Study of BT8009 Alone or with Pembrolizumab for Patients with Advanced or Metastatic Bladder Cancer

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What is this study about?

This clinical trial is focused on studying treatments for urothelial cancer, which is a type of cancer that affects the bladder and other parts of the urinary system. The study is investigating a new treatment called BT8009, which is being tested both on its own and in combination with other medications. These medications include pembrolizumab, cisplatin, carboplatin, gemcitabine, and avelumab. The purpose of the study is to evaluate how effective BT8009 is in treating this type of cancer, either alone or when used with other drugs.

Participants in the study will receive treatments through an infusion, which means the medication is given directly into the bloodstream. The study is divided into different groups, or cohorts. In one group, BT8009 will be combined with pembrolizumab and compared to standard chemotherapy treatments, which may include cisplatin or carboplatin with gemcitabine, and possibly avelumab. In another group, BT8009 will be given alone to see how well it works by itself. The study will monitor how the cancer responds to these treatments over time.

The trial aims to understand how these treatments affect the progression of the cancer and the overall response of the participants. The study will last for several months, with regular check-ups to assess the effectiveness of the treatment. Participants will be closely monitored by medical professionals throughout the study to ensure their safety and to gather important data on the treatments being tested.

1 joining the study

Upon joining the study, the participant will be assigned to one of two groups, known as cohorts. Each cohort has a different treatment plan.

2 treatment plan for cohort 1

Participants in cohort 1 will receive a combination of BT8009 and pembrolizumab or chemotherapy. The chemotherapy may include cisplatin or carboplatin with gemcitabine, followed by maintenance treatment with avelumab if indicated.

The medications are administered as a solution for infusion, which means they are given through a vein over a period of time.

3 treatment plan for cohort 2

Participants in cohort 2 will receive BT8009 either alone or in combination with pembrolizumab.

These medications are also administered as a solution for infusion.

4 medication administration

The specific dosage and frequency of each medication will be determined by the study protocol and the participant’s response to treatment.

The duration of treatment will depend on the participant’s progress and the study’s guidelines.

5 monitoring and assessments

Throughout the study, participants will undergo regular assessments to monitor their health and the effectiveness of the treatment.

These assessments may include imaging tests, blood tests, and other evaluations as required by the study protocol.

6 end of treatment

The study is expected to continue until December 31, 2030, but individual participation may end earlier based on the participant’s health and response to treatment.

After completing the treatment phase, participants may have follow-up visits to monitor their long-term health.

Who Can Join the Study?

  • Must be able to understand the study procedures and agree to participate by providing written consent.
  • Must be at least 18 years old.
  • Must have a confirmed diagnosis of locally advanced or metastatic urothelial cancer, which is a type of cancer affecting the urinary system, including the bladder and urethra. If the cancer has mixed types, the main type should be transitional cell cancer.
  • Must have measurable disease, meaning the cancer can be measured using specific criteria. If the cancer was previously treated with radiation, it should show signs of growth to be considered measurable.
  • Must have tumor tissue available for testing, either from a previous sample or a new one.
  • Must have a life expectancy of at least 12 weeks.
  • Must have adequate organ function, which includes:
    • Normal levels of bilirubin, a substance made by the liver, unless you have a specific condition called Gilbert disease.
    • Normal levels of albumin, a protein in the blood.
    • Normal levels of liver enzymes (AST and ALT) unless there are liver metastases, which means the cancer has spread to the liver.
    • Normal levels of alkaline phosphatase unless there are liver or bone metastases.
    • A good kidney function, measured by a test called eGFR.
  • Must have normal blood clotting times unless taking medication to prevent blood clots, in which case the levels should be within the safe range for that medication.
  • Women who can have children must have a negative pregnancy test before starting the study.
  • Women and men with partners who can have children must agree to use effective birth control methods during the study and for a certain period after the last dose of study medication.
  • Men must agree not to donate sperm during the study and for a certain period after the last dose of study medication. Women must not breastfeed or donate eggs during the study and for a certain period after the last dose of study medication.

Who Cannot Join the Study?

  • Patients who have a different type of cancer than the one being studied, which is locally advanced or metastatic urothelial cancer.
  • Patients who are not within the specified age range for the study.
  • Patients who are not able to follow the study procedures or attend the required visits.
  • Patients who have other serious health conditions that might interfere with the study treatment.
  • Patients who are pregnant or breastfeeding.
  • Patients who have had another cancer treatment recently that might affect the study results.
  • Patients who have allergies or reactions to the study drugs or similar medications.
  • Patients who are participating in another clinical trial at the same time.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Hospital Universitario De Navarra Pamplona Spain

Other Sites

Site Name City Country Status
Hospital General Universitario Gregorio Maranon Madrid Spain
Hospital Universitario 12 De Octubre Madrid Spain
Fundacion Instituto Valenciano De Oncologia Valencia Spain
Hospital Clinic De Barcelona Barcelona Spain
Hospital Universitario Fundacion Jimenez Diaz Madrid Spain
Universidade De Santiago De Compostela Santiago De Compostela Spain
Hyxnpqzo Uhapjeprnzygf Makpfxi Db Vhpftxszpt Santander Spain
Iznnrltl Cwyzma Douxylwwbahrwqfjr L'hospitalet De Llobregat Spain
Hlauidga Unqdmvvwepwxt Dkglvtkc Donostia / San Sebastian Spain
Hrjxbqag Dg Lc Sljjr Cuxe I Skkl Pzz Barcelona Spain
Ftftjcezo Pekd Lu Ivelikvnyhfhn Bnsdmpcsl Dkr Hwekkatj Uokhitwulzovq Ly Pug Madrid Spain

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

Trial status

Country Status Recruitment Start
Spain Spain
Not yet recruiting
15.04.2024

Trial locations

BT8009 is an experimental medication being studied for its potential to treat urothelial cancer. It is being tested both as a standalone treatment and in combination with other therapies to see how well it works in slowing down or stopping the growth of cancer cells.

Pembrolizumab is a medication that helps the immune system fight cancer. It is used in combination with BT8009 in this study to see if it can improve the effectiveness of the treatment for urothelial cancer.

Cisplatin is a chemotherapy drug used to kill cancer cells. In this study, it is used as part of a combination treatment to compare its effectiveness with other therapies.

Carboplatin is another chemotherapy drug similar to cisplatin. It is used in this study to help determine the best treatment options for patients with urothelial cancer.

Gemcitabine is a chemotherapy medication that works by stopping the growth of cancer cells. It is used in combination with other drugs in this study to evaluate its effectiveness in treating urothelial cancer.

Avelumab is a medication that helps the immune system attack cancer cells. It is used as a maintenance therapy in this study to see if it can help keep the cancer from coming back after initial treatment.

Investigated diseases:

Locally advanced or metastatic 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 locally advanced, the cancer has spread beyond the original site but is still within the nearby tissues or lymph nodes. In the metastatic stage, the cancer has spread to distant parts of the body, such as the liver, lungs, or bones. The disease often progresses through stages, starting from the inner lining of the bladder and potentially moving deeper into the bladder wall and beyond. Symptoms may include blood in the urine, frequent urination, and pain during urination. As the disease advances, it can lead to more severe symptoms and complications depending on the organs affected by metastasis.

Trial ID:
2023-504231-41-00
Protocol code:
BT8009-230
Trial Phase:
Therapeutic use (Phase IV)

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