Full Title
MODERN: An Integrated Phase 2/3 and Phase 3 Trial of MRD-Based Optimization of ADjuvant ThErapy in URothelial CaNcer (A032103) (CIRB)Purpose
This study is assessing a blood test that may tell doctors which people need immunotherapy after bladder cancer surgery. Many types of tumors lose cells into the bloodstream and shed their DNA. This circulating tumor DNA (ctDNA) may be found before changes in a tumor can be seen on scans.
Doctors can measure ctDNA to see which people may have a high chance of the bladder cancer coming back. They can monitor ctDNA through a blood test which can detect recurrent cancer, in addition to standard imaging with CT or MRI scans.
Researchers in this study will measure ctDNA to see if there are still cancer cells in the body and determine if immunotherapy may be helpful. Immunotherapy boosts the ability of the immune system to find and kill cancer cells. The immunotherapy drugs used in this study are nivolumab and relatlimab.
Doctors want to learn if nivolumab helps people live longer after bladder cancer surgery. They also want to see if adding relatlimab to treatment slows cancer growth or extends patients’ lives. Nivolumab and relatlimab are both given intravenously (by vein).
Who Can Join
To join this study, there are a few conditions. You must:
- Have had a radical cystectomy (removal of the bladder) as treatment for bladder cancer within 3-12 weeks of starting the study.
- Not have evidence of bladder cancer metastasis (spread).
- Not have received anti-cancer medication or radiation therapy after bladder cancer surgery.
- Be able to walk and do routine activities for more than half the time you are awake.
- Be age 18 or older.
Contact
For more information and to see if you can join this study, please call Dr. David Aggen’s office at 646-422-4679.