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

Janssen (J&J Innovative Medicine)

Status and phase: Withdrawn; Phase 2

Conditions: Prostatic Neoplasms, Castration-Resistant

Treatments: Drug: Apalutamide; Drug: JNJ-809

Study type: Interventional

Funder types: Industry

Identifiers

NCT02906605

64041809PCR2002 (Other Identifier)

CR108224

2016-001917-26 (EudraCT Number)

Details and patient eligibility

About

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).

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

JNJ-809 plus Apalutamide (Group A)

Experimental group

Description:

JNJ-809 given as an infusion and Apalutamide 240 milligram (mg) daily.

Treatment:

Drug: Apalutamide

Drug: JNJ-809

Apalutamide (Group B)

Experimental group

Description:

Apalutamide 240 mg orally daily.

Treatment:

Drug: Apalutamide