Alliance A032103: MODERN study for bladder cancer

What is the Purpose of this Study?

We are doing this study to find out if a medical technology called the Signatera blood test can help doctors and patients determine the best course of treatment for bladder cancer after the patient has a radical cystectomy (removal of the bladder and surrounding lymph nodes). The Signatera test is used to detect cancer DNA in the blood before cancer can be seen using imaging (like MRI or CT scans).

What is the Condition Being Studied?

Bladder Cancer

Who Can Participate in the Study?

Adults ages 18+ who:

  • Are diagnosed with urothelial cancer of the bladder
  • Had a radical cystectomy (RC) surgery at least 3 weeks, but no more than 12 weeks, before joining the study
  • Have no evidence of remaining disease after RC surgery
  • Have not had any postoperative/adjuvant systemic therapy or radiation
  • Have never been treated with any PD-1 or PD-L1 axis inhibitors

For more information, contact the study team at nick.jeffries@duke.edu.

Age Group
Adults

What is Involved?

This study wants to find out if a blood test can help doctors make better choices about who should get immunotherapy after bladder cancer surgery and which treatment is the best. DNA is the material inside every cell that tells the cell how to work. Cancer cells often have DNA that looks different from normal DNA. New tests can find bladder cancer DNA in the blood, which may show that cancer cells are still in the body. Researchers want to see if this information can help guide treatment after the bladder is removed.

Study Details

Full Title
A032103: MODERN: An Integrated Phase 2/3 and Phase 3 Trial of MRD-Based Optimization of Adjuvant Therapy in Urothelial Cancer
Principal Investigator
Assistant Professor of Medicine
Protocol Number
IRB: PRO00116700
NCT: NCT05987241
Phase
Phase II/III
ClinicalTrials.gov
Enrollment Status
OPEN TO ACCRUAL