Study comparing enfortumab vedotin versus chemotherapy combination (docetaxel, paclitaxel, vinflunine) in patients with previously treated advanced or metastatic bladder cancer

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What is this study about?

This study focuses on patients with locally advanced or metastatic urothelial cancer, which is a type of cancer that develops in the urinary system. The research compares two treatment approaches: a medication called enfortumab vedotin versus standard chemotherapy drugs including vinflunine, docetaxel, or paclitaxel. All medications are given through intravenous administration (into a vein).

The main purpose of this research is to determine if enfortumab vedotin helps patients live longer compared to traditional chemotherapy treatments. The study is designed for patients whose cancer has continued to grow or spread after receiving previous treatments, including both platinum-based chemotherapy and immunotherapy.

During the study, patients will be randomly assigned to receive either enfortumab vedotin or one of the standard chemotherapy medications. The treatment will continue as long as it is helping the patient and side effects remain manageable. Throughout the study, doctors will monitor patients’ overall health, perform regular medical examinations, and evaluate how well the treatment is working.

1 Initial assessment

Before treatment begins, you will undergo laboratory tests to check your: blood cell counts, liver function, kidney function, and other health parameters

Your doctor will evaluate your overall physical condition using the ECOG performance status scale (a measure of your ability to perform daily activities)

A tissue sample from your tumor will be sent to a central laboratory for analysis

2 Treatment assignment

You will be randomly assigned to receive either enfortumab vedotin or standard chemotherapy (vinflunine, docetaxel, or paclitaxel)

All medications will be given through an intravenous infusion (directly into your vein)

3 Treatment period

Your treatment will continue as long as it is providing benefit and you are not experiencing unacceptable side effects

Regular assessments will track changes in your cancer using imaging scans

Your doctor will monitor your health status and any side effects throughout the treatment

4 Quality of life assessment

Throughout the study, you will complete questionnaires about your quality of life and health status

These assessments use standard forms called QLQ-C30 and EQ-5D-5L

5 Follow-up period

After completing treatment, you will have regular follow-up visits to monitor your health

The study will continue until February 2025

Who Can Join the Study?

You must sign an informed consent form approved by the ethics committee before any study procedures
You must be legally an adult according to local regulations
You must have confirmed urothelial cancer (cancer of the urinary system lining)
Your cancer must have progressed during or after treatment with immunotherapy (treatment that helps your immune system fight cancer)
You must have previously received treatment with platinum chemotherapy (cisplatin or carboplatin)
Your cancer must be advanced or spread to other parts of the body
A tumor tissue sample must be available for laboratory testing
You must have good physical function (ECOG score of 0 or 1, meaning you can perform daily activities)
Your blood tests must show:
– Adequate white blood cell count
– Adequate platelet count
– Adequate hemoglobin level
– Acceptable liver function
– Acceptable kidney function
For women who can become pregnant:
– Must have a negative pregnancy test
– Must use effective birth control during the study and for 6 months after
– Must not breastfeed during the study and for 6 months after
For men with partners who can become pregnant:
– Must use condoms during the study and for 6 months after
– Partner must use effective birth control
– Must not donate sperm during this time
You must not participate in other clinical trials while in this study

Who Cannot Join the Study?

History of severe allergic reactions to any medications
Active brain or spinal cord metastases (cancer that has spread to brain/spine) that are not treated and stable
Significant heart problems including:
- Heart failure
- Heart attack within past 6 months
- Irregular heartbeat requiring medication
Active infection requiring systemic treatment (medications that affect entire body)
Other active cancers requiring treatment (except non-melanoma skin cancer or localized prostate cancer)
Any major surgery within 4 weeks before starting the study
Pregnancy or breastfeeding
Serious medical conditions that could interfere with study participation
Current participation in other clinical trials
Unable to swallow oral medications
Known HIV infection, active hepatitis B, or active hepatitis C
History of organ transplant requiring immunosuppression (medications that lower immune system function)

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

No sites found in this category

Other Sites

Site Name	City	Country	Status
Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E.	Porto	Portugal

Trial status

Country	Status	Recruitment Start
Portugal	Not recruiting	27.06.2018
Spain	Not recruiting	27.06.2018

Trial locations

Investigated drugs:

Enfortumab vedotin is a medication designed to treat advanced bladder cancer (urothelial cancer). It works by targeting cancer cells with a specific protein on their surface, delivering a drug that helps kill these cancer cells. This medication is given through an intravenous (IV) infusion.

Standard Chemotherapy refers to traditional cancer-fighting drugs that work by killing rapidly dividing cells in the body. In this trial, it serves as a comparison treatment to enfortumab vedotin. Chemotherapy is typically administered through an IV infusion and is a well-established treatment for various types of cancer, including bladder cancer.

Investigated diseases:

Bladder transitional cell carcinoma

Urothelial Cancer – A type of cancer that begins in the urothelial cells, which line the urinary system, including the bladder, urethra, ureters, and renal pelvis. The disease typically starts in the bladder’s inner lining and can grow into deeper layers of the bladder wall. When described as locally advanced, it means the cancer has grown into nearby tissues or lymph nodes. In metastatic cases, the cancer has spread beyond its original location to other parts of the body. The disease often develops gradually, with the first signs being blood in urine or changes in urination patterns. Urothelial cancer can affect both men and women, though it is more common in older adults.

Trial ID:

2024-517571-20-00

Protocol code:

7465-CL-0301

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study comparing enfortumab vedotin versus chemotherapy combination (docetaxel, paclitaxel, vinflunine) in patients with previously treated advanced or metastatic bladder cancer

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?