A phase 2, randomized, open-label study of gemcitabine/cisplatin plus cemiplimab (REGN2810, anti-PD-1) with or without fianlimab (REGN3767, anti-LAG-3) for organ preservation in patients with localized muscle-invasive bladder cancer (NeoSTOP-IT)

This study is for patients with a localized bladder cancer called muscle-invasive bladder cancer. Muscle-invasive bladder cancer is usually treated with a combination of chemotherapy and surgery. This surgery removes the entire bladder, which changes how they urinate for the rest of their life. Some patients will have a small opening in the skin of their abdomen where urine will leave their body and go into a bag (this is called an ileal conduit). The goal of this study is to see if we can find ways of sparing patients from having to undergo this surgery. In this study, they will first receive chemotherapy for 4 cycles (each cycle is 3 weeks) to shrink the tumor. In addition to chemotherapy, you will be randomly assigned to receive one or two immunotherapy study drugs: either cemiplimab alone or cemiplimab and fianlimab. The goal is to shrink your tumor more effectively with these additional treatments. The study will enroll 36 patients. 24 will be randomized received both immunotherapy study drugs (cemiplimab and fianlimab) while 12 will be randomized ( like flipping a coin) to receive cemiplimab alone.

Are you Eligible? (Inclusion Criteria)

• Be willing and able to provide written informed consent for the trial. 2. Be age ≥18 years of age on day of signing informed consent. 3. You have been diagnosed with muscle-invasive bladder cancer, which has been confirmed by examining tissue under a microscope. This type of cancer has grown into the muscle layer of the bladder wall