Carcinoma, Renal Cell study: Belzutifan vs Zanzalintinib
Official title A Clinical Study of Belzutifan (MK-6482) and Zanzalintinib in People With Renal Cell Carcinoma (RCC) (LITESPARK-034/LS-034/MK-6482-034)
ClinicalTrials.gov ID: NCT07489495
What this study is testing
What is Belzutifan?
an investigational oral tablet being studied as a potential treatment for advanced renal cell carcinoma is designed to block the HIF‑2α protein, which helps cancer cells grow and survive
Also referred to as MK-6482, PT2977, Welireg.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is testing whether adding zanzalintinib to belzutifan works better than belzutifan alone. It looks at how long people live and if the cancer stays under control.
- Who it's for
- You may be able to join if you have advanced kidney cancer.
- What's involved
- You would take belzutifan every day. You would also take zanzalintinib or a pretend pill with no medicine.
- Time commitment
- The study lasts until the cancer grows or you stop taking the medicine.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Has a histologically confirmed diagnosis of unresectable, advanced renal cell carcinoma (RCC) with clear cell component (with or without sarcomatoid...
- 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...
You likely can't join if
- 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...
- Has a left ventricular ejection fraction ≤50% or below the institutional (or local laboratory) normal range as determined by multigated acquisition...
- Has had major surgery within 8 weeks before randomization
- Has current pneumonitis/interstitial lung disease
See the full eligibility criteria
- 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...
- 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
- 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
The study team makes the final eligibility decision.
Where it is enrolling
- Duarte, California, United States
- Irvine, California, United States
- Marietta, Georgia, United States
- Louisville, Kentucky, United States
- Boston, Massachusetts, United States
- Grand Rapids, Michigan, United States
- St Louis, Missouri, United States
- Hackensack, New Jersey, United States
- Morristown, New Jersey, United States
- New York, New York, United States
- Germantown, Tennessee, United States
- Dallas, Texas, United States
- CABA, Buenos Aires, Argentina
- Ciudad de Buenos Aires, Buenos Aires, Argentina
- Mar del Plata, Buenos Aires, Argentina
- Río Cuarto, Córdoba Province, Argentina
- Rosario, Santa Fe Province, Argentina
- CABA, Argentina
- La Rioja, Argentina
- San Juan, Argentina
+ 76 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Duarte, California, United States; Irvine, California, United States; Marietta, Georgia, United States; Louisville, Kentucky, United States; Boston, Massachusetts, United States; Grand Rapids, Michigan, United States and 90 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.