MSD MK 6482-011
An Open-label, Randomized, Phase 3 Study of MK-6482 in Combination with Lenvatinib (MK-7902) vs Cabozantinib for Treatment in Participants with Advanced Renal Cell Carcinoma Who Have Progressed After Prior Anti-PD-1/L1 Therapy
- Unresectable, locally advanced or metastatic clear cell renal cell carcinoma (RCC).
- Disease progression on or after an antiPD-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.
- 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.
- Adequate organ function.
- 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.
- History of solid organ transplantation.
- Prior treatment with belzutifan or another hypoxia-inducible factor (HIF)-2α inhibitor.
- Prior treatment with lenvatinib.
- Prior treatment with cabozantinib.
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.
The primary hypothesis is that belzutifan + lenvatinib is superior to cabozantinib in terms of progression-free survival or overall survival.
For more information regarding this clinical trial click here.