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 study about?

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.

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.

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.

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.

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.

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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Institut Gustave Roussy	Villejuif	France
Oncopole Claudius Regaud	Toulouse	France
Hospital Universitario De Navarra	Pamplona	Spain

Other Sites

Site Name	City	Country
Complejo Hospitalario Universitario Insular Materno Infantil	Las Palmas De Gran Canaria	Spain
Hospital Clinic De Barcelona	Barcelona	Spain
Hospital Universitario Lucus Augusti	Lugo	Spain
Ojfwndtdlfdjqaewkijntfqdrs	Aalst	Belgium

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	08.05.2018
France	Not recruiting	08.05.2018
Spain	Not recruiting	08.05.2018

Trial locations

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.

Investigated diseases:

Transitional cell carcinoma

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.

Trial ID:

2023-510296-56-00

Protocol code:

42756493BLC3001

Trial Phase:

Therapeutic confirmatory (Phase III)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?