Trials / Recruiting
RecruitingNCT06820255
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.
- Status
- Recruiting
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 135 (estimated)
- Sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2025-01-07
- Primary completion
- 2026-01-07
- Completion
- 2027-01-07
- First posted
- 2025-02-11
- Last updated
- 2025-02-11
Locations
1 site across 1 country: Italy
Source: ClinicalTrials.gov record NCT06820255. Inclusion in this directory is not an endorsement.