Clinical trial NCT02906605: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Prostatic Neoplasms, Castration-Resistant
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2016-09-20
Enrollment: 0
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: 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

Primary outcomes:
measure: Time to Prostate-specific Antigen (PSA) Progression
timeFrame: approximately 2 years
Secondary outcomes:
measure: PSA Doubling Time (PSADT)
timeFrame: approximately 2 years
measure: Radiographic Progression-free Survival
timeFrame: approximately 2 years
measure: Time to Unequivocal Clinical Progression
timeFrame: approximately 2 years
measure: Overall Survival
timeFrame: approximately 2 years
measure: Number of Participants With Adverse Events (AEs) as a Measure of Safety and Tolerability
timeFrame: approximately 2 years
measure: Blood Culture and Shedding Profile of JNJ-809 From Cultured Samples of Feces, Urine, and Saliva
timeFrame: approximately 2 years
Other outcomes:
Locations:
city: New York
country: United States
state: New York
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: