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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03338790




Registration number
NCT03338790
Ethics application status
Date submitted
8/11/2017
Date registered
9/11/2017
Date last updated
23/06/2020

Titles & IDs
Public title
An Investigational Immunotherapy Study of Nivolumab in Combination With Rucaparib, Docetaxel, or Enzalutamide in Metastatic Castration-resistant Prostate Cancer
Scientific title
A Phase 2 Study of Nivolumab in Combination With Either Rucaparib, Docetaxel, or Enzalutamide in Men With Castration-resistant Metastatic Prostate Cancer
Secondary ID [1] 0 0
CA209-9KD
Universal Trial Number (UTN)
Trial acronym
CheckMate 9KD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostate Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - nivolumab
Treatment: Drugs - docetaxel
Treatment: Drugs - enzalutamide
Treatment: Drugs - rucaparib
Treatment: Drugs - prednisone

Experimental: nivolumab + rucaparib - Specified dose on specified days

Experimental: nivolumab + docetaxel + prednisone - Specified dose on specified days

Experimental: nivolumab + enzalutamide - Specified dose on specified days


Other interventions: nivolumab
Specified dose on specified days

Treatment: Drugs: docetaxel
Specified dose on specified days

Treatment: Drugs: enzalutamide
Specified dose on specified days

Treatment: Drugs: rucaparib
Specified dose on specified days

Treatment: Drugs: prednisone
Specified dose on specified days

Intervention code [1] 0 0
Other interventions
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Objective Response Rate (ORR)
Timepoint [1] 0 0
Approximately 12 months
Primary outcome [2] 0 0
Prostate-specific antigen response rate (RR-PSA)
Timepoint [2] 0 0
Approximately 12 months
Secondary outcome [1] 0 0
Radiographic progression-free survival (rPFS)
Timepoint [1] 0 0
Approximately 12 months
Secondary outcome [2] 0 0
Time to response (TTR)
Timepoint [2] 0 0
Approximately 12 months
Secondary outcome [3] 0 0
Duration of response (DOR)
Timepoint [3] 0 0
Approximately 12 months
Secondary outcome [4] 0 0
Time to prostate-specific antigen progression (TTP-PSA)
Timepoint [4] 0 0
Approximately 12 months
Secondary outcome [5] 0 0
Overall Survival (OS)
Timepoint [5] 0 0
Up to 5 years
Secondary outcome [6] 0 0
Incidence of adverse events (AEs)
Timepoint [6] 0 0
Approximately 12 months
Secondary outcome [7] 0 0
Incidence of serious adverse events (SAEs)
Timepoint [7] 0 0
Approximately 12 months
Secondary outcome [8] 0 0
Incidence of AEs leading to discontinuation
Timepoint [8] 0 0
Approximately 12 months
Secondary outcome [9] 0 0
Incidence of immune-mediated AEs
Timepoint [9] 0 0
Approximately 12 months
Secondary outcome [10] 0 0
Incidence of deaths
Timepoint [10] 0 0
Approximately 12 months
Secondary outcome [11] 0 0
Incidence of Laboratory Abnormalities
Timepoint [11] 0 0
Approximately 12 months
Secondary outcome [12] 0 0
Number of clinically significant changes in lab assessment of blood
Timepoint [12] 0 0
Approximately 12 months
Secondary outcome [13] 0 0
Number of clinically significant changes in lab assessment of blood serum
Timepoint [13] 0 0
Approximately 12 months

Eligibility
Key inclusion criteria
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
visit www.BMSStudyConnect.com



