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

NCT06820255 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 135

Last updated 2025-02-11

No results posted yet for this study

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.

Conditions

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

Sponsors & Collaborators

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    lead OTHER

Principal Investigators

  • Roberto Iacovelli, Prof · Fondazione Policlinico Universitario A. Gemelli, IRCCS

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-07
Primary Completion
2026-01-07
Completion
2027-01-07

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06820255 on ClinicalTrials.gov