Clinical trial NCT03338790: An Investigational Immunotherapy Study of Nivolumab in Combination With Rucaparib, Docetaxel, or Enzalutamide in Metastatic Castration-resistant Prostate Cancer
Official title: A Phase 2 Study of Nivolumab in Combination With Either Rucaparib, Docetaxel, or Enzalutamide in Men With Castration-resistant Metastatic Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prostate Cancer
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
Collaborators: name: Clovis Oncology, Inc.
name: Astellas Pharma Inc
First posted: 2017-11-09
Enrollment: 292
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Objective Response Rate Per Prostate Cancer Clinical Trials Working Group 3 (ORR-PCWG3)
timeFrame: Up to approximately 36 months
measure: Prostate-Specific Antigen Response Rate (RR-PSA)
timeFrame: Up to approximately 36 months
Secondary outcomes:
measure: Radiographic Progression-Free Survival (rPFS)
timeFrame: Up to approximately 36 months
measure: Time to Response Per Prostate Cancer Clinical Trials Working Group 3 (TTR-PCWG3)
timeFrame: Up to approximately 36 months
measure: Duration of Response Per Prostate Cancer Clinical Trials Working Group 3 (DOR-PCWG3)
timeFrame: Up to approximately 36 months
measure: Prostate-Specific Antigen Time to Progression (TTP-PSA)
timeFrame: Up to approximately 36 months
measure: Overall Survival (OS)
timeFrame: Up to approximately 36 months
measure: Number of Participants With Adverse Events (AEs)
timeFrame: From first dose to up to 30 days post last dose (Up to 34 months)
measure: Number of Deaths
timeFrame: Up to 36 months
measure: Number of Participants With Laboratory Abnormalities in Specific Liver Tests
timeFrame: From first dose to up to 30 days post last dose (up to 34 months)
measure: Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests
timeFrame: From first dose to up to 30 days post last dose (Up to 34 months)
measure: Number of Participants With Laboratory Values Change From Baseline
timeFrame: From first dose to up to 30 days post last dose (Up to 34 months)
Other outcomes:
Locations:
city: Daphne
country: United States
facility: Local Institution - 0036
state: Alabama
city: Rancho Mirage
country: United States
facility: Local Institution - 0010
state: California
city: New Haven
country: United States
facility: Local Institution - 0049
state: Connecticut
city: Miami
country: United States
facility: Local Institution - 0037
state: Florida
city: Marietta
country: United States
facility: Local Institution - 0009
state: Georgia
city: Louisville
country: United States
facility: Local Institution - 0065
state: Kentucky
city: New Orleans
country: United States
facility: Tulane University
state: Louisiana
city: Rockville
country: United States
facility: Local Institution - 0040
state: Maryland
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
city: Detroit
country: United States
facility: Local Institution - 0012
state: Michigan
city: Jackson
country: United States
facility: Local Institution - 0069
state: Mississippi
city: Saint Louis
country: United States
facility: Local Institution - 0011
state: Missouri
city: Omaha
country: United States
facility: Local Institution - 0035
state: Nebraska
city: Albany
country: United States
facility: Local Institution - 0038
state: New York
city: New York
country: United States
facility: Local Institution - 0068
state: New York
city: Durham
country: United States
facility: Local Institution - 0041
state: North Carolina
city: Portland
country: United States
facility: Local Institution - 0024
state: Oregon
city: Allentown
country: United States
facility: Local Institution - 0053
state: Pennsylvania
city: Fairfax
country: United States
facility: Local Institution - 0039
state: Virginia
city: Caba
country: Argentina
facility: Local Institution - 0052
state: Buenos Aires
city: Capital Federal
country: Argentina
facility: Local Institution - 0042
state: Buenos Aires
city: Villa Siburu
country: Argentina
facility: Local Institution - 0062
state: Cordoba
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: Local Institution - 0044
state: Distrito Federal
city: Caba
country: Argentina
facility: Local Institution - 0043
city: Camperdown
country: Australia
facility: Local Institution - 0015
state: New South Wales
