Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
PlainTrials
RecruitingPhase 2 / Phase 3interventionalRules rewrite

Phase 2 / Phase 3: testing Nivolumab for Muscle Invasive Bladder Urothelial Carcinoma

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.

Official registry: https://clinicaltrials.gov/study/NCT05987241 · National Cancer Institute (NCI) · enrollment listed as 992

What this phase means

Phase 2/3: earlier tests looked promising enough to expand. This stage asks, in a larger group, whether the treatment really works and is safe enough to seek approval.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Biospecimen Collection, cfDNA or ctDNA Measurement, or Computed Tomography. The registry lists allocation as randomized. 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.

They plan to enroll about 992 people at 505 sites. Taking part typically means an infusion or injection of a biologic, a procedure as part of the study plus check-ins.

Official title (unrewritten)

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

Interventions: Biospecimen Collection, cfDNA or ctDNA Measurement, Computed Tomography, Cystoscopy, Magnetic Resonance Imaging, Nivolumab, Questionnaire Administration, Relatlimab

Primary outcome (registry wording): Proportion of patients who are circulating tumor DNA negative (ctDNA[-]) (Cohort A Phase II)

Who it is for (from inclusion criteria)

  • Ages 18 Years to any
  • PRE-REGISTRATION (STEP 0): Histologically confirmed muscle-invasive urothelial carcinoma of the urethra, bladder, ureter or renal pelvis
  • PRE-REGISTRATION (STEP 0): Patients who have had a partial cystectomy as definitive therapy are not eligible
  • PRE-REGISTRATION (STEP 0): No gross cancer at the surgical margins. Microscopic invasive urothelial carcinoma at the surgical margins (i.e., "positive margins") are allowed. Carcinoma in situ (CIS) at margins is considered negative margins
  • PRE-REGISTRATION (STEP 0): No evidence of residual cancer or metastasis after radical cystectomy or nephroureterectomy or ureterectomy (imaging is not required prior to pre-registration but is required prior to registration)
  • (i) Patients who have not received neoadjuvant systemic therapy: pT4N0 or pTanyN+ on radical surgery pathology specimen (i.e., cystectomy, nephroureterectomy, or ureterectomy) and are not eligible for adjuvant cisplatin chemotherapy
  • (i) Patients ineligible for cisplatin due to at least one of the following criteria and reason for ineligibility should be documented:
  • (i) Creatinine Clearance (using Cockcroft-Gault): \< 60 mL/min

Contact

No central phone on the registry card. Use the official listing to reach a site.

Sites listed on ClinicalTrials.gov

505 listed

+ 10 sites outside the US on the same record

FAQ about this NCT record

Is NCT05987241 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT05987241?

Phase 2 / Phase 3. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT05987241?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

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