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Study on the Safety and Effectiveness of Erdafitinib Alone or with Cetrelimab and Chemotherapy for Patients with Metastatic or Advanced Urothelial Cancer

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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 metastatic or locally advanced urothelial cancer, a type of cancer that affects the bladder and other parts of the urinary system. The study is evaluating the safety and effectiveness of a medication called erdafitinib, which is taken as a film-coated tablet. Erdafitinib is being tested alone and in combination with another medication called cetrelimab, which is given as an infusion into a vein. Additionally, the study is exploring the combination of erdafitinib and cetrelimab with chemotherapy drugs, cisplatin or carboplatin, which are also administered through an intravenous drip.

The purpose of this study is to understand how these treatments work in the body, how they are processed and eliminated, and to determine their safety and potential benefits for patients with this type of cancer. The study is divided into two phases. In the first phase, the focus is on finding the best dose and schedule for using erdafitinib with cetrelimab, and with chemotherapy. The second phase aims to evaluate the safety and effectiveness of erdafitinib alone and in combination with cetrelimab in patients who cannot receive cisplatin and have specific changes in their FGFR genes, which are involved in cell growth and division.

Participants in the study will receive the study medications and will be monitored for any side effects and how well the cancer responds to the treatment. The study will help researchers gather important information about these treatment options for urothelial cancer, potentially leading to new ways to manage the disease.

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 assessment
Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes a review of medical history and a physical examination.
A pregnancy test is required for women of childbearing potential within 7 days before the first dose of the study drug.
Step 2
Phase 1b: dose escalation
The purpose of this phase is to determine the safe dosage of erdafitinib in combination with cetrelimab and to identify the recommended dose for the next phase.
Participants receive erdafitinib as a film-coated tablet taken orally. The dosage and schedule are adjusted based on individual tolerance.
Participants also receive cetrelimab as a solution for infusion administered intravenously.
Step 3
Combination with chemotherapy
In this step, erdafitinib and cetrelimab are combined with chemotherapy drugs, either carboplatin or cisplatin, administered via intravenous drip.
The goal is to assess the safety and determine the appropriate dosage when combined with chemotherapy.
Step 4
Phase 2: dose expansion
This phase evaluates the safety and effectiveness of erdafitinib alone and in combination with cetrelimab in patients who cannot receive cisplatin.
Participants continue to receive erdafitinib orally and cetrelimab intravenously, with adjustments based on the findings from Phase 1b.
Step 5
Monitoring and follow-up
Throughout the trial, regular monitoring is conducted to assess the response to treatment and any side effects.
Participants undergo imaging tests to measure disease progression according to specific criteria.

Who can join the trial?

10 criteria

Must be **18 years or older**.
Women who can have children must have a **negative pregnancy test** before starting the study.
Must have a **type of bladder cancer** called transitional cell carcinoma. Other types of this cancer are also acceptable.
Must have **metastatic or locally advanced urothelial cancer**, which means the cancer has spread or is in an advanced stage.
Must have a **gene fusion or mutation** in the tumor, which is a specific change in the genes.
Must have **measurable disease** as seen in medical imaging tests.
For some parts of the study, must have had no prior treatment for metastatic cancer, while for others, any number of previous treatments is allowed. **Kidney function** must be at a certain level to participate.
Must have a certain level of **physical health** as measured by the ECOG Performance Status, which is a scale to assess how the disease affects daily living abilities.
Must have **adequate organ function** at the start of the study.
Women and men who can have children must agree to use **effective birth control** during the study and for 5 months after the last dose of the study drug. This includes using methods like implants, IUDs, or hormonal pills. They must also agree not to donate eggs or sperm during this time.

Who cannot join the trial?

4 criteria

Patients who have had previous treatment for their metastatic or locally advanced urothelial cancer cannot participate. This means if you have already received systemic therapy, you are not eligible.
Patients with certain changes in their FGFR gene are not eligible. The FGFR gene is a part of your DNA that can affect how cells grow.
Patients who are not able to receive cisplatin chemotherapy are excluded. Cisplatin is a type of medication used to treat cancer.
Patients who are considered part of a vulnerable population are not eligible. This means people who might need extra protection or care.

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Hospital Universitario Fundacion Jimenez Diaz
Madrid, Spain

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Investigated drugs

Erdafitinib
is a medication being studied for its potential to treat metastatic or locally advanced urothelial cancer. It works by targeting specific genetic alterations in the cancer cells, which may help to slow down or stop the growth of the cancer. In this trial, erdafitinib is being tested both on its own and in combination with other treatments to determine its safety and effectiveness.
Cetrelimab
is an investigational drug that is being tested in combination with erdafitinib. It is designed to help the immune system recognize and attack cancer cells more effectively. The combination of cetrelimab with erdafitinib aims to enhance the overall treatment effect against urothelial cancer.
Cisplatin
is a type of chemotherapy used in this study. It works by damaging the DNA of cancer cells, which can lead to their death. Cisplatin is being combined with erdafitinib and cetrelimab to see if this combination can improve treatment outcomes for patients with urothelial cancer.
Carboplatin
is another chemotherapy drug included in the trial. Similar to cisplatin, it targets the DNA of cancer cells to prevent them from growing and dividing. Carboplatin is used in combination with erdafitinib and cetrelimab to evaluate its effectiveness in treating urothelial cancer.

What is already known about the treatment

Erdafitinib – Erdafitinib is administered orally and is currently being studied in clinical trials for its safety and effectiveness in treating metastatic or locally advanced urothelial cancer. It is primarily indicated for patients with specific genetic alterations in the FGFR gene. The medication works by inhibiting the activity of the fibroblast growth factor receptor (FGFR), which plays a role in cell growth and division. Erdafitinib is classified as a tyrosine kinase inhibitor, a type of targeted cancer therapy.

Investigated diseases

Metastatic or Locally Advanced Urothelial Cancer – This is a type of cancer that begins in the urothelial cells lining the bladder, ureters, or other parts of the urinary tract. When it is described as metastatic, it means the cancer has spread to other parts of the body beyond its original site. Locally advanced indicates that the cancer has grown into nearby tissues or lymph nodes but has not yet spread to distant organs. The disease often progresses by invading surrounding tissues and can eventually affect other organs if it becomes metastatic. Symptoms may include blood in the urine, frequent urination, and pain during urination. The progression and symptoms can vary depending on the extent and location of the cancer spread.