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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

Primary Purpose

Prostatic Neoplasms, Castration-Resistant

Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
JNJ-809
Apalutamide
Sponsored by
Janssen Research & Development, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostatic Neoplasms, Castration-Resistant

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept 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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

JNJ-809 plus Apalutamide (Group A)

Apalutamide (Group B)

Arm Description

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

Apalutamide 240 mg orally daily.

Outcomes

Primary Outcome Measures

Time to Prostate-specific Antigen (PSA) Progression
Time to PSA progression will be measured using Prostate Cancer Working Group 3 (PCWG3).

Secondary Outcome Measures

PSA Doubling Time (PSADT)
The PSADT will be determined using the method as recommended by PCWG3 criteria.
Radiographic Progression-free Survival
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 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
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
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
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.

Full Information

First Posted
September 15, 2016
Last Updated
November 18, 2016
Sponsor
Janssen Research & Development, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT02906605
Brief Title
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
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 Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Withdrawn
Why Stopped
Study start delayed due to pending collection and analysis of additional phase 1 data.
Study Start Date
October 2016 (undefined)
Primary Completion Date
September 2018 (Anticipated)
Study Completion Date
September 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen Research & Development, LLC

4. Oversight

Data Monitoring Committee
Yes

5. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostatic Neoplasms, Castration-Resistant

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
JNJ-809 plus Apalutamide (Group A)
Arm Type
Experimental
Arm Description
JNJ-809 given as an infusion and Apalutamide 240 milligram (mg) daily.
Arm Title
Apalutamide (Group B)
Arm Type
Experimental
Arm Description
Apalutamide 240 mg orally daily.
Intervention Type
Drug
Intervention Name(s)
JNJ-809
Intervention Description
JNJ-809 (1*10^9) colony forming units (CFU) given as an infusion.
Intervention Type
Drug
Intervention Name(s)
Apalutamide
Intervention Description
Apalutamide 240 mg orally daily.
Primary Outcome Measure Information:
Title
Time to Prostate-specific Antigen (PSA) Progression
Description
Time to PSA progression will be measured using Prostate Cancer Working Group 3 (PCWG3).
Time Frame
approximately 2 years
Secondary Outcome Measure Information:
Title
PSA Doubling Time (PSADT)
Description
The PSADT will be determined using the method as recommended by PCWG3 criteria.
Time Frame
approximately 2 years
Title
Radiographic Progression-free Survival
Description
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 Frame
approximately 2 years
Title
Time to Unequivocal Clinical Progression
Description
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.
Time Frame
approximately 2 years
Title
Overall Survival
Description
Overall survival defined as time from the date of randomization to death from any cause.
Time Frame
approximately 2 years
Title
Number of Participants With Adverse Events (AEs) as a Measure of Safety and Tolerability
Description
Comparison of the AE profiles of the two treatment groups.
Time Frame
approximately 2 years
Title
Blood Culture and Shedding Profile of JNJ-809 From Cultured Samples of Feces, Urine, and Saliva
Description
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.
Time Frame
approximately 2 years

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen Research & Development, LLC Clinical Trial
Organizational Affiliation
Janssen Research & Development, LLC
Official's Role
Study Director
Facility Information:
City
New York
State/Province
New York
Country
United States

12. IPD Sharing Statement

Learn more about this 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

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