TAR-200/Cetrelimab vs. chemoradiotherapy in MIBC (Bladder Cancer)
What is the Purpose of this Study?
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.
- 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.
What is the Condition Being Studied?
Muscular Invasive Bladder Cancer (MIBC)
Who Can Participate in this 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
Adults
Participating Institutions
What is Involved?
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.
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
Protocol Number
IRB:
PRO00107531
NCT:
NCT04658862
ClinicalTrials.gov
View on ClinicalTrials.gov