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

• Register: ClinicalTrials.gov
• Last refreshed on: 8 April 2024
• Main ID: NCT03338790
• Date of registration: 08/11/2017
• Prospective Registration: Yes
• Primary sponsor: Bristol-Myers Squibb
• Public title: An Investigational Immunotherapy Study of Nivolumab in Combination With Rucaparib, Docetaxel, or Enzalutamide in Metastatic Castration-resistant Prostate Cancer CheckMate 9KD
• Scientific title: A Phase 2 Study of Nivolumab in Combination With Either Rucaparib, Docetaxel, or Enzalutamide in Men With Castration-resistant Metastatic Prostate Cancer
• Date of first enrolment: December 19, 2017
• Target sample size: 292
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT03338790
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

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

Contacts

• Name: Bristol-Myers Squibb
• Affiliation: Bristol-Myers Squibb

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Male

Health Condition(s) or Problem(s) studied

Prostate Cancer

Intervention(s)

Drug: docetaxel

Biological: nivolumab

Drug: prednisone

Drug: enzalutamide

Drug: rucaparib

Primary Outcome(s)

Objective Response Rate Per Prostate Cancer Clinical Trials Working Group 3 (ORR-PCWG3) [Time Frame: Up to approximately 36 months]

Prostate-Specific Antigen Response Rate (RR-PSA) [Time Frame: Up to approximately 36 months]

Secondary Outcome(s)

Overall Survival (OS) [Time Frame: Up to approximately 36 months]

Number of Deaths [Time Frame: Up to 36 months]

Number of Participants With Laboratory Values Change From Baseline [Time Frame: From first dose to up to 30 days post last dose (Up to 34 months)]

Number of Participants With Adverse Events (AEs) [Time Frame: From first dose to up to 30 days post last dose (Up to 34 months)]

Time to Response Per Prostate Cancer Clinical Trials Working Group 3 (TTR-PCWG3) [Time Frame: Up to approximately 36 months]

Radiographic Progression-Free Survival (rPFS) [Time Frame: Up to approximately 36 months]

Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests [Time Frame: From first dose to up to 30 days post last dose (Up to 34 months)]

Duration of Response Per Prostate Cancer Clinical Trials Working Group 3 (DOR-PCWG3) [Time Frame: Up to approximately 36 months]

Number of Participants With Laboratory Abnormalities in Specific Liver Tests [Time Frame: From first dose to up to 30 days post last dose (up to 34 months)]

Prostate-Specific Antigen Time to Progression (TTP-PSA) [Time Frame: Up to approximately 36 months]

Secondary ID(s)

CA209-9KD

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Astellas Pharma Inc

Clovis Oncology, Inc.

Results

• Results available: Yes
• Date Posted: 09/02/2022
• URL: https://clinicaltrials.gov/ct2/show/results/NCT03338790