An Investigational Immunotherapy Study of Nivolumab in Combination With Rucaparib, Docetaxel, or Enzalutamide in Metastatic Castration-resistant Prostate Cancer

Prostate Cancer Clinical Trial

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Official title:

A Phase 2 Study of Nivolumab in Combination With Either Rucaparib, Docetaxel, or Enzalutamide in Men With Castration-resistant Metastatic Prostate Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03338790
• Other study ID #: CA209-9KD
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: December 19, 2017
• Est. completion date: September 15, 2024

Study information

• Verified date: March 2024
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to assess the safety and efficacy of nivolumab in combination with rucaparib, docetaxel, or enzalutamide in participants with castration-resistant prostate cancer that has spread.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 292
• Est. completion date: September 15, 2024
• Est. primary completion date: January 13, 2021
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Histologic confirmation of adenocarcinoma of the prostate
• Evidence of stage IV disease on previous bone, CT, and/or MRI scan
• Ongoing androgen deprivation therapy (ADT) with a gonadotropin-releasing hormone (GnRH) analogue or bilateral orchiectomy
• Mandatory plasma and fresh or archival tumor tissue must be submitted

Exclusion Criteria:

• Prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the breast
• Participants with active brain metastases
• Participants must have recovered from the effects of major surgery requiring general anesthesia or significant traumatic injury at least 14 days before treatment arm assignment Other protocol defined inclusion/exclusion criteria could apply

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Biological:
• nivolumab
Specified dose on specified days

Drug:
• docetaxel
Specified dose on specified days
• enzalutamide
Specified dose on specified days
• rucaparib
Specified dose on specified days
• prednisone
Specified dose on specified days

Locations

Country	Name	City	State
Argentina	Local Institution - 0043	Caba
Argentina	Local Institution - 0052	Caba	Buenos Aires
Argentina	Local Institution - 0042	Capital Federal	Buenos Aires
Argentina	Local Institution - 0044	Ciudad Autonoma de Buenos Aires	Distrito Federal
Argentina	Local Institution - 0062	Villa Siburu	Cordoba
Australia	Local Institution - 0015	Camperdown	New South Wales
Australia	Local Institution - 0050	Clayton	Victoria
Australia	Local Institution - 0016	Elizabeth Vale	South Australia
Australia	Local Institution - 0013	Heidelberg	Victoria
Australia	Local Institution - 0014	South Brisbane	Queensland
Australia	Local Institution - 0017	Westmead	New South Wales
Brazil	Local Institution - 0020	Belo Horizonte	Minas Gerais
Brazil	Local Institution - 0074	Belo Horizonte	Minas Gerais
Brazil	Local Institution - 0022	Campinas	SAO Paulo
Brazil	Local Institution - 0075	Curitiba	Parana
Brazil	Local Institution - 0018	Ijui	RIO Grande DO SUL
Brazil	Local Institution - 0021	Porto Alegre	RIO Grande DO SUL
Brazil	Local Institution - 0019	Rio de Janeiro
Brazil	Local Institution - 0073	Sao Paulo
Brazil	Local Institution - 0071	São Paulo	SAO Paulo
Canada	Local Institution - 0055	Hamilton	Ontario
Canada	Local Institution - 0067	Kelowna	British Columbia
Canada	Local Institution - 0059	Moncton	New Brunswick
Canada	Local Institution - 0066	Montreal	Quebec
Canada	Local Institution - 0056	Quebec
Chile	Local Institution - 0034	Santiago	Metropolitana
Chile	Local Institution - 0051	Vina del Mar	Valparaiso
Colombia	Local Institution - 0026	Medellin
Colombia	Local Institution - 0027	Monteria	Cordoba
France	Local Institution - 0033	Besancon
France	Local Institution - 0032	Clermont-ferrand
France	Local Institution - 0031	Lyon
France	Local Institution - 0030	Marseille
France	Local Institution - 0029	Villejuif
Germany	Local Institution - 0001	Essen
Germany	Local Institution - 0006	Goettingen
Germany	Local Institution - 0004	Heidelberg
Germany	Local Institution - 0002	Jena
Germany	Local Institution - 0007	Koblenz
Germany	Local Institution - 0064	Muenchen
Mexico	Local Institution - 0025	Culiacan	Sinaloa
Mexico	Local Institution - 0048	Guadalajara	Jalisco
Mexico	Local Institution - 0061	Guadalajara	Jalisco
Mexico	Local Institution - 0054	Leon	Guanajuato
Spain	Local Institution - 0045	Madrid
Spain	Local Institution - 0046	Pamplona
Spain	Local Institution - 0047	Sevilla
United States	Local Institution - 0038	Albany	New York
United States	Local Institution - 0053	Allentown	Pennsylvania
United States	Boston Medical Center	Boston	Massachusetts
United States	Local Institution - 0036	Daphne	Alabama
United States	Karmanos Cancer Center	Detroit	Michigan
United States	Local Institution - 0041	Durham	North Carolina
United States	Local Institution - 0039	Fairfax	Virginia
United States	Local Institution - 0069	Jackson	Mississippi
United States	Local Institution - 0065	Louisville	Kentucky
United States	Northwest Georgia Oncology Centers, P.C.	Marietta	Georgia
United States	Baptist Health Medical Group Oncology	Miami	Florida
United States	Local Institution - 0049	New Haven	Connecticut
United States	Tulane University	New Orleans	Louisiana
United States	Local Institution - 0068	New York	New York
United States	Nebraska Cancer Specialists	Omaha	Nebraska
United States	Local Institution - 0024	Portland	Oregon
United States	Local Institution - 0010	Rancho Mirage	California
United States	Local Institution - 0040	Rockville	Maryland
United States	Local Institution - 0011	Saint Louis	Missouri

Sponsors (3)

Lead Sponsor	Collaborator
Bristol-Myers Squibb	Astellas Pharma Inc, Clovis Oncology, Inc.

