Merck LiteSpark-011: Advanced rCC progression after immunotherapy (Renal Cell Carcinoma)
What is the Purpose of this Study?
If you choose to join this study, you will:
- Be assigned to receive either cabozantinib or belzutifan+lenvatinib (both drugs are pills that you will take each day)
- Have blood draws and give urine samples
- Have imaging tests (CT or MRI, and possibly bone or brain scans, depending on where your cancer has spread)
- Answer questionnaires
- Be assigned to receive either cabozantinib or belzutifan+lenvatinib (both drugs are pills that you will take each day)
- Have blood draws and give urine samples
- Have imaging tests (CT or MRI, and possibly bone or brain scans, depending on where your cancer has spread)
- Answer questionnaires
What is the Condition Being Studied?
Advanced or Metastatic Renal Cell Carcinoma (RCC) with a Clear Cell Component
Who Can Participate in this Study?
Adults who:
- Are diagnosed with advanced or metastatic RCC
- Have already received an anti-PD-1/L1 therapy
- Have not received more than 2 prior treatments for their cancer
For more information about who can join this study, please contact the study team at kellie.shobe@duke.edu.
Age Group
Adults
Participating Institutions
What is Involved?
We are doing this study to learn if the study drug combination belzutifan+lenvatinib is a safe and effective treatment for renal cell carcinoma. We want to learn what kind of side effects people have when they are taking belzutifan+lenvatinib compared to cabozantinib (an approved treatment for RCC).
Study Details
Full Title
An Open-label, Randomized, Phase 3 Study of MK-6482 in Combination with 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
Participants with Advanced Renal Cell Carcinoma Who Have Progressed After Prior Anti-PD-1/L1 Therapy
Principal Investigator
Protocol Number
IRB:
PRO00110313
NCT:
NCT04586231
ClinicalTrials.gov
View on ClinicalTrials.gov