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Recruitment on holdLast updated: 2 February 2024

MK-6482-022: This phase III study is evaluating how safe and effective an oral cancer drug (belzutifan), compared with a placebo, is in combination with immunotherapy (pembrolizumab) in people with kidney cancer who have had surgeryA 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)

Clinical summary

Summary

Eligible participants will be randomly allocated to either the Experimental Arm or the Active Comparator Arm. In the Experimental Arm, participants will receive belzutifan (120mg) orally, once daily, in combination with pembrolizumab (400mg) administered via intravenous infusion (IV) once every 6 weeks, for approximately 54 weeks. In the Active Comparator Arm, participants will receive a daily oral placebo, in combination with pembrolizumab (400mg) via IV once every 6 weeks for approximately to 54 weeks.

Conditions

This trial is treating patients with renal cell carcinoma.

Cancer

Urinary System Cancers Genitourinary

Age

People18+

Phase

III

Trial Acronym

MK-6482-022

More information

Trial Identifiers

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Trial sponsor

Merck

Scientific Title

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)

Eligibility

Inclusion

The main inclusion and exclusion criteria include but are not limited to the following:

  • 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

  • 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

Inclusion

  • You are able to swallow medication by mouth.
  • You have had a certain type of treatment or surgical procedure.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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