A Clinical Study of Belzutifan (MK-6482) and Zanzalintinib in People With Renal Cell Carcinoma (RCC) (LITESPARK-034/LS-034/MK-6482-034)

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A Clinical Study of Belzutifan (MK-6482) and Zanzalintinib in People With Renal Cell Carcinoma (RCC) (LITESPARK-034/LS-034/MK-6482-034)

Status
Active
Cancer Type
Kidney Cancer
Unknown Primary
Trial Phase
Phase III
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCT ID
NCT07489495
Protocol IDs
6482-034 (primary)
NCI-2026-05944
2024-516993-31-00
LITESPARK-034
LS-034
MK-6482-034
U1111-1311-4692
Study Sponsor
Merck Sharp and Dohme LLC

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.

Eligibility

  1. 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

Treatment Sites in Georgia

Northwest Georgia Oncology Centers - Cobb Hospital (Hiram)


144 Bill Carruth Parkway
Suite 3100
Hiram, GA 30141
770-281-5131
www.ngoc.com

Northwest Georgia Oncology Centers - Douglasville


6002 Professional Parkway
Suite 140
Douglasville, GA 30134
770-281-5101
www.ngoc.com

Northwest Georgia Oncology Centers - Tanner Medical Center Villa Rica


157 Clinic Avenue
Suite 202
Carrollton, GA 30117
770-281-5101
www.ngoc.com

Northwest Georgia Oncology Centers (NGOC) - Cobb Hospital (Marietta)


340 Kennestone Hospital Blvd.
Suite 100
Marietta, GA 30060
770-281-5101


**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.