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NCT05987241 · ClinicalTrials.gov registry record · Phase 2
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
A Phase 2 study of Muscle Invasive Bladder Urothelial Carcinoma and Stage IV Bladder Urothelial Carcinoma AJCC v7, sponsored by National Cancer Institute (NCI).
- Recruiting
- Registry status
- Phase 2
- Development phase
- 992
- Enrollment target
- 20
- Study locations
NCT05987241: Recruiting Phase 2 study of Muscle Invasive Bladder Urothelial Carcinoma and Stage IV Bladder Urothelial Carcinoma AJCC v7, sponsored by National Cancer Institute (NCI).
NCT05987241 is a Phase 2 study of Muscle Invasive Bladder Urothelial Carcinoma and Stage IV Bladder Urothelial Carcinoma AJCC v7 that is actively recruiting participants, run by National Cancer Institute (NCI). The registered enrollment target is 992 participants, above the 417-participant average among 5 other Muscle Invasive Bladder Urothelial Carcinoma trials with a reported enrollment target (138% higher). The trial reports 20 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05987241, a Phase 2 study of Muscle Invasive Bladder Urothelial Carcinoma and Stage IV Bladder Urothelial Carcinoma AJCC v7, is actively recruiting participants, sponsored by National Cancer Institute (NCI).
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 992 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
Will be determined for each treatment arm as the number of patients who are ctDNA(-) after 12 weeks of treatment divided by the total number of patients on the treatment arm. Patients who do not have a 12-week ctDNA result will be deemed to be ctDNA(+). The comparison of the proportions of patients who are ctDNA(-) after 12 weeks of treatment between the two arms will be performed with a chi-square test.
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Computed Tomography
- PROCEDURE Magnetic Resonance Imaging
- PROCEDURE Cystoscopy
- OTHER cfDNA or ctDNA Measurement
Study Locations (20)
California
- Kaiser Permanente-Anaheim - Anaheim
- Kaiser Permanente-Baldwin Park - Baldwin Park
- Kaiser Permanente-Bellflower - Bellflower
- Kaiser Permanente Dublin - Dublin
- Kaiser Permanente-Fontana - Fontana
- Kaiser Permanente-Fremont - Fremont
- Kaiser Permanente Fresno Orchard Plaza - Fresno
- Kaiser Permanente-Fresno - Fresno
- Kaiser Permanente South Bay - Harbor City
- Kaiser Permanente-Irvine - Irvine
- UC San Diego Moores Cancer Center - La Jolla
- Keck Medicine of USC Koreatown - Los Angeles
Arizona
- Cancer Center at Saint Joseph's - Phoenix
- Mayo Clinic Hospital in Arizona - Phoenix
- University of Arizona Cancer Center-Orange Grove Campus - Tucson
- Banner University Medical Center - Tucson - Tucson
- University of Arizona Cancer Center-North Campus - Tucson
Arkansas
- Highlands Oncology Group - Fayetteville - Fayetteville
- Highlands Oncology Group - Rogers - Rogers
- Highlands Oncology Group - Springdale
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 992 participants |
| Start Date | 2024-02-02 |
| Est. Completion | 2030-09-02 |
| Phase | Phase 2 |
What NCT05987241 shows while recruiting
NCT05987241 is an interventional study that assigns participants to a tested intervention. The registered 992 participants enrollment target is mid-sized for trials with a published cap, above the 417-participant average among 5 other Muscle Invasive Bladder Urothelial Carcinoma trials with a reported enrollment target (138% higher).
The record links to 7 conditions, with Muscle Invasive Bladder Urothelial Carcinoma appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT05987241 names 20 study sites across 3 states, led by California, Arizona, Arkansas.
Frequently Asked Questions
What is clinical trial NCT05987241 about?
NCT05987241 is a clinical study titled "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". 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 type...
What is the current status of trial NCT05987241?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 992 participants. The study started on 2024-02-02. Estimated completion is 2030-09-02.
What conditions does trial NCT05987241 study?
This clinical trial studies the following conditions: Muscle Invasive Bladder Urothelial Carcinoma, Stage IV Bladder Urothelial Carcinoma AJCC v7, Stage III Bladder Urothelial Carcinoma AJCC v6 and v7, Stage II Bladder Urothelial Carcinoma AJCC v6 and v7, Muscle Invasive Renal Pelvis Urothelial Carcinoma.
What interventions are being tested in trial NCT05987241?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Magnetic Resonance Imaging (PROCEDURE), Cystoscopy (PROCEDURE), cfDNA or ctDNA Measurement (OTHER).
Who is sponsoring clinical trial NCT05987241?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05987241 being conducted?
This trial has 20 study locations across Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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