Recruiting
Phase 2

Pembrolizumab & Androgen Axis Blockade

Sponsor:

Mark Garzotto, MD

Code:

NCT03753243

Conditions

Prostate Cancer

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Pembrolizumab

Enzalutamide

Study Details

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.

Conditions

Prostate Cancer

Study ID

NCT03753243

Start date

Dec 3, 2018

Status verified date

Apr, 2022

Completion date

Apr 30, 2023

Anticipated

Primary completion date

Sep 3, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

32 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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

Pembrolizumab

Pembrolizumab 200 mg will be administered as a 30 minute IV infusion every 3 weeks.

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.

Primary outcome measure

  • Pathologic Complete Response [ Time Frame: 4 months ]

Central Contacts and Locations

Central contacts

Wesley Stoller, MA

5032208262stoller@ohsu.edu

Mark Garzotto, MD

5032208262mark.garzotto@va.gov

Locations

VA Portland Healthcare System

Recruiting

Portland, Oregon, United States, 97239

Contacts

Wesley Stoller, MA

503-220-8262stoller@ohsu.edu

Principal Investigator:

Mark Garzotto, MD

More Information

Sponsor

Mark Garzotto, MD

Last update posted

Apr 20, 2022

Last verified

Apr, 2022

Keywords

  • Neoadjuvant
  • Programmed cell death protein 1 (PD-1)

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mark Garzotto, MD on 2022-04-20.