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DDR Genes Alteration and Response to Platinum-based Chemotherapy in Advanced Urothelial Cancer. | Clinical Trials | Clareo Health

RECRUITINGPHASE4

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.

NCT06820255•Fondazione Policlinico Universitario Agostino Gemelli IRCCS

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Informed consent obtained before any study-specific procedures. Patients must be able to understand and be willing to sign a written informed consent.
•2. Male or female patient ≥18 years of age.
•3. Histological or cytological documentation of urothelial cancer.
•4. Available tumor tissue for analysis
•5. Measurable disease according to Response Evaluation Criteria in Solid Tumors criteria, version 1.1.
•6. Eastern Cooperative Oncology Group performance status of ≤2. (Patients with ECOG PS of 2 were required to also meet the additional criteria: hemoglobin ≥10 g/dL, GFR ≥50mL/min, may not have NYHA class III heart failure).
•7. Life expectancy of at least 6 months.
•8. Eligible to standard chemotherapy with cisplatin or carboplatin + gemcitabine as per clinical practice.
•9. Women of childbearing potential and men must agree to use adequate contraception since signing of the informed consent form until 180 days after the last dose of chemotherapy and 30 days after the last dose of avelumab. The investigator or a designated associate is requested to advise the subject how to achieve an adequate birth control. Adequate contraception is defined in the study as any medically recommend method (or combination of methods) as per standard of care.
•10. Adequate bone-marrow, liver, and renal function as assessed by the following laboratory requirements conducted within 7 days of starting to study treatment:
+2 more criteria

Exclusion Criteria

•1. Previous treatment for metastatic or locally advanced disease.
•2. Previous adjuvant therapy within 1 year from the diagnosis of metastatic disease.
•3. Prior treatment with immunotherapy.
•4. 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.
•5. Major surgical procedure, open biopsy, or significant traumatic injury within 28 days before start of study medication
•6. Pregnancy or breast-feeding. Women of childbearing potential must have a pregnancy test performed a maximum of 7 days before start of treatment, and a negative result must be documented before start of treatment.
•7. Any cardiological condition among:
•1. Congestive heart failure of New York Heart Association class 3 or worse.
•2. Unstable angina (angina symptoms at rest), new-onset angina (begun within the last 3 months). Myocardial infarction less than 6 months before start of study drug.
•3. Cardiac arrhythmias requiring anti-arrhythmic therapy (beta-blockers or digoxin are permitted).
+14 more criteria

Locations (1)

Fondazione Policlinico Universitario A. Gemelli IRCCS

Rome, Italy

Key Dates

Start Date

January 7, 2025

Primary Completion Date

January 7, 2026

Completion Date

January 7, 2027

Last Updated

February 11, 2025

Enrollment

135

ESTIMATED participants

Conditions

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

Interventions

Platinum + Gemcitabine

DRUG

Avelumab first-line maintenance

DRUG

NGS test for DDR alterations

DIAGNOSTIC_TEST

Contacts

Roberto Iacovelli, Prof

CONTACT

+390630157373 roberto.iacovelli@policlinicogemelli.it

SeqUential GeMcitabine and MITomycin Treatment for Favorable High-Risk Upper Urinary Tract Urothelial Carcinoma

NCT06822010

Urinary Bladder CancerUpper Tract Urothelial Cancer+1 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 11, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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