Description:
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.
Title
- Brief Title: An Investigational Immunotherapy Study of Nivolumab in Combination With Rucaparib, Docetaxel, or Enzalutamide in Metastatic Castration-resistant Prostate Cancer
- Official Title: A Phase 2 Study of Nivolumab in Combination With Either Rucaparib, Docetaxel, or Enzalutamide in Men With Castration-resistant Metastatic Prostate Cancer
Clinical Trial IDs
- ORG STUDY ID:
CA209-9KD
- NCT ID:
NCT03338790
Conditions
Interventions
Drug | Synonyms | Arms |
---|
nivolumab | BMS-936558, Opdivo | nivolumab + docetaxel + prednisone |
docetaxel | | nivolumab + docetaxel + prednisone |
enzalutamide | | nivolumab + enzalutamide |
rucaparib | | nivolumab + rucaparib |
prednisone | | nivolumab + docetaxel + prednisone |
Purpose
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.
Trial Arms
Name | Type | Description | Interventions |
---|
nivolumab + rucaparib | Experimental | Specified dose on specified days | |
nivolumab + docetaxel + prednisone | Experimental | Specified dose on specified days | - nivolumab
- docetaxel
- prednisone
|
nivolumab + enzalutamide | Experimental | Specified dose on specified days | |
Eligibility Criteria
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
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | Male |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Objective Response Rate (ORR) |
Time Frame: | Approximately 12 months |
Safety Issue: | |
Description: | |
Secondary Outcome Measures
Measure: | Radiographic progression-free survival (rPFS) |
Time Frame: | Approximately 12 months |
Safety Issue: | |
Description: | |
Measure: | Time to response (TTR) |
Time Frame: | Approximately 12 months |
Safety Issue: | |
Description: | |
Measure: | Duration of response (DOR) |
Time Frame: | Approximately 12 months |
Safety Issue: | |
Description: | |
Measure: | Time to prostate-specific antigen progression (TTP-PSA) |
Time Frame: | Approximately 12 months |
Safety Issue: | |
Description: | |
Measure: | Overall Survival (OS) |
Time Frame: | Up to 5 years |
Safety Issue: | |
Description: | |
Measure: | Incidence of adverse events (AEs) |
Time Frame: | Approximately 12 months |
Safety Issue: | |
Description: | |
Measure: | Incidence of serious adverse events (SAEs) |
Time Frame: | Approximately 12 months |
Safety Issue: | |
Description: | |
Measure: | Incidence of AEs leading to discontinuation |
Time Frame: | Approximately 12 months |
Safety Issue: | |
Description: | |
Measure: | Incidence of immune-mediated AEs |
Time Frame: | Approximately 12 months |
Safety Issue: | |
Description: | |
Measure: | Incidence of deaths |
Time Frame: | Approximately 12 months |
Safety Issue: | |
Description: | |
Measure: | Incidence of Laboratory Abnormalities |
Time Frame: | Approximately 12 months |
Safety Issue: | |
Description: | |
Measure: | Number of clinically significant changes in lab assessment of blood |
Time Frame: | Approximately 12 months |
Safety Issue: | |
Description: | |
Measure: | Number of clinically significant changes in lab assessment of blood serum |
Time Frame: | Approximately 12 months |
Safety Issue: | |
Description: | |
Details
Phase: | Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Active, not recruiting |
Lead Sponsor: | Bristol-Myers Squibb |
Last Updated
September 10, 2020