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New treatment option for Renal Cell Carcinoma
Official title Substudy 03C: A Study of Combination Therapies in Participants With Renal Cell Carcinoma With Recurrent Disease During or After Anti-PD-(L)1 Therapy (MK-3475-03C/KEYMAKER-U03)
ClinicalTrials.gov ID: NCT07049926
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 renal cell carcinoma.
Also referred to as WELIREG®, MK-6482.
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
- Substudy 03C is part of a larger research study that is testing experimental treatments for renal cell carcinoma (RCC). The larger study is the umbrella study (U03).
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 120
You may be able to join if
- The main include but are not limited to the following:
- Has a histologically confirmed diagnosis of unresectable locally advanced/metastatic renal cell carcinoma (RCC) with clear cell component
- Has received no other prior systemic therapy for treatment of advanced/metastatic clear cell renal cell carcinoma (ccRCC) except for adjuvant...
- Has disease recurrence during adjuvant anti- PD-(L)1 therapy or ≤24 months following the last dose of adjuvant anti-PD-(L)1 therapy
- Is able to swallow oral medication
You likely can't join if
- include but are not limited to the following:
- Has clinically significant hematuria, hematemesis, or hemoptysis of (\>2.5 mL) of red blood, or other history of significant bleeding
- Has clinically significant cardiovascular disease within 12 months from first dose of study intervention
- Has deep vein thrombosis within 3 months before allocation/randomization unless stable, asymptomatic, and treated with therapeutic anticoagulation...
- Has history of idiopathic pulmonary fibrosis, organizing pneumonia, or evidence of active pneumonitis
- Has serious wound, ulcer or bone fracture or has had major surgery within 8 weeks before first dose of study intervention
See the full eligibility criteria
- The main include but are not limited to the following:
- Has a histologically confirmed diagnosis of unresectable locally advanced/metastatic renal cell carcinoma (RCC) with clear cell component
- Has received no other prior systemic therapy for treatment of advanced/metastatic clear cell renal cell carcinoma (ccRCC) except for adjuvant programmed cell death ligand 1 (PD-(L)1) therapy
- Has disease recurrence during adjuvant anti- PD-(L)1 therapy or ≤24 months following the last dose of adjuvant anti-PD-(L)1 therapy
- Is able to swallow oral medication
- Submits an archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated
- Participants receiving bone resorptive therapy (must have therapy initiated at least 2 weeks before allocation/randomization)
- Has adequately controlled blood pressure (BP) with or without antihypertensive medications, defined as BP ≤140/90 mm Hg with no change in antihypertensive medications within 1 week before allocation/randomization
- Has adequate organ function The main
- include but are not limited to the following:
- Has clinically significant hematuria, hematemesis, or hemoptysis of (\>2.5 mL) of red blood, or other history of significant bleeding
- Has clinically significant cardiovascular disease within 12 months from first dose of study intervention
- Has deep vein thrombosis within 3 months before allocation/randomization unless stable, asymptomatic, and treated with therapeutic anticoagulation for at least 4 weeks before allocation/randomization
- Has history of idiopathic pulmonary fibrosis, organizing pneumonia, or evidence of active pneumonitis
- Has serious wound, ulcer or bone fracture or has had major surgery within 8 weeks before first dose of study intervention
- Has symptomatic pleural effusion (for example cough, dyspnea, pleuritic chest pain), ascites, or pericardial fluid requiring drainage in the last 4 weeks before allocation/randomization
- Has gastrointestinal (GI) disorders, including those associated with a high risk of perforation or fistula formation
- Has malabsorption due to prior GI surgery or GI disease
- Has moderate to severe hepatic impairment
- Has received colony-stimulating factors within 28 days prior to intervention allocation/randomization
- Has received prior radiotherapy within 2 weeks of start of study intervention, or has radiation-related toxicities, requiring corticosteroids
- Is currently receiving strong inhibitors of cytochrome P450 3A4 (CYP3A4) that cannot be discontinued for the duration of the study
- Has received a live or live attenuated vaccine within 30 days before the first dose of study intervention
- Is currently receiving anticoagulants or platelet inhibitors that cannot be discontinued for the duration of the study
- Have been previously allocated/assigned by chance to study intervention in any sub study of protocol MK-3475-U03
- Has a known additional malignancy that is progressing or has required active treatment within the past 3 years
- Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
- Has radiographic evidence of encasement or invasion of a major blood vessel, or of intratumoral cavitation
- Has active autoimmune disease that has required systemic treatment in the past 2 years
- Has an active infection requiring systemic therapy
- Has history of human immunodeficiency virus (HIV) infection
- Has hepatitis B or hepatitis C virus infection
The study team makes the final eligibility decision.
Where it's taking place
- San Francisco, California, United States
- Mineola, New York, United States
- New York, New York, United States
- Durham, North Carolina, United States
- Pittsburgh, Pennsylvania, United States
- Nashville, Tennessee, United States
- Santiago, Region M. de Santiago, Chile
- Strasbourg, Bas-Rhin, France
- Toulouse, Haute-Garonne, France
- Rennes, Ille-et-Vilaine, France
- Vandœuvre-lès-Nancy, Meurthe-et-Moselle, France
- Villejuif, Île-de-France Region, France
- Haifa, Israel
- Petah Tikva, Israel
- Ramat Gan, Israel
- Tel Aviv, Israel
- Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland
- Gdansk, Pomeranian Voivodeship, Poland
- Seoul, South Korea
- Madrid, Madrid, Comunidad de, Spain
+ 6 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 to 120 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include San Francisco, California, United States; Mineola, New York, United States; New York, New York, United States; Durham, North Carolina, United States; Pittsburgh, Pennsylvania, United States; Nashville, Tennessee, United States and 20 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.