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Withdrawn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

First listed
Sep 20, 2016
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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