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Neoadjuvant Pembrolizumab Plus Androgen Axis Blockade Prior to Prostatectomy for High Risk Localized Prostate Cancer

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ClinicalTrials.gov Identifier: NCT03753243
Recruitment Status : Recruiting
First Posted : November 26, 2018
Last Update Posted : August 30, 2019
Sponsor:
Collaborators:
Merck Sharp & Dohme Corp.
Astellas Pharma Inc
Information provided by (Responsible Party):
Mark Garzotto, MD, Portland VA Medical Center

Tracking Information
First Submitted Date  ICMJE November 20, 2018
First Posted Date  ICMJE November 26, 2018
Last Update Posted Date August 30, 2019
Actual Study Start Date  ICMJE December 3, 2018
Estimated Primary Completion Date June 3, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 21, 2018)
Pathologic Complete Response [ Time Frame: 4 months ]
No cancer detected on pathology examination of prostatectomy specimen
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03753243 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 21, 2018)
  • Treatment Related Adverse Events [ Time Frame: 4 months + 30 days ]
    Grade 3 or higher adverse event (AE) possibly related or related to any of three treatment drugs (pembrolizumab, enzalutamide, Gonadotropin-releasing hormone (GNRH) agonist) per CTCAE v4.03, evaluated up until 30 days after prostatectomy
  • Immune -related Adverse Events [ Time Frame: 4 months + 30 days ]
    Grade 2 or higher immune related AE possibly related or related to any of three treatment drugs (pembrolizumab, enzalutamide, GNRH agonist) per CTCAE v4.03, evaluated up until 30 days after prostatectomy
  • Biochemical Complete Response [ Time Frame: 4 months ]
    Prostate-Specific Antigen (PSA) < 0.1 ng/mL prior to prostatectomy
  • Incidence of Surgical Complications [ Time Frame: 4 months ]
    Clavien-Dindo Classification of Surgical Complications compared to historical department incidence rates.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Neoadjuvant Pembrolizumab Plus Androgen Axis Blockade Prior to Prostatectomy for High Risk Localized Prostate Cancer
Official Title  ICMJE Phase II Study of Neoadjuvant Pembrolizumab Plus Intensive Androgen Axis Blockade Prior to Prostatectomy for High Risk Localized Prostate Cancer
Brief Summary Pembrolizumab will be administered at a dose of 200 mg will be administered as a 30 minute IV infusion every 3 weeks. Enzalutamide will be administered at dose of 160 mg orally every day. All patients will be required to have at least one high-risk criteria.
Detailed Description

The investigators propose to study the effects of pembrolizumab combined with intensive androgen receptor (AR) targeting prior to prostatectomy with extended pelvic lymph node dissection in subjects with high-risk localized prostate cancer (HRLPC).

Trial Design- single arm, single-stage, open label Phase II of neoadjuvant immune-hormonal therapy in high-risk localized prostate cancer.

Objectives To evaluate efficacy and safety of pembrolizumab combined with intensive AR targeting prior to prostatectomy in subjects with high-risk localized prostate cancer (HRLPC).

Primary Endpoint Pathologic complete response (pCR) defined as absence of detectable malignant cells in the prostatectomy specimen evaluated by standard histologic techniques.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Intervention Model Description:
single arm, single-stage open label Phase II of neoadjuvant immune-hormonal therapy in high-risk Localized prostate cancer.
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Prostate Cancer
Intervention  ICMJE
  • Drug: Pembrolizumab
    Pembrolizumab 200 mg will be administered as a 30 minute IV infusion every 3 weeks.
    Other Name: Keytruda
  • Drug: Enzalutamide
    Patients will receive daily oral doses of study drug (enzalutamide 160 mg/day), which will be administered as four capsules/day to be taken at or near the same time each day.
    Other Name: Xtandi
Study Arms  ICMJE Experimental: Intervention
Treatment will be planned for a total of 14 to 16 weeks. Pembrolizumab will be administered every 3 weeks via IV infusion with a dose of 200 mg per infusion. Enzalutamide will be given orally and dispensed to the patient on the date of their first infusion. The dosage of Enzalutamide will be 160 mg, administered once daily for approx. 16 weeks. GNRH agonist therapy will be administered as a standard of care therapy and will follow a standard dosage to maintain castrate levels.
Interventions:
  • Drug: Pembrolizumab
  • Drug: Enzalutamide
Publications * Not Provided

*   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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 21, 2018)
32
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 30, 2023
Estimated Primary Completion Date June 3, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Be willing and able to provide written informed consent/assent for the trial.
  • Capability to understand and comply with the protocol and signed informed consent document.
  • Be ≥ 18 years of age on day of signing informed consent.
  • Have measurable disease based on RECIST 1.1.
  • Histologically confirmed, non-metastatic adenocarcinoma of the prostate
  • Prostatectomy with extended lymph node dissection planned as primary therapy
  • 10 year or longer life expectancy based on other co-morbidities
  • Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale.
  • Any one of the following three high risk features:

    • Gleason grade > 8-10
    • PSA > 20 ng/ml
    • Clinical stage T3a (resectable)
  • No evidence of metastases .
  • No other diagnosis of malignancy (with exception of non-melanoma skin cancer or a malignancy diagnosed ≥5 years ago).
  • Male subjects of childbearing potential must agree to use an adequate method of contraception. Contraception, starting with the first dose of study therapy through the time of surgery. Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject.
  • Demonstrate adequate organ function, all screening labs should be performed within 30 days of treatment initiation.
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: Wesley Stoller, MA 5032208262 ext 54931 stoller@ohsu.edu
Contact: Mark Garzotto, MD 5032208262 ext 51982 mark.garzotto@va.gov
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03753243
Other Study ID Numbers  ICMJE 15235
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Mark Garzotto, MD, Portland VA Medical Center
Study Sponsor  ICMJE Mark Garzotto, MD
Collaborators  ICMJE
  • Merck Sharp & Dohme Corp.
  • Astellas Pharma Inc
Investigators  ICMJE
Principal Investigator: Mark Garzotto, MD Portland VA Medical Center
PRS Account Portland VA Medical Center
Verification Date August 2019

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