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Protocol No. UW17037

Principal Investigator Kyriakopoulos, Christos

Phase III

Age Group Adult

Scope National

Sponsor Type Industry

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)

Objective The purpose of this study is to test the safety and tolerability of the research study drug, pembrolizumab/KEYTRUDA® (MK-3475). The study will also test the effectiveness of the research study drug compared to placebo (look-alike with no active ingredients).

Treatment Pembrolizumab, which is approved in the USA and some other countries, is available by prescription to treat several different cancers, but may not be approved to treat your type of cancer. Pembrolizumab works by helping your immune system to fight your cancer.

Description You will be assigned by chance to get either MK-3475 or placebo (look-alike with no active ingredients). This study drug will be administered intravenously (through a needle into your vein) over 30 minutes. You have a 1 in 2 chance of getting placebo only (like the flip of a coin). Neither you nor the study doctor will know which of these you are receiving. You may receive up to 17 doses of study treatment.

Key Eligibility
  • Be ≥ 18 years of age on day of signing informed consent
  • Have intermediate-high risk, high risk, or M1 NED
  • Have received no prior systemic therapy for advanced RCC (except nephrectomy or metastasectomy)
  • Have undergone a partial nephroprotective or radical complete nephrectomy (and complete resection of metastatic lesion(s) in M1 NED participants) with negative surgical margins
  • Must have undergone a nephrectomy (and metastasectomy for M1 NED) ≥28 days prior to signing informed consent and must be randomized ≤12 weeks after surgery
  • Must be tumor-free as assessed by the Investigator and validated by either CT or MRI scan of the brain and CAP and a bone scan ≤28 days from randomization
  • Have provided adequate tissue from the primary tumor (and resected metastatic lesion for M1 NED participants)
  • If patient has had major surgery, other than nephrectomy plus resection of pre-existing metastases for M1 NED participants, within 12 weeks prior to randomization they are excluded
  • If patient has received prior radiotherapy for RCC, they are excluded
  • If patient has residual thrombus post nephrectomy in the vena renalis or vena cava, they are excluded
  • If patient has an active autoimmune disease that has required systemic treatment in past 2 years, they are excluded
  • If patient has a known additional malignancy that is progressing or requires active treatment they are excluded
  • If patient has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis, they are excluded
  • If patient has an active infection requiring systemic therapy, they are excluded
  • If patient has a known history of human immunodeficiency virus infection, known active hepatitis B or hepatitis C virus, they are excluded
  • If patient has as a known history of active tuberculosis, they are excluded
  • If patient is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, they are excluded

Applicable Disease Sites Kidney

Therapies Involved Immunotherapy

Drugs Involved Keytruda (pembrolizumab); MK-3475 (pembrolizumab); pembrolizumab; placebo

Status Open

Participating Institutions UW Hospital and Clinics