RecruitingPhase 4NCT06820255

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

Prospective Evaluation of the DDR Genes Alteration to Predict Response to Platinum-based Chemotherapy in Advanced Urothelial Cancer.

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Enrollment

135 participants

Start Date

Jan 7, 2025

Study Type

INTERVENTIONAL

Conditions

Bladder (Urothelial, Transitional Cell) Cancer Metastatic or Unresectable Upper Tract Urothelial Cancer

Summary

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This observational study looks at whether people with advanced bladder or urinary tract cancer (urothelial cancer) who have specific DNA repair gene mutations (called DDR gene alterations) respond better to platinum-based chemotherapy. **You may be eligible if...** - You are 18 or older with a confirmed diagnosis of urothelial (bladder or urinary tract) cancer - You have measurable disease on imaging - You have tumor tissue available for genetic testing - Your overall health status is adequate (ECOG 0-2) - Your life expectancy is at least 6 months **You may NOT be eligible if...** - You have already received platinum-based chemotherapy for this cancer - You do not have adequate tumor tissue available - Your organ function is too poor to tolerate chemotherapy - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPlatinum + Gemcitabine

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

DRUGAvelumab 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_TESTNGS test for DDR alterations

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