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An Investigational Immunotherapy Study of Nivolumab in Combination With Rucaparib, Docetaxel, or Enzalutamide in Metastatic Castration-resistant Prostate Cancer (CheckMate 9KD)

Primary Purpose

Prostate Cancer

Status
Active
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
nivolumab
docetaxel
enzalutamide
rucaparib
prednisone
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Local Institution - 0036
  • Local Institution - 0010
  • Local Institution - 0049
  • Baptist Health Medical Group Oncology
  • Northwest Georgia Oncology Centers, P.C.
  • Local Institution - 0065
  • Tulane University
  • Local Institution - 0040
  • Boston Medical Center
  • Karmanos Cancer Center
  • Local Institution - 0069
  • Local Institution - 0011
  • Nebraska Cancer Specialists
  • Local Institution - 0038
  • Local Institution - 0068
  • Local Institution - 0041
  • Local Institution - 0024
  • Local Institution - 0053
  • Local Institution - 0039
  • Local Institution - 0052
  • Local Institution - 0042
  • Local Institution - 0062
  • Local Institution - 0044
  • Local Institution - 0043
  • Local Institution - 0015
  • Local Institution - 0017
  • Local Institution - 0014
  • Local Institution - 0016
  • Local Institution - 0050
  • Local Institution - 0013
  • Local Institution - 0020
  • Local Institution - 0074
  • Local Institution - 0075
  • Local Institution - 0018
  • Local Institution - 0021
  • Local Institution - 0022
  • Local Institution - 0071
  • Local Institution - 0019
  • Local Institution - 0073
  • Local Institution - 0067
  • Local Institution - 0059
  • Local Institution - 0055
  • Local Institution - 0066
  • Local Institution - 0056
  • Local Institution - 0034
  • Local Institution - 0051
  • Local Institution - 0027
  • Local Institution - 0026
  • Local Institution - 0033
  • Local Institution - 0032
  • Local Institution - 0031
  • Local Institution - 0030
  • Local Institution - 0029
  • Local Institution - 0001
  • Local Institution - 0006
  • Local Institution - 0004
  • Local Institution - 0002
  • Local Institution - 0007
  • Local Institution - 0064
  • Local Institution - 0054
  • Local Institution - 0061
  • Local Institution - 0048
  • Local Institution - 0025
  • Local Institution - 0045
  • Local Institution - 0046
  • Local Institution - 0047

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

nivolumab + rucaparib

nivolumab + docetaxel + prednisone

nivolumab + enzalutamide

Arm Description

Specified dose on specified days

Specified dose on specified days

Specified dose on specified days

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

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
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
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
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
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
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)
Number of Deaths
Number of deaths in all treated participants
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
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
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

Full Information

First Posted
November 8, 2017
Last Updated
March 14, 2023
Sponsor
Bristol-Myers Squibb
Collaborators
Clovis Oncology, Inc., Astellas Pharma Inc
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1. Study Identification

Unique Protocol Identification Number
NCT03338790
Brief Title
An Investigational Immunotherapy Study of Nivolumab in Combination With Rucaparib, Docetaxel, or Enzalutamide in Metastatic Castration-resistant Prostate Cancer
Acronym
CheckMate 9KD
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

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 19, 2017 (Actual)
Primary Completion Date
January 13, 2021 (Actual)
Study Completion Date
June 28, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb
Collaborators
Clovis Oncology, Inc., Astellas Pharma Inc

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
292 (Actual)

8. Arms, Groups, and Interventions

Arm Title
nivolumab + rucaparib
Arm Type
Experimental
Arm Description
Specified dose on specified days
Arm Title
nivolumab + docetaxel + prednisone
Arm Type
Experimental
Arm Description
Specified dose on specified days
Arm Title
nivolumab + enzalutamide
Arm Type
Experimental
Arm Description
Specified dose on specified days
Intervention Type
Biological
Intervention Name(s)
nivolumab
Other Intervention Name(s)
BMS-936558, Opdivo
Intervention Description
Specified dose on specified days
Intervention Type
Drug
Intervention Name(s)
docetaxel
Intervention Description
Specified dose on specified days
Intervention Type
Drug
Intervention Name(s)
enzalutamide
Intervention Description
Specified dose on specified days
Intervention Type
Drug
Intervention Name(s)
rucaparib
Intervention Description
Specified dose on specified days
Intervention Type
Drug
Intervention Name(s)
prednisone
Intervention Description
Specified dose on specified days
Primary Outcome Measure Information:
Title
Objective Response Rate Per Prostate Cancer Clinical Trials Working Group 3 (ORR-PCWG3)
Description
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
Time Frame
Up to approximately 36 months
Title
Prostate-Specific Antigen Response Rate (RR-PSA)
Description
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
Time Frame
Up to approximately 36 months
Secondary Outcome Measure Information:
Title
Radiographic Progression-Free Survival (rPFS)
Description
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
Time Frame
Up to approximately 36 months
Title
Time to Response Per Prostate Cancer Clinical Trials Working Group 3 (TTR-PCWG3)
Description
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
Time Frame
Up to approximately 36 months
Title
Duration of Response Per Prostate Cancer Clinical Trials Working Group 3 (DOR-PCWG3)
Description
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
Time Frame
Up to approximately 36 months
Title
Prostate-Specific Antigen Time to Progression (TTP-PSA)
Description
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
Time Frame
Up to approximately 36 months
Title
Overall Survival (OS)
Description
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
Time Frame
Up to approximately 36 months
Title
Number of Participants With Adverse Events (AEs)
Description
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)
Time Frame
From first dose to up to 30 days post last dose (Up to 34 months)
Title
Number of Deaths
Description
Number of deaths in all treated participants
Time Frame
Up to 36 months
Title
Number of Participants With Laboratory Abnormalities in Specific Liver Tests
Description
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
Time Frame
From first dose to up to 30 days post last dose (up to 34 months)
Title
Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests
Description
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
Time Frame
From first dose to up to 30 days post last dose (Up to 34 months)
Title
Number of Participants With Laboratory Values Change From Baseline
Description
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
Time Frame
From first dose to up to 30 days post last dose (Up to 34 months)

