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
- Conditions
- Prostatic Neoplasms, Castration-Resistant
- Interventions
- Registration Number
- NCT02906605
- Lead Sponsor
- Janssen Research & Development, LLC
- Brief Summary
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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- Male
- Target Recruitment
- Not specified
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description JNJ-809 plus Apalutamide (Group A) Apalutamide JNJ-809 given as an infusion and Apalutamide 240 milligram (mg) daily. JNJ-809 plus Apalutamide (Group A) JNJ-809 JNJ-809 given as an infusion and Apalutamide 240 milligram (mg) daily. Apalutamide (Group B) Apalutamide Apalutamide 240 mg orally daily.
- Primary Outcome Measures
Name Time Method Time to Prostate-specific Antigen (PSA) Progression approximately 2 years Time to PSA progression will be measured using Prostate Cancer Working Group 3 (PCWG3).
- Secondary Outcome Measures
Name Time Method Blood Culture and Shedding Profile of JNJ-809 From Cultured Samples of Feces, Urine, and Saliva approximately 2 years 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.
Overall Survival approximately 2 years Overall survival defined as time from the date of randomization to death from any cause.
Number of Participants With Adverse Events (AEs) as a Measure of Safety and Tolerability approximately 2 years Comparison of the AE profiles of the two treatment groups.
PSA Doubling Time (PSADT) approximately 2 years The PSADT will be determined using the method as recommended by PCWG3 criteria.
Time to Unequivocal Clinical Progression approximately 2 years 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.
Radiographic Progression-free Survival approximately 2 years 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.