AEs Leading to Discontinuation
timeFrame: From first dose to 100 days follow up to last dose (Approximately 22 months)
measure: Number of Participants Who Died
timeFrame: From first dose to 100 days follow up to last dose (Approximately 22 months)
Secondary outcomes:
measure: Prostate Specific Antigen Response Rate (PSA-RR)
timeFrame: From first dose to 100 days follow up to last dose (Approximately 22 months)
measure: Objective Response Rate
timeFrame: From first dose to 100 days follow up to last dose (Approximately 22 months)
measure: Time to Response
timeFrame: From first dose to 100 days follow up to last dose (Approximately 22 months)
measure: Duration of Response
timeFrame: From first dose to 100 days follow up to last dose (Approximately 22 months)
measure: Overall Survival
timeFrame: From first dose to 100 days follow up to last dose (Approximately 22 months)
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Arizona Oncology - Tucson - Wilmot Road Location
state: Arizona
city: Los Angeles
country: United States
facility: Kaiser Permanente Los Angeles Medical Center
state: California
city: Littleton
country: United States
facility: Rocky Mountain Cancer Centers - Littleton
state: Colorado
city: New Haven
country: United States
facility: Yale School Of Medicine
state: Connecticut
city: Newark
country: United States
facility: Medical Oncology Hematology Consultants - Newark
state: Delaware
city: Atlanta
country: United States
facility: The Winship Cancer Institute of Emory University
state: Georgia
city: Marietta
country: United States
facility: Local Institution - 0004
state: Georgia
city: Chicago
country: United States
facility: The University of Chicago Medical Center - Duchossois Center for Advanced Medicine
state: Illinois
city: Iowa City
country: United States
facility: University Of Iowa Hospitals And Clinics
state: Iowa
city: Baltimore
country: United States
facility: The Johns Hopkins Hospital
state: Maryland
city: Saint Louis
country: United States
facility: Washington University School of Medicine in St. Louis
state: Missouri
city: New York
country: United States
facility: Local Institution - 0006
state: New York
city: Durham
country: United States
facility: Duke Cancer Institute
state: North Carolina
city: Cincinnati
country: United States
facility: Oncology Hematology Care, Inc. - Eastgate
state: Ohio
city: Eugene
country: United States
facility: Willamette Valley Cancer Institute
state: Oregon
city: Beaumont
country: United States
facility: Texas Oncology-Beaumont Mamie McFaddin Ward Cancer Center
state: Texas
city: Bedford
country: United States
facility: Texas Oncology
state: Texas
city: Denton
country: United States
facility: Texas Oncology - Denton North
state: Texas
city: Flower Mound
country: United States
facility: Texas Oncology
state: Texas
city: Fort Worth
country: United States
facility: Texas Oncology - Fort Worth Cancer Center
state: Texas
city: Houston
country: United States
facility: The University of Texas - MD Anderson Cancer Center - Genitourinary (GU) Cancer Center
state: Texas
city: McKinney
country: United States
facility: Texas Oncology - McKinney
state: Texas
city: Tyler
country: United States
facility: Texas Oncology- Tyler
state: Texas
city: Hampton
country: United States
facility: Local Institution - 0056
state: Virginia
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
city: Toulouse
country: France
facility: Local Institution - 0003
city: Milano
country: Italy
facility: Local Institution - 0037
state: MI
city: Rozzano
country: Italy
facility: Local Institution - 0021
state: MI
city: Meldola
country: Italy
facility: Local Institution - 0071
city: Modena
country: Italy
facility: Local Institution - 0016
city: Pozzuoli
country: Italy
facility: Local Institution - 0029
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: