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Study of drug combination with gemcitabine, cisplatin, carboplatin and avelumab in patients with advanced urothelial cancer to evaluate response to platinum-based chemotherapy

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial focuses on patients with metastatic or locally advanced urothelial cancer. The study aims to determine if patients whose cancer has specific genetic changes in DDR genes respond better to treatment with platinum-based chemotherapy compared to those without these genetic changes.

The treatment in this study involves a combination of medications given through intravenous infusion. Patients will receive either cisplatin or carboplatin together with gemcitabine hydrochloride. Some patients may also receive avelumab, which belongs to a group of medications called monoclonal antibodies that help the immune system fight cancer cells.

During the study, doctors will regularly check how well the treatment is working by taking scans and monitoring any side effects. The treatment period may last up to 18 months for chemotherapy medications and up to 24 months for avelumab. The effectiveness of the treatment will be measured by looking at how the tumors respond and how long patients live without their cancer getting worse.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial eligibility assessment

    Your eligibility for the study will be evaluated based on laboratory tests of your bone marrow, liver, and kidney function. These tests must be completed within 7 days before starting treatment.

    A tissue sample from your tumor will be analyzed to determine if specific genetic changes are present.

    Your overall health status will be evaluated using the ECOG performance status scale, which measures your ability to perform daily activities.

  2. Step 2

    Treatment phase

    You will receive chemotherapy treatment through intravenous infusion (medication delivered directly into your vein).

    The treatment will include either cisplatin or carboplatin combined with gemcitabine.

    Some patients may also receive avelumab as part of their treatment.

    Your doctor will determine which specific combination is most appropriate for your situation.

  3. Step 3

    Monitoring and evaluation

    Your response to treatment will be regularly assessed using imaging scans to measure any changes in your cancer.

    Side effects will be monitored and recorded throughout the treatment period.

    Regular blood tests will be performed to check your health status.

  4. Step 4

    Follow-up period

    After completing treatment, you will need to use appropriate birth control methods for 180 days following the last chemotherapy dose.

    If you received avelumab, birth control should be continued for 30 days after the last dose.

    Your health status will continue to be monitored after treatment completion.

Who can join the trial?

12 criteria

  • Patient must be 18 years of age or older
  • Patient must be able to understand and sign a written informed consent form before any study procedures
  • Patient must have confirmed urothelial cancer (cancer of the urinary system) through tissue or cell examination
  • Patient must have cancer that can be measured using specific medical criteria (RECIST 1.1)
  • Patient must have tumor tissue available for testing
  • Patient must have adequate organ function, including:
    • Good kidney function (creatinine less than 2.5 mg/dl)
    • Acceptable liver function tests
    • Adequate blood cell counts
    • Patient must have a good level of physical function (ECOG performance status of 2 or better)
    • Patient must have a life expectancy of at least 6 months
    • Patient must be suitable for standard chemotherapy with cisplatin or carboplatin plus gemcitabine
    • Patient must agree to use effective birth control methods during the study and for 180 days after the last chemotherapy dose

Who cannot join the trial?

13 criteria

  • Age below 18 years old
  • Previous treatment with platinum-based chemotherapy (drugs containing platinum used to treat cancer)
  • Presence of active brain metastases (cancer that has spread to the brain)
  • Severe kidney dysfunction (poor kidney function that could affect treatment)
  • Severe liver dysfunction (poor liver function that could affect treatment)
  • Uncontrolled heart conditions
  • Active infections requiring systemic treatment (infections needing medication that affects the whole body)
  • Known allergic reactions to platinum-containing medications
  • Pregnancy or breastfeeding
  • Unable to provide informed consent
  • Participation in another clinical trial within the past 30 days
  • Life expectancy less than 3 months
  • Any condition that, in the opinion of the investigator, would interfere with safe participation in the study
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Investigated drugs

Based on the provided trial data, I can identify that the trial involves: Platinum-based chemotherapy is a type of cancer treatment that uses platinum-containing drugs to fight cancer cells. This type of chemotherapy works by damaging the DNA of cancer cells, preventing them from dividing and growing. It is commonly used to treat various types of cancer, including urothelial (bladder) cancer. Note: The trial appears to focus on studying how genetic alterations (specifically in DDR genes) affect the response to this type of chemotherapy, rather than testing new medications. No other specific medications are mentioned in the provided trial data.

What is already known about the treatment

  • Gemcitabine hydrochloride

    This drug is given by slow intravenous infusion. It is an approved chemotherapy agent used for many cancers, including advanced urothelial carcinoma, and is well described in medical literature. It works by acting like a building block of DNA, which stops cancer cells from copying their genetic material and leads to cell death. Pharmacologically it is classified as an antimetabolite, specifically a nucleoside analog.

  • Cisplatin

    Cisplatin is administered through an intravenous infusion. It is a widely used and well‑studied platinum‑based chemotherapy drug for a range of solid tumors such as bladder cancer. The medicine creates strong links between DNA strands, preventing the DNA from separating and stopping cancer cells from dividing. It belongs to the class of platinum compounds and is considered an alkylating‑like agent.

  • Avelumab

    Avelumab is given as an intravenous infusion. It is an approved immune‑checkpoint inhibitor used for metastatic urothelial cancer and several other malignancies, and its safety and effectiveness are documented in many clinical trials. The drug binds to the PD‑L1 protein on tumor cells, allowing the immune system to recognize and attack the cancer. It is classified as a monoclonal antibody that targets the PD‑L1 pathway.

  • Carboplatin

    Carboplatin is delivered by intravenous infusion. It is an established platinum‑based chemotherapy drug approved for a variety of cancers, including advanced bladder cancer, and is frequently referenced in oncology research. Like cisplatin, it forms cross‑links in DNA that block replication and cause cancer cell death. It is classified as a platinum compound within the alkylating‑like drug group.

Investigated diseases

Urothelial Cancer - A cancer that begins in the urothelial cells, which line the urinary system, including the bladder, urethra, ureters, and renal pelvis. The disease typically starts in the bladder's inner lining and can spread to nearby tissues and organs. When described as locally advanced, it means the cancer has grown into deeper layers of the bladder wall or nearby structures. In metastatic cases, the cancer cells have spread beyond the original site to other parts of the body through the bloodstream or lymph system. The disease can progress from early stages where it affects only the urinary system lining to more advanced stages where it invades surrounding tissues.
Trial detailsLast updated 21 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-516450-21-00Protocol codeSELECTIO-UCEstimated enrolment135 patientsSponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS

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