Active not recruitingPHASE3INTERVENTIONAL

Enfortumab Vedotin and Pembrolizumab vs. Chemotherapy Alone in Untreated Locally Advanced or Metastatic Urothelial Cancer

This research study aims to find out if a combination of two medicines, enfortumab vedotin and pembrolizumab, is a more effective treatment for a type of bladder cancer called urothelial cancer. This is for patients whose cancer has grown or spread beyond the bladder and hasn't been treated with other medicines yet. We'll be comparing these new drugs to the standard chemotherapy treatments that are usually given for this condition. The study will help doctors understand which treatment works best, considering factors like how long the treatment lasts and any side effects. It's a big step in finding better ways to help people with this type of advanced cancer.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Astellas Pharma Global Development, Inc.

Enrolment target

886

Start

30 Mar 2020

Estimated completion

01 Mar 2028

Urothelial Cancer

Results

Results from this study

Posted September 2024

Results have been published for this study.

Primary outcome

Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1 by Blinded Independent Central Review (BICR)

PFS was defined as the time from date of randomization to first documentation of disease progression (PD), or to death due to any cause, whichever occurred first. PD: at least a 20 percent (%) increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeter (mm). PD could also be unequivocal progression of non-target lesions or the presence of unequivocal new lesions. Kaplan-Meier method was used for analysis.

Full results on the registry

What is this study about?

This study is designed to explore whether a new combination of treatments could be better for people with advanced urothelial cancer, which is a type of cancer that starts in the lining of the bladder and other parts of the urinary system. "Advanced" means the cancer has either grown locally into surrounding tissues or spread to other parts of the body. If you haven't received medication for this advanced cancer before, this study might be relevant to you.

The research compares two different treatment approaches. One group of patients will receive a combination of two drugs: enfortumab vedotin and pembrolizumab. The other group will receive standard chemotherapy, which commonly involves drugs like cisplatin or carboplatin, usually with gemcitabine. The aim is to see if the new drug combination can offer a more effective way to control the cancer compared to current standard treatments. This includes looking at how well the cancer responds to treatment and any potential side effects.

Enfortumab vedotin works by targeting cancer cells and delivering a powerful anti-cancer medicine directly to them, while pembrolizumab is an immunotherapy that helps your own immune system fight the cancer. The chemotherapy drugs work by killing fast-growing cells, including cancer cells. By comparing these different approaches, doctors hope to identify which treatment path offers the most benefit to patients with previously untreated advanced urothelial cancer.

Key takeaways

Compares new drug combination (enfortumab vedotin + pembrolizumab) to standard chemotherapy for advanced urothelial cancer.
For patients whose cancer has not been treated with medication before.
Aims to find out which treatment is more effective and tolerable.
Participation involves regular hospital visits for treatment and monitoring.
You have the right to withdraw from the study at any time.

Who may be eligible?

To join this study, you would need to have been diagnosed with advanced urothelial cancer that doctors can see and measure. This means the cancer shouldn't be able to be completely removed by surgery, or it has spread. You also shouldn't have had any medication for this advanced cancer before, though some exceptions apply, for example, if you had chemotherapy for an earlier stage of cancer and it's been more than a year since it was completed.

Your doctor would need to think you are well enough to receive standard chemotherapy drugs like cisplatin or carboplatin. You also can't have received certain types of immunotherapy or drugs similar to enfortumab vedotin in the past. Your overall health and blood test results would be checked to make sure you are suitable for the study.

Anyone aged 18 or over, male or female, can be considered. However, if you have conditions like uncontrolled diabetes, or if doctors estimate your life expectancy is less than 12 weeks, you wouldn't be able to take part. It's important to discuss all your medical history with the study team.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Have you been diagnosed with advanced urothelial cancer that can be measured?
Have you not received any prior drug treatment for your advanced urothelial cancer?
Are you considered well enough by your doctor to receive standard chemotherapy?
Do you have adequate blood and organ function, as determined by medical tests?
Are you 18 years of age or older?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would be randomly assigned to receive either the new drug combination (enfortumab vedotin and pembrolizumab) or the standard chemotherapy. This is like flipping a coin for fairness. Both treatments are given intravenously, meaning through a drip into your arm.

The enfortumab vedotin may be given for an open-ended period, as long as it's helping and you're tolerating it. Pembrolizumab would be given for up to 35 treatment cycles, or until symptoms or side effects make it necessary to stop. If you're in the chemotherapy group, you would typically receive up to 6 cycles of treatment. Throughout the study, you'll have regular hospital visits for assessments, blood tests, and scans to monitor your health and how the treatment is working. The exact number and frequency of visits will be explained by the study team. You can stop participating in the study at any time.

Potential risks and benefits

Taking part in this study could potentially offer you access to new treatments before they are widely available, which might be more effective than current options. However, there's no guarantee that the treatment will work for you, and like all medicines, there are potential side effects and risks associated with both the new drugs and standard chemotherapy. These will be fully explained to you before you decide to join. It's important to remember that you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (260)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Ironwood Cancer & Research Centers - Chandler
Verified postcode
Chandler, United States
Arizona Oncology Associates PD - HOPE
Verified postcode
Tucson, United States
Providence St Joseph Medical Center
Verified postcode
Burbank, United States
City of Hope National Medical Center
Verified postcode
Duarte, United States
University of California Los Angeles Medical Center
Verified postcode
Los Angeles, United States
University of California Irvine - Newport
Verified postcode
Orange, United States
Rocky Mountain Cancer Centers - Aurora
Verified postcode
Aurora, United States
University of Colorado Hospital / University of Colorado
Verified postcode
Aurora, United States
Cancer Centers of Colorado - Denver
Verified postcode
Denver, United States
Yale Cancer Center
Verified postcode
New Haven, United States
Eastern CT Hematology and Oncology Associates
Verified postcode
Norwich, United States
Lombardi Cancer Center / Georgetown University Medical Center
Verified postcode
Washington D.C., United States

Common questions

What is urothelial cancer?

Urothelial cancer is a type of cancer that begins in the cells lining your bladder, ureters, or renal pelvis (parts of your urinary system).

What does 'locally advanced or metastatic' mean?

This means the cancer has either grown into nearby tissues (locally advanced) or has spread to other parts of your body (metastatic).

Will I definitely get the new drugs?

Participants are randomly assigned to either receive the new drug combination or standard chemotherapy. It's like a lottery; you won't get to choose which one you receive.

What happens if the treatment isn't working?

Your doctors will regularly monitor how well the treatment is working and your general health. If the treatment isn't effective or if you experience significant side effects, they would discuss options with you, including stopping the study treatment.

Can I stop participating in the study if I change my mind?

Yes, you are free to withdraw from the study at any time, for any reason, and this will not affect your ongoing medical care.