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Avelumab Maintenance in Patients with Metastatic Urothelial Carcinoma After Second-Line Platinum-Based Chemotherapy

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What is this trial about?

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

This clinical trial is studying metastatic urothelial carcinoma, a cancer that starts in the lining of the urinary tract and has spread to other parts of the body. The treatment being tested is avelumab, given by vein, as maintenance treatment, which means it is used after earlier cancer treatment to help keep the disease under control. The study is looking at whether avelumab can help people whose cancer has already responded to or stayed stable after platinum-based chemotherapy, a common type of cancer drug treatment that uses medicines containing platinum.

In this trial, one group receives avelumab and the other group receives best supportive care, which means care focused on relieving symptoms and keeping the person as comfortable as possible. The purpose of the study is to see whether avelumab can help control the cancer better than supportive care alone. During the study, treatment is given over time, and doctors follow the course of the disease and watch for side effects and changes in health.

The study also includes people whose cancer had already gotten worse after earlier treatment with pembrolizumab and enfortumab vedotin, which are cancer medicines used in advanced bladder and urinary tract cancer. The trial is designed to understand how well this treatment approach works and how safe it is for people with advanced or metastatic disease.

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

    Start of the trial

    After joining the trial, you enter the study treatment period for maintenance treatment after having had a response or stable disease following second-line platinum-based chemotherapy for advanced or metastatic urothelial carcinoma that had already progressed after first-line pembrolizumab plus enfortumab vedotin.

    Your trial treatment is either avelumab or best supportive care.

    The trial is planned to start on 2026-05-04 and is expected to end on 2030-11-04.

  2. Step 2

    Treatment with avelumab

    If you are assigned to the avelumab group, you receive avelumab 800 mg by intravenous administration, which means it is given through a vein.

    The medicine is given every 2 weeks (q2w), meaning once every 14 days.

    This treatment continues as maintenance treatment during the trial period.

  3. Step 3

    Best supportive care

    If you are assigned to the best supportive care group, you receive best supportive care instead of avelumab.

    The trial description does not give a medicine dose, frequency, or duration for best supportive care.

  4. Step 4

    Trial assessments during treatment

    During the trial, your disease is checked to see whether it is getting better, staying stable, or getting worse.

    The main measure is progression-free survival (PFS), which means the length of time during which the cancer does not get worse.

    The trial also looks at how long any response lasts, the rate of disease control, and overall survival, which means how long patients live after starting the study treatment.

    Safety is also checked by recording adverse events, which are unwanted medical problems, and laboratory abnormalities, which are unusual test results from blood or other samples.

    Patient-reported outcomes are collected, including bladder cancer symptoms, daily functioning, overall quality of life, health status, and the time until symptoms or functioning get worse.

Who can join the trial?

13 criteria

  • Be an adult, meaning 18 years of age or older.
  • Have a confirmed diagnosis, by tissue or cell testing, of metastatic or locally advanced unresectable urothelial carcinoma of the bladder or upper urinary tract, with mostly transitional cell carcinoma type.
  • Have already received first-line treatment with enfortumab vedotin plus pembrolizumab and second-line treatment with cisplatin or carboplatin plus gemcitabine, with at least 3 cycles of the second-line treatment. A cycle means one planned treatment period.
  • Have had stable disease, partial response, or complete response after finishing 3 to 6 cycles of the second-line chemotherapy. Stable disease means the cancer has not gotten worse. Partial response means the cancer has shrunk. Complete response means no signs of cancer are seen on scans or tests.
  • Have measurable disease according to RECIST v1.1, which means the cancer can be measured on scans using standard research rules.
  • Have a life expectancy of at least 3 months.
  • Have an ECOG performance status of 0 or 1. This is a scale of how well a person can do daily activities; 0 means fully active, and 1 means able to do light work.
  • Be in a stable medical condition, with no recent worsening of long-term illnesses, no serious infections, and no major surgery within the 4 weeks before joining the study.
  • Have adequate organ and bone marrow function, meaning the body is making enough blood cells and the liver and kidneys are working well, including all of the following: absolute neutrophil count of at least 1,500/mm3 or 1.5 x 10^9/L (neutrophils are white blood cells that help fight infection), platelets of at least 100,000/mm3 or 100 x 10^9/L (platelets help blood clot), hemoglobin of at least 9 g/dL (hemoglobin carries oxygen in the blood; a transfusion is allowed), creatinine clearance of at least 30 mL/min by the Cockcroft-Gault formula (this measures kidney function), ALT and AST less than 2.5 times the upper limit of normal (these are liver enzymes), and total bilirubin of 1.5 times the upper limit of normal or lower; if the person has Gilbert's disease, bilirubin may be up to 3 mg/dL (bilirubin is a substance processed by the liver).
  • For females who can become pregnant, have a negative pregnancy test at screening.
  • If able to have children, agree to use highly effective contraception during the study and for at least 30 days after the last dose. This means reliable birth control; for females, licensed hormonal methods are allowed, and for males, condom use is required.
  • Be willing and able to follow the study visits and procedures and be available for the full study period.
  • Have signed the informed consent form, showing the person understands the study and agrees to take part.

