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Safety & Immunogenicity of JNJ-64041809, a Live Attenuated Double-deleted Listeria Immunotherapy, in Participants With Metastatic Castration-resistant Prostate Cancer

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ClinicalTrials.gov Identifier: NCT02625857
Recruitment Status : Completed
First Posted : December 9, 2015
Last Update Posted : August 9, 2019
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Tracking Information
First Submitted Date  ICMJE December 7, 2015
First Posted Date  ICMJE December 9, 2015
Last Update Posted Date August 9, 2019
Actual Study Start Date  ICMJE December 10, 2015
Actual Primary Completion Date July 3, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 23, 2016)
  • Part 1: Incidence of Dose-limiting-toxicity (DLT) [ Time Frame: first 21 days after the first infusion ]
    Percentage of Participants who Experienced DLT will be evaluated. The DLT dose level is defined as an unacceptable level of toxicity as evidenced by a DLT rate of greater than or equal to (>=) 33 percent (%).
  • Part 2: Antigen-specific T-cell Response [ Time Frame: up to 1 year ]
    Biomarker studies will be performed to evaluate immune responses to the vaccine after the first intravenous (IV) immunization.
  • Part 1 and Part 2: Incidence of Adverse Events (AEs) [ Time Frame: From signing of informed consent form to 30 days after last dose of study drug ]
    An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Incidence was defined as the number of participants who experienced an adverse event within their period of participation in this study. Incidence of adverse events will be assessed using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE).
Original Primary Outcome Measures  ICMJE
 (submitted: December 7, 2015)
  • Part 1: Incidence of Dose-limiting-toxicity (DLT) [ Time Frame: first 21 days after the first infusion ]
    Percentage of Participants who Experienced DLT will be evaluated. The DLT dose level is defined as an unacceptable level of toxicity as evidenced by a DLT rate of greater than or equal to (>=) 33 percent (%).
  • Part 2: Antigen-specific T-cell Response [ Time Frame: up to 1 year ]
    Leukapheresis will be performed to evaluate immune responses to the vaccine after an single intravenous (IV) immunization.
  • Part 1 and Part 2: Incidence of Adverse Events (AEs) [ Time Frame: From signing of informed consent form to 30 days after last dose of study drug ]
    An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Incidence was defined as the number of participants who experienced an adverse event within their period of participation in this study. Incidence of adverse events will be assessed using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE).
Change History Complete list of historical versions of study NCT02625857 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 28, 2016)
  • Part 1 and Part 2: Objective Response Rate (ORR) [ Time Frame: Baseline up to 30 days after last dose of study drug ]
    Objective response rate is defined as the percentage of participants who achieve complete response (CR) or partial response (PR), as assessed by the investigator.
  • Part 1 and Part 2: Duration of Response (DOR) [ Time Frame: Baseline up to 30 days after last dose of study drug ]
    Duration of response will be calculated from the date of initial documentation of a response (CR or PR) to the date of first documented evidence of progressive disease (or relapse for participants who experience CR during the study) or death.
  • Part 1 and Part 2: Progression-free Survival (PFS) [ Time Frame: Baseline up to 30 days after last dose of study drug ]
    Progression-free survival is defined as the duration from the date of first dose of study drug until the date of first documented evidence of progressive disease (or relapse for participants who experience CR during the study) or death, whichever comes first.
  • Part 1 and Part 2: Time to Prostate Specific Antigen (PSA) progression (TTPP) [ Time Frame: Baseline up to 30 days after last dose of study drug ]
    Time to PSA progression is measured from the date of first dose of study drug until the date of PSA progression according to the Prostate Cancer Clinical Trials Working Group (PCWG2) criteria.
  • Part 1 and Part 2: Blood Culture Assessment of JNJ-64041809 [ Time Frame: Periodically during treatment and up to one year after End of Treatment (EOT) visit ]
    This assessment will include the reporting of surveillance blood cultures (peripherally drawn, and through venous access device [if applicable]) for 1 year after the completion of JNJ-64041809 therapy.
  • Part 1 and Part 2: Shedding Profile of JNJ-64041809 From Cultured Samples of Feces, Urine, and Saliva [ Time Frame: During cycle 1 (up to 21 days of treatment period) and at EOT visit (within 30 days after last dose) ]
    The shedding of JNJ-64041809 will be studied in cultures of (1) feces by stool or rectal swab, (2) urine samples, and (3) saliva samples.
Original Secondary Outcome Measures  ICMJE
 (submitted: December 7, 2015)
  • Part 1 and Part 2: Objective Response Rate (ORR) [ Time Frame: Baseline up to 30 days after last dose of study drug ]
    Objective response rate is defined as the percentage of participants who achieve complete response (CR) or partial response (PR), as assessed by the investigator.
  • Part 1 and Part 2: Duration of Response (DOR) [ Time Frame: Baseline up to 30 days after last dose of study drug ]
    Duration of response will be calculated from the date of initial documentation of a response (CR or PR) to the date of first documented evidence of progressive disease (or relapse for participants who experience CR during the study) or death.
  • Part 1 and Part 2: Progression-free Survival (PFS) [ Time Frame: Baseline up to 30 days after last dose of study drug ]
