Full Title
A Phase 1b/2 Study of Immune and Targeted Combination Therapies in Participants with RCC (KEYMAKER-U03)Purpose
The purpose of this study is to assess the safety and effectiveness of different combinations of drugs to treat advanced clear cell renal cell carcinoma, a type of kidney cancer, in patients who have not received any prior treatment or who have recently developed worsening disease while receiving immunotherapy that targets the PD-1/PD-L1 proteins.
- Patients who have not previously received treatment for their advanced cancer will be randomly assigned to receive pembrolizumab immunotherapy and lenvatinib alone or in combination with MK-1308 (quavonlimab, an anti-CTLA-4 immunotherapy), MK-4280 (favezelimab, an anti-LAG3 immunotherapy), or MK-6482 (belzutifan, an anti-HIF2).
- Patients who were previously treated with immunotherapy will be randomly assigned to receive pembrolizumab with MK-1308, MK-4280, MK-4830, or MK-6482; lenvatinib with MK-6482; or pembrolizumab with lenvatinib.
The combination of these therapies may increase the immune system’s activity against cancer cells. Lenvatinib and MK-6482 are taken orally (by mouth) and the other medications are given intravenously (by vein).
Contact
For more information and to inquire about eligibility for this study, please contact Dr. Robert Motzer at 646-888-4722.
Protocol
21-148
Phase
Phase I/II (phases 1 and 2 combined)
Disease Status
Newly Diagnosed & Relapsed/Refractory
Investigator
Co-Investigators
Diseases
Locations
ClinicalTrials.gov ID
NCT04626518
ClinicalTrials.gov