Actively Recruiting
Prospective Evaluation of DNA Repair Gene Alterations to Predict Response to Platinum-based Chemotherapy in Advanced Urothelial Cancer
Led by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Updated on 2025-02-11
135
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are assessing whether changes in certain genes involved in DNA repair affect how well patients with advanced urothelial or bladder cancer respond to platinum-based chemotherapy. This prospective study is conducted under medical supervision to better understand the link between these gene alterations and treatment outcomes in metastatic or unresectable urothelial cancers. Participants receive standard platinum-based chemotherapy, such as cisplatin or carboplatin combined with gemcitabine. All patients will have their tumor tissue tested for DNA damage response (DDR) gene alterations using a specialized genetic test. Those who have stable disease or respond to chemotherapy may then receive maintenance treatment with avelumab every two weeks until the cancer progresses or side effects become unacceptable. During the study, researchers will monitor treatment response, progression-free survival, overall survival, disease control rates, and treatment-related side effects over periods of six to twelve months. Patients will undergo regular assessments including imaging and clinical evaluations to measure outcomes. The study is planned to follow participants from treatment start through one year to gather comprehensive data on how gene alterations impact chemotherapy effectiveness and patient survival.
CONDITIONS
Brief Title
DDR Genes Alteration and Response to Platinum-based Chemotherapy in Advanced Urothelial Cancer.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to understand and sign informed consent before any study procedures
- Male or female aged 18 years or older
- Histological or cytological confirmation of urothelial cancer
- Available tumor tissue for genetic testing
- Measurable disease by RECIST 1.1 criteria
- ECOG performance status of 0, 1, or 2 (with additional health criteria for ECOG 2)
- Life expectancy of at least 6 months
- Eligible for standard platinum-based chemotherapy with cisplatin or carboplatin plus gemcitabine
- Agree to use adequate contraception during and after treatment as specified
- Adequate bone marrow, liver, and kidney function based on laboratory tests within 7 days before treatment start
You will not qualify if you...
- Previous treatment for metastatic or locally advanced urothelial cancer
- Adjuvant therapy within 1 year before metastatic diagnosis
- Prior immunotherapy treatment
- Other cancers within 3 years except certain non-invasive or treated cancers
- Major surgery, open biopsy, or significant injury within 28 days before study drug
- Pregnancy or breastfeeding
- Certain heart conditions including severe heart failure, unstable angina, recent heart attack, arrhythmias requiring treatment, uncontrolled hypertension, recent thrombotic events
- Active infections above grade 2 severity
- Known HIV or chronic hepatitis B or C infection
- Autoimmune diseases contraindicating maintenance immunotherapy
- Seizure disorders requiring medication
- Symptomatic brain or meningeal metastases unless stable and treated
- History of organ transplant
- Bleeding disorders or recent major bleeding events
- Non-healing wounds, ulcers, or fractures
- Kidney failure requiring dialysis
- Any unstable illness or condition jeopardizing safety or compliance
- Live vaccine within 30 days before first study drug
- Participation in another clinical trial at enrollment time
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 months
Participants receive platinum-based chemotherapy with cisplatin or carboplatin plus gemcitabine. Those with stable disease or tumor response after chemotherapy start maintenance treatment with avelumab every 2 weeks until disease progression or unacceptable toxicity.
Regular visits every 2 weeks during maintenance treatment
Duration - Up to 12 months
Participants are monitored for disease progression, survival, and treatment-related toxicity following treatment.
Periodic visits up to 12 months after treatment
Trial Site Locations
Total: 1 location
1
Fondazione Policlinico Universitario A. Gemelli IRCCS
Rome, Italy, 00168
Actively Recruiting
Research Team
R
Roberto Iacovelli, Prof
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here