Safety and Efficacy Study of Pembrolizumab (MK-3475) as Monotherapy in the Adjuvant Treatment of Renal Cell Carcinoma Post Nephrectomy (MK-3475-564/KEYNOTE-564)

Completed · Phase 3 · Has a placebo group

Conditions studied: Renal Cell Carcinoma

In brief

The purpose of this study is to evaluate the safety and efficacy of pembrolizumab (MK-3475) in the adjuvant treatment of adult participants who have undergone nephrectomy and have intermediate-high risk, high risk, or M1 no evidence of disease (M1 NED) renal cell carcinoma (RCC) with clear cell component. The primary study hypothesis is that pembrolizumab is superior to placebo with respect to Disease-free Survival (DFS) as assessed by the Investigator in male and female participants with intermediate-high risk, high risk and M1 NED RCC.

Key facts

Study ID

NCT03142334

Run by

Merck Sharp & Dohme LLC

People needed

994

Starts

2017-06-09

Expected to finish

2026-02-04

Last updated by the study team

2026-03-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Has histologically confirmed diagnosis of renal cell carcinoma (RCC) with clear cell component with or without sarcomatoid features
• Female participants of childbearing potential must be willing to use an adequate method of contraception, for the course of the study through 120 days after the last dose of study treatment
• Male participants of childbearing potential must agree to use an adequate method of contraception, starting with the first dose of study treatment through 120 days after the last dose of study treatment
• Has intermediate-high risk, high risk, or M1 no evidence of disease (NED) RCC as defined by the following pathological tumor-node-metastasis and Fuhrman grading status:
• Intermediate-high risk RCC: pT2, Grade 4 or sarcomatoid, N0, M0; pT3, Any Grade, N0, M0
• High risk RCC: pT4, Any Grade N0, M0; pT Any stage, Any Grade, N+, M0
• M1 NED RCC participants who present not only with the primary kidney tumor but also solid, isolated, soft tissue metastases that can be completely resected at one of the following: the time of nephrectomy (synchronous) or, ≤1 year from nephrectomy (metachronous)
• Has received no prior systemic therapy for advanced RCC
• Has undergone a partial nephroprotective or radical complete nephrectomy (and complete resection of solid, isolated, soft tissue metastatic lesion(s) in M1 NED participants) with negative surgical margins
• Must have undergone a nephrectomy and/or metastasectomy ≥28 days prior to signing informed consent and ≤12 weeks prior to randomization
• Must be tumor-free as assessed by the Investigator and validated by either computed tomography (CT) or magnetic resonance imaging (MRI) scan of the brain and chest, abdomen, and pelvis and a bone scan ≤28 days from randomization
• Must have provided adequate tissue per the following: Nephrectomy only: tissue from nephrectomy (required); Synchronous M1 NED: tissue from nephrectomy (required) AND, metastasectomy tissue (if available); Metachronous M1 NED: tissue from metastasectomy (required) AND, nephrectomy tissue (if available)
• Has an Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 or 1
• Has adequate organ function

You may not qualify if…

• Has had major surgery, other than nephrectomy and/or resection of pre-existing metastases for M1 NED participants, within 12 weeks prior to randomization
• Has received prior radiotherapy for RCC
• Has pre-existing brain or bone metastatic lesions
• Has residual thrombus post nephrectomy in the vena renalis or vena cava
• Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study treatment
• Has an active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy is allowed
• Has a known additional malignancy that is progressing or required active treatment ≤3 years ago. Exceptions include early-stage cancers (carcinoma in situ or Stage 1) treated with curative intent, basal cell carcinoma of the skin, squamous cell carcinoma of the skin, in situ cervical cancer, in situ prostate cancer, or in situ breast cancer that has undergone potentially curative therapy
• Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis
• Has an active infection requiring systemic therapy
• Has a history of, or is currently on, dialysis
• Has a known history of human immunodeficiency virus (HIV) infection
• Has known active hepatitis B or hepatitis C virus infection
• Has a known history of active tuberculosis (Bacillus tuberculosis)
• Has had a prior solid organ transplant
• Has severe hypersensitivity (≥ Grade 3) to pembrolizumab and/or any of its excipients
• Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study, starting with the Screening visit through 120 days after the last dose of study treatment
• Has received prior therapy with an anti-programmed cell death protein 1 (anti-PD-1), anti-programmed cell death-ligand 1 (anti-PD-L1), or anti-programmed cell death-ligand 2 (anti-PD-L2) agent or with an agent directed to another co-inhibitory T-cell receptor (i.e., cytotoxic T-lymphocyte-associated protein 4 [CTLA-4], OX-40, CD137 [tumor necrosis factor receptor superfamily member 9 (TNFRSF9)]) or has previously participated in a Merck pembrolizumab (MK-3475) clinical trial
• Has received prior anticancer therapy, monoclonal antibody, chemotherapy, or an investigational agent or device within 4 weeks or 5 half-lives (whichever is longer) before first dose of study treatment or not recovered (i.e., must be ≤ Grade 1 or at Baseline) from AEs due to previously administered agents
• Has received a live vaccine within 30 days prior to the first dose of study treatment
• Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment

Where it is running

• USC Norris Comprehensive Cancer Center ( Site 0038) — Los Angeles, California, United States
• UCSF Helen Diller Family Comprehensive Cancer Center ( Site 0056) — San Francisco, California, United States
• Sansum Clinic Research ( Site 8014) — Santa Barbara, California, United States
• Stanford Cancer Center ( Site 0028) — Stanford, California, United States
• Rocky Mountain Cancer Center ( Site 8010) — Aurora, Colorado, United States
• Georgetown University Medical Center ( Site 0002) — Washington D.C., District of Columbia, United States
• Boca Raton Regional Hospital- Lynn Cancer Institute ( Site 0035) — Boca Raton, Florida, United States
• Manatee Medical Research Institute ( Site 0039) — Bradenton, Florida, United States
• Woodlands Medical Specialists, PA ( Site 8021) — Pensacola, Florida, United States
• Northwest Georgia Oncology Centers PC ( Site 0014) — Marietta, Georgia, United States
• Illinois Cancer Specialists ( Site 8001) — Niles, Illinois, United States
• McFarland Clinic ( Site 0025) — Ames, Iowa, United States
• University of Iowa Hospital and Clinics ( Site 0031) — Iowa City, Iowa, United States
• University Medical Center New Orleans ( Site 0053) — New Orleans, Louisiana, United States
• Weinberg Cancer Institute at Franklin Square ( Site 0046) — Baltimore, Maryland, United States
• Maryland Oncology Hematology, P.A. ( Site 8020) — Rockville, Maryland, United States
• Beth Israel Deaconess Medical Ctr. ( Site 0044) — Boston, Massachusetts, United States
• Dana-Farber Cancer Institute (Boston) ( Site 0007) — Boston, Massachusetts, United States
• University of Michigan ( Site 0045) — Ann Arbor, Michigan, United States
• Karmanos Cancer Institute ( Site 0013) — Detroit, Michigan, United States
• Henry Ford Hospital ( Site 0032) — Detroit, Michigan, United States
• Quest Research Institute ( Site 0036) — Royal Oak, Michigan, United States
• Fairview Southdale Medical Oncology Clinic ( Site 0041) — Edina, Minnesota, United States
• Minnesota Oncology Specialist, PA ( Site 8002) — Minneapolis, Minnesota, United States
• Arizona Oncology Associates, PC- HAL ( Site 8018) — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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