Not recruiting

Study of Futibatinib and Pembrolizumab for Patients with Advanced or Metastatic Bladder, Urethra, or Pelvis Cancer Not Suitable for Platinum Treatment

Verified siteRegistered drug

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 the treatment of Advanced or Metastatic Urothelial Carcinoma, which is a type of cancer that affects the bladder, urethra, or pelvis. The study involves two medications: Futibatinib and Pembrolizumab. Futibatinib, also known by its code name TAS-120, is taken as a film-coated tablet, while Pembrolizumab, sometimes referred to by its code name MK-3475, is administered as a solution for infusion. The purpose of the study is to evaluate how well these medications work together in treating this type of cancer.

Participants in the study will receive both medications over a period of time. The study will monitor the response of the cancer to the treatment, looking for signs of improvement such as a reduction in tumor size or slowing of disease progression. The study will also assess the safety and tolerability of the treatment, keeping track of any side effects experienced by participants. The goal is to determine the effectiveness of the combination of Futibatinib and Pembrolizumab in patients who are not suitable for traditional platinum-based chemotherapy treatments.

Throughout the study, participants will have regular check-ups and assessments to monitor their health and the progress of the treatment. The study aims to provide valuable information on the potential benefits of using these medications together for treating Advanced or Metastatic Urothelial Carcinoma, offering hope for improved outcomes in patients with this challenging condition.

The research process

The trial runs in 6 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, health status, and previous treatments.
A consent form is signed to acknowledge understanding of the study's procedures and potential risks.
Step 2
Initial assessment
An initial assessment is conducted to evaluate health status and establish a baseline for the study.
This includes physical examinations, blood tests, and imaging studies to measure the extent of the disease.
Step 3
Treatment phase
The treatment involves two medications: pembrolizumab and futibatinib.
Pembrolizumab is administered as an intravenous infusion. The dosage is 25 mg/mL, given every three weeks.
Futibatinib is taken orally in the form of film-coated tablets. The dosage and frequency are determined by the study protocol.
Step 4
Monitoring and follow-up
Regular follow-up visits are scheduled to monitor response to treatment and manage any side effects.
These visits include physical exams, blood tests, and imaging studies to assess the disease's progression.
Step 5
End of treatment
The treatment phase continues until the disease progresses, unacceptable side effects occur, or the study ends.
A final assessment is conducted to evaluate the overall response to the treatment.
Step 6
Post-study follow-up
After completing the treatment, follow-up visits may continue to monitor long-term health and any delayed side effects.
These visits help gather data on the overall survival and quality of life after the study.

Who can join the trial?

14 criteria

You must have a confirmed diagnosis of **advanced or metastatic urothelial carcinoma**. This means the cancer has spread beyond its original location.
You should not have received any systemic treatment for advanced metastatic disease. If you had chemotherapy or chemo-radiation before, there must be a gap of more than 12 months since your last treatment.
You must be unable to receive or tolerate **cisplatin**, a type of chemotherapy, due to certain health conditions like kidney disease, hearing problems, or nerve damage.
You need to be willing and able to provide written consent to participate in the trial.
You must be at least 18 years old.
Your **performance status** should be 0 to 1, which means you are fully active or have some symptoms but can still carry out light work.
Your organs must be functioning well, as shown by specific blood test results.
You should have recovered from any side effects of previous treatments for nonmetastatic disease.
You need to provide a sample of your tumor tissue, either from a previous biopsy or a new one.
You must have a measurable disease, meaning the cancer can be measured by scans or tests.
If you are a male, you must agree to use contraception during the study and for at least 6 months after the last dose of treatment.
If you are a female, you must not be pregnant or breastfeeding. If you can have children, you must agree to use contraception during the study and for at least 6 months after the last dose of treatment. You also need to have a negative pregnancy test before starting the treatment.
You must be able to take medications by mouth.
You should be willing and able to attend scheduled visits and follow study procedures.

Who cannot join the trial?

5 criteria

Patients who have received a **platinum-based treatment** before. This refers to a type of chemotherapy that uses drugs containing the metal platinum.
Patients with other types of cancer that are not **advanced or metastatic urothelial carcinoma**. This means the cancer has spread to other parts of the body.
Patients who are part of a **vulnerable population**. This usually includes groups like children, pregnant women, or those unable to give consent.
Patients who are not within the specified **age range** for the study. The study may have specific age requirements.
Patients who have any medical condition that the study doctors believe would make it unsafe for them to 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

Verified
Institut De Cancerologie Strasbourg Europe
STRASBOURG, Alsace, 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

Futibatinib (TAS-120)
is a medication being studied for its potential to treat advanced or metastatic urothelial carcinoma, a type of bladder cancer. It works by targeting specific proteins in cancer cells, which may help to stop the growth and spread of the cancer.
Pembrolizumab
is an immunotherapy drug used in the treatment of various types of cancer. It helps the immune system recognize and attack cancer cells more effectively. In this study, it is being combined with futibatinib to see if the combination is more effective in treating urothelial carcinoma than either treatment alone.

What is already known about the treatment

Futibatinib
This medication is administered orally and is currently being studied in clinical trials for its effectiveness in treating advanced or metastatic urothelial carcinoma. It is not yet widely used in standard medical practice but shows promise in ongoing research. Futibatinib works by inhibiting specific enzymes involved in cancer cell growth, thereby slowing down or stopping the progression of the disease. It is classified as a kinase inhibitor, targeting molecular pathways that are crucial for cancer cell survival.
Pembrolizumab
This medication is given through intravenous infusion and is an established treatment in the medical field, particularly for various types of cancer, including advanced or metastatic urothelial carcinoma. It is an immune checkpoint inhibitor that helps the immune system recognize and attack cancer cells more effectively. Pembrolizumab blocks a specific protein on cancer cells, allowing the immune system to better target and destroy them. It belongs to the class of drugs known as monoclonal antibodies.

Investigated diseases

Advanced or Metastatic Urothelial Carcinoma – This is a type of cancer that begins in the urothelial cells lining the bladder and can spread to other parts of the body. In its advanced or metastatic stages, the cancer has moved beyond the bladder to nearby tissues or distant organs. The disease often progresses by invading surrounding tissues and can spread through the lymphatic system or bloodstream. Symptoms may include blood in the urine, frequent urination, and pain during urination. As the disease advances, it may cause more systemic symptoms like weight loss and fatigue. The progression of the disease can vary, with some patients experiencing rapid spread while others may have a slower progression.