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

Prostatic Neoplasms, Castration-Resistant Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02906605
• Other study ID #: CR108224
• Secondary ID: 64041809PCR20022
• Status: Withdrawn
• Phase: Phase 2
• First received: September 15, 2016
• Last updated: November 18, 2016
• Start date: October 2016
• Est. completion date: September 2018

Study information

• Verified date: November 2016
• Source: Janssen Research & Development, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2018
• Est. primary completion date: September 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostatic Neoplasms
• Prostatic Neoplasms, Castration-Resistant

Intervention

Drug:
• JNJ-809
JNJ-809 (1*10^9) colony forming units (CFU) given as an infusion.
• Apalutamide
Apalutamide 240 mg orally daily.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Research & Development, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to Prostate-specific Antigen (PSA) Progression	Time to PSA progression will be measured using Prostate Cancer Working Group 3 (PCWG3).	approximately 2 years	No
Secondary	PSA Doubling Time (PSADT)	The PSADT will be determined using the method as recommended by PCWG3 criteria.	approximately 2 years	No
Secondary	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	No
Secondary	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	No
Secondary	Overall Survival	Overall survival defined as time from the date of randomization to death from any cause.	approximately 2 years	No
Secondary	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	No
Secondary	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	No