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

Sponsor

Janssen Research & Development, LLC (Industry)

Overall Status

Withdrawn

CT.gov ID

NCT02906605

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Prostatic Neoplasms, Castration-Resistant	Drug: JNJ-809 Drug: Apalutamide	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 Start Date :

Oct 1, 2016

Anticipated Primary Completion Date :

Sep 1, 2018

Anticipated Study Completion Date :

Sep 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: JNJ-809 plus Apalutamide (Group A) JNJ-809 given as an infusion and Apalutamide 240 milligram (mg) daily.	Drug: JNJ-809 JNJ-809 (110^9) colony forming units (CFU) given as an infusion. Drug: Apalutamide* Apalutamide 240 mg orally daily.
Experimental: Apalutamide (Group B) Apalutamide 240 mg orally daily.	Drug: Apalutamide Apalutamide 240 mg orally daily.

Arm

Intervention/Treatment

Experimental: JNJ-809 plus Apalutamide (Group A)

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

Drug: JNJ-809

JNJ-809 (1*10^9) colony forming units (CFU) given as an infusion.

Drug: Apalutamide

Apalutamide 240 mg orally daily.

Experimental: Apalutamide (Group B)

Apalutamide 240 mg orally daily.

Drug: Apalutamide

Apalutamide 240 mg orally daily.

Outcome Measures

Primary Outcome Measures

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

PSA Doubling Time (PSADT) [approximately 2 years]
The PSADT will be determined using the method as recommended by PCWG3 criteria.
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.
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.
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.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Male

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		New York	New York	United States

Sponsors and Collaborators

Janssen Research & Development, LLC

Investigators

Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Janssen Research & Development, LLC

ClinicalTrials.gov Identifier:

NCT02906605

Other Study ID Numbers:

CR108224
64041809PCR2002
2016-001917-26

First Posted:

Sep 20, 2016

Last Update Posted:

Nov 22, 2016

Last Verified:

Nov 1, 2016

Additional relevant MeSH terms:

Prostatic Neoplasms

Prostatic Neoplasms, Castration-Resistant

Study Results

No Results Posted as of Nov 22, 2016