Full Title
A Randomized Phase II, Double-Blind, Multicenter Study Evaluating the Efficacy and Safety of Autogene Cevumeran Plus Nivolumab Versus Nivolumab as Adjuvant Therapy in Patients with High-Risk Muscle-Invasive Urothelial CarcinomaPurpose
Researchers want to see if adding autogene cevumeran to nivolumab is better than nivolumab alone to treat urothelial (bladder) cancer. The people in this study have muscle-invasive urothelial cancer (MIUC) that has been removed with surgery.
Autogene cevumeran, a personalized mRNA cancer vaccine, is an immunotherapy made from your tumor tissue and blood samples. The tumor tissue and blood cells are genetically modified (changed) to make autogene cevumeran. This treatment uses proteins to activate and train your immune system to find and kill cancer cells.
If you join this study, you will be randomly assigned to get one of these treatments:
- Autogene cevumeran plus nivolumab
- Nivolumab plus a placebo (inactive drug)
These medications are given intravenously (by vein).
Who Can Join
To join this study, there are a few conditions. You must:
- Have MIUC that has been surgically removed.
- Not have received chemotherapy or radiation therapy after your cancer surgery.
- 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. David Aggen’s office at 646-422-4679.