OncoMatch/Clinical Trials/NCT06820255
DDR Genes Alteration and Response to Platinum-based Chemotherapy in Advanced Urothelial Cancer.
Is NCT06820255 recruiting? Yes, currently enrolling (May 2026). This Phase 4 trial studies multiple treatments including Platinum + Gemcitabine and Avelumab first-line maintenance for bladder (urothelial, transitional cell) cancer metastatic or unresectable.
Treatment: Platinum + Gemcitabine · Avelumab first-line maintenance — This study aims to prospectively observe whether certain alterations in some genes related to the DNA repair mechanism are related to better response to platinum-based chemotherapy used to treat metastatic bladder or urothelial cancers.
Check if I qualifyExtracted eligibility criteria
Cancer type
Urothelial Carcinoma
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: systemic therapy for metastatic or locally advanced disease
Previous treatment for metastatic or locally advanced disease.
Cannot have received: adjuvant therapy
Exception: allowed if >1 year from diagnosis of metastatic disease
Previous adjuvant therapy within 1 year from the diagnosis of metastatic disease.
Cannot have received: immunotherapy
Prior treatment with immunotherapy.
Lab requirements
Blood counts
Platelet count ≥100,000/mm3, hemoglobin >9 g/dl (≥10 g/dL for ECOG 2), ANC >1,500/mm3
Kidney function
Creatinine <2.5 mg/dl and creatinine clearance >30 ml/min (Cockcroft-Gault); GFR ≥50mL/min for ECOG 2; renal failure requiring hemodialysis or peritoneal dialysis excluded
Liver function
Total bilirubin ≤1.5 × ULN; ALT and AST ≤2 × ULN (≤5 × ULN for patients with liver involvement); alkaline phosphatase ≤2.5 × ULN (≤5 × ULN for patients with liver involvement)
Cardiac function
No NYHA class III or worse heart failure (ECOG 2 must not have NYHA class III); no unstable angina, new-onset angina within 3 months, MI <6 months, cardiac arrhythmias requiring anti-arrhythmic therapy (beta-blockers/digoxin permitted), uncontrolled hypertension (SBP >150 mmHg or DBP >90 mmHg despite optimal management), no arterial/venous thrombotic/embolic events (CVA, TIA, PE) within 4 months
Adequate bone-marrow, liver, and renal function as assessed by the following laboratory requirements conducted within 7 days of starting to study treatment: Creatinine value <2.5 mg/dl and creatinine clearance > 30 ml/min evaluated by the Cockcroft-Gault Formula. Total bilirubin ≤1.5 × ULN; ALT and AST ≤2 × ULN (≤5 × ULN for patients with liver involvement); INR and PTT ≤1.5 × ULN (anticoagulation allowed if stable); Platelet count ≥100,000/mm3, hemoglobin >9 g/dl, ANC >1,500/mm3; alkaline phosphatase ≤2.5 × ULN (≤5 × ULN for patients with liver involvement).
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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