Randomized Combination Therapy Study for Treatment of Kidney Cancer

National Clinical Trial Number:

NCT04736706

Contact Information

Clinical Trial Protocol Description:

Clinical Trial Title

An Open-label, Randomized Phase 3 Study to Evaluate Efficacy and Safety of Pembrolizumab (MK-3475) in Combination with Belzutifan (MK-6482) and Lenvatinib (MK-7902), or MK-1308A in Combination with Lenvatinib, versus Pembrolizumab and Lenvatinib, as First-line Treatment in Participants with Advanced Clear Cell Renal Cell Carcinoma (ccRCC)

The goal of this study is to evaluate the efficacy and safety of pembrolizumab plus belzutifan plus lenvatinib or pembrolizumab/quavonlimab plus lenvatinib versus pembrolizumab plus lenvatinib as first-line treatment in participants with advanced clear cell renal cell carcinoma (ccRCC).

Clinical Trial Eligibility Criteria:

In order to participate you must meet the following criteria:

  • Has histologically confirmed diagnosis of RCC with clear cell component
  • Has received no prior systemic therapy for advanced ccRCC
  • Has adequately controlled blood pressure with or without antihypertensive medications
  • Has adequate organ function
  • Participants receiving bone resorptive therapy must have therapy initiated at least 2 weeks prior to randomization/allocation

You will be excluded from the study if any of the following criteria apply to you:

  • Has a known additional malignancy that is progressing or has required active treatment within the past 3 years
  • Has had major surgery, other than nephrectomy within 4 weeks prior to randomization
  • Has known central nervous system (CNS) metastases and/or carcinomatous meningitis
  • Has received prior radiotherapy within 2 weeks prior to first dose of study intervention

This is a partial list of inclusion and exclusion criteria.

Study Details

Clinical Trial Investigator

Alan Tan, MD

Contact Information

Pamela Sroka

Clinical Trial Location

Rush University Cancer Center

Location

Rush University Cancer Center

1725 W Harrison St
Professional Building - Suite 1010
Chicago, IL 60612

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