An open-label, multicenter, phase 1b/2 study of E7386 in combination with pembrolizumab in previously treated subjects with selected solid tumors
This research study is looking at new ways to treat advanced bowel cancer, melanoma, and liver cancer in people who have had treatment before. The study is testing a new drug called E7386, given together with pembrolizumab. Some participants will also receive a third drug called lenvatinib. This is a "Phase 1b/2" study, which means it will first check for safety and the right dose, and then look at how well the new drug combinations work at shrinking tumors. Doctors will be carefully monitoring participants for any side effects and how their cancer responds to the treatment.
At a glance
What is this study about?
Imagine your body as a garden, and cancer cells are like weeds that grow out of control. This study is testing new combinations of 'weed killers' to see if they can better tackle difficult-to-treat cancers such as bowel cancer, melanoma (a type of skin cancer), and liver cancer. These are cancers that have already been treated in the past, but the cancer has either come back or continued to grow.
The main goal of this study is to find out if combining new drugs can be a safe and effective way to fight these cancers. Specifically, it's looking at E7386, an investigational drug, alongside pembrolizumab (which you might know as Keytruda). Some people in the study might also get a third drug called lenvatinib (also known as Lenvima). Researchers want to see if these combinations are safe, what side effects they might cause, and if they can shrink the tumors or stop them from growing.
This study has two main parts. The first part (Phase 1b) focuses on safety and finding the best dose of the new drug combinations, looking for any serious side effects. The second part (Phase 2) then focuses on whether the treatments work well, by measuring how many people's tumors shrink or stop growing. This helps doctors understand if these new approaches could be helpful for future patients.
Key takeaways
- This study evaluates new drug combinations for advanced bowel, melanoma, or liver cancer.
- It aims to find out if E7386 with pembrolizumab (and sometimes lenvatinib) is safe and effective.
- Participation involves regular hospital visits, including tests and scans.
- Potential benefits include access to new treatments; risks include possible side effects.
- You can discuss this study with your doctor and choose to withdraw at any time.
Who may be eligible?
To join this study, people need to be at least 18 years old and can be any gender. The study is looking for individuals who have already received treatment for their bowel cancer, melanoma, or liver cancer, but the cancer has either returned or continued to grow.
There will be other important health checks to make sure people are suitable and that taking part would be safe for them. This includes reviewing overall health, other medical conditions, and certain blood test results. A doctor will carefully go through all these details to see if someone can join 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.
- Are you 18 years old or older?
- Do you have advanced bowel cancer, melanoma, or liver cancer?
- Have you already received treatment for your cancer?
- Are you willing and able to attend regular hospital appointments for treatment and check-ups?
What does participation involve?
If you decide to take part, you'll be given the study drugs as either capsules (Lenvima, E7386) or through a drip into your arm (Keytruda, E7386). You'll have regular hospital visits for check-ups, blood tests, and scans (like CT or MRI) to see how you're responding to the treatment and to monitor for any side effects. Each visit will involve assessments to monitor your health and how the treatment is working.
The length of your participation will depend on how you respond to the treatment and whether you experience any side effects. You will continue to have treatment and follow-up visits for as long as the treatment is helping and you are tolerating it well. Even after you stop the main study treatment, there will be follow-up appointments to check on your long-term health and any lasting effects.
Potential risks and benefits
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Common questions
What kind of cancer is this study for?
This study is for people with certain types of advanced bowel cancer, melanoma (skin cancer), or liver cancer that have been treated before but are still progressing.
What are the treatments being tested?
The study is testing a new drug called E7386 in combination with pembrolizumab (Keytruda). Some participants will also receive lenvatinib (Lenvima) as a third drug.
What does 'Phase 1b/2' mean?
This means the study first checks if the treatment is safe and finds the right dose (Phase 1b). Then, it looks at how well the treatment works to shrink or control cancer (Phase 2).
Will I know if I'm getting the new drug?
This is an 'open-label' study, which means both you and your study doctor will know which treatments you are receiving.
Who can join this study?
Anyone over 18 years old, male or female, with the specific types of cancer mentioned, who has had previous treatment, might be eligible. Your doctor will check other health requirements.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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