    Progression-free survival is defined as the duration from the date of first dose of study drug until the date of first documented evidence of progressive disease (or relapse for participants who experience CR during the study) or death, whichever comes first.
  • Part 1 and Part 2: Time to Prostate Specific Antigen (PSA) progression (TTPP) [ Time Frame: Baseline up to 30 days after last dose of study drug ]
    Time to PSA progression is measured from the date of first dose of study drug until the date of PSA progression according to the Prostate Cancer Clinical Trials Working Group (PCWG2) criteria.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety & Immunogenicity of JNJ-64041809, a Live Attenuated Double-deleted Listeria Immunotherapy, in Participants With Metastatic Castration-resistant Prostate Cancer
Official Title  ICMJE An Open-Label, Phase 1 Study of the Safety and Immunogenicity of JNJ-64041809, a Live Attenuated Listeria Monocytogenes Immunotherapy, in Subjects With Metastatic Castration-resistant Prostate Cancer
Brief Summary The purpose of this study is to find and evaluate the recommended Phase 2 dose (RP2D) of JNJ-64041809, a live attenuated double deleted (LADD) Listeria monocytogenes (bacteria in which two virulence genes, which encode molecules that help cause disease, have been removed) when administered intravenously to participants with metastatic castration-resistant prostate cancer (mCRPC).
Detailed Description This is a first-in-human (FIH), Phase 1, open-label, multicenter and 2-part study. The Part 1 of study will be Dose Escalation phase to determine the recommended Phase 2 dose (RP2D) based on safety and pharmacodynamic assessments and Part 2 will be Dose Expansion Phase to evaluate 2 expansion cohorts (Cohort 2A and 2B) after the RP2D for JNJ-64041809 is determined in Part 1. The study will consist of a Screening Period (from signing of informed consent until immediately before the first dose), an open-label Treatment Period (from the first dose of study drug until the End-of-Treatment Visit); and a Post treatment Follow-up Period (after the End-of Treatment Visit until study discontinuation). Participants will be primarily evaluated for RP2D. Participants safety will be evaluated throughout the study.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Prostatic Neoplasms, Castration-Resistant
Intervention  ICMJE
  • Biological: JNJ-64041809 (Cohort 1A and 1B)
    JNJ-64041809 will be administered IV at a lower dose in Cohort 1A (1x10^8 colony forming units [CFU]) and at a higher dose in Cohort 1B (1x10^9 CFU).
  • Biological: JNJ-64041809 (Cohort 2A and 2B)
    JNJ-64041809 will be administered intravenously (IV) once every 21 days at the recommended dose as determined in Cohort 1A or 1B.
Study Arms  ICMJE
  • Experimental: Dose Cohort 1A and 1B
    JNJ-64041809 will be administered intravenously (IV) once every 21 days.
    Intervention: Biological: JNJ-64041809 (Cohort 1A and 1B)
  • Experimental: Dose Cohort 2A and 2B
    JNJ-64041809 will be administered intravenously (IV) once every 21 days.
    Intervention: Biological: JNJ-64041809 (Cohort 2A and 2B)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 4, 2017)
26
Original Estimated Enrollment  ICMJE
 (submitted: December 7, 2015)
42
Actual Study Completion Date  ICMJE July 3, 2018
Actual Primary Completion Date July 3, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Histologically confirmed adenocarcinoma of the prostate with progressive metastatic disease which, in the opinion of the investigator, requires initiation of new treatment. The assessment of disease progression can be based on either PSA rise, new or progressive soft tissue disease (based on computed tomography [CT] or magnetic resonance imaging [MRI] scans), or new or progressive bony disease based on radionuclide bone scan or 18F-sodium fluoride positron emission tomography/computed tomography [NaF PET/CT] scans). Participants being considered for Cohort 2B must, in addition, have primary or metastatic lesions amenable to tumor biopsies
  • Must have received at least 2 prior approved therapies
  • Ongoing androgen depletion therapy with a Gonadotropin Releasing Hormone analog or inhibitor, or orchiectomy (surgical or medical castration)
  • Serum testosterone levels less than (<) 50 nanogram per deciliter (ng/dL) determined within 4 weeks prior to start of study drug
  • For participants previously treated with first generation anti-androgens (ie, flutamide, nilutamide, or bicalutamide), discontinuation of flutamide or nilutamide therapy must occur greater than (>) 4 weeks (>6 weeks for bicalutamide) prior to start of study drug with no evidence of an anti-androgen withdrawal response (no decline in serum PSA)

Exclusion Criteria:

  • Untreated brain metastases. Participants must have completed treatment for brain metastasis, and be neurologically stable off steroids, for at least 28 days prior to first dose of study drug
  • Untreated spinal cord compression
  • History of listeriosis or vaccination with a listeria-based vaccine or prophylactic vaccine (example influenza, pneumococcal, diphtheria, tetanus, and pertussis [dTP/dTAP]) within 28 days of study treatment
  • Known allergy to both penicillin and trimethoprim/sulfamethoxazole. Participants who are allergic to only one of these antibiotics are allowed to enroll
  • Concurrent treatment with anti -Tumor necrosis factor (TNF) alpha therapies, systemic corticosteroids (prednisone dose >10 mg per day or equivalent) or other immune suppressive drugs within the 2 weeks prior to Screening. Steroids that are topical, inhaled, nasal (spray), or ophthalmic solution are permitted
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02625857
Other Study ID Numbers  ICMJE CR107668
64041809PCR1001 ( Other Identifier: Janssen Research & Development, LLC )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Janssen Research & Development, LLC
Study Sponsor  ICMJE Janssen Research & Development, LLC
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
PRS Account Janssen Research & Development, LLC
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP