A Study of the Clinical Activity and Safety of JNJ-64041809, a Live Attenuated Listeria Monocytogenes Immunotherapy, in Combination With Apalutamide Versus Apalutamide in Subjects With Metastatic Castration-resistant Prostate Cancer
NCT ID: NCT02906605
Last Updated: 2016-11-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE2
INTERVENTIONAL
2016-10-31
2018-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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JNJ-809 plus Apalutamide (Group A)
JNJ-809 given as an infusion and Apalutamide 240 milligram (mg) daily.
JNJ-809
JNJ-809 (1\*10\^9) colony forming units (CFU) given as an infusion.
Apalutamide
Apalutamide 240 mg orally daily.
Apalutamide (Group B)
Apalutamide 240 mg orally daily.
Apalutamide
Apalutamide 240 mg orally daily.
Interventions
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JNJ-809
JNJ-809 (1\*10\^9) colony forming units (CFU) given as an infusion.
Apalutamide
Apalutamide 240 mg orally daily.
Eligibility Criteria
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Inclusion Criteria
* Metastatic disease as documented by technetium-99m (99mTc) bone scan or metastatic lesions by computed tomography (CT) or magnetic resonance imaging (MRI) scans
* Surgically or medically castrated, with testosterone levels of less than (\<)50 nanogram per deciliter (ng/dL)
* Castration-resistant prostate cancer documented by time to prostate-specific antigen (PSA) increase during continuous treatment with androgen deprivation therapy (ADT) OR radiographic progression of soft tissues OR radiographic progression of bone according to PCWG3
Exclusion Criteria
* Known brain metastases (even if treated) or untreated epidural spread
* Prior chemotherapy for prostate cancer, except if administered in the adjuvant/neoadjuvant setting, or up to 6 cycles of docetaxel for metastatic hormone-sensitive prostate cancer
* Treatment with medications known to lower the seizure threshold or any investigational agent that were not discontinued or substituted greater than or equal to (\>=)28 days prior to randomization
18 Years
MALE
No
Sponsors
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Janssen Research & Development, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen Research & Development, LLC Clinical Trial
Role: STUDY_DIRECTOR
Janssen Research & Development, LLC
Locations
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New York, New York, United States
Countries
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Other Identifiers
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64041809PCR2002
Identifier Type: OTHER
Identifier Source: secondary_id
2016-001917-26
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CR108224
Identifier Type: -
Identifier Source: org_study_id