OncoMatch/Clinical Trials/NCT06820255
DDR Genes Alteration and Response to Platinum-based Chemotherapy in Advanced Urothelial Cancer.
Is NCT06820255 recruiting? Yes, currently enrolling (Jun 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
Treatments studied
Chemotherapy
Other
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.
Frequently asked questions
Is NCT06820255 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages