Not recruiting

Study on the Effects of 3 vs 6 Cycles of Platinum-based Chemotherapy and Avelumab in Patients with Advanced Urothelial Cancer

Verified siteRegistered drugNo placebo

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

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

This clinical trial is focused on studying advanced urothelial cancer, which is a type of cancer that affects the bladder and other parts of the urinary system. The study is investigating the effects of a treatment called avelumab, which is a medication given through an intravenous infusion. Avelumab is a type of protein that helps the immune system fight cancer cells. In this study, avelumab is used as a maintenance treatment after patients receive a specific type of chemotherapy known as platinum-based chemotherapy.

The purpose of the study is to compare the outcomes of patients who receive either three or six cycles of platinum-based chemotherapy before starting maintenance treatment with avelumab. The study aims to understand how the number of chemotherapy cycles affects patients' quality of life and overall health. Participants will be randomly assigned to receive either three or six cycles of chemotherapy, followed by avelumab. Some participants may receive a placebo instead of avelumab to help researchers understand the true effects of the medication.

Throughout the study, participants will be monitored for changes in their health and quality of life. This will include regular assessments to track any side effects and the overall response to the treatment. The study will continue for a period of time to gather enough information to determine the best approach for treating advanced urothelial cancer with avelumab. The findings from this study could help improve treatment strategies for patients with this type of cancer in the future.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial treatment phase
The trial begins with a treatment phase involving platinum-based chemotherapy. This phase consists of either 3 or 6 cycles of chemotherapy, depending on the group assignment.
Chemotherapy options include gemcitabine/cisplatin or gemcitabine/carboplatin. The choice between these options is based on specific health criteria and the doctor's assessment.
Step 2
Maintenance treatment phase
Following the initial chemotherapy phase, the maintenance treatment involves the administration of avelumab.
Avelumab is given as an intravenous infusion using a solution called Bavencio 20 mg/mL concentrate for solution for infusion.
Step 3
Treatment duration
The maintenance treatment with avelumab continues until the completion of 10 cycles of treatment or until the study's end date, whichever comes first.
The total duration of the trial is estimated to end by April 30, 2028.
Step 4
Quality of life assessments
Throughout the trial, quality of life is assessed using a specific questionnaire called the EORTC QLQ-C30.
These assessments occur at various points, including baseline, after 6 cycles, and at the end of the trial.
Step 5
Monitoring and evaluations
Regular monitoring of health status and side effects is conducted throughout the trial.
Evaluations include measuring the response to treatment and any adverse effects experienced.

Who can join the trial?

10 criteria

Willing and able to provide written informed consent.
Agreement to use adequate contraceptive measures.
Ability to comply with the study protocol, including completing specific questionnaires.
Must be 18 years of age or older.
Have a confirmed diagnosis of **urothelial carcinoma**, which is a type of cancer affecting the bladder, renal pelvis, ureter, or urethra. This includes certain mixed cell types, but a part of the cancer must be urothelial.
Have measurable disease according to specific medical criteria.
Eligible for certain chemotherapy treatments, specifically gemcitabine with cisplatin or carboplatin. Eligibility depends on factors like kidney function, performance status, hearing ability, and heart health.
Have an **ECOG Performance Status** score of 0, 1, or 2, which is a scale used to assess how a patient's disease is progressing and how the disease affects their daily living abilities.
Have adequate blood and organ function, including specific levels of hemoglobin, neutrophils, platelets, bilirubin, liver enzymes, and kidney function.
For female patients of childbearing potential, a negative pregnancy test is required within two weeks before starting the study treatment. Non-childbearing potential is defined by age, menopause status, or certain surgical procedures.

Who cannot join the trial?

5 criteria

Patients who have a different type of cancer than urothelial carcinoma cannot participate. Urothelial carcinoma is a type of cancer that affects the lining of the urinary system.
Patients who are not within the specified age range for the study cannot participate. The study is open to certain age groups only.
Patients who are not able to receive platinum-based chemotherapy cannot participate. This is a type of cancer treatment that uses drugs containing the metal platinum to kill cancer cells.
Patients who cannot receive avelumab as a maintenance treatment cannot participate. Avelumab is a medication used to help keep cancer from coming back after initial treatment.
Patients who are part of a vulnerable population, such as those who cannot give consent or are in a dependent relationship with the study staff, cannot participate.

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Responsive
Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Paz
Madrid, Spain
Responsive
Hospital Universitario Hm Sanchinarro
Madrid, Spain
Responsive
Institut De Cancerologie De Lorraine
Vandoeuvre Les Nancy, France

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not recruiting

Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

Avelumab
is a medication used in this trial as a maintenance therapy for patients with advanced urothelial cancer. It is an immunotherapy drug that helps the body's immune system to attack cancer cells. Avelumab works by blocking a protein that cancer cells use to protect themselves from the immune system, allowing the immune system to better recognize and destroy the cancer cells.
Platinum-based Chemotherapy
refers to a group of chemotherapy drugs that contain the metal platinum. These drugs are used to treat various types of cancer, including urothelial cancer. In this trial, platinum-based chemotherapy is used as an initial treatment to shrink the cancer and slow its growth before starting maintenance therapy with avelumab. The trial is comparing the effects of receiving either 3 or 6 cycles of this chemotherapy.

Avelumab

What is already known about the treatment

Avelumab – Avelumab is administered as an intravenous infusion, typically given in a healthcare setting. It is currently used in the treatment of advanced urothelial carcinoma, often as a maintenance therapy following initial chemotherapy. Avelumab works by blocking a protein called PD-L1, which helps cancer cells evade the immune system. By inhibiting this protein, avelumab allows the immune system to better recognize and attack cancer cells. It is classified as an immune checkpoint inhibitor, a type of immunotherapy.

Investigated diseases

Urothelial Carcinoma – Urothelial carcinoma is a type of cancer that typically begins in the cells lining the bladder, known as urothelial cells. It can also occur in other parts of the urinary tract, such as the ureters and urethra. The disease often starts as a superficial tumor, which may cause symptoms like blood in the urine or frequent urination. As it progresses, it can invade deeper layers of the bladder wall and potentially spread to nearby lymph nodes and other organs. The progression of the disease can vary, with some tumors growing slowly and others more aggressively. Monitoring and management are crucial to address changes in the disease's behavior over time.