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

Part of paid clinical trials in Portland, Oregon.

Sponsor
Mark Garzotto, MD
Study ID
NCT03753243
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Dec 3, 2018
Status verified
Apr 2022
Primary completion
Sep 3, 2022
Completion
Apr 30, 2023

Study Design

Enrollment
32 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

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.

Primary Outcome Measure

Pathologic Complete Response [ Time Frame: 4 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
VA Portland Healthcare SystemPortlandOregon97239
Wesley Stoller, MA
[email protected]
503-220-8262
Mark Garzotto, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Portland, OR

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
VA Portland Healthcare System· Portland, OR

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