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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: Pembrolizumab Drug: Enzalutamide Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: N/A
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
Official Title: Phase II Study of Neoadjuvant Pembrolizumab Plus Intensive Androgen Axis Blockade Prior to Prostatectomy for High Risk Localized Prostate Cancer
Actual Study Start Date : December 3, 2018
Estimated Primary Completion Date : June 3, 2020
Estimated Study Completion Date : April 30, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arms and Interventions
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Arm Intervention/treatment
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.
 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


Outcome Measures
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Primary Outcome Measures :
  1. Pathologic Complete Response [ Time Frame: 4 months ]
    No cancer detected on pathology examination of prostatectomy specimen


Secondary Outcome Measures :
  1. 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

  2. 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

  3. Biochemical Complete Response [ Time Frame: 4 months ]
    Prostate-Specific Antigen (PSA) < 0.1 ng/mL prior to prostatectomy

  4. Incidence of Surgical Complications [ Time Frame: 4 months ]
    Clavien-Dindo Classification of Surgical Complications compared to historical department incidence rates.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03753243


Contacts
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Contact: Wesley Stoller, MA 5032208262 ext 54931 stoller@ohsu.edu
Contact: Mark Garzotto, MD 5032208262 ext 51982 mark.garzotto@va.gov

Locations
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United States, Oregon
VA Portland Healthcare System Recruiting
Portland, Oregon, United States, 97239
Contact: Wesley Stoller, MA    503-220-8262 ext 54931    stoller@ohsu.edu   
Principal Investigator: Mark Garzotto, MD         
Sponsors and Collaborators
Mark Garzotto, MD
Merck Sharp & Dohme Corp.
Astellas Pharma Inc
Investigators
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Principal Investigator: Mark Garzotto, MD Portland VA Medical Center
  Study Documents (Full-Text)

Documents provided by Mark Garzotto, MD, Portland VA Medical Center:
Study Protocol and Statistical Analysis Plan  [PDF] July 13, 2017

More Information
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Responsible Party: Mark Garzotto, MD, Director of Urologic Oncology, Portland VA Medical Center
ClinicalTrials.gov Identifier: NCT03753243    
Other Study ID Numbers: 15235
First Posted: November 26, 2018    Key Record Dates
Last Update Posted: August 30, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Mark Garzotto, MD, Portland VA Medical Center:
Neoadjuvant
Programmed cell death protein 1 (PD-1)
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
 Prostatic Diseases
Pembrolizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents