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Study Comparing Erdafitinib with Vinflunine, Docetaxel, or Pembrolizumab for Patients with Advanced Urothelial Cancer and FGFR Gene Changes

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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 focused on studying treatments for Advanced Urothelial Cancer, a type of cancer that affects the bladder and other parts of the urinary system. The study is comparing the effectiveness of a medication called Erdafitinib with other treatments, including Vinflunine, Docetaxel, and Pembrolizumab. Erdafitinib is a medication taken as a tablet, while Vinflunine, Docetaxel, and Pembrolizumab are given as infusions, which means they are administered directly into the bloodstream through a vein.

The purpose of the study is to evaluate how well Erdafitinib works compared to the other treatments in patients with advanced urothelial cancer who have specific changes in their FGFR genes. These changes, known as gene aberrations, can affect how cancer grows and responds to treatment. The study is divided into two groups: one group will receive Erdafitinib or chemotherapy (Vinflunine or Docetaxel) if they have previously been treated with a type of medication called an anti-PD-(L)1 agent, and the other group will receive Erdafitinib or Pembrolizumab if they have not been treated with an anti-PD-(L)1 agent before.

Participants in the study will receive their assigned treatment and will be monitored to see how long they live after starting the treatment, which is known as overall survival. The study aims to provide valuable information on which treatment option may be more effective for patients with advanced urothelial cancer and specific FGFR gene changes. The study will help doctors understand better treatment options for this type of cancer.

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
Joining the study
Upon joining the study, eligibility is confirmed based on specific criteria, including age, cancer type, and previous treatments.
Participants are divided into two groups based on their treatment history with anti-PD-(L)1 agents.
Step 2
Randomization
Participants are randomly assigned to receive either erdafitinib or one of the comparator treatments: vinflunine, docetaxel, or pembrolizumab.
The assignment depends on the participant's previous treatment history.
Step 3
Treatment administration
Participants receiving erdafitinib take it orally in the form of film-coated tablets.
Participants receiving vinflunine or docetaxel receive these medications intravenously as a solution for infusion.
Participants receiving pembrolizumab also receive it intravenously as a solution for infusion.
Step 4
Treatment duration
The duration of treatment varies based on individual response and tolerance.
Regular assessments are conducted to monitor the effectiveness and any side effects of the treatment.
Step 5
Follow-up and evaluation
Participants undergo regular follow-up visits to evaluate overall survival and other health outcomes.
The primary endpoint is overall survival, measured from the date of randomization to the date of death or last known alive status.

Who can join the trial?

9 criteria

Must be **18 years or older** (or the legal age of consent in the area where the study is conducted).
Must have a confirmed diagnosis of **transitional cell carcinoma** of the urothelium. This means a type of bladder cancer, and it's okay if there are small parts of other types of cancer cells.
Must have **metastatic** or **surgically unresectable** urothelial cancer, meaning the cancer has spread or cannot be removed by surgery.
Must have documented **progressive disease (PD)**, which means the cancer has gotten worse and needs a change in treatment.
For **Cohort 1**: Must have had prior treatment with an **anti-PD-(L)1 agent**, which is a type of cancer treatment, either alone or with other treatments. No more than two previous treatments are allowed.
For **Cohort 2**: Must not have had any prior treatment with an **anti-PD-(L)1 agent** and only one previous treatment is allowed.
Must meet specific **molecular eligibility criteria**, which means certain genetic changes in the cancer must be present. This is determined by special tests on tissue or blood samples.
Must have an **ECOG performance status** of Grade 0, 1, or 2, which is a scale that measures how well a person can perform daily activities.
Must have adequate **bone marrow, liver, and kidney function**. This means certain blood tests must show that these organs are working well enough.

Who cannot join the trial?

6 criteria

Patients who have not been diagnosed with advanced urothelial cancer cannot participate. This type of cancer affects the bladder and other parts of the urinary system.
Patients who have not received 1 or 2 prior treatments for their cancer are excluded. At least one of these treatments must include an anti-programmed death-ligand 1 (PD-[L]1) agent, which is a type of medicine that helps the immune system fight cancer.
Patients who do not have specific changes in their cancer related to FGFR aberrations cannot join. FGFR stands for Fibroblast Growth Factor Receptor, which is a protein that can affect cancer growth.
Patients who are not in the age range specified for the study are excluded. The study includes certain age groups, but the exact ages are not specified here.
Patients who are not male or female are excluded, as the study includes both genders.
Patients who are considered part of a vulnerable population may be excluded. This term refers to groups of people who might need special protection or care.

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Verified sites

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

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Complejo Hospitalario Universitario Insular Materno Infantil
Las Palmas De Gran Canaria, Spain
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Hospital Clinic De Barcelona
Barcelona, Spain
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Hospital Universitario De Navarra
Pamplona, Spain

Trial locations

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Investigated drugs

Erdafitinib
is a medication being studied for its effectiveness in treating advanced urothelial cancer. It is specifically being tested in patients whose cancer has certain genetic changes known as FGFR gene aberrations. This medication is being compared to other treatments to see if it can help patients live longer.
Vinflunine
is a type of chemotherapy used in this study as a comparison treatment. It works by stopping cancer cells from dividing and growing, which can help slow down or stop the progression of the cancer.
Docetaxel
is another chemotherapy drug used in the trial. It is designed to interfere with the growth of cancer cells, ultimately leading to their death. This medication is being compared to erdafitinib to evaluate its effectiveness in treating advanced urothelial cancer.
Pembrolizumab
is an immunotherapy drug included in the study. It helps the immune system recognize and attack cancer cells. This medication is being compared to erdafitinib to determine which treatment is more effective for patients with advanced urothelial cancer who have not previously received certain types of immunotherapy.

What is already known about the treatment

Erdafitinib
Erdafitinib is administered orally and is currently being studied in clinical trials for its effectiveness in treating advanced urothelial cancer with specific FGFR gene changes. It is classified as a tyrosine kinase inhibitor and works by blocking the activity of FGFR proteins, which are involved in cell growth and division. This medication is being compared to other treatments like chemotherapy and pembrolizumab to determine its efficacy in patients who have already undergone previous treatments.
Vinflunine
Vinflunine is given through intravenous infusion and is used in the treatment of advanced urothelial cancer. It is a type of chemotherapy drug known as a vinca alkaloid, which works by disrupting the formation of microtubules, essential components of cell division, thereby inhibiting cancer cell growth. Vinflunine is being evaluated in clinical trials to compare its effectiveness against other treatments like erdafitinib and docetaxel.
Docetaxel
Docetaxel is administered via intravenous infusion and is used in the treatment of advanced urothelial cancer. It belongs to the class of chemotherapy drugs called taxanes, which work by stabilizing microtubules and preventing cell division, leading to cancer cell death. In clinical trials, docetaxel is being compared to erdafitinib and vinflunine to assess its effectiveness in patients with specific FGFR gene changes.
Pembrolizumab
Pembrolizumab is given as an intravenous infusion and is used in the treatment of advanced urothelial cancer. It is an immune checkpoint inhibitor that works by blocking the PD-1 pathway, helping the immune system recognize and attack cancer cells. Pembrolizumab is being studied in clinical trials to compare its efficacy with erdafitinib in patients who have not previously received anti-PD-(L)1 treatments.

Investigated diseases

Advanced Urothelial Cancer – This is a type of cancer that occurs in the urothelial cells lining the bladder and other parts of the urinary tract. It is considered advanced when it has spread beyond the bladder to nearby tissues or distant organs. The disease often progresses through stages, starting from the inner lining of the bladder and potentially moving to the muscle wall and beyond. Symptoms may include blood in the urine, frequent urination, and pain during urination. As the cancer advances, it may cause more severe symptoms and affect other parts of the body. The progression can vary based on individual factors and the presence of specific genetic mutations.