Belzutifan plus zanzalintinib versus belzutifan alone for advanced renal cell carcinoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized Phase 3 trial compares belzutifan combined with zanzalintinib to belzutifan plus placebo in people with unresectable, advanced renal cell carcinoma that has a clear-cell component. Eligible participants must have measurable disease and may have received up to three prior systemic therapies, including no more than one prior PD-1/PD-L1 inhibitor. The co-primary goals are to compare overall survival and time without disease worsening (progression-free survival) between the two treatment arms. The multicenter international study is sponsored by Merck Sharp & Dohme with collaboration from Exelixis and is open at sites in countries including Argentina and Australia.

Why it matters

Who can join: the full rules

Inclusion Criteria:

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

* Has a histologically confirmed diagnosis of unresectable, advanced renal cell carcinoma (RCC) with clear cell component (with or without sarcomatoid features) ie, Stage IV RCC per American Joint Committee on Cancer (8th Edition)
* Has measurable disease per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1)
* Has received no more than 3 prior systemic regimens for RCC, including only 1 prior anti-Programmed Cell Death-1/Programmed Cell Death 1 Ligand 1 therapy

Exclusion Criteria:

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

* Has any of the following: a pulse oximeter reading \<92% at rest, requires intermittent supplemental oxygen, or required chronic supplemental oxygen
* Has clinically significant cardiovascular disease within 12 months from first dose of study intervention
* Has deep vein thrombosis within 3 months before randomization unless stable, asymptomatic, and treated with therapeutic anticoagulation for at least 4 weeks before randomization
* Has a left ventricular ejection fraction ≤50% or below the institutional (or local laboratory) normal range as determined by multigated acquisition or echocardiogram
* Has had major surgery within 8 weeks before randomization
* Has current pneumonitis/interstitial lung disease
* Has a history of human immunodeficiency virus infection
* Has Hepatitis B or Hepatitis C virus infection
* Has a known additional malignancy that is progressing or has required active treatment within the past 3 years
* Has a history of solid organ transplant
* Has not adequately recovered from major surgery or has ongoing surgical complications

Where it's running

• City of Hope Comprehensive Cancer Center ( Site 0129)
  Duarte, California, United States Recruiting
• City of Hope Lennar Foundation Cancer Center ( Site 0142)
  Irvine, California, United States Recruiting
• Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital ( Site 0102)
  Marietta, Georgia, United States Recruiting
• University of Louisville, James Graham Brown Cancer Center ( Site 0133)
  Louisville, Kentucky, United States Recruiting
• Norton Women's and Children's Hospital-Norton Cancer Institute - St. Matthews ( Site 0104)
  Louisville, Kentucky, United States Recruiting
• Beth Israel Deaconess Medical Center ( Site 0139)
  Boston, Massachusetts, United States Recruiting

+61 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Toll Free Number
• Email: Trialsites@msd.com
• Phone: 1-888-577-8839

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.