A Study of the Clinical Activity and Safety of JNJ-640418... | NCT02906605

Studies
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

NCT02906605

Sponsor

Janssen Research & Development, LLC

Status

Withdrawn

Last Update Posted

Nov 22, 2016Estimated

Enrollment

0Actual

Phase

Phase 2

Conditions

Prostatic Neoplasms, Castration-Resistant

Interventions

JNJ-809
Apalutamide

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

ID	Type	Description	Link
64041809PCR2002	Other Identifier	Janssen Research & Development, LLC
2016-001917-26	EudraCT Number

Status Module

Record Verification Date

Nov 2016

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Study start delayed due to pending collection and analysis of additional phase 1 data.

Expanded Access Info

Start Date

Oct 2016

Primary Completion Date

Sep 2018Estimated

Completion Date

Sep 2018Estimated

First Submitted Date

Sep 15, 2016

First Submission Date that Met QC Criteria

Sep 15, 2016

First Posted Date

Sep 20, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 18, 2016

Last Update Posted Date

Nov 22, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
JNJ-809 plus Apalutamide (Group A)	Experimental	JNJ-809 given as an infusion and Apalutamide 240 milligram (mg) daily.	Drug: JNJ-809 Drug: Apalutamide
Apalutamide (Group B)	Experimental	Apalutamide 240 mg orally daily.	Drug: Apalutamide

Interventions

Name	Type	Description	Arm Group Labels	Other Names
JNJ-809	Drug	JNJ-809 (1*10^9) colony forming units (CFU) given as an infusion.	JNJ-809 plus Apalutamide (Group A)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Time to Prostate-specific Antigen (PSA) Progression	Time to PSA progression will be measured using Prostate Cancer Working Group 3 (PCWG3).	approximately 2 years

Secondary Outcomes

Measure	Description	Time Frame
PSA Doubling Time (PSADT)	The PSADT will be determined using the method as recommended by PCWG3 criteria.	approximately 2 years
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.

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D011471	Prostatic Neoplasms
D005834	Genital Neoplasms, Male
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D005832	Genital Diseases, Male
D000091662	Genital Diseases
D000091642	Urogenital Diseases
D011469	Prostatic Diseases
D052801	Male Urogenital Diseases