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Phase 3 Study of Belzutifan in Combination With Lenvatinib Versus Cabozantinib for Treatment of RCC
EU CTIS ID: 2024-510620-39-00
What this study is testing
1. To compare belzutifan+lenvatinib to cabozantinib with respect to PFS per Response Criteria in Solid Tumors (RECIST) 1.1 as assessed by blinded independent central review (BICR). 2. To compare belzutifan+lenvatinib to cabozantinib with respect to OS.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Unresectable, locally advanced or metastatic clear cell renal cell carcinoma (RCC).
- Adequate organ function.
- Disease progression on or after an anti-programmed cell death-1/ligand 1 (PD-1/L1) therapy as either first or second-line treatment for locally advanced/metastatic RCC or as adjuvant treatment or neoadjuvant/adjuvant with progression on or within 6 months of last dose.
- Measurable disease per RECIST 1.1 criteria as assessed by local study investigator.
- Karnofsky performance status (KPS) score of at least 70% assessed within 10 days before randomization.
- Received no more than 2 prior systemic regimens including: one anti-PD-1/L1 containing adjuvant or neoadjuvant/adjuvant regimens with progression on or within 6 months from the last dose of that regimen OR one or 2 regimens for locoregional/advanced disease
You likely can't join if
- A pulse oximeter reading <92% at rest, requires intermittent supplemental oxygen, or requires chronic supplemental oxygen.
- History of solid organ transplantation.
- Known psychiatric or substance abuse disorder that would interfere with cooperation with the requirements of the study.
- Unable to swallow orally administered medication or has a gastrointestinal disorder affecting absorption (e.g., gastrectomy, partial bowel obstruction, malabsorption).
- Known hypersensitivity or allergy to the active pharmaceutical ingredients or any component of the study intervention formulations.
- Received colony-stimulating factors [eg, granulocyte colony-stimulating factor (G-CSF), granulocyte macrophage colony-stimulating factor (GMCSF) or recombinant erythropoietin (EPO)] within 28 days before randomization.
See the full eligibility criteria
Who can join
- Unresectable, locally advanced or metastatic clear cell renal cell carcinoma (RCC).
- Adequate organ function.
- Disease progression on or after an anti-programmed cell death-1/ligand 1 (PD-1/L1) therapy as either first or second-line treatment for locally advanced/metastatic RCC or as adjuvant treatment or neoadjuvant/adjuvant with progression on or within 6 months of last dose.
- Measurable disease per RECIST 1.1 criteria as assessed by local study investigator.
- Karnofsky performance status (KPS) score of at least 70% assessed within 10 days before randomization.
- Received no more than 2 prior systemic regimens including: one anti-PD-1/L1 containing adjuvant or neoadjuvant/adjuvant regimens with progression on or within 6 months from the last dose of that regimen OR one or 2 regimens for locoregional/advanced disease
- Received only 1 prior antiPD-1/L1 therapy for adjuvant, neoadjuvant/adjuvant or locally advanced/metastatic RCC.
- A male participant is eligible to participate if he is abstinent from heterosexual intercourse or agrees to use contraception during the intervention period and for at least 7 days after the last dose of belzutifan or lenvatinib in the belzutifan+lenvatinib arm, whichever occurs last, and 23 days after the last dose of cabozantinib.
- A female participant is eligible to participate if they are not pregnant, not breastfeeding, and at least 1 of the following conditions applies: Not a woman of childbearing potential (WOCBP) or a WOCBP who agrees to follow the contraceptive guidance during the intervention period and for at least 30 days after the last dose of study intervention in the belzutifan+ lenvatinib arm, or 120 days after the last dose of study intervention in the cabozantinib arm.
- Adequately controlled blood pressure.
What rules you out
- A pulse oximeter reading <92% at rest, requires intermittent supplemental oxygen, or requires chronic supplemental oxygen.
- History of solid organ transplantation.
- Known psychiatric or substance abuse disorder that would interfere with cooperation with the requirements of the study.
- Unable to swallow orally administered medication or has a gastrointestinal disorder affecting absorption (e.g., gastrectomy, partial bowel obstruction, malabsorption).
- Known hypersensitivity or allergy to the active pharmaceutical ingredients or any component of the study intervention formulations.
- Received colony-stimulating factors [eg, granulocyte colony-stimulating factor (G-CSF), granulocyte macrophage colony-stimulating factor (GMCSF) or recombinant erythropoietin (EPO)] within 28 days before randomization.
- Prior treatment with belzutifan or another hypoxia-inducible factor (HIF)-2α inhibitor.
- Prior treatment with lenvatinib.
- Prior treatment with cabozantinib.
- Currently participating in a study of an investigational agent or using an investigational device.
- Active infection requiring systemic therapy.
- Known additional malignancy that is progressing or has required active treatment within the past 3 years except for basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (eg, breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy.
- History of human immunodeficiency virus (HIV) infection.
- History of hepatitis B or known active hepatitis C infection.
- Known central nervous system (CNS) metastases and/or carcinomatous meningitis.
- Clinically significant cardiac disease within 6 months of first dose of study intervention.
- Prolongation of QTc interval to >480 ms.
- Symptomatic pleural effusion (e.g., cough, dyspnea, pleuritic chest pain) that is not clinically stable.
- Pre-existing ≥Grade 3 gastrointestinal or nongastrointestinal fistula.
- Moderate to severe hepatic impairment.
- History of significant bleeding within 3 months before randomization.
The study team makes the final eligibility decision.
Where it's taking place
- Canada
- Brazil
- Chile
- United Kingdom
- Japan
- Switzerland
- United States
- Russian Federation
- Korea, Republic of
- Argentina
- Colombia
- Australia
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, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Canada; Brazil; Chile; United Kingdom; Japan; Switzerland and 6 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 EU CTIS; the study team decides eligibility.