Testing the Combination of Two Anticancer Drugs M1774 (Tuvusertib) and Avelumab to Evaluate Their Safety and Effectiveness in Treating Merkel Cell Skin Cancer, MATRiX Trial
This study is investigating a new way to treat Merkel cell skin cancer that has spread or is difficult to remove and hasn't responded to previous immunotherapy. It's comparing two approaches: one group will receive a drug called tuvusertib on its own, and another group will get tuvusertib combined with avelumab. Tuvusertib works by targeting a specific enzyme involved in cancer growth, while avelumab helps your immune system fight the cancer. The main goal is to find out if the combination treatment can keep the cancer from growing or spreading for longer than tuvusertib by itself. Patients will have scans, biopsies, and blood tests during the study to monitor their health and the cancer's response.
At a glance
What is this study about?
This study is for people in the UK who have a type of skin cancer called Merkel cell carcinoma. This cancer can be challenging to treat, especially when it's advanced, meaning it has spread to other parts of the body, or hasn't responded to earlier treatments.
The trial is looking at two different medicines: tuvusertib and avelumab. Tuvusertib is a newer drug designed to block an enzyme inside cancer cells that helps them grow and repair themselves. By stopping this enzyme, tuvusertib might help kill cancer cells. Avelumab is a type of immunotherapy. Immunotherapy works by boosting your body's own immune system to recognise and fight cancer cells more effectively. This study wants to see if giving both tuvusertib and avelumab together is more effective at stopping the cancer from growing than giving tuvusertib alone.
The main aim is to see if the combination treatment can keep the cancer under control for a longer time before it starts to get worse. Researchers will also be looking at how safe the treatments are and how patients feel while taking them. This is a "Phase II" trial, which means it’s still in the earlier stages of testing new treatments, building on what has been learned in even earlier studies.
Key takeaways
- This study evaluates two drugs, tuvusertib and avelumab, for advanced Merkel cell skin cancer.
- It's for people whose cancer has progressed after previous immunotherapy.
- The main goal is to see if combining the drugs keeps cancer from worsening for longer.
- You'll either receive tuvusertib alone or tuvusertib with avelumab.
- Regular scans, blood tests, and visits will monitor your health and cancer.
- Participation offers access to new treatments, but side effects are possible.
Who may be eligible?
To join this study, you must have a confirmed diagnosis of Merkel cell skin cancer that is advanced, meaning it has either spread or can't be removed with surgery. Crucially, your cancer must also have gotten worse after you've already had treatment with a type of immunotherapy drug (like avelumab or pembrolizumab).
You need to be at least 18 years old and generally well enough to take part in the study activities. Doctors will check your overall health, including blood tests, to make sure it's safe for you to participate. You must also have areas of cancer that can be measured during the study.
There are also some other health requirements that the doctors will check, such as your blood count and liver function, to ensure the treatments will be as safe as possible for you. If you've recently had chemotherapy, there are specific timings around when you can join.
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 advanced Merkel cell skin cancer that has spread or cannot be removed?
- Has my cancer gotten worse after receiving an immunotherapy drug in the past?
- Am I at least 18 years old?
- Am I generally well enough for daily activities? (Your doctor will check this.)
- Do I have areas of cancer that can be measured on scans?
What does participation involve?
If you decide to join this study, you'll be assigned by chance to one of two groups. One group will take tuvusertib capsules by mouth once a day for 14 days, with a break of 7 days, making each cycle 21 days long. The other group will take tuvusertib capsules in the same way, but will also receive avelumab through a drip into a vein on the first day of each 21-day cycle.
Throughout your time in the study, you will have regular hospital visits for physical exams, blood tests, and imaging scans like CT, PET, or MRI scans to monitor your cancer and your general health. You may also be asked to provide tissue samples (biopsies) and stool or cheek swabs. These tests help the study doctors understand how the treatment is working and if there are any side effects. You will continue treatment for as long as it's helping and you're not experiencing severe side effects. If your cancer gets worse while you're taking tuvusertib alone, you might be able to switch to the combination treatment.
Potential risks and benefits
Locations (51)
- UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory CareVerified postcodeIrvine, United States
- UC San Diego Moores Cancer CenterVerified postcodeLa Jolla, United States
- Keck Medicine of USC KoreatownVerified postcodeLos Angeles, United States
- Los Angeles General Medical CenterVerified postcodeLos Angeles, United States
- USC / Norris Comprehensive Cancer CenterVerified postcodeLos Angeles, United States
- USC Norris Oncology/Hematology-Newport BeachVerified postcodeNewport Beach, United States
- UC Irvine Health/Chao Family Comprehensive Cancer CenterVerified postcodeOrange, United States
- Stanford Cancer Institute Palo AltoVerified postcodePalo Alto, United States
- UCHealth University of Colorado HospitalVerified postcodeAurora, United States
- Yale UniversityVerified postcodeNew Haven, United States
- Sibley Memorial HospitalVerified postcodeWashington D.C., United States
- UM Sylvester Comprehensive Cancer Center at AventuraVerified postcodeAventura, United States
Common questions
What is Merkel cell skin cancer?
It's a rare and aggressive type of skin cancer. In this study, it refers to cancer that has spread or cannot be removed easily.
What is immunotherapy?
Immunotherapy is a treatment that helps your body's immune system recognise and fight cancer cells more effectively.
What is a 'Phase II' trial?
This means it's an early study to see if a new treatment is effective and safe in a larger group of people, building on earlier research.
Will I know which treatment I'm getting?
Yes, you will know if you are receiving tuvusertib alone or tuvusertib plus avelumab. Your treatment group will be decided by chance, like flipping a coin.
What happens if the treatment stops working?
If your cancer starts to get worse while on tuvusertib alone, you might have the option to switch to the combination treatment with avelumab.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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