An Investigational Immunotherapy Study of Nivolumab in Combination With Rucaparib, Docetaxel, or Enzalutamide in Metastatic Castration-resistant Prostate Cancer (CheckMate 9KD)
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| ClinicalTrials.gov Identifier: NCT03338790 |
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Recruitment Status :
Active, not recruiting
First Posted : November 9, 2017
Results First Posted : February 9, 2022
Last Update Posted : February 9, 2022
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Sponsor:
Bristol-Myers Squibb
Collaborators:
Clovis Oncology, Inc.
Astellas Pharma Inc
Information provided by (Responsible Party):
Bristol-Myers Squibb
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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.
| 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) |
| Actual Enrollment : | 292 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 19, 2017 |
| Actual Primary Completion Date : | January 13, 2021 |
| Estimated Study Completion Date : | July 15, 2023 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Prostate cancer
MedlinePlus related topics:
Prostate Cancer
| Arm | Intervention/treatment |
|---|---|
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Experimental: nivolumab + rucaparib
Specified dose on specified days
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Biological: nivolumab
Specified dose on specified days
Other Name: BMS-936558, Opdivo Drug: rucaparib Specified dose on specified days |
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Experimental: nivolumab + docetaxel + prednisone
Specified dose on specified days
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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 |
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Experimental: nivolumab + enzalutamide
Specified dose on specified days
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Biological: nivolumab
Specified dose on specified days
Other Name: BMS-936558, Opdivo Drug: enzalutamide Specified dose on specified days |
Primary Outcome Measures :
- Objective Response Rate Per Prostate Cancer Clinical Trials Working Group 3 (ORR-PCWG3) [ Time Frame: Up to approximately 36 months ]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) [ Time Frame: Up to approximately 36 months ]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) [ Time Frame: Up to approximately 36 months ]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 Frame: Up to approximately 36 months ]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) [ Time Frame: Up to approximately 36 months ]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) [ Time Frame: Up to approximately 36 months ]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) [ Time Frame: Up to approximately 36 months ]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) [ Time Frame: From first dose to up to 30 days post last dose (Up to 34 months) ]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 [ Time Frame: Up to 36 months ]Number of deaths in all treated participants
- 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) ]
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 [ Time Frame: From first dose to up to 30 days post last dose (Up to 34 months) ]
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 [ Time Frame: From first dose to up to 30 days post last dose (Up to 34 months) ]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
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | Male |
| Gender Based Eligibility: | Yes |
| Accepts Healthy Volunteers: | No |
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
Information from the National Library of Medicine
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
Locations
Show 66 study locations
Sponsors and Collaborators
Bristol-Myers Squibb
Clovis Oncology, Inc.
Astellas Pharma Inc
Investigators
| Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
Study Documents (Full-Text)
Documents provided by Bristol-Myers Squibb:
Documents provided by Bristol-Myers Squibb:
Study Protocol [PDF] August 8, 2019
Statistical Analysis Plan [PDF] December 19, 2019
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier: | NCT03338790 |
| Other Study ID Numbers: |
CA209-9KD |
| First Posted: | November 9, 2017 Key Record Dates |
| Results First Posted: | February 9, 2022 |
| Last Update Posted: | February 9, 2022 |
| Last Verified: | February 2022 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
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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 Immune Checkpoint Inhibitors Poly(ADP-ribose) Polymerase Inhibitors Enzyme Inhibitors |