Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder, Kidney, Ureter, and Urethra for Urothelial Cancer Treatment, MODERN Study

Summary

This phase II/III trial examines whether patients who have undergone surgical removal of bladder, kidney, ureter or urethra, but require an additional treatment called immunotherapy to help prevent their urinary tract (urothelial) 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 urothelial cancer patients who have undergone surgical removal of their bladder, kidney, ureter or urethra.

Conditions

• Muscle Invasive Bladder Urothelial Carcinoma
• Muscle Invasive Renal Pelvis Urothelial Carcinoma
• Muscle Invasive Ureter Urothelial Carcinoma
• Muscle Invasive Urethral 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

Interventions

PROCEDURE

Biospecimen Collection

Undergo collection of tissue and blood

OTHER

cfDNA or ctDNA Measurement

Undergo ctDNA surveillance

PROCEDURE

Computed Tomography

Undergo CT

PROCEDURE

Cystoscopy

Undergo cystoscopy

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

BIOLOGICAL

Nivolumab

Given IV

OTHER

Questionnaire Administration

Ancillary studies

BIOLOGICAL

Relatlimab

Given IV

Sponsors & Collaborators

• National Cancer Institute (NCI)

  lead NIH

Principal Investigators

• Matthew D Galsky · Alliance for Clinical Trials in Oncology

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-02-02

Primary Completion

2030-09-02

Completion

2030-09-02

FDA Drug

Yes

Countries

• United States
• Canada

Study Locations