Status:
COMPLETED
An Investigational Immunotherapy Study of Nivolumab in Combination With Rucaparib, Docetaxel, or Enzalutamide in Metastatic Castration-resistant Prostate Cancer
Lead Sponsor:
Bristol-Myers Squibb
Collaborating Sponsors:
Clovis Oncology, Inc.
Astellas Pharma Inc
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to assess safety and efficacy of nivolumab in combination with rucaparib, docetaxel, or enzalutamide in participants with castration-resistant prostate cancer that has spr...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 19 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 10 2025
Estimated Enrollment :
292 Patients enrolled
Trial Details
Trial ID
NCT03338790
Start Date
December 19 2017
End Date
January 10 2025
Last Update
February 10 2025
Active Locations (66)
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1
Local Institution - 0036
Daphne, Alabama, United States, 36526
2
Local Institution - 0010
Rancho Mirage, California, United States, 92270
3
Local Institution - 0049
New Haven, Connecticut, United States, 06520
4
Local Institution - 0037
Miami, Florida, United States, 33176