city: Westmead
country: Australia
facility: Local Institution - 0017
state: New South Wales
city: South Brisbane
country: Australia
facility: Local Institution - 0014
state: Queensland
city: Elizabeth Vale
country: Australia
facility: Local Institution - 0016
state: South Australia
city: Clayton
country: Australia
facility: Local Institution - 0050
state: Victoria
city: Heidelberg
country: Australia
facility: Local Institution - 0013
state: Victoria
city: Belo Horizonte
country: Brazil
facility: Local Institution - 0020
state: Minas Gerais
city: Belo Horizonte
country: Brazil
facility: Local Institution - 0074
state: Minas Gerais
city: Curitiba
country: Brazil
facility: Local Institution - 0075
state: Parana
city: Ijui
country: Brazil
facility: Local Institution - 0018
state: RIO Grande DO SUL
city: Porto Alegre
country: Brazil
facility: Local Institution - 0021
state: Rio Grande Do Sul
city: Campinas
country: Brazil
facility: Local Institution - 0022
state: SAO Paulo
city: São Paulo
country: Brazil
facility: Local Institution - 0071
state: SAO Paulo
city: Rio de Janeiro
country: Brazil
facility: Local Institution - 0019
city: Sao Paulo
country: Brazil
facility: Local Institution - 0073
city: Kelowna
country: Canada
facility: Local Institution - 0067
state: British Columbia
city: Moncton
country: Canada
facility: Local Institution - 0059
state: New Brunswick
city: Hamilton
country: Canada
facility: Local Institution - 0055
state: Ontario
city: Montreal
country: Canada
facility: Local Institution - 0066
state: Quebec
city: Quebec City
country: Canada
facility: Local Institution - 0056
state: Quebec
city: Santiago
country: Chile
facility: Local Institution - 0034
state: Metropolitana
city: Vina del Mar
country: Chile
facility: Local Institution - 0051
state: Valparaiso
city: Monteria
country: Colombia
facility: Local Institution - 0027
state: Cordoba
city: Medellin
country: Colombia
facility: Local Institution - 0026
city: Besancon
country: France
facility: Local Institution - 0033
city: Clermont-ferrand
country: France
facility: Local Institution - 0032
city: Lyon
country: France
facility: Local Institution - 0031
city: Marseille
country: France
facility: Local Institution - 0030
city: Villejuif
country: France
facility: Local Institution - 0029
city: Essen
country: Germany
facility: Local Institution - 0001
city: Goettingen
country: Germany
facility: Local Institution - 0006
city: Heidelberg
country: Germany
facility: Local Institution - 0004
city: Jena
country: Germany
facility: Local Institution - 0002
city: Koblenz
country: Germany
facility: Local Institution - 0007
city: Muenchen
country: Germany
facility: Local Institution - 0064
city: Leon
country: Mexico
facility: Local Institution - 0054
state: Guanajuato
city: Guadalajara
country: Mexico
facility: Local Institution - 0061
state: Jalisco
city: Guadalajara
country: Mexico
facility: Local Institution - 0048
state: Jalisco
city: Culiacan
country: Mexico
facility: Local Institution - 0025
state: Sinaloa
city: Madrid
country: Spain
facility: Local Institution - 0045
city: Pamplona
country: Spain
facility: Local Institution - 0046
city: Sevilla
country: Spain
facility: Local Institution - 0047
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
citation: Fizazi K, Retz M, Petrylak DP, Goh JC, Perez-Gracia J, Lacombe L, Zschabitz S, Burotto M, Mahammedi H, Gravis G, Bastos DA, McCune SL, Vazquez Limon JC, Kwan EM, Castellano D, Flechon A, Saad F, Grimm MO, Shaffer DR, Armstrong AJ, Bhagavatheeswaran P, Amin NP, Unsal-Kacmaz K, Wang X, Li J, Loehr A, Pachynski RK. Nivolumab plus rucaparib for metastatic castration-resistant prostate cancer: results from the phase 2 CheckMate 9KD trial. J Immunother Cancer. 2022 Aug;10(8):e004761. doi: 10.1136/jitc-2022-004761.
citation: Fizazi K, Gonzalez Mella P, Castellano D, Minatta JN, Rezazadeh Kalebasty A, Shaffer D, Vazquez Limon JC, Sanchez Lopez HM, Armstrong AJ, Horvath L, Bastos DA, Amin NP, Li J, Unsal-Kacmaz K, Retz M, Saad F, Petrylak DP, Pachynski RK. Nivolumab plus docetaxel in patients with chemotherapy-naive metastatic castration-resistant prostate cancer: results from the phase II CheckMate 9KD trial. Eur J Cancer. 2022 Jan;160:61-71. doi: 10.1016/j.ejca.2021.09.043. Epub 2021 Nov 18.