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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

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ClinicalTrials.gov Identifier: NCT02906605
Recruitment Status : Withdrawn (Study start delayed due to pending collection and analysis of additional phase 1 data.)
First Posted : September 20, 2016
Last Update Posted : November 22, 2016
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
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 : October 2016
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : September 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
Drug Information available for: Apalutamide

Arms and Interventions
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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
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Primary Outcome Measures :
  1. Time to Prostate-specific Antigen (PSA) Progression [ Time Frame: approximately 2 years ]
    Time to PSA progression will be measured using Prostate Cancer Working Group 3 (PCWG3).


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

  2. Radiographic Progression-free Survival [ Time Frame: 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.

  3. Time to Unequivocal Clinical Progression [ Time Frame: 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.

  4. Overall Survival [ Time Frame: approximately 2 years ]
    Overall survival defined as time from the date of randomization to death from any cause.

  5. Number of Participants With Adverse Events (AEs) as a Measure of Safety and Tolerability [ Time Frame: approximately 2 years ]
    Comparison of the AE profiles of the two treatment groups.

  6. Blood Culture and Shedding Profile of JNJ-809 From Cultured Samples of Feces, Urine, and Saliva [ Time Frame: 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
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02906605


Locations
United States, New York
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
More Information
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Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT02906605     History of Changes
Other Study ID Numbers: CR108224
64041809PCR2002 ( Other Identifier: Janssen Research & Development, LLC )
2016-001917-26 ( EudraCT Number )
First Posted: September 20, 2016    Key Record Dates
Last Update Posted: November 22, 2016
Last Verified: November 2016

Additional relevant MeSH terms:
Prostatic Neoplasms
Prostatic Neoplasms, Castration-Resistant
Genital Neoplasms, Male
Urogenital Neoplasms
 Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases