TAR-200/Cetrelimab vs. chemoradiotherapy in MIBC (Bladder Cancer) - Clinical Trial
What is the Purpose of this Study?
We are doing this study to find out if an investigational drug called TAR-200 (the study drug) is safe and effective when it is given in combination with cetrelimab to patients with MIBC. We want to compare this study treatment to chemoradiotherapy and see which option has better outcomes.
Muscular Invasive Bladder Cancer (MIBC)
Who Can Participate in the Study?
Adults ages 18+ who:
- Are diagnosed with MIBC
- Are not pregnant and willing to use contraception during the study
- Do not have liver, kidney, thyroid, or bone marrow disease
For more information about who can join this study, please contact the study team at firstname.lastname@example.org.
What is Involved?
If you choose to join this study, you will be randomly assigned (like a coin flip) to one of the following groups:
- Group 1: You will get the study drug and also receive infusions of cetrelimab. This study regimen will last up to 3 years.
- Group 2: You will get emcitabine or cisplatin (per study doctor recommendation) in combination with radiation therapy. This study regimen will last up to 6.5 weeks.
All participants will:
- Have blood and urine tests
- Have tumor samples taken
- Have physical exams
- Have images taken (MRI or CT scans)
- Answer Questionnaires
- Have follow-up visits after the study regimen is stopped
Participation in this study lasts 3-to-5 years depending on your group assignment.