Not yet recruiting

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

Fast replyRegistered 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 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.

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, the participant will be assigned to one of two groups, known as cohorts. Each cohort has a different treatment plan.
Step 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.
Step 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.
Step 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.
Step 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.
Step 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 trial?

15 criteria

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.
check
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 trial?

8 criteria

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.

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
Fundacion Instituto Valenciano De Oncologia
Valencia, Spain
Responsive
Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Paz
Madrid, Spain
Verified
Hospital Clinic De Barcelona
Barcelona, Spain

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not yet 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

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.

What is already known about the treatment

BT8009 – BT8009 is an investigational medication currently being studied in clinical trials for the treatment of locally advanced or metastatic urothelial cancer. It is administered as an intravenous infusion, either as a monotherapy or in combination with pembrolizumab. The main therapeutic indication is to improve progression-free survival and overall response rate in patients with this type of cancer. BT8009 works by targeting specific proteins on cancer cells, disrupting their growth and survival. It is classified as an antibody-drug conjugate, a type of targeted cancer therapy.

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.