Study on Pembrolizumab with Belzutifan and Lenvatinib, or Pembrolizumab/Quavonlimab with Lenvatinib, Compared to Pembrolizumab and Lenvatinib for Advanced Kidney Cancer

Sponsor: Merck Sharp & Dohme LLC

Sponsor score: 40

ClinicalTrials ID:NCT04736706

This clinical trial is testing different combinations of medications to see which works best as a first treatment for advanced clear cell kidney cancer. The study compares three different treatment combinations to find out which one helps patients live longer and keeps the cancer from getting worse.

Patient Parameters

Program Overview

The purpose of this study is to find out if combining pembrolizumab with belzutifan and lenvatinib, or pembrolizumab/quavonlimab with lenvatinib, is more effective than pembrolizumab with lenvatinib alone for treating advanced clear cell kidney cancer. Researchers want to see if these combinations can help patients live longer and prevent the cancer from progressing.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with kidney cancer that has a clear cell component.
  • Have not received any previous treatment for advanced clear cell kidney cancer.
  • Male participants must agree to use birth control or abstain from sex during the study and for at least 7 days after the last dose of belzutifan and lenvatinib.
  • Female participants must not be pregnant or breastfeeding and must use effective birth control or abstain from sex during the study and for a specified time after the last dose of the study drugs.
  • Blood pressure must be well-controlled, with or without medication.
  • Must have good organ function.
  • If receiving bone-strengthening therapy, it must have started at least 2 weeks before joining the study.

Exclusion Criteria

  • Have another cancer that is getting worse or needed treatment in the last 3 years.
  • Had major surgery, except kidney removal, within 4 weeks before starting the study.
  • Have cancer that has spread to the brain or spinal cord.
  • Received radiation therapy within 2 weeks before starting the study.
  • Have low oxygen levels or need oxygen therapy.
  • Have serious heart disease within the last year.
  • Have a history of lung disease.
  • Have fluid around the lungs that causes symptoms, unless stable after treatment.
  • Have abnormal connections between organs or tissues.
  • Have a weakened immune system or are taking medications that suppress the immune system.
  • Have mental health or substance abuse issues that would interfere with the study.
  • Received a live vaccine within 30 days before starting the study.
  • Have an active autoimmune disease needing treatment in the last 2 years.
  • Have a history of lung inflammation needing steroids or current lung inflammation.
  • Have an active infection needing treatment.
  • Have a history of HIV or Hepatitis B.
  • Have tumors affecting major blood vessels.
  • Have had significant bleeding in the last 3 months.
  • Have had a tissue or organ transplant.

Locations

FACILITYZIPCITYSTATE
The University of Alabama at Birmingham ( Site 0010)35294-3300BirminghamAlabama
UC San Diego ( Site 0050)92037La JollaCalifornia
Cedars Sinai Medical Center ( Site 0027)90048Los AngelesCalifornia
University of California Irvine ( Site 0029)92868OrangeCalifornia
UCLA Hematology Oncology Santa Monica ( Site 0048)90404Santa MonicaCalifornia
Hartford Hospital ( Site 0024)06102HartfordConnecticut
Advent Health Hematology & Oncology ( Site 0003)32804OrlandoFlorida
University Cancer & Blood Center, LLC ( Site 0057)30607AthensGeorgia
Emory University Winship Cancer Institute ( Site 0012)30322AtlantaGeorgia
Rush University Medical Center ( Site 0040)60607ChicagoIllinois

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