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Brazil,  Canada,  Chile,  Colombia,  France,  Germany,  Mexico,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective Response Rate Per Prostate Cancer Clinical Trials Working Group 3 (ORR-PCWG3)	Objective response rate per prostate cancer clinical trials working group 3 (ORR-PCWG3) for target lesions and assessed by MRI is the percentage of participants who have a confirmed complete or partial best overall response (BOR) per PCWG3 among treated participants who have measurable disease	Up to approximately 36 months
Primary	Prostate-Specific Antigen Response Rate (RR-PSA)	Prostate-specific antigen response rate (RR-PSA) is the percentage of treated participants with a 50% or greater decrease in PSA from baseline to the lowest post-baseline PSA result	Up to approximately 36 months
Secondary	Radiographic Progression-Free Survival (rPFS)	Radiographic progress-free survival (rPFS) is the time between treatment initiation and the first date of documented progression or death due to any cause, whichever occurs first assessed by the investigator per PCWG3	Up to approximately 36 months
Secondary	Time to Response Per Prostate Cancer Clinical Trials Working Group 3 (TTR-PCWG3)	Time to response per prostate cancer clinical trials working group 3 (TTR-PCWG3) is the time from treatment initiation to the date of the first documented complete response (CR) or partial response (PR) per PCWG3	Up to approximately 36 months
Secondary	Duration of Response Per Prostate Cancer Clinical Trials Working Group 3 (DOR-PCWG3)	Duration of response per prostate cancer clinical trials working group 3 (DOR-PCWG3) is the time between the date of first response (complete response/partial response per PCWG3) to the date of first documented radiographic progression per PCWG3 or death due to any cause	Up to approximately 36 months
Secondary	Prostate-Specific Antigen Time to Progression (TTP-PSA)	Prostate-specific antigen time to progression (TTP-PSA) is the time between treatment initiation to the date of PSA progression per prostate cancer clinical trails working group 3	Up to approximately 36 months
Secondary	Overall Survival (OS)	Overall Survival (OS) is the time between treatment initiation and the date of death from any cause. For participants who are alive, their survival time will be censored at the last date that they were known to be alive. OS will be censored for participants at the date of treatment initiation if they had no follow-up	Up to approximately 36 months
Secondary	Number of Participants With Adverse Events (AEs)	Number of Participants with any grade adverse events (AEs), serious adverse events (SAEs), AEs leading to discontinuation, and immune-mediated AEs using the Common Toxicity Criteria Grade for Adverse Events (CTCAE V4)	From first dose to up to 30 days post last dose (Up to 34 months)
Secondary	Number of Deaths	Number of deaths in all treated participants	Up to 36 months
Secondary	Number of Participants With Laboratory Abnormalities in Specific Liver Tests	Number of participants with laboratory abnormalities in specific liver tests based on SI conventional units to assess the overall safety and tolerability of BMS-986213 in combination with chemotherapy vs. Nivolumab in combination with chemotherapy. The number of participants with the following laboratory abnormalities from on-treatment evaluations will be summarized: ALT or AST > 3 x ULN, > 5 x ULN, > 10 x ULN and > 20 x ULN; Total bilirubin > 2 x ULN; ALP > 1.5 x ULN; Concurrent (within 1 day) ALT or AST > 3 x ULN and total bilirubin > 1.5 x ULN; Concurrent (within 30 days) ALT or AST > 3 x ULN and total bilirubin > 1.5 x ULN; Concurrent (within 1 day) ALT or AST > 3 x ULN and total bilirubin > 2 x ULN; Concurrent (within 30 days) ALT or AST > 3 x ULN and total bilirubin > 2 x ULN	From first dose to up to 30 days post last dose (up to 34 months)
Secondary	Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests	Number of participants with laboratory abnormalities in specific thyroid tests based on US conventional units. The number of participants with the following laboratory abnormalities from on-treatment evaluations will be summarized: TSH value > ULN and; with baseline TSH value <= ULN; with at least one FT3/FT4 test value < LLN within 2-week window after the abnormal TSH test; with all FT3/FT4 test values >= LLN within 2-week window after the abnormal TSH test; with FT3/FT4 missing within 2-week window after the abnormal TSH test.; TSH < LLN and; with baseline TSH value >= LLN; with at least one FT3/FT4 test value > ULN within 2-week window after the abnormal TSH test; with all FT3/FT4 test values <= ULN within 2-week window after the abnormal TSH test; with FT3/FT4 missing within 2-week window after the abnormal TSH test	From first dose to up to 30 days post last dose (Up to 34 months)
Secondary	Number of Participants With Laboratory Values Change From Baseline	Number of participants changed from baseline in laboratory values of worst toxicity grade (grade 0= wnl, grade 1= mild, grade 2= moderate, grade 3= severe) based on US conventional units by cohort	From first dose to up to 30 days post last dose (Up to 34 months)

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting