Clinical trial for Carcinoma, Renal Cell
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?
Belzutifan is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for carcinoma, renal cell.
Also referred to as MK-6482, PT2977.
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
- 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.
- 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
- The main 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...
- 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
- 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...
- 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
See the full eligibility criteria
- The main 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...
- 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Marietta, Georgia, United States
- St Louis, Missouri, United States
- New York, New York, United States
- Germantown, Tennessee, 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
- Macquarie University, New South Wales, Australia
- Woolloongabba, Queensland, Australia
- Melbourne, Victoria, Australia
- Vitória, Espírito Santo, Brazil
- Curitiba, Paraná, Brazil
- Natal, Rio Grande do Norte, Brazil
- Ribeirão Preto, São Paulo, Brazil
- São José do Rio Preto, São Paulo, Brazil
+ 63 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 - 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?
Study sites include Marietta, Georgia, United States; St Louis, Missouri, United States; New York, New York, United States; Germantown, Tennessee, United States; CABA, Buenos Aires, Argentina; Ciudad de Buenos Aires, Buenos Aires, Argentina and 77 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.