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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT03338790
Ethics application status
Date submitted
8/11/2017
Date registered
9/11/2017
Date last updated
15/10/2024

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
Treatment: Other - 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


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

Outcomes
Primary outcome [1] 0 0
Objective Response Rate Per Prostate Cancer Clinical Trials Working Group 3 (ORR-PCWG3)
Timepoint [1] 0 0
Up to approximately 36 months
Primary outcome [2] 0 0
Prostate-Specific Antigen Response Rate (RR-PSA)
Timepoint [2] 0 0
Up to approximately 36 months
Secondary outcome [1] 0 0
Radiographic Progression-Free Survival (rPFS)
Timepoint [1] 0 0
Up to approximately 36 months
Secondary outcome [2] 0 0
Time to Response Per Prostate Cancer Clinical Trials Working Group 3 (TTR-PCWG3)
Timepoint [2] 0 0
Up to approximately 36 months
Secondary outcome [3] 0 0
Duration of Response Per Prostate Cancer Clinical Trials Working Group 3 (DOR-PCWG3)
Timepoint [3] 0 0
Up to approximately 36 months
Secondary outcome [4] 0 0
Prostate-Specific Antigen Time to Progression (TTP-PSA)
Timepoint [4] 0 0
Up to approximately 36 months
Secondary outcome [5] 0 0
Overall Survival (OS)
Timepoint [5] 0 0
Up to approximately 36 months
Secondary outcome [6] 0 0
Number of Participants With Adverse Events (AEs)
Timepoint [6] 0 0
From first dose to up to 30 days post last dose (Up to 34 months)
Secondary outcome [7] 0 0
Number of Deaths
Timepoint [7] 0 0
Up to 36 months
Secondary outcome [8] 0 0
Number of Participants With Laboratory Abnormalities in Specific Liver Tests
Timepoint [8] 0 0
From first dose to up to 30 days post last dose (up to 34 months)
Secondary outcome [9] 0 0
Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests
Timepoint [9] 0 0
From first dose to up to 30 days post last dose (Up to 34 months)
Secondary outcome [10] 0 0
Number of Participants With Laboratory Values Change From Baseline
Timepoint [10] 0 0
From first dose to up to 30 days post last dose (Up to 34 months)

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
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
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
19/12/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
15/10/2024
Actual
Sample size
Target
Accrual to date
Final
292
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Local Institution - 0015 - Camperdown
Recruitment hospital [2] 0 0
Local Institution - 0017 - Westmead
Recruitment hospital [3] 0 0
Local Institution - 0014 - South Brisbane
Recruitment hospital [4] 0 0
Local Institution - 0016 - Elizabeth Vale
Recruitment hospital [5] 0 0
Local Institution - 0050 - Clayton
Recruitment hospital [6] 0 0
Local Institution - 0013 - 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
0 - 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
Mississippi
Country [12] 0 0
United States of America
State/province [12] 0 0
Missouri
Country [13] 0 0
United States of America
State/province [13] 0 0
Nebraska
Country [14] 0 0
United States of America
State/province [14] 0 0
New York
Country [15] 0 0
United States of America
State/province [15] 0 0
North Carolina
Country [16] 0 0
United States of America
State/province [16] 0 0
Oregon
Country [17] 0 0
United States of America
State/province [17] 0 0
Pennsylvania
Country [18] 0 0
United States of America
State/province [18] 0 0
Virginia
Country [19] 0 0
Argentina
State/province [19] 0 0
Buenos Aires
Country [20] 0 0
Argentina
State/province [20] 0 0
Cordoba
Country [21] 0 0
Argentina
State/province [21] 0 0
Distrito Federal
Country [22] 0 0
Argentina
State/province [22] 0 0
Caba
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
Rio Grande Do Sul
Country [27] 0 0
Brazil
State/province [27] 0 0
SAO Paulo
Country [28] 0 0
Brazil
State/province [28] 0 0
Rio de Janeiro
Country [29] 0 0
Brazil
State/province [29] 0 0
Sao Paulo
Country [30] 0 0
Canada
State/province [30] 0 0
British Columbia
Country [31] 0 0
Canada
State/province [31] 0 0
New Brunswick
Country [32] 0 0
Canada
State/province [32] 0 0
Ontario
Country [33] 0 0
Canada
State/province [33] 0 0
Quebec
Country [34] 0 0
Chile
State/province [34] 0 0
Metropolitana
Country [35] 0 0
Chile
State/province [35] 0 0
Valparaiso
Country [36] 0 0
Colombia
State/province [36] 0 0
Cordoba
Country [37] 0 0
Colombia
State/province [37] 0 0
Medellin
Country [38] 0 0
France
State/province [38] 0 0
Besancon
Country [39] 0 0
France
State/province [39] 0 0
Clermont-ferrand
Country [40] 0 0
France
State/province [40] 0 0
Lyon
Country [41] 0 0
France
State/province [41] 0 0
Marseille
Country [42] 0 0
France
State/province [42] 0 0
Villejuif
Country [43] 0 0
Germany
State/province [43] 0 0
Essen
Country [44] 0 0
Germany
State/province [44] 0 0
Goettingen
Country [45] 0 0
Germany
State/province [45] 0 0
Heidelberg
Country [46] 0 0
Germany
State/province [46] 0 0
Jena
Country [47] 0 0
Germany
State/province [47] 0 0
Koblenz
Country [48] 0 0
Germany
State/province [48] 0 0
Muenchen
Country [49] 0 0
Mexico
State/province [49] 0 0
Guanajuato
Country [50] 0 0
Mexico
State/province [50] 0 0
Jalisco
Country [51] 0 0
Mexico
State/province [51] 0 0
Sinaloa
Country [52] 0 0
Spain
State/province [52] 0 0
Madrid
Country [53] 0 0
Spain
State/province [53] 0 0
Pamplona
Country [54] 0 0
Spain
State/province [54] 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
Trial website
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
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT03338790