Testing the Addition of Tazemetostat to the Immunotherapy Drug, Pembrolizumab (MK-3475), in Advanced Urothelial Carcinoma
This research study is for people with advanced bladder cancer, which means it has spread to nearby tissue or other parts of the body. The study aims to find the best and safest dose of a drug called tazemetostat when given alongside another drug, pembrolizumab. Tazemetostat works by blocking certain things cancer cells need to grow, while pembrolizumab helps your body's immune system fight the cancer. Researchers believe that using these two drugs together might be more effective than pembrolizumab alone. They will be watching for any side effects and how well patients respond to this combination treatment. The study is divided into two parts to first find the right dose and then to see how well it works.
At a glance
What is this study about?
This study is about finding better ways to treat advanced bladder cancer. This is bladder cancer that has either grown into nearby parts of the body or has spread to other areas. The research involves two different medicines: tazemetostat and pembrolizumab. Tazemetostat is a newer type of drug that tries to stop cancer cells from growing by blocking certain enzymes they need to survive. Pembrolizumab is an immunotherapy drug, which means it helps your own body's defence system (your immune system) recognise and attack the cancer cells. By giving these two drugs together, the doctors hope to see if they can be more powerful in fighting the cancer than using pembrolizumab by itself.
The main goal of this study is to first figure out what is the safest and most effective dose of tazemetostat to give when combined with pembrolizumab. Once they find this ideal dose, they will then look at how well this combination works against the cancer. This includes seeing if the cancer shrinks or stops growing, how long people stay healthy without their cancer getting worse, and whether the immune system responds to the treatment. They also want to understand if certain features of a person's cancer cells can predict how well the treatment might work.
To understand all this, the doctors will collect different types of samples, like blood and tissue from your cancer, throughout the study. This helps them learn more about how the drugs affect your body and the cancer, and why some people might respond better than others. This information is really important because it could lead to new and better treatment options for people with advanced bladder cancer in the future.
Key takeaways
- This study combines two drugs, tazemetostat and pembrolizumab, for advanced bladder cancer.
- It aims to find the safest dose and see how well this combination fights cancer.
- The study is for people whose cancer has spread or who cannot have standard chemotherapy.
- Participation involves taking daily medication and getting regular infusions, scans, and blood tests.
- It could offer access to a new treatment, but there are potential side effects to consider.
- You can withdraw from the study at any time.
Who may be eligible?
This study is for adults generally aged 18 and over who have bladder cancer that has spread to nearby tissue or other parts of the body (this is called advanced urothelial carcinoma).
To be considered for the study, your cancer must have been officially diagnosed by a doctor. You will usually need to have visible cancer that can be measured on scans. Importantly, you would typically have tried a type of chemotherapy called platinum-based chemotherapy (like cisplatin or carboplatin) and found that your cancer either didn't respond or started to grow again within 12 months. Alternatively, you might be someone who cannot safely receive platinum-based chemotherapy, or even any chemotherapy, for other health reasons determined by your doctor.
There are also other medical requirements for joining, which the study team will discuss with you. These would include things like your general health, other medical conditions you might have, and medications you are currently taking. The study team will review all of these details to ensure the study is 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.
- Have I been diagnosed with urothelial carcinoma (a type of bladder cancer)?
- Has my cancer spread to nearby tissues or other parts of my body?
- Have I already tried platinum-based chemotherapy, or am I unable to receive it?
- Am I generally 18 years old or older?
- Am I willing to have regular scans and provide blood/tissue samples?
What does participation involve?
If you decide to take part in this study, you will be given two drugs: tazemetostat and pembrolizumab. Tazemetostat is taken by mouth, twice a day, for 21 days in each cycle. Pembrolizumab is given as a drip into your vein (intravenously) over about 30 minutes, usually on day 1 of each cycle. Each cycle typically lasts for 21 days, and you could receive this treatment for up to two years, as long as the treatment is helping and side effects are manageable.
Throughout the study, you will have various appointments for tests and check-ups. These will involve collecting blood and tissue samples to help researchers understand how the treatment is working. You will also have regular scans, such as CT scans or MRI scans, to see how your cancer is responding to the treatment. These assessments will help the doctors monitor your health and the effects of the medication. The study team will explain the full schedule of visits and tests to you in detail.
Potential risks and benefits
Locations (34)
- Mayo Clinic Hospital in ArizonaVerified postcodePhoenix, United States
- Mayo Clinic in ArizonaVerified postcodeScottsdale, United States
- Smilow Cancer Hospital-Derby Care CenterVerified postcodeDerby, United States
- Smilow Cancer Hospital Care Center-FairfieldVerified postcodeFairfield, United States
- Smilow Cancer Hospital Care Center - GuilfordVerified postcodeGuilford, United States
- Smilow Cancer Hospital Care Center at Saint FrancisVerified postcodeHartford, United States
- Smilow Cancer Center/Yale-New Haven HospitalVerified postcodeNew Haven, United States
- Yale UniversityVerified postcodeNew Haven, United States
- Yale-New Haven Hospital North Haven Medical CenterVerified postcodeNorth Haven, United States
- Smilow Cancer Hospital-Orange Care CenterVerified postcodeOrange, United States
- Smilow Cancer Hospital-Torrington Care CenterVerified postcodeTorrington, United States
- Smilow Cancer Hospital Care Center-TrumbullVerified postcodeTrumbull, United States
Common questions
What is urothelial carcinoma?
Urothelial carcinoma is the most common type of bladder cancer. It starts in the cells lining the bladder, but can sometimes be found in other parts of the urinary system.
What does 'locally advanced' or 'metastatic' mean?
Locally advanced means the cancer has grown into nearby tissues or lymph nodes. Metastatic means the cancer has spread from where it started to other parts of the body, like the lungs or bones.
What do the drugs tazemetostat and pembrolizumab do?
Tazemetostat aims to stop cancer cells from growing. Pembrolizumab helps your body's immune system fight the cancer.
What are the phases (Phase 1, Phase 2) of the trial?
Phase 1 trials primarily check for the safest dose and side effects of a new treatment. Phase 2 trials then test if the treatment works well for specific conditions, building on the safety information from Phase 1.
How long would I be on this treatment?
You could receive this combination treatment for up to two years, as long as the treatment is helping you and any side effects are manageable.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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