An Investigational Immunotherapy Study of Nivolumab in Combination With Rucaparib, Docetaxel, or Enzalutamide in Metastatic Castration-resistant Prostate Cancer (CheckMate 9KD)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03338790 |
Recruitment Status :
Active, not recruiting
First Posted : November 9, 2017
Last Update Posted : September 10, 2020
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Prostate Cancer | Biological: nivolumab Drug: docetaxel Drug: enzalutamide Drug: rucaparib Drug: prednisone | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 330 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase 2 Study of Nivolumab in Combination With Either Rucaparib, Docetaxel, or Enzalutamide in Men With Castration-resistant Metastatic Prostate Cancer |
Actual Study Start Date : | December 15, 2017 |
Estimated Primary Completion Date : | January 20, 2021 |
Estimated Study Completion Date : | November 18, 2021 |

Arm | Intervention/treatment |
---|---|
Experimental: nivolumab + rucaparib
Specified dose on specified days
|
Biological: nivolumab
Specified dose on specified days
Other Name: BMS-936558, Opdivo Drug: rucaparib Specified dose on specified days |
Experimental: nivolumab + docetaxel + prednisone
Specified dose on specified days
|
Biological: nivolumab
Specified dose on specified days
Other Name: BMS-936558, Opdivo Drug: docetaxel Specified dose on specified days Drug: prednisone Specified dose on specified days |
Experimental: nivolumab + enzalutamide
Specified dose on specified days
|
Biological: nivolumab
Specified dose on specified days
Other Name: BMS-936558, Opdivo Drug: enzalutamide Specified dose on specified days |
- Objective Response Rate (ORR) [ Time Frame: Approximately 12 months ]
- Prostate-specific antigen response rate (RR-PSA) [ Time Frame: Approximately 12 months ]
- Radiographic progression-free survival (rPFS) [ Time Frame: Approximately 12 months ]
- Time to response (TTR) [ Time Frame: Approximately 12 months ]
- Duration of response (DOR) [ Time Frame: Approximately 12 months ]
- Time to prostate-specific antigen progression (TTP-PSA) [ Time Frame: Approximately 12 months ]
- Overall Survival (OS) [ Time Frame: Up to 5 years ]
- Incidence of adverse events (AEs) [ Time Frame: Approximately 12 months ]
- Incidence of serious adverse events (SAEs) [ Time Frame: Approximately 12 months ]
- Incidence of AEs leading to discontinuation [ Time Frame: Approximately 12 months ]
- Incidence of immune-mediated AEs [ Time Frame: Approximately 12 months ]
- Incidence of deaths [ Time Frame: Approximately 12 months ]
- Incidence of Laboratory Abnormalities [ Time Frame: Approximately 12 months ]
- Number of clinically significant changes in lab assessment of blood [ Time Frame: Approximately 12 months ]
- Number of clinically significant changes in lab assessment of blood serum [ Time Frame: Approximately 12 months ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Male |
Gender Based Eligibility: | Yes |
Accepts Healthy Volunteers: | No |
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03338790

Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
Responsible Party: | Bristol-Myers Squibb |
ClinicalTrials.gov Identifier: | NCT03338790 |
Other Study ID Numbers: |
CA209-9KD |
First Posted: | November 9, 2017 Key Record Dates |
Last Update Posted: | September 10, 2020 |
Last Verified: | September 2020 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms Prostatic Diseases Prednisone Docetaxel Nivolumab Rucaparib Antineoplastic Agents Tubulin Modulators |
Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Anti-Inflammatory Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Antineoplastic Agents, Hormonal Antineoplastic Agents, Immunological Poly(ADP-ribose) Polymerase Inhibitors Enzyme Inhibitors |