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

Purpose

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.

Condition

  • Carcinoma, Renal Cell

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Triple (Participant, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Belzutifan + Zanzalintinib
Participants will receive 120 mg belzutifan orally and 60 mg zanzalintinib once daily for approximately 24 months.
  • Drug: Belzutifan
    Tablet for oral administration.
    Other names:
    • MK-6482
    • PT2977
    • WELIREG
  • Drug: Zanzalintinib
    Tablet for oral administration.
    Other names:
    • XL092
Active Comparator
Belzutifan + Placebo
Participants will receive 120 mg belzutifan orally and zanzalintinib-matching placebo once daily for approximately 24 months.
  • Drug: Belzutifan
    Tablet for oral administration.
    Other names:
    • MK-6482
    • PT2977
    • WELIREG
  • Drug: Placebo
    Zanzalintinib-matching placebo tablet for oral administration.

Recruiting Locations

Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital ( Site 0102)
Marietta, Georgia 30060
Contact:
Study Coordinator
770-281-5124

The West Clinic, P.C. ( Site 0115)
Germantown, Tennessee 38138
Contact:
Study Coordinator
901-683-0055

More Details

Status
Recruiting
Sponsor
Merck Sharp & Dohme LLC

Study Contact

Toll Free Number
1-888-577-8839
Trialsites@msd.com