A Study of Efficacy and Safety of Pembrolizumab Plus Enfortumab Vedotin (EV) +/- Investigational Agents in First-Line Metastatic Urothelial Carcinoma (mUC) (MK-3475-04B/KEYMAKER-U04)
This research is testing new combinations of medicines for advanced bladder cancer that has spread (metastatic urothelial carcinoma). The main aim is to see how well certain drugs, like coformulated favezelimab/pembrolizumab or vibostolimab/pembrolizumab, work when given with enfortumab vedotin (EV) and pembrolizumab. Scientists are comparing these new combinations to just pembrolizumab plus EV to understand if they are more effective and safe for patients. This is an early-stage study (Phase 1 and 2), which means researchers are carefully checking for side effects and how the new treatments affect the cancer. The hope is to find better ways to treat this type of cancer.
At a glance
What is this study about?
This study is a clinical trial, which means it's a carefully planned research study involving people. The main goal here is to find better ways to treat a type of bladder cancer that has spread to other parts of the body, known as metastatic urothelial carcinoma. When cancer spreads, it can be harder to treat, so doctors are always looking for new and more effective medicines.
In this study, researchers are testing different combinations of drugs. You may have heard of pembrolizumab; it's an immunotherapy that helps your body's own immune system fight cancer. They are combining it with enfortumab vedotin (EV), another cancer drug, and then adding one of two new investigational medicines: favezelimab or vibostolimab. Think of it like trying different recipes to see which one tastes best – in this case, which combination works best to fight cancer.
This is an early-stage study (Phase 1 and Phase 2), meaning the doctors are carefully watching to see how safe these new drug combinations are and how well they shrink or control the cancer. The information gathered from this study will help them decide if these new combinations are promising enough to be studied in larger groups of patients in the future. It’s an important step in finding new treatments for advanced bladder cancer.
Key takeaways
- This study is for people with advanced, spread bladder cancer who haven't had prior treatment for it.
- It's testing new combinations of anti-cancer drugs, including immunotherapy.
- The main goals are to see if these new combinations are safe and how well they work.
- Participation involves receiving study drugs and having regular medical checks.
- It's an important early-stage study that could help find better treatments for bladder cancer.
Who may be eligible?
To be considered for this study, you must have advanced bladder cancer (urothelial carcinoma) that has spread, and it must be your first time receiving treatment for this advanced stage. If you've had treatment for an earlier stage of bladder cancer, that might be okay, especially if the cancer came back more than a year later.
Doctors will need to look at a small sample of your tumor, which you might already have, or they might ask for a new one. This helps them understand your cancer better. Also, any side effects you might have from past cancer treatments should have mostly cleared up, or be very mild.
There are also reasons why you might not be able to join. For example, if you have other serious cancers (unless they've been successfully treated for at least 3 years), or if your bladder cancer has spread to your brain in certain ways that aren't stable or well-controlled. Your medical team will go through all the details with you to see if this study is a good fit.
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 you have advanced bladder cancer that has spread?
- Is this your first time receiving treatment for this advanced stage of cancer?
- Have any side effects from your previous cancer treatments mostly gone away or are very mild?
- Are you willing to provide a tumor sample (biopsy)?
- Are you at least 18 years old?
What does participation involve?
If you join this study, you will receive combinations of study drugs which will be given as infusions (into a vein). The study itself is divided into two parts, though the second part may not happen. The doctors will closely monitor you with regular check-ups, scans, and blood tests to see how you are responding to the treatment and to check for any side effects. You will need to provide tissue samples, either from existing biopsies or potentially a new one, for evaluation.
While the detailed schedule of visits isn't provided here, clinical trials usually involve frequent trips to the hospital or clinic, especially at the beginning, for treatments and assessments. There will also be follow-up appointments after your treatment period ends to continue monitoring your health. The total time you spend on the study can vary depending on how you respond to the treatment, but these types of studies often last for several months or even longer, with ongoing monitoring.
Potential risks and benefits
Locations (47)
- Moores Cancer Center ( Site 3028)Verified postcodeLa Jolla, United States
- University of California, Irvine (UCI) Health - UC Irvine Medical Center ( Site 3045)Verified postcodeOrange, United States
- UCSF Medical Center at Mission Bay ( Site 3044)Verified postcodeSan Francisco, United States
- Anschutz Cancer Pavilion ( Site 3017)Verified postcodeAurora, United States
- Emory University School of Medicine ( Site 3043)Verified postcodeAtlanta, United States
- Indiana University Melvin and Bren Simon Cancer Center ( Site 3011)Verified postcodeIndianapolis, United States
- Dana-Farber Cancer Institute ( Site 3047)Verified postcodeBoston, United States
- Siteman Cancer Center ( Site 3038)Verified postcodeSt Louis, United States
- Icahn School of Medicine at Mount Sinai ( Site 3018)Verified postcodeNew York, United States
- Memorial Sloan Kettering Cancer Center ( Site 3031)Verified postcodeNew York, United States
- Duke Cancer Institute ( Site 3027)Verified postcodeDurham, United States
- Cleveland Clinic-Taussig Cancer Center ( Site 3036)Verified postcodeCleveland, United States
Common questions
What type of cancer is this study for?
This study is for advanced bladder cancer that has spread to other parts of the body (metastatic urothelial carcinoma).
What medicines are being</b> tested?
The study is testing combinations of pembrolizumab, enfortumab vedotin (EV), and either favezelimab or vibostolimab.
Is this a new treatment?
Yes, some of the drug combinations being tested are new and are still in early stages of research (Phase 1 and 2).
Will I get to choose which medicine I receive?
No, you won't get to choose. You would be assigned to one of the treatment combinations as part of the study design.
Can I stop being part of the study at any time?
Yes, you can choose to leave the study at any point, and it won't affect your regular medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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