NCT06820255View on ClinicalTrials.gov

DDR Genes Alteration and Response to Platinum-based Chemotherapy in Advanced Urothelial Cancer.

PHASE4RecruitingINTERVENTIONAL
Enrollment

135

Participants

Timeline

Start Date

January 7, 2025

Primary Completion Date

January 7, 2026

Study Completion Date

January 7, 2027

Conditions
Bladder (Urothelial, Transitional Cell) Cancer Metastatic or UnresectableUpper Tract Urothelial Cancer
Interventions
DRUG

Platinum + Gemcitabine

Eligible patients will be treated with platinum-based chemotherapy (i.e. cisplatin + gemcitabine or carboplatin + gemcitabine).

DRUG

Avelumab first-line maintenance

Patients with stable disease or tumor response after treatment with platinum-based chemotherapy will start treatment with avelumab 800 mg fat dose Q2 weeks until progression of disease or unacceptable toxicity

DIAGNOSTIC_TEST

NGS test for DDR alterations

All patients will be tested for DDR alterations on tumor tissue.

Trial Locations (1)

00168

RECRUITING

Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome

All Listed Sponsors
lead

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER