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

Withdrawn before enrolling · Phase 2

Conditions studied: Prostatic Neoplasms, Castration-Resistant

In brief

The purpose of this study is to evaluate if the anti-tumor activity of JNJ-809 combined with apalutamide is improved compared with apalutamide alone for subjects with metastatic castration-resistant prostate cancer (mCRPC).

Key facts

Study ID

NCT02906605

Run by

Janssen Research & Development, LLC

People needed

0

Starts

2016-10-01

Expected to finish

2018-09-01

Last updated by the study team

2016-11-22

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Adenocarcinoma of the prostate
• 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

You may not qualify if…

• Predominately small cell or neuroendocrine carcinoma of the prostate
• 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

Where it is running

• Study site — New York, New York, United States

Full record on ClinicalTrials.gov

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