Clinical Trial TitleAn Open-label, Randomized, Phase 3 Study of MK-6482 in Combinationwith Lenvatinib (MK-7902) vs Cabozantinib for Second-line or Third-line Treatment in Participants with Advanced Renal Cell Carcinoma Who Have Progressed After Prior Anti- PD-1/L1 Therapy
National Clinical Trial Number:NCT04586231
Clinical Trial Protocol Description:
This study will compare the efficacy and safety of belzutifan + lenvatinib versus cabozantinib in participants with advanced renal cell carcinoma (RCC) with clear cell component after prior therapy.
Clinical Trial Eligibility Criteria:
In order to participate you must meet the following criteria:
- Have unresectable, locally advanced or metastatic clear cell renal cell carcinoma (RCC).
- Have disease progression on or after having received systemic treatment with anti-programmed cell death-1/ligand 1 (PD-1/L1) for locally advanced or metastatic RCC.
- Have measurable disease per RECIST 1.1 criteria as assessed by local study investigator.
- Have Karnofsky performance status (KPS) score of at least 70% assessed within 10 days before randomization.
- Can submit an archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated.
You will be excluded from the study if any of the following criteria apply to you:
- Have hypoxia (pulse oximeter reading <92% at rest), require intermittent supplemental oxygen, or require chronic supplemental oxygen.
- Have 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.
- Have known central nervous system (CNS) metastases and/or carcinomatous meningitis.
- Have clinically significant cardiac disease within 6 months of first dose of study intervention.
This is a partial list of eligibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via email, please include the title of the study in your message.
Clinical Trial Investigator
Alan Tan, MD
RUSH University Medical Center
1620 W Harrison St
Chicago, IL 60612