Who cannot join the trial?

17 criteria

  • The cancer got worse during second-line chemotherapy according to RECIST v1.1, which is a standard way to measure tumor growth on scans.
  • There is active heart or blood vessel disease, such as a stroke within the last 6 months, a heart attack within the last 6 months, unstable chest pain, heart failure of class II or higher, or a serious heart rhythm problem that needs medicine.
  • There was a previous severe allergic reaction to the study drug, any part of it, or to a monoclonal antibody (a lab-made protein used as a medicine), with a reaction level of grade 3 or higher.
  • There is current or recent use of immunosuppressive medicine within 7 days before randomization, except for allowed low-risk steroid use such as nasal, inhaled, skin, or local steroid injections, low-dose prednisone or similar medicine, or steroid medicine used only before an allergy-related procedure.
  • There is an active or uncontrolled infection. Some people with HIV, hepatitis B, or hepatitis C may still qualify only if strict control and lab requirements are met.
  • There are other serious short-term or long-term medical problems that could make study treatment unsafe or make the study results hard to interpret, including immune colitis (inflammation of the colon caused by the immune system), inflammatory bowel disease, immune pneumonitis (lung inflammation caused by the immune system), pulmonary fibrosis (scarring of the lungs), severe psychiatric illness, recent or active suicidal thoughts or behavior, or serious abnormal lab results.
  • There has been a previous organ transplant, including a stem-cell transplant from another person.
  • There was a vaccination within 4 weeks before the first study dose, or the person plans to receive vaccines during the study, except for inactivated vaccines such as a dead-virus flu shot.
  • The patient is pregnant or breastfeeding, or is unable or unwilling to use 2 highly effective birth control methods during the study and for at least 60 days after the last dose. This applies to men who can father a child and to women who can become pregnant.
  • There was a previous grade 3 or higher side effect from an immune-checkpoint inhibitor (a type of cancer medicine that helps the immune system fight cancer), except for thyroid problems.
  • There is ongoing side effect from prior treatment that is worse than grade 1. Hair loss, nerve symptoms of grade 2 or less, or other mild problems of grade 2 or less may still be allowed if the doctor thinks they are not a safety risk.
  • There are known symptomatic central nervous system metastases (cancer spread to the brain or spinal cord) that need steroids. People may still qualify only if treatment was finished at least 4 weeks before the first study dose, recovery is complete, and they are neurologically stable, meaning their nervous system symptoms are not getting worse.
  • There was major surgery within 4 weeks before the first study dose, unless the wound has completely healed on its own.
  • There was radiotherapy (treatment with radiation) within 2 weeks before the first study dose, except for palliative radiation to bone metastases, which is allowed if it ended at least 48 hours before the first dose.
  • There is active autoimmune disease that needs high-dose steroids or other medicines that suppress the immune system. People with type 1 diabetes, vitiligo, psoriasis, or thyroid disease that does not need immune-suppressing treatment may still qualify.
  • There has been another cancer within the past 5 years, except for certain cancers that were treated completely or are low risk, such as some skin cancers, carcinoma in situ of the breast or cervix, or low-grade prostate cancer being watched without treatment.
  • There was participation in another study using an investigational drug within 4 weeks before randomization, except for observational studies, which only collect information and do not test a new treatment.
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Investigated drugs

Avelumab is a medicine given through a vein. In this trial, it is used as maintenance treatment after the patient has responded to second-line platinum-based chemotherapy. The goal is to help keep the cancer from growing or coming back for as long as possible. It is being compared with best supportive care to see whether it can improve the time before the cancer gets worse.

What is already known about the treatment

Avelumab - Avelumab is given as an intravenous infusion, which means it is placed directly into a vein by a healthcare professional. It is a medicine still actively used and studied in cancer care, especially in medical literature for certain advanced cancers. It is mainly used to treat metastatic urothelial carcinoma and some other cancers, and it belongs to the group of medicines called immune checkpoint inhibitors, more specifically PD-L1 blockers. At the molecular level, it works by blocking the PD-L1 protein on cancer cells and some immune cells, which helps the body’s T cells recognize and attack the cancer more effectively.

Investigated diseases

Metastatic urothelial carcinoma - A cancer that begins in the urothelial cells lining the urinary tract and has spread to other parts of the body. It usually develops from earlier localized disease and progresses by invading nearby tissues, spreading to lymph nodes, and then to distant organs. As it advances, it may cause increasing urinary symptoms, pain, blood in the urine, and general weakness.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-524077-16-00Protocol codeGOIRC-02-2025Estimated enrolment144 patientsSponsorGOIRC Gruppo Oncologico Italiano Di Ricerca Clinica

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