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

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS

About this trial

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 criteria

Qualifiers

Informed consent obtained before any study-specific procedures. Patients must be able to understand and be willing to sign a written informed consent.

Male or female patient ≥18 years of age.

Histological or cytological documentation of urothelial cancer.

Available tumor tissue for analysis

Disqualifiers

Previous treatment for metastatic or locally advanced disease.

Previous adjuvant therapy within 1 year from the diagnosis of metastatic disease.

Prior treatment with immunotherapy.

Previous or concurrent cancer that is distinct in primary site or histology from urothelial cancer within 3 years before enrollment EXCEPT for curatively treated cervical cancer in situ, non-melanoma skin cancer and superficial bladder tumors (Ta [non-invasive tumor], Tis [carcinoma in situ], and T1 [tumor invades lamina propria]), pT2 prostate cancer with PSA<0.01.

Trial design

Treatments tested in this trial

  • Platinum + Gemcitabine
  • Avelumab first-line maintenance
  • NGS test for DDR alterations

Treatment groups

135 Participants
are divided into 2 treatment groups