Clinical Trial: 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

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional

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

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 Summary:
Sponsor: Janssen Research & Development, LLC

Current Primary Outcome: 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).


Original Primary Outcome: Same as current

Current Secondary Outcome:

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


Original Secondary Outcome: Same as current

Information By: Janssen Research & Development, LLC

Dates:
Date Received: September 15, 2016
Date Started: October 2016
Date Completion: September 2018
Last Updated: November 18, 2016
Last Verified: November 2016