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.

What is the Condition Being Studied?

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 urologyresearch@duke.edu.

Age Group

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.

Study Details

Full Title
A Phase 3, Multi-center, Randomized Study Evaluating Efficacy of TAR-200 in Combination With Cetrelimab Versus Concurrent Chemoradiotherapy in Participants With Muscle- Invasive Urothelial Carcinoma (MIBC) of the Bladder who are not Receiving Radical Cystectomy
Principal Investigator
Surgical Oncologist
Protocol Number
IRB: PRO00107531
NCT: NCT04658862
Phase III
Enrollment Status
Open for Enrollment
Contact the Duke Recruitment Innovation Center