Tebentafusp Regimen Versus Investigator's Choice in Previously Treated Advanced Melanoma (TEBE-AM)
This study is for people with advanced melanoma, a type of skin cancer, that has come back or spread after previous treatments. Researchers are testing a new medicine called tebentafusp. They want to find out if tebentafusp, either on its own or combined with another drug called pembrolizumab, is a safe and effective treatment. This will be compared against treatments doctors usually choose for patients in this situation, or supportive care to manage symptoms. The study is in its third phase, meaning it's well into testing, and aims to provide more options for people with advanced melanoma. Doctors will look closely at how well the new treatments work and if they cause any side effects.
At a glance
What is this study about?
This study is investigating a new treatment for a type of skin cancer called advanced melanoma. This is for people whose cancer has spread or can't be removed with surgery, and who have already tried other treatments that didn't work well enough. The main drug being tested is called tebentafusp. Researchers want to see if tebentafusp alone, or tebentafusp given with another drug called pembrolizumab, is a better option than the treatments doctors currently choose for patients, or just receiving care to help manage symptoms and improve comfort. This is a "Phase 3" study, which means it's one of the final stages of testing before a new medicine might become widely available.
The main goal is to find out if tebentafusp-based treatments can help people live longer or stop their cancer from growing for a longer time, compared to current approaches. Doctors will also be carefully monitoring for any side effects to understand how safe these new treatments are. By comparing these different approaches, the study aims to improve treatment options for people living with advanced melanoma, especially when other treatments haven't been successful.
Taking part in this study could offer you access to a new treatment that isn't widely available yet. It's an important step in finding better ways to fight advanced melanoma, and your involvement could help future patients. However, it's also important to remember that new treatments don't always work for everyone, and there can be side effects.
Key takeaways
- This study is for advanced melanoma, previously treated.
- It tests a new drug called tebentafusp, alone or with pembrolizumab.
- It aims to find safer and more effective treatments.
- You must meet specific health and medical history criteria.
- Participation involves regular hospital visits, tests, and medication.
Who may be eligible?
The study is looking for adults aged 18 or older with advanced melanoma that is not located in the eye. You must have already received some specific previous treatments for your melanoma, including a type of therapy called anti-PD1. To join, your body's immune system needs to have a specific marker called HLA-A*02:01. The doctors will check this with a simple blood test.
There are also some requirements about your general health. You should be well enough to carry out most daily activities, and your cancer must have parts that can be measured or seen by doctors. You'll also need to provide a sample of your tumor tissue, either from one you've had taken before, or a small new biopsy.
However, some people won't be able to join. For example, if you are pregnant or breastfeeding, or if you have another type of cancer, or if your melanoma is in your eye. You also can't participate if you have severe allergies to certain medications or have an active autoimmune disease that requires specific treatments. People with untreated or severe brain metastases or mental health conditions that might affect involvement in the study will also not be eligible.
- Are you 18 years old or older?
- Do you have advanced melanoma that isn't in your eye?
- Have you already had treatment for your melanoma that included anti-PD1 therapy?
- Are you generally well enough to go about your daily activities?
- Are you able to provide a past or new tissue sample of your cancer?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you decide to take part in this study, you might receive tebentafusp on its own, tebentafusp with pembrolizumab, or participate in the "investigator's choice" arm, which means you'll receive a treatment chosen by your doctor based on what's currently available for your condition. This could include other clinical trials, standard care, or care focused on your comfort and quality of life.
You will have regular appointments at the hospital for treatments and check-ups. These visits will involve blood tests, physical exams, and scans (like CT scans) to see how the treatment is affecting your cancer. Some visits might include collecting extra samples for research, such as tissue biopsies. The doctor and study team will explain exactly what this means for you, including how often you'll need to visit and for how long. The study will continue as long as the treatment is helping, or until side effects make it necessary to stop, or if you decide you no longer wish to participate.
Potential risks and benefits
Locations (82)
- Mayo Clinic ArizonaPhoenix, United States· Recruiting
- Mayo Clinic FloridaJacksonville, United States· Recruiting
- Orlando Health Cancer InstituteOrlando, United States· Recruiting
- Winship Cancer Institute of Emory UniversityAtlanta, United States· Recruiting
- University of Kansas Cancer Center - WestwoodWestwood, United States· Recruiting
- St Elizabeth Healthcare (St Elizabeth Medical Center)Edgewood, United States· Recruiting
- St Elizabeth Healthcare (St Elizabeth MedicalEdgewood, United States· Recruiting
- Massachusetts General HospitalBoston, United States· Recruiting
- Beth Israel Deaconess Medical Center (BIDMC)Boston, United States· Recruiting
- Dana Farber Cancer InstituteBoston, United States· Recruiting
- University of Minnesota Medical CenterMinneapolis, United States· Recruiting
- Mayo Clinic MinnesotaRochester, United States· Recruiting
+70 more sites — see the official record for the full list.
Common questions
What is advanced melanoma?
Advanced melanoma is a type of skin cancer that has either spread to other parts of the body or cannot be completely removed by surgery.
What is tebentafusp?
Tebentafusp is a new investigational drug being tested in this study. It's designed to help your immune system fight cancer cells.
Will I know which treatment I'm getting?
Yes, this is an "open-label" study, which means both you and your doctor will know which treatment you are receiving.
How long will I be in the study?
You will remain in the study as long as the treatment is helping you, or until you experience significant side effects, or choose to leave the study.
Are there any costs for me to participate?
Usually, clinical trials cover the costs of study-related treatments and tests. The study team will explain any potential costs or reimbursement for travel.
How to find out more
Immunocore Medical Information
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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