A Study to Find Out if Enfortumab Vedotin Given With Pembrolizumab Helps People With Muscle-invasive Bladder Cancer Keep Their Bladder
This study is exploring a new way to treat muscle-invasive bladder cancer, which is a type of bladder cancer that has spread into the muscle wall. The usual treatment often involves chemotherapy followed by surgery to remove the bladder, which can greatly change a person's life. This study wants to see if two medicines, Enfortumab Vedotin and Pembrolizumab, can help people avoid this major surgery and keep their bladder. These medicines have shown promise in other bladder cancer cases. The main goals are to check how many people respond well to this treatment and still have their bladder after two years. It's for adults who could have bladder removal surgery but are interested in other options.
במבט חטוף
על מה המחקר הזה?
When bladder cancer grows into the muscle wall, it's called muscle-invasive bladder cancer. The standard treatment for this often means having chemotherapy first, then a big operation to remove the whole bladder. This surgery, called a radical cystectomy, can have a major impact on a person's life, leading to long-term changes. For some people, chemotherapy isn't an option, or they may not want to have their bladder removed. Because of this, doctors are always looking for new treatments that might allow people to keep their bladder.
This study is looking at two medicines called Enfortumab Vedotin and Pembrolizumab. We already know that these medicines can help people with more advanced bladder cancer. They've also shown good results for people with muscle-invasive bladder cancer who couldn't have chemotherapy, when given before and after surgery. However, some people might not be able to have, or might choose not to have, bladder removal surgery at all. This study aims to find out if these medicines can help people avoid surgery and keep their bladder.
The main aims of this study are to see how many people continue to respond well to the combination of Enfortumab Vedotin and Pembrolizumab, and crucially, how many people still have their bladder after two years. This is especially important for those who respond well to the medicines, as they might be able to continue this treatment instead of having surgery.
נקודות עיקריות
- This study is for a specific type of bladder cancer that has spread into the muscle.
- It tests two new medicines to see if they can help people keep their bladder instead of having surgery.
- The usual treatment involves chemotherapy and surgery to remove the bladder.
- You'll receive regular treatments and check-ups over several months or longer.
- There's a chance to avoid major surgery, but there might be side effects from the medicines.
- You can stop participating at any time if you change your mind.
מי עשוי להיות זכאי?
This study is for adults who have been diagnosed with muscle-invasive bladder cancer. This means your cancer has grown into the muscle layer of your bladder. You must also be well enough that doctors would consider you suitable for surgery to remove your bladder.
There are some reasons why you wouldn't be able to join the study. For example, if you have nerve damage (like numbness or weakness) that is moderate or severe, or if you have certain other types of cancer. You also can't take part if your diabetes isn't well controlled (with a specific blood sugar level) or if you've had an organ transplant.
האם מחקר זה יכול להתאים לך?
ענה על השאלות המהירות הללו כדי לבדוק אם אתה עשוי להיות זכאי. זהו מדריך בלבד — צוות המחקר מקבל את ההחלטה הסופית.
- Do I have bladder cancer that has grown into the muscle wall?
- Am I well enough to have surgery to remove my bladder, if needed?
- Do I have any nerve damage (numbness/weakness) that is moderate or severe?
- Is my diabetes well-controlled, if I have it?
- Have I had an organ transplant?
- Do I have any other significant medical conditions listed by the study team?
מה כרוך בהשתתפות?
If you join this study, you will receive two medicines. One is called Enfortumab Vedotin, which you'll get as a drip into your arm on the 1st and 8th day of a 21-day cycle (that's every three weeks). The other medicine, Pembrolizumab, will also be given as a drip on the 1st day of every 21-day cycle. You'll have regular check-ups at the clinic, where doctors will monitor your health and do safety checks. They'll also check your tumours at some visits to see how they're responding.
You'll continue to receive these treatments unless your cancer doesn't get better after nine cycles, or if it gets worse. Treatment would also stop if you can't cope with the side effects, if you start other cancer treatments, or if you or your doctor decide it's best to stop. If treatment stops because your cancer isn't improving or gets worse, you might then have bladder surgery, radiotherapy, or chemotherapy.
After you stop the study treatment, you'll still have follow-up visits to check on your health. You'll also have scans every 12 weeks (3 months) for the first two years to check your cancer. If your cancer remains stable, these scans will then happen every 24 weeks (6 months) for up to five years. If your cancer does get worse at any point, the scans will stop, but you'll have telephone health checks every three months.
סיכונים ותועלות פוטנציאליים
מיקומים (66)
- Arkansas Urology Associatesמיקוד מאומתליטל רוק, ארצות הברית· גיוס
- Stanford University School of Medicineמיקוד מאומתסטנפורד, ארצות הברית· גיוס
- University of Illinois College of Medicine - UIC Cancer Centerמיקוד מאומתשיקגו, ארצות הברית· גיוס
- Accellacare of Dulyמיקוד מאומתLisle, United States· גיוס
- Indiana University School of Medicine - Simon Cancer Centerמיקוד מאומתאינדיאנפוליס, ארצות הברית· גיוס
- The University of Kansas Cancer Centerמיקוד מאומתWestwood, United States· גיוס
- Karmanos Cancer Instituteמיקוד מאומתדטרויט, ארצות הברית· גיוס
- Profound Research LLC at Michigan Hematology and Oncology Consultantsמיקוד מאומתRoyal Oak, United States· גיוס
- Sidney Kimmel Comprehensive Cancer Center (SKCCC) Cherry Hillמיקוד מאומתCherry Hill, United States· גיוס
- Sidney Kimmel Comprehensive Cancer Center (SKCC) Washington Townshipמיקוד מאומתWashington Township, United States· גיוס
- NYU Langone Urology Associatesמיקוד מאומתניו יורק, ארצות הברית· גיוס
- Centers for Advanced Urology, LLPמיקוד מאומתBala-Cynwyd, United States· גיוס
שאלות נפוצות
What is muscle-invasive bladder cancer?
It's a type of bladder cancer where the cancer cells have grown into the muscle wall of your bladder.
What are Enfortumab Vedotin and Pembrolizumab?
These are two different medicines that are being tested together to see if they can treat bladder cancer without the need for surgery.
מדוע מחקר זה חשוב?
The study aims to find new ways to treat bladder cancer that allow people to keep their bladder, avoiding a major surgery that can significantly change their life.
How long would I be on the study treatment?
You would continue treatment as long as your cancer is improving or stable, you are tolerating the treatment, and you or your doctor wish to continue, or until your cancer gets worse.
האם אני יכול לעזוב את המחקר אם אשנה את דעתי?
Yes, you can decide to stop participating in the study at any time, for any reason. Your decision will not affect your usual medical care.
כיצד לגלות עוד
Astellas Pharma Global Development, Inc.
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