Not recruiting

Study on Enfortumab Vedotin and Pembrolizumab for Patients with Advanced Urothelial Cancer

Verified siteRegistered drugNo placebo

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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 urothelial cancer, a type of cancer that occurs in the urinary system, including the bladder. The study is investigating the use of a medication called enfortumab vedotin, which is being tested both as a standalone treatment and in combination with other cancer therapies. One of the combinations being explored includes pembrolizumab, a medication that helps the immune system fight cancer. The purpose of the study is to assess the safety and effectiveness of these treatments in patients with urothelial cancer.

Participants in the study will receive the treatments through an intravenous infusion, which means the medication is delivered directly into the bloodstream through a vein. The study will monitor how well the treatments work in reducing the size of the cancer and how safe they are for patients. Some participants may receive a placebo, which is a substance with no active medication, to compare the effects of the actual treatments.

The study will take place over a period of time, during which participants will have regular check-ups and assessments to track their progress. The goal is to gather information on how these treatments can help manage urothelial cancer and improve patient outcomes. This research is important for developing new and effective ways to treat this type of cancer.

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 related to the type and stage of urothelial cancer.
Participants must have a confirmed diagnosis of locally advanced or metastatic urothelial cancer or muscle invasive bladder cancer.
Step 2
Treatment initiation
Treatment begins with the administration of enfortumab vedotin and pembrolizumab.
Both medications are given through an intravenous infusion, which means they are delivered directly into the bloodstream through a vein.
Step 3
Medication details
Enfortumab vedotin is provided in two forms: Padcev 20 mg and Padcev 30 mg, both as a powder for solution.
Pembrolizumab is provided as a 25 mg/mL concentrate for solution.
Step 4
Treatment schedule
The treatment schedule involves regular infusions, with specific dosages and frequency determined by the study protocol.
The duration of treatment is based on the study's objectives and the participant's response to the medication.
Step 5
Monitoring and assessments
Participants undergo regular monitoring to assess the safety and effectiveness of the treatment.
Assessments include measuring the response of the cancer to the treatment using imaging and other diagnostic tools.
Step 6
Completion of treatment
The study is estimated to conclude by August 31, 2026.
Participants will have follow-up visits to monitor their health and any long-term effects of the treatment.

Who can join the trial?

16 criteria

Must have **urothelial cancer**, which is a type of cancer that affects the lining of the urinary system.
For certain groups, the cancer must be **locally advanced** (spread to nearby areas) or **metastatic** (spread to other parts of the body).
Must have a **histologically documented** diagnosis, meaning the cancer has been confirmed by examining tissue under a microscope.
For some groups, must be eligible for **platinum-based chemotherapy** (a type of cancer treatment) and have not received prior treatment for advanced cancer.
For other groups, must be ineligible for **cisplatin-based chemotherapy** due to specific health conditions like reduced kidney function or heart problems.
Must not have received certain types of cancer treatment within the last 12 months.
For muscle invasive bladder cancer, the cancer must be confirmed and primarily urothelial in nature.
Must be ineligible for **cisplatin** if you have muscle invasive bladder cancer.
Must not have received prior systemic treatment, chemoradiation, or radiation therapy for muscle invasive bladder cancer.
Must have an **ECOG performance status** of 0, 1, or 2, which is a scale that measures how well you can perform daily activities.
Must have a life expectancy of at least 3 months.
Must provide tumor samples for analysis before starting the study treatment.
Must be eligible for a surgical procedure called **radical cystectomy** and **pelvic lymph node dissection**.
Must be eligible for **pembrolizumab**, a type of cancer treatment, for certain groups.
Must be between the ages of 18 and 65.
Both male and female participants are eligible.

Who cannot join the trial?

8 criteria

Patients who have a different type of cancer other than urothelial cancer cannot participate. Urothelial cancer is a type of cancer that affects the lining of the bladder and other parts of the urinary system.
Patients who are not within the specified age range for the study cannot participate. The study is open to certain age groups only.
Patients who are not able to provide informed consent or understand the study requirements cannot participate. Informed consent means understanding the details of the study and agreeing to take part.
Patients who have certain medical conditions that might interfere with the study cannot participate. These conditions are not specified but could affect the study's results.
Patients who are pregnant or breastfeeding cannot participate. This is to ensure the safety of both the mother and the baby.
Patients who are currently participating in another clinical trial cannot participate. This is to avoid any interference with the study results.
Patients who have had a recent major surgery or are recovering from surgery cannot participate. This is to ensure the patient's safety and recovery.
Patients who have a history of severe allergic reactions to the study drugs cannot participate. Severe allergic reactions can be dangerous and need to be avoided.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Centre Hospitalier Lyon Sud
Verified
Pierre Benite, France
Institut De Cancerologie De Lorraine
Responsive
Vandoeuvre Les Nancy, France

Trial locations

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Investigated drugs

Enfortumab Vedotin
is a medication being studied for its potential to treat urothelial cancer. It is used either on its own or in combination with other cancer treatments. The goal is to see how safe and tolerable it is for patients, as well as how effective it is in reducing or eliminating cancer cells.
Pembrolizumab
is another medication involved in this study. It is used in combination with enfortumab vedotin to see if the two drugs together can improve treatment outcomes for patients with urothelial cancer. Pembrolizumab works by helping the immune system recognize and attack cancer cells.

What is already known about the treatment

Enfortumab Vedotin – This medication is administered intravenously and is currently being studied for its effectiveness in treating urothelial cancer, either alone or in combination with other cancer therapies. It is in the clinical trial phase, with ongoing research to determine its safety and effectiveness. The main therapeutic indication is for locally advanced or metastatic urothelial cancer. Enfortumab vedotin works by targeting a protein on cancer cells, delivering a toxic agent that disrupts the cells' ability to grow and divide. It is classified as an antibody-drug conjugate, combining a monoclonal antibody with a cytotoxic drug to specifically target and kill cancer cells.

Investigated diseases

Urothelial Cancer – Urothelial cancer is a type of cancer that begins in the urothelial cells lining the bladder and other parts of the urinary tract. It is the most common form of bladder cancer and can also occur in the ureters and renal pelvis. The disease often starts in the bladder's inner lining and can progress to invade deeper layers of the bladder wall. As it advances, it may spread to nearby tissues and organs, including the lymph nodes and other parts of the body. Symptoms may include blood in the urine, frequent urination, and pain during urination. The progression of the disease can vary, with some cases remaining superficial while others become more invasive.