Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Irvine, California and other locations
Dates
study started
study ends around
Principal Investigator
by Nataliya Mar

Description

Summary

Researchers are looking for new ways to treat advanced renal cell carcinoma (RCC).

A standard (usual) treatment for certain people with RCC is belzutifan (a study medicine), which is a targeted therapy. Targeted therapy is a treatment that works to control how specific types of cancer cells grow and spread. Researchers want to learn if adding another targeted therapy called zanzalintinib (another study medicine) can treat more people with advanced RCC than belzutifan alone.

The goal of this study is to learn if people who receive belzutifan and zanzalintinib live longer overall and without the cancer getting worse compared to people who receive belzutifan and placebo.

Official Title

A Phase 3, Randomized, Double-blind, Study of Belzutifan + Zanzalintinib Versus Belzutifan + Placebo in Participants With Advanced RCC Who Have Progressed on or After Both PD-1/L1 and VEGF-TKI Therapies in Sequence or in Combination (LITESPARK-034)

Keywords

Carcinoma, Renal Cell, Renal Cell Carcinoma, belzutifan, Zanzalintinib, Belzutifan + Zanzalintinib

Eligibility

You can join if…

Open to people ages 18 years and up

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

You CAN'T join if...

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

Locations

  • City of Hope Lennar Foundation Cancer Center ( Site 0142) accepting new patients
    Irvine California 92618 United States
  • City of Hope Comprehensive Cancer Center ( Site 0129) accepting new patients
    Duarte California 91010 United States

Lead Scientist at UC Irvine

  • Nataliya Mar
    Associate Clinical Professor, Medicine, School of Medicine. Authored (or co-authored) 45 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Merck Sharp & Dohme LLC
Links
Merck Clinical Trials Information
ID
NCT07489495
Phase
Phase 3 research study
Study Type
Interventional
Participants
Expecting 758 study participants
Last Updated