Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UC Davis UCSD
Dates
study started
completion around
Principal Investigator
by Tyler Stewart (ucsd)Mamta Parikh (ucdavis)
Headshot of Tyler Stewart
Tyler Stewart

Description

Summary

This phase II/III trial examines whether patients who have undergone surgical removal of bladder, but require an additional treatment called immunotherapy to help prevent their bladder cancer from coming back, can be identified by a blood test. Many types of tumors tend to lose cells or release different types of cellular products including their DNA which is referred to as circulating tumor DNA (ctDNA) into the bloodstream before changes can be seen on scans. Health care providers can measure the level of ctDNA in blood or other bodily fluids to determine which patients are at higher risk for disease progression or relapse. In this study, a blood test is used to measure ctDNA and see if there is still cancer somewhere in the body after surgery and if giving a treatment will help eliminate the cancer. Immunotherapy with monoclonal antibodies, such as nivolumab and relatlimab, can help the body's immune system to attack the cancer, and can interfere with the ability of tumor cells to grow and spread. This trial may help doctors determine if ctDNA measurement in blood can better identify patients that need additional treatment, if treatment with nivolumab prolongs patients' life and whether the additional immunotherapy treatment with relatlimab extends time without disease progression or prolongs life of bladder cancer patients who have undergone surgical removal of their bladder.

Official Title

MODERN: An Integrated Phase 2/3 and Phase 3 Trial of MRD-Based Optimization of ADjuvant ThErapy in URothelial CaNcer

Details

Keywords

Muscle Invasive Bladder Urothelial Carcinoma, Stage II Bladder Urothelial Carcinoma AJCC v6 and v7, Stage III Bladder Urothelial Carcinoma AJCC v6 and v7, Stage IV Bladder Urothelial Carcinoma AJCC v7, Carcinoma, Transitional Cell Carcinoma, Nivolumab, Relatlimab, Immunoglobulins, Immunoglobulin G, Biospecimen Collection, cfDNA or ctDNA Measurement, Computed Tomography, Magnetic Resonance Imaging, Quality-of-Life Assessment

Eligibility

Locations

Lead Scientists at University of California Health

  • Tyler Stewart (ucsd)
    Assistant Professor Of Clinical, Medicine, Vc-health Sciences-schools. Authored (or co-authored) 39 research publications
  • Mamta Parikh (ucdavis)
    I am a clinical researcher focusing on genitourinary malignancies, with a growing interest in cancer research education.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
National Cancer Institute (NCI)
ID
NCT05987241
Phase
Phase 2/3 research study
Study Type
Interventional
Participants
Expecting 1190 study participants
Last Updated