OncoMatch/Clinical Trials/NCT07475403
Urinary Tumor DNA-Guided Systemic Immunotherapy for Unresectable Very-High-Risk Non-Muscle-Invasive Bladder Cancer
Is NCT07475403 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Systemic immunotherapy for bladder cancer.
Treatment: Systemic immunotherapy — This study aims to evaluate whether urinary tumor DNA (utDNA) can guide treatment duration in patients with unresectable very-high-risk non-muscle-invasive bladder cancer (VHR NMIBC) who achieve complete clinical response after systemic immunotherapy. Participants will receive systemic immunotherapy followed by response assessment using pathology, cystoscopy, urine cytology, and utDNA testing. Patients who achieve complete clinical response will receive a short additional course of immunotherapy before stopping treatment according to the study protocol. The study hypothesizes that a shortened duration of systemic immunotherapy guided by utDNA monitoring may maintain favorable oncologic outcomes in this population.
Check if I qualifyExtracted eligibility criteria
Cancer type
Urothelial Carcinoma
Disease stage
Required: Stage NON-MUSCLE-INVASIVE, VERY-HIGH-RISK (VHR) PER EAU 2025 GUIDELINE (EAU 2025 guideline)
Excluded: Stage ≥T2
non-muscle-invasive urothelial carcinoma of the bladder classified as very-high-risk (VHR) according to EAU 2025 guideline criteria
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: immune checkpoint inhibitor
Prior treatment with immune
Lab requirements
Blood counts
absolute neutrophil count ≥1.5 × 10⁹/l, platelet count ≥100 × 10⁹/l, hemoglobin ≥9 g/dl
Kidney function
serum creatinine ≤1.5 × uln or creatinine clearance ≥60 ml/min
Liver function
total bilirubin ≤1.5 × uln, ast ≤2.5 × uln, alt ≤2.5 × uln
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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