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Clinical Trials in China / NCT05239728
Active, not recruiting Phase 3

A Study of Belzutifan (MK-6482) Plus Pembrolizumab (MK-3475) Versus Placebo Plus Pembrolizumab in Participants With Clear Cell Renal Cell Carcinoma Post Nephrectomy (MK-6482-022)

NCT05239728 · tracked via the Priya Life Science China tracker
Sponsor
Merck Sharp & Dohme LLC
Phase
Phase 3
Started
2022-03-15
Last updated
2026-05-15

Condition(s) studied

Carcinoma, Renal Cell

Investigational drug(s) / intervention(s)

Belzutifan →Pembrolizumab →Placebo

Belzutifan: Three 40 mg tablets given as a single oral 120 mg dose.

Pembrolizumab: 400 mg via IV infusion

Placebo: Oral tablet

Study summary

The purpose of this study is to assess the efficacy and safety of oral belzutifan (MK-6482) plus intravenous (IV) pembrolizumab (MK-3475) compared to placebo plus pembrolizumab, in the adjuvant treatment of Clear Cell Renal Cell Carcinoma (ccRCC) post nephrectomy.

The primary study hypothesis is that belzutifan plus pembrolizumab is superior to placebo plus pembrolizumab with respect to disease-free survival (DFS).

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
The main inclusion and exclusion criteria include but are not limited to the following: Inclusion Criteria: * Has a histologically or cytologically confirmed diagnosis of RCC with clear cell component per American Joint Committee on Cancer (AJCC) (8th Edition), with or without sarcomatoid features * Has intermediate-high risk, high risk, or M1 no evidence of disease (NED) RCC as defined by the following pathological tumor-node metastasis and tumor grading: 1. Intermediate-high risk RCC: pT2, Grade 4 or sarcomatoid, N0, M0; pT3, any grade, N0, M0 2. High risk RCC: pT4, any Grade N0, M0; pT any stage, any Grade, N+, M0 3. 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, ≤2 years from nephrectomy (metachronous) * Has undergone complete resection of the primary tumor (partial or radical nephrectomy) and complete resection of solid, isolated, soft tissue metastatic lesion(s) in M1 NED participants * Must have undergone a nephrectomy and/or metastasectomy ≤12 weeks prior to randomization * Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 within 10 days before randomization. * Male participants must agree to continue contraception at least 7 days after the last dose of belzutifan/placebo * 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 pembrolizumab or at least 30 days after last dose of belzutifan/placebo, whichever occurs last * Has adequate organ function Exclusion Criteria: * Has had a major surgery, other than nephrectomy plus resection of preexisting metastases for M1 NED participants, within 4 weeks prior to randomization * Has a pulse oximeter reading \<92% at rest, requires intermittent supplemental oxygen, or requires chronic supplemental oxygen * Has clinically significant cardiovascular disease within 6 months from first dose of study intervention * Has other clinically significant disorders such as: serious active nonhealing wound/ulcer/bone fracture; requirement for hemodialysis or peritoneal dialysis * Has preexisting brain or bone metastatic lesions * Has received prior systemic therapy for RCC * Has received prior radiotherapy for RCC * Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention; administration of killed vaccines are allowed * Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy * Has a known additional malignancy (other than RCC treated with nephrectomy and/or metastasectomy) that is progressing or has required active treatment within the past 3 years * 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 history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease * Has an active infection, requiring systemic therapy * Has a known history of human immunodeficiency virus (HIV) infection, a known history of Hepatitis B or known active Hepatitis C virus infection * Has had an allogenic tissue/solid organ transplant

Primary outcome measure(s)

Trial sites (285)

FacilityCityRegionStatus
Mayo Clinic in Arizona - Phoenix ( Site 3554) Phoenix Arizona
City of Hope Comprehensive Cancer Center ( Site 3567) Duarte California
Moores Cancer Center-Clinical Trials Office- Genitourinary ( Site 3516) La Jolla California
UCLA Hematology/Oncology - Westwood (Building 200 Suite 140)-Department of Urology/Institute of Uro ( Site 3520) Los Angeles California
University of California, Irvine (UCI) Health - UC Irvine Medical Center ( Site 3518) Orange California
Stanford Cancer Center ( Site 3523) Palo Alto California
University of Colorado Anschutz Medical Campus ( Site 3514) Aurora Colorado
Intermountain Health St. Mary's Regional Hospital ( Site 3562) Grand Junction Colorado
Georgetown University Medical Center ( Site 3534) Washington D.C. District of Columbia
University of Miami Hospital and Clinics, Sylvester Cancer Center-Cancer Research Services ( Site 3517) Miami Florida
Moffitt Cancer Center ( Site 3540) Tampa Florida
Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital-Research ( Site 3515) Marietta Georgia
Parkview Research Center at Parkview Regional Medical Center ( Site 3526) Fort Wayne Indiana
Johns Hopkins Hospital-Sidney Kimmel Comprehensive Cancer Center- GU Oncology ( Site 3549) Baltimore Maryland
Massachusetts General Hospital ( Site 3571) Boston Massachusetts
Beth Israel Deaconess Medical Center-Cancer Clinical Trials Office ( Site 3572) Boston Massachusetts
Dana-Farber Cancer Institute-GU ( Site 3505) Boston Massachusetts
Cancer and Hematology Centers of Western Michigan ( Site 3502) Grand Rapids Michigan
Washington University-Internal Medicine/Oncology ( Site 3531) St Louis Missouri
St. Vincent Frontier Cancer Center-Research ( Site 3506) Billings Montana
Oncology Hematology West, PC dba Nebraska Cancer Specialists ( Site 3550) Omaha Nebraska
Englewood Hospital and Medical Center ( Site 3557) Englewood New Jersey
Rutgers Cancer Institute of New Jersey ( Site 3541) New Brunswick New Jersey
Monter Cancer Center ( Site 3560) Lake Success New York
Icahn School of Medicine at Mount Sinai ( Site 3539) New York New York
Memorial Sloan Kettering Cancer Center ( Site 3568) New York New York
University of Rochester Medical Center ( Site 3528) Rochester New York
The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive C ( Site 3507) Columbus Ohio
MidLantic urology ( Site 3501) Bala-Cynwyd Pennsylvania
Fox Chase Cancer Center-GU Oncology ( Site 3535) Philadelphia Pennsylvania
Sanford Cancer Center ( Site 3551) Sioux Falls South Dakota
The West Clinic, PLLC dba West Cancer Center ( Site 3522) Germantown Tennessee
Urology Associates ( Site 3512) Nashville Tennessee
UT Southwestern Medical Center ( Site 3529) Dallas Texas
University of Texas MD Anderson Cancer Center-Urology ( Site 3569) Houston Texas
Inova Schar Cancer Institute ( Site 3525) Fairfax Virginia
Seattle Cancer Care Alliance-Renal/Melanoma/MCC ( Site 3524) Seattle Washington
Blacktown Hospital ( Site 0002) Blacktown New South Wales
Macquarie University-MQ Health Clinical Trials Unit ( Site 0003) Macquarie University New South Wales
Tamworth Hospital-North West Cancer Centre ( Site 0006) North Tamworth New South Wales

+ 245 more sites — see the full list on the official registry below.

On this site

📄 Keytruda (pembrolizumab) drug profile →

More Merck Sharp & Dohme LLC trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05239728 on ClinicalTrials.gov ↗ ← All trials in China