A Multicenter, Double-blind, Randomized Phase 3 Study to Compare the Efficacy and Safety of Belzutifan (MK-6482) Plus Pembrolizumab (MK-3475) Versus Placebo Plus Pembrolizumab, in the Adjuvant Treatment of Clear Cell Renal Cell Carcinoma (ccRCC) Post Nephrectomy (MK-6482-022)

  • STATUS
    Recruiting
  • End date
    Jan 25, 2030
  • participants needed
    1600
  • sponsor
    Merck Sharp & Dohme LLC
Updated on 28 October 2022
cancer
carcinoma
metastasis
pembrolizumab
primary tumor
kidney tumor
nephrectomy
clear cell renal cell carcinoma

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).

Details
Condition Clear Cell Renal Cell Carcinoma
Treatment Placebo, Pembrolizumab, Belzutifan
Clinical Study IdentifierNCT05239728
SponsorMerck Sharp & Dohme LLC
Last Modified on28 October 2022

Eligibility

Yes No Not Sure

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
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, ≤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
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