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Prostatic Neoplasms, Castration-ResistantPhase 2NCT02906605

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

A Phase 2 study testing JNJ-809 and Apalutamide in people with Prostatic Neoplasms, Castration-Resistant, run by Janssen Research & Development, LLC at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
JNJ-809 and Apalutamide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
Oct 2016to Sep 2018
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Study site

    New York, New York

Other trials in United States

About this study

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

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).

Being tested
JNJ-809, Apalutamide
Medical subject headings
Prostatic Neoplasms, Castration-Resistant

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • JNJ-809Drug

    JNJ-809 (1*10^9) colony forming units (CFU) given as an infusion.

  • ApalutamideDrug

    Apalutamide 240 mg orally daily.

Study groups in NCT02906605
Study groupRoleWhat they receive
JNJ-809 plus Apalutamide (Group A)ExperimentalJNJ-809 given as an infusion and Apalutamide 240 milligram (mg) daily.
Receives: Drug: JNJ-809; Drug: Apalutamide
Apalutamide (Group B)ExperimentalApalutamide 240 mg orally daily.
Receives: Drug: Apalutamide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time to Prostate-specific Antigen (PSA) Progression

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

    Measured: approximately 2 years

Secondary outcomes (6)

  1. PSA Doubling Time (PSADT)

    The PSADT will be determined using the method as recommended by PCWG3 criteria.

    Measured: approximately 2 years

  2. 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.

    Measured: approximately 2 years

  3. 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.

    Measured: approximately 2 years

  4. Overall Survival

    Overall survival defined as time from the date of randomization to death from any cause.

    Measured: approximately 2 years

  5. Number of Participants With Adverse Events (AEs) as a Measure of Safety and Tolerability

    Comparison of the AE profiles of the two treatment groups.

    Measured: approximately 2 years

  6. 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.

    Measured: approximately 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Sep 2016 (estimated)
  2. Study startOct 2016
  3. Primary completionSep 2018 (estimated)
  4. Study completionSep 2018 (estimated)

Why it stopped: Study start delayed due to pending collection and analysis of additional phase 1 data.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02906605
Sponsor's protocol ID
CR108224
Other IDs
64041809PCR2002, 2016-001917-26, 2016
Status last verified
Nov 2016
First submitted
15 Sep 2016
Last updated
22 Nov 2016
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing JNJ-809 and Apalutamide in people with Prostatic Neoplasms, Castration-Resistant, run by Janssen Research & Development, LLC at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 22 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to Prostate-specific Antigen (PSA) Progression (time frame: approximately 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02906605.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2016.

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