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

Part of paid clinical trials in New York, New York.

Sponsor
Janssen Research & Development, LLC
Study ID
NCT02906605
Phase
PHASE2
Status
Withdrawn

Conditions

  • Prostatic Neoplasms, Castration-Resistant

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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).

Key Dates

Start date
Oct 31, 2016
Status verified
Nov 2016
Primary completion
Sep 30, 2018
Completion
Sep 30, 2018

Study Design

Enrollment
0 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: JNJ-809 plus Apalutamide (Group A)
    JNJ-809 given as an infusion and Apalutamide 240 milligram (mg) daily.
  • Experimental: Apalutamide (Group B)
    Apalutamide 240 mg orally daily.

Primary Outcome Measure

Time to Prostate-specific Antigen (PSA) Progression [ Time Frame: approximately 2 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
-New YorkNew York--

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