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About this trial

Approximately 950 eligible participants will be randomized (1:1) to receive either placebo or pembrolizumab 200 mg, administered by IV infusion every 3 weeks. Participants will be assigned to receive study treatment until disease recurrence, unacceptable adverse events (AEs), intercurrent illness that prevents further administration of treatment, Investigator’s decision to withdraw the participant, noncompliance with study treatment or procedural requirements, administrative reasons requiring cessation of treatment, or until the participant has received 17 cycles of study treatment (approximately 1 year).

Patient Profile

This trial will enroll participants with RCC with clear cell component that is intermediate-high risk, high risk, or M1 NED (M1 NED refers to participants who present not only with the primary kidney tumor but also solid, isolated, soft tissue metastases that can be completely resected ≤1 year from the time of nephrectomy).

Where’s this trial being run?

Beaumont Hospital, St Vincents University Hospital, and University Hospital Waterford

Can I join this study / trial?

The first thing you do is to talk to your doctor and/or the cancer trials research team in your hospital. The contact details for the cancer trials research units in Ireland is here.

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For more detailed information

Questions?

Here’s a list of questions you may have for your doctor or local cancer research team.

Summary Data

Name: KEYNOTE-564
Number: CTRIAL-IE 18-31
Full Title:

A Phase III, Randomized, Double-Blind, Placebo-Controlled Clinical Trial of Pembrolizumab (MK-3475) as Monotherapy in the Adjuvant Treatment of Renal Cell Carcinoma Post Nephrectomy (KEYNOTE-564)

Principal Investigator: Prof Ray McDermott (St. Vincent's University Hospital)
Type: Industry Sponsored
Sponsor:

Merck Sharp & Dohme Corp.

Recruitment Started: Global: June 2017
Ireland: February 2019
Global Recruitment Target: 950
Ireland Recruitment Target: 12