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

Study Overview
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Brief Summary
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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).

Official Title
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An Open-label, Randomized, Phase 2 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

Conditions
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Prostatic Neoplasms, Castration-Resistant

Intervention / Treatment
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* Drug: JNJ-809
* Drug: Apalutamide


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: JNJ-809 plus Apalutamide (Group A)<br>JNJ-809 given as an infusion and Apalutamide 240 milligram (mg) daily. | Drug: JNJ-809<br>* JNJ-809 (1*10^9) colony forming units (CFU) given as an infusion.<br>Drug: Apalutamide<br>* Apalutamide 240 mg orally daily.<br>|
| Experimental: Apalutamide (Group B)<br>Apalutamide 240 mg orally daily. | Drug: Apalutamide<br>* Apalutamide 240 mg orally daily.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Prostate-specific Antigen (PSA) Progression | Time to PSA progression will be measured using Prostate Cancer Working Group 3 (PCWG3). | approximately 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PSA Doubling Time (PSADT) | The PSADT will be determined using the method as recommended by PCWG3 criteria. | approximately 2 years | 
| Radiographic Progression-free Survival | Radiographic progression-free survival, is defined as the time from the date of randomization to the date of radiographic progression or death, whichever occurs first. | approximately 2 years | 
| Time to Unequivocal Clinical Progression | Time to unequivocal clinical progression defined as the time from the date of randomization to the date of unequivocal clinical progression as evaluated by the investigator. | approximately 2 years | 
| Overall Survival | Overall survival defined as time from the date of randomization to death from any cause. | approximately 2 years | 
| Number of Participants With Adverse Events (AEs) as a Measure of Safety and Tolerability | Comparison of the AE profiles of the two treatment groups. | approximately 2 years | 
| Blood Culture and Shedding Profile of JNJ-809 From Cultured Samples of Feces, Urine, and Saliva | Blood culture samples will be collected after the mandatory prophylactic antibiotic therapy. Bacterial shedding will be evaluated from cultured samples of feces by stool or rectal swab, urine, and sputum. | approximately 2 years |