- 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
Minimum age
18 Years
Maximum age
No limit
Gender
Males
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Chris O'Brien Lifehouse Hospital - Camperdown
Recruitment hospital [2] 0 0
Westmead Hospital - Westmead
Recruitment hospital [3] 0 0
Integrated Clinical Oncology Network Pty Ltd (ICON) - South Brisbane
Recruitment hospital [4] 0 0
Lyell McEwin Hospital - Elizabeth Vale
Recruitment hospital [5] 0 0
Monash Medical Centre Clayton - Clayton
Recruitment hospital [6] 0 0
Austin Hospital - Heidelberg
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2145 - Westmead
Recruitment postcode(s) [3] 0 0
4101 - South Brisbane
Recruitment postcode(s) [4] 0 0
5112 - Elizabeth Vale
Recruitment postcode(s) [5] 0 0
3168 - Clayton
Recruitment postcode(s) [6] 0 0
3084 - Heidelberg
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Connecticut
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Kentucky
Country [7] 0 0
United States of America
State/province [7] 0 0
Louisiana
Country [8] 0 0
United States of America
State/province [8] 0 0
Maryland
Country [9] 0 0
United States of America
State/province [9] 0 0
Massachusetts
Country [10] 0 0
United States of America
State/province [10] 0 0
Michigan
Country [11] 0 0
United States of America
State/province [11] 0 0
Minnesota
Country [12] 0 0
United States of America
State/province [12] 0 0
Mississippi
Country [13] 0 0
United States of America
State/province [13] 0 0
Missouri
Country [14] 0 0
United States of America
State/province [14] 0 0
Nebraska
Country [15] 0 0
United States of America
State/province [15] 0 0
New York
Country [16] 0 0
United States of America
State/province [16] 0 0
North Carolina
Country [17] 0 0
United States of America
State/province [17] 0 0
Oregon
Country [18] 0 0
United States of America
State/province [18] 0 0
Pennsylvania
Country [19] 0 0
United States of America
State/province [19] 0 0
Virginia
Country [20] 0 0
Argentina
State/province [20] 0 0
Buenos Aires
Country [21] 0 0
Argentina
State/province [21] 0 0
Caba
Country [22] 0 0
Argentina
State/province [22] 0 0
Cordoba
Country [23] 0 0
Brazil
State/province [23] 0 0
Minas Gerais
Country [24] 0 0
Brazil
State/province [24] 0 0
Parana
Country [25] 0 0
Brazil
State/province [25] 0 0
RIO Grande DO SUL
Country [26] 0 0
Brazil
State/province [26] 0 0
SAO Paulo
Country [27] 0 0
Brazil
State/province [27] 0 0
Rio de Janeiro
Country [28] 0 0
Brazil
State/province [28] 0 0
Santa Catarina
Country [29] 0 0
Brazil
State/province [29] 0 0
Sao Paulo
Country [30] 0 0
Canada
State/province [30] 0 0
Alberta
Country [31] 0 0
Canada
State/province [31] 0 0
British Columbia
Country [32] 0 0
Canada
State/province [32] 0 0
New Brunswick
Country [33] 0 0
Canada
State/province [33] 0 0
Ontario
Country [34] 0 0
Canada
State/province [34] 0 0
Montreal
Country [35] 0 0
Canada
State/province [35] 0 0
Quebec
Country [36] 0 0
Chile
State/province [36] 0 0
Metropolitana
Country [37] 0 0
Chile
State/province [37] 0 0
Valparaiso
Country [38] 0 0
Colombia
State/province [38] 0 0
Cordoba
Country [39] 0 0
Colombia
State/province [39] 0 0
Bogota
Country [40] 0 0
Colombia
State/province [40] 0 0
Medellin
Country [41] 0 0
France
State/province [41] 0 0
Besancon
Country [42] 0 0
France
State/province [42] 0 0
Clermont-ferrand
Country [43] 0 0
France
State/province [43] 0 0
Lyon
Country [44] 0 0
France
State/province [44] 0 0
Marseille
Country [45] 0 0
France
State/province [45] 0 0
Villejuif
Country [46] 0 0
Germany
State/province [46] 0 0
Essen
Country [47] 0 0
Germany
State/province [47] 0 0
Goettingen
Country [48] 0 0
Germany
State/province [48] 0 0
Heidelberg
Country [49] 0 0
Germany
State/province [49] 0 0
Jena
Country [50] 0 0
Germany
State/province [50] 0 0
Koblenz
Country [51] 0 0
Germany
State/province [51] 0 0
Munich
Country [52] 0 0
Mexico
State/province [52] 0 0
Guanajuato
Country [53] 0 0
Mexico
State/province [53] 0 0
Jalisco
Country [54] 0 0
Mexico
State/province [54] 0 0
Sinaloa
Country [55] 0 0
Spain
State/province [55] 0 0
Madrid
Country [56] 0 0
Spain
State/province [56] 0 0
Pamplona
Country [57] 0 0
Spain
State/province [57] 0 0
Sevilla

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Bristol-Myers Squibb
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Clovis Oncology, Inc.
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Commercial sector/Industry
Name [2] 0 0
Astellas Pharma Inc
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/show/NCT03338790
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bristol-Myers Squibb
Address 0 0
Bristol-Myers Squibb
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Recruiting sites have contact information. Please contact the sites directly. If there is no contact information,
Address 0 0
Country 0 0
Phone 0 0
please email:
Fax 0 0
Email 0 0
Clinical.Trials@bms.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03338790