A Phase 1/2, Umbrella Study of the Efficacy and Safety of Pembrolizumab plus Enfortumab vedotin +/- Investigational Agents in First-Line metastatic urothelial carcinoma
This research study is investigating new ways to treat advanced bladder cancer (urothelial carcinoma) that has spread to other parts of the body. It's an 'umbrella study,' meaning it tests different combinations of medicines under one larger research plan. The main treatment being looked at is a combination of two existing drugs, pembrolizumab and enfortumab vedotin. Sometimes, other new medications might be added to this mix. The study aims to find out if these combinations are safe and effective as a very first treatment for patients with this type of cancer. It includes both early-stage (Phase 1) and later-stage (Phase 2) testing.
At a glance
What is this study about?
Imagine your body like a house, and sometimes, unwanted guests like cancer cells try to set up camp in different rooms. For people with advanced bladder cancer, called metastatic urothelial carcinoma, it means the cancer has spread beyond the bladder. This study is like trying out a new team of security guards and tools to fight these unwelcome guests.
The study focuses on a treatment combination that includes pembrolizumab and enfortumab vedotin. Pembrolizumab helps your body's own immune system find and fight cancer cells, like boosting your security team. Enfortumab vedotin is a targeted treatment that delivers a strong medicine directly to cancer cells while trying to leave healthy cells alone. Sometimes, the study might also try adding other new investigational medicines to this team to see if they can make the fight even more effective.
The main goal is to see two things: first, if these treatments are safe and what side effects they might have (this is the Phase 1 part). Second, if they actually help shrink the cancer or stop it from growing (this is the Phase 2 part). By combining these two phases, researchers can quickly learn more about these potential new treatments as a first option for advanced bladder cancer.
Key takeaways
- This study evaluates new treatment combinations for advanced bladder cancer that has spread.
- It combines existing drugs (pembrolizumab, enfortumab vedotin) and sometimes new investigational ones.
- The goal is to find safe and effective 'first-line' options before other treatments are tried.
- It's open to adults aged 18 and over, both men and women.
- Participation involves regular clinic visits for monitoring and assessments.
- Patients can leave the study at any time without affecting their standard care.
Who may be eligible?
To join this study, you would need to be an adult, 18 years old or older. The study welcomes both men and women.
Basically, the study is for people who have advanced bladder cancer (urothelial carcinoma) that has spread to other parts of their body and have not received treatment for this advanced stage before. Other specific health conditions and previous treatments will be checked by the study doctors to make sure the study treatment is suitable and safe for you.
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.
- Are you 18 years old or older?
- Have you been diagnosed with advanced bladder cancer (urothelial carcinoma) that has spread?
- Have you NOT received any prior treatment specifically for this advanced stage of cancer?
- Are you able to travel to the study clinic for regular appointments?
- Are you willing to undergo regular blood tests and scans as part of your participation?
What does participation involve?
If you decide to take part, you would receive the study medication (pembrolizumab and enfortumab vedotin, possibly with another investigational drug). You would need to visit the clinic regularly for check-ups. These visits will include physical examinations, blood tests, and scans (like CT or MRI) to see how you are responding to the treatment and to monitor for any side effects. The exact number of visits and tests will be explained to you in detail.
The treatment period will continue as long as the treatment is helping you and you are tolerating it well. After you stop taking the study medication, you will have follow-up visits or calls for a certain period to track your health. The total time you might be involved in the study, including follow-up, can vary, but it will be fully explained before you agree to participate.
Potential risks and benefits
Locations (4)
- —UnverifiedNetherlands
- —UnverifiedSpain
- —UnverifiedItaly
- —UnverifiedFrance
Common questions
What is 'urothelial carcinoma'?
It's the most common type of bladder cancer. When it's 'advanced' and 'metastatic,' it means the cancer has grown and spread to other parts of the body.
What does 'first-line treatment' mean?
It means this study is looking at treatments that would be given as the very first therapy for your advanced cancer, before other treatments have been tried for this stage.
Are the treatments in this study totally new?
Pembrolizumab and enfortumab vedotin are already approved drugs, but this study is testing them together and sometimes with other new drugs as a first treatment for advanced bladder cancer.
What are Phase 1 and Phase 2 studies?
Phase 1 studies mostly check if a new treatment is safe and what dose to use. Phase 2 studies look at whether the treatment works well for a particular condition, while also continuing to check safety.
Will I know if I'm getting the active drugs or a placebo?
This study is testing active drugs and combinations. It is not comparing against a placebo (an inactive dummy treatment).
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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