10. Eligibility

Sex
Male
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Local Institution - 0036
City
Daphne
State/Province
Alabama
ZIP/Postal Code
36526
Country
United States
Facility Name
Local Institution - 0010
City
Rancho Mirage
State/Province
California
ZIP/Postal Code
92270
Country
United States
Facility Name
Local Institution - 0049
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States
Facility Name
Baptist Health Medical Group Oncology
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Facility Name
Northwest Georgia Oncology Centers, P.C.
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Local Institution - 0065
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40207
Country
United States
Facility Name
Tulane University
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Local Institution - 0040
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20850
Country
United States
Facility Name
Boston Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
Karmanos Cancer Center
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Local Institution - 0069
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39202
Country
United States
Facility Name
Local Institution - 0011
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Nebraska Cancer Specialists
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68130
Country
United States
Facility Name
Local Institution - 0038
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
Local Institution - 0068
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Local Institution - 0041
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Local Institution - 0024
City
Portland
State/Province
Oregon
ZIP/Postal Code
97225
Country
United States
Facility Name
Local Institution - 0053
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18103
Country
United States
Facility Name
Local Institution - 0039
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Facility Name
Local Institution - 0052
City
Caba
State/Province
Buenos Aires
ZIP/Postal Code
1426
Country
Argentina
Facility Name
Local Institution - 0042
City
Capital Federal
State/Province
Buenos Aires
ZIP/Postal Code
1426
Country
Argentina
Facility Name
Local Institution - 0062
City
Villa Siburu
State/Province
Cordoba
ZIP/Postal Code
5003
Country
Argentina
Facility Name
Local Institution - 0044
City
Ciudad Autonoma de Buenos Aires
State/Province
Distrito Federal
ZIP/Postal Code
C1280
Country
Argentina
Facility Name
Local Institution - 0043
City
Caba
ZIP/Postal Code
1199
Country
Argentina
Facility Name
Local Institution - 0015
City
Camperdown
State/Province
New South Wales
ZIP/Postal Code
2050
Country
Australia
Facility Name
Local Institution - 0017
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Facility Name
Local Institution - 0014
City
South Brisbane
State/Province
Queensland
ZIP/Postal Code
4101
Country
Australia
Facility Name
Local Institution - 0016
City
Elizabeth Vale
State/Province
South Australia
ZIP/Postal Code
5112
Country
Australia
Facility Name
Local Institution - 0050
City
Clayton
State/Province
Victoria
ZIP/Postal Code
0
Country
Australia
Facility Name
Local Institution - 0013
City
Heidelberg
State/Province
Victoria
ZIP/Postal Code
3084
Country
Australia
Facility Name
Local Institution - 0020
City
Belo Horizonte
State/Province
Minas Gerais
ZIP/Postal Code
30110-022
Country
Brazil
Facility Name
Local Institution - 0074
City
Belo Horizonte
State/Province
Minas Gerais
ZIP/Postal Code
30130-090
Country
Brazil
Facility Name
Local Institution - 0075
City
Curitiba
State/Province
Parana
ZIP/Postal Code
81480-580
Country
Brazil
Facility Name
Local Institution - 0018
City
Ijui
State/Province
RIO Grande DO SUL
ZIP/Postal Code
98700-000
Country
Brazil
Facility Name
Local Institution - 0021
City
Porto Alegre
State/Province
RIO Grande DO SUL
ZIP/Postal Code
90035-001
Country
Brazil
Facility Name
Local Institution - 0022
City
Campinas
State/Province
SAO Paulo
ZIP/Postal Code
13075-460
Country
Brazil
Facility Name
Local Institution - 0071
City
São Paulo
State/Province
SAO Paulo
ZIP/Postal Code
05652-900
Country
Brazil
Facility Name
Local Institution - 0019
City
Rio de Janeiro
ZIP/Postal Code
22793-080
Country
Brazil
Facility Name
Local Institution - 0073
City
Sao Paulo
ZIP/Postal Code
01308-050
Country
Brazil
Facility Name
Local Institution - 0067
City
Kelowna
State/Province
British Columbia
ZIP/Postal Code
V1Y 5L3
Country
Canada
Facility Name
Local Institution - 0059
City
Moncton
State/Province
New Brunswick
ZIP/Postal Code
E1C 6Z8
Country
Canada
Facility Name
Local Institution - 0055
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8V 5C2
Country
Canada
Facility Name
Local Institution - 0066
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2X 0C1
Country
Canada
Facility Name
Local Institution - 0056
City
Quebec
ZIP/Postal Code
G1R 3S1
Country
Canada
Facility Name
Local Institution - 0034
City
Santiago
State/Province
Metropolitana
ZIP/Postal Code
8420383
Country
Chile
Facility Name
Local Institution - 0051
City
Vina del Mar
State/Province
Valparaiso
ZIP/Postal Code
2540364
Country
Chile
Facility Name
Local Institution - 0027
City
Monteria
State/Province
Cordoba
ZIP/Postal Code
0
Country
Colombia
Facility Name
Local Institution - 0026
City
Medellin
ZIP/Postal Code
0
Country
Colombia
Facility Name
Local Institution - 0033
City
Besancon
ZIP/Postal Code
25030
Country
France
Facility Name
Local Institution - 0032
City
Clermont-ferrand
ZIP/Postal Code
63000
Country
France
Facility Name
Local Institution - 0031
City
Lyon
ZIP/Postal Code
69008
Country
France
Facility Name
Local Institution - 0030
City
Marseille
ZIP/Postal Code
13273
Country
France
Facility Name
Local Institution - 0029
City
Villejuif
ZIP/Postal Code
94800
Country
France
Facility Name
Local Institution - 0001
City
Essen
ZIP/Postal Code
45122
Country
Germany
Facility Name
Local Institution - 0006
City
Goettingen
ZIP/Postal Code
37075
Country
Germany
Facility Name
Local Institution - 0004
City
Heidelberg
ZIP/Postal Code
D-69120
Country
Germany
Facility Name
Local Institution - 0002
City
Jena
ZIP/Postal Code
07747
Country
Germany
Facility Name
Local Institution - 0007
City
Koblenz
ZIP/Postal Code
56068
Country
Germany
Facility Name
Local Institution - 0064
City
Muenchen
ZIP/Postal Code
81675
Country
Germany
Facility Name
Local Institution - 0054
City
Leon
State/Province
Guanajuato
ZIP/Postal Code
37000
Country
Mexico
Facility Name
Local Institution - 0061
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44130
Country
Mexico
Facility Name
Local Institution - 0048
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44280
Country
Mexico
Facility Name
Local Institution - 0025
City
Culiacan
State/Province
Sinaloa
ZIP/Postal Code
80230
Country
Mexico
Facility Name
Local Institution - 0045
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Local Institution - 0046
City
Pamplona
ZIP/Postal Code
31008
Country
Spain
Facility Name
Local Institution - 0047
City
Sevilla
ZIP/Postal Code
41013
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
35977756
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.
Results Reference
derived
PubMed Identifier
34802864
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.
Results Reference
derived
Links:
URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
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BMS Clinical Trial Information
URL
https://www.bmsstudyconnect.com/s/US/English/USenHome
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BMS Clinical Trial Patient Recruiting
URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Description
Investigator Inquiry Form
URL
https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
Description
FDA Safety Alerts and Recalls

Learn more about this trial

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

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