Full Title
A Pilot Phase II Study of Neoadjuvant Cemiplimab + Fianlimab in Patients with Locally Advanced Clear Cell Renal Cell Carcinoma Undergoing NephrectomyPurpose
Researchers want to see if it is practical to give immunotherapy before kidney cancer surgery. The people in this study have no evidence of cancer spread in other parts of their body. Researchers also want to see if this treatment causes any delays in surgery. Immunotherapy is treatment that boosts the body’s natural defenses to fight cancer.
The patients in this study have large kidney tumors caused by clear cell renal cell carcinoma. This will have to be confirmed with a needle biopsy of the kidney tumor. Patients then receive immunotherapy for several weeks, followed by nephrectomy (surgery to remove a kidney).
If you join this study, you will get the immunotherapy drugs cemiplimab and fianlimab before nephrectomy. It is currently not standard care to give immunotherapy before operations; patients typically go straight to surgery.
The thought behind this clinical trial is that this treatment may work best before surgery. This is when the cancer is still present and can be targeted by immune cells. These immune effects may make for an easier surgery and could prevent the cancer from coming back. Cemiplimab and fianlimab are both given intravenously (by vein).
Who Can Join
To join this study, there are a few conditions. You must:
- Have a kidney tumor that will be removed by an expert surgeon at Memorial Sloan Kettering Cancer Center.
- Have no imaging findings suggesting that cancer has spread to other parts of your body.
- Undergo a needle biopsy as part of this clinical trial to confirm the type of kidney cancer (clear cell renal cell carcinoma).
- Not have received prior treatment for this cancer.
- Not have needed immune suppressive medication for any health problems.
- Be well enough to walk and take care of yourself. You must be able to do activities such as office work or light housework.
- Be age 18 or older.
Contact
For more information or to see if you can join this study, please call Dr. Martin Voss’ office at 646-888-4721.