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

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What is this study about?

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.

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.

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.

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.

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.

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.

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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name City Country Status
Institut De Cancerologie Strasbourg Europe STRASBOURG, Alsace France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Not recruiting
17.05.2021

Trial locations

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.

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.

Trial ID:
2024-513760-26-00
Protocol code:
TAS-120-203
Trial Phase:
Therapeutic exploratory (Phase II)

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