A Substudy of Investigational Agents in Programmed Cell Death-1/Ligand 1 (PD-1/L1) Refractory Locally Advanced or Metastatic Urothelial Carcinoma (mUC) (MK-3475-04A)
This study is for people with advanced bladder cancer, or cancer in the kidney, ureter, or urethra, that has spread and needs new treatment options. It's designed to test different new medicines, sometimes alongside an existing drug called pembrolizumab. The study is specifically for patients whose cancer has not responded well to certain immune-boosting treatments (called PD-1/L1 inhibitors) in the past. The main goal is to find out if these new investigational drugs can help shrink the cancer or stop it from growing. Participants will be assigned to different treatment groups, and doctors will carefully monitor their health and how the treatment affects their cancer. It's a way to explore better ways to fight advanced urothelial carcinoma when standard options are no longer effective.
At a glance
What is this study about?
This study is looking for new ways to treat a type of cancer called urothelial carcinoma. This cancer can start in the bladder, but can also be found in the tubes that carry urine, like the ureters and renal pelvis, or the urethra. Sometimes, the cancer can be advanced, meaning it has grown quite a bit, or it might have spread to other parts of the body (this is called metastatic cancer).
The important thing about this study is that it's for people whose cancer hasn't responded well to a common type of treatment called PD-1/L1 inhibitors. These are medicines that work by boosting your body's own immune system to fight the cancer. When these treatments don't work or stop working, doctors need new options. This study aims to find those new options by testing different investigational drugs.
Think of this study as a way to explore new paths when the usual ones are blocked. It's part of a larger research effort to find better and more effective treatments for this specific type of cancer. Doctors will be trying out new medicines, sometimes combined with an existing one, to see how well they work and if they can offer hope to patients who need other choices.
Key takeaways
- This study is for advanced urothelial cancer that hasn't responded to previous immune treatments.
- It tests new, investigational drugs, sometimes alongside an existing one.
- You would need to provide a cancer tissue sample (biopsy).
- Regular monitoring and clinic visits are part of taking part.
- The goal is to find new and better treatment options.
- Participation is voluntary, and you can withdraw at any time.
Who may be eligible?
To join this study, you would need to have a confirmed diagnosis of urothelial cancer that is either advanced in a local area or has spread to other parts of the body. This cancer could be in your bladder, kidney, ureter, or urethra. A key requirement is that your cancer has not responded to previous treatments that work by boosting your immune system (called PD-1/L1 inhibitors).
You would also need to provide a sample of your cancer tissue. This can be a sample that was taken previously and saved, or it might involve taking a new small tissue sample (biopsy) from one of your cancer sites. This helps researchers understand more about your cancer and how it might respond to the new treatments.
There are also some reasons why you might not be able to join. For example, if you have another type of cancer that is active or has needed treatment in the last three years. Also, you couldn't have had other cancer treatments, including other experimental drugs, within the last four weeks before starting the study.
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.
- Do I have a diagnosis of locally advanced or metastatic urothelial cancer (bladder, kidney, ureter, or urethra)?
- Has my cancer not responded to previous immune checkpoint inhibitor treatments (PD-1/L1 inhibitors)?
- Am I able to provide a sample of my cancer tissue (either an old one or new biopsy)?
- Have I been free of other active cancers for the past three years?
- Have I avoided other cancer treatments (including experimental ones) in the last four weeks?
What does participation involve?
If you decide to take part in this study, you will receive one or more investigational medicines. These are drugs that are still being tested to see if they are safe and effective. You'll have regular visits to the clinic so the study doctors can carefully monitor your health and how the treatment is affecting you. These visits will involve various tests, such as blood tests, scans, and physical examinations, to check the cancer and your overall well-being. The treatment schedule and frequency of visits will depend on which study medicine you receive. You will continue to be monitored throughout the treatment period and for a follow-up period afterwards. The total time you'd be involved in the study would vary depending on your medical response and the specific treatment plan, but it could potentially last for several months or longer.
Potential risks and benefits
Locations (28)
- University of California, Irvine (UCI) Health - UC Irvine Medical Center ( Site 1045)Verified postcodeOrange, United States· Recruiting
- University of California San Francisco ( Site 1044)Verified postcodeSan Francisco, United States· Recruiting
- Anschutz Cancer Pavilion ( Site 1017)Verified postcodeAurora, United States· Completed
- University of Chicago Medical Center ( Site 1037)Verified postcodeChicago, United States· Recruiting
- Indiana University Melvin and Bren Simon Cancer Center ( Site 1011)Verified postcodeIndianapolis, United States· Recruiting
- Siteman Cancer Center ( Site 1038)Verified postcodeSt Louis, United States· Recruiting
- Memorial Sloan Kettering Cancer Center ( Site 1031)Verified postcodeNew York, United States· Recruiting
- Cleveland Clinic-Taussig Cancer Center ( Site 1036)Verified postcodeCleveland, United States· Recruiting
- UPMC Hillman Cancer Center ( Site 1014)Verified postcodePittsburgh, United States· Recruiting
- Huntsman Cancer Institute ( Site 1041)Verified postcodeSalt Lake City, United States· Recruiting
- Royal Brisbane and Women's Hospital-Medical Oncology Clinical Trials Unit, Cancer Care Services ( Site 1952)Verified postcodeBrisbane, Australia· Completed
- Princess Margaret Cancer Centre ( Site 1106)Verified postcodeToronto, Canada· Recruiting
Common questions
What is urothelial carcinoma?
Urothelial carcinoma is a type of cancer that starts in the cells lining your bladder, ureters, renal pelvis, and urethra. These are all parts of your urinary system.
What does 'PD-1/L1 refractory' mean?
It means your cancer hasn't responded well to a specific type of immune-boosting medicine called PD-1/L1 inhibitors, or it stopped working after a while. This study is aimed at people in this situation.
Are the treatments in this study new?
Yes, some of the treatments are 'investigational agents,' which means they are new medicines still being tested to see how well they work and if they are safe.
What is a tissue sample or biopsy?
A tissue sample or biopsy is a small piece of your cancer tissue that doctors take to examine closely. It helps them understand more about your cancer and can be taken before the study starts.
Can I stop participating in the study if I change my mind?
Yes, you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.
How to find out more
Toll Free Number
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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