Using Nivolumab Alone or With Cabozantinib to Prevent Mucosal Melanoma Return After Surgery
This research study is about mucosal melanoma, a rare form of skin cancer that can grow on moist surfaces inside the body, like the mouth or nose. Doctors want to see if combining two drugs, nivolumab and cabozantinib, works better than nivolumab alone after surgery to prevent the cancer from returning. Nivolumab helps your body's immune system fight cancer, while cabozantinib aims to stop cancer cells from growing and spreading. For some patients who cannot have all their cancer removed or whose cancer has spread, the study will also look at how this drug combination works. This is a Phase 2 study, meaning researchers are checking if the treatments are effective and safe in a larger group of people.
At a glance
What is this study about?
This study is particularly looking at mucosal melanoma, which is a less common type of melanoma than those found on the skin after sun exposure. Mucosal melanomas can appear in various places such as the mouth, nose, throat, or other internal areas like the digestive or genital tracts. Because these melanomas can be harder to treat and have a higher chance of coming back, researchers are always looking for better treatment options.
The main aim of this study is to compare two different treatment approaches: giving a drug called nivolumab on its own, or giving nivolumab together with another drug called cabozantinib. Nivolumab is an 'immunotherapy' drug. Think of it as a way to give your own immune system a boost, helping it recognise and attack cancer cells more effectively. Cabozantinib works differently; it tries to block specific signals that cancer cells need to grow and spread throughout the body. By combining these two drugs, doctors hope to create a stronger attack against the cancer.
For people who have had their mucosal melanoma fully or mostly removed by surgery, the study wants to see if these treatments can prevent the cancer from returning. For those who couldn't have all their cancer removed or whose cancer has spread, the study will investigate how well the combination of nivolumab and cabozantinib works to shrink the cancer and improve life.
Key takeaways
- The study investigates treatments for a rare cancer called mucosal melanoma.
- It tests nivolumab (an immune booster) alone or combined with cabozantinib (a growth blocker).
- The goal is to stop cancer from returning after surgery or to treat existing cancer.
- There are different treatment paths depending on whether your cancer was fully removed.
- Participation involves regular appointments, medication, and scans.
- You can stop participating at any time.
Who may be eligible?
To join this study, doctors will first need to confirm you have mucosal melanoma based on tests. They'll also need to check a special marker (a 'PD-L1' test) on your cancer cells to understand how your immune system might respond to treatment.
You might be able to join if you've already had surgery to remove your mucosal melanoma, and the doctors believe they've either removed all of it or most of it. This applies to melanomas found in specific areas like the head, neck, digestive, or genital areas, especially if they involved lymph nodes or were more advanced. Importantly, you shouldn't have received any previous immunotherapy treatments for your mucosal melanoma.
There's also a part of the study for people whose cancer could not be fully removed by surgery, or for those whose cancer has spread to other parts of the body. For all participants, detailed scans of your brain, chest, tummy, and pelvis will be needed to check your overall health and the extent of the cancer.
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 you been diagnosed with mucosal melanoma?
- Has your doctor checked a special 'PD-L1' marker on your cancer cells?
- Have you NOT had previous immunotherapy for your mucosal melanoma?
- Have you had surgery to remove your mucosal melanoma, or do you have cancer that could not be fully removed or has spread?
- Are you 18 years or older?
What does participation involve?
If you join the study, what happens next depends on your situation. If your tumour was fully or mostly removed by surgery, you'll be assigned by chance (like flipping a coin) to one of two groups. One group will receive nivolumab by drip into a vein every four weeks and a dummy pill (placebo) every day. The other group will receive nivolumab by drip every four weeks and cabozantinib pills every day. This treatment will continue for up to 13 cycles (about one year) unless your cancer grows or side effects become too strong. If your tumour couldn't be fully removed or has spread, you'll receive both nivolumab by drip and cabozantinib pills, ongoing for up to 26 cycles (about two years).
During the study, you'll have regular checks by the study team. This will include blood tests, physical exams, and scans like CT, MRI, or PET scans to monitor your health and how the treatment is working. You'll also have heart scans (echocardiograms) at the start and during the study if needed. All these visits and tests are designed to track your progress and ensure your safety throughout the study.
Potential risks and benefits
Locations (147)
- Sutter Auburn Faith HospitalVerified postcodeAuburn, United States· Recruiting
- Alta Bates Summit Medical Center-Herrick CampusVerified postcodeBerkeley, United States· Suspended
- Palo Alto Medical Foundation-FremontVerified postcodeFremont, United States· Recruiting
- Keck Medicine of USC KoreatownVerified postcodeLos Angeles, United States· Recruiting
- Los Angeles General Medical CenterVerified postcodeLos Angeles, United States· Recruiting
- USC / Norris Comprehensive Cancer CenterVerified postcodeLos Angeles, United States· Recruiting
- Memorial Medical CenterVerified postcodeModesto, United States· Recruiting
- USC Norris Oncology/Hematology-Newport BeachVerified postcodeNewport Beach, United States· Recruiting
- Palo Alto Medical Foundation Health CareVerified postcodePalo Alto, United States· Suspended
- Stanford Cancer Institute Palo AltoVerified postcodePalo Alto, United States· Recruiting
- Sutter Roseville Medical CenterVerified postcodeRoseville, United States· Recruiting
- Sutter Medical Center SacramentoVerified postcodeSacramento, United States· Recruiting
Common questions
What is mucosal melanoma?
It's a rare type of skin cancer that grows on the moist surfaces inside your body, like your mouth, nose, throat, or genital areas, rather than on skin exposed to the sun.
What are nivolumab and cabozantinib?
Nivolumab is an immunotherapy drug that helps your immune system fight cancer. Cabozantinib is a drug that blocks signals cancer cells need to grow and spread.
What does 'Phase 2 trial' mean?
It means this is an early study to see if a new treatment is effective and safe in a larger group of people, after initial safety tests.
Will I know which treatment I'm getting?
If your cancer was removed by surgery, you will be assigned by chance to receive either nivolumab with a dummy pill, or nivolumab with cabozantinib. If your cancer was not fully removed or has spread, you will receive both nivolumab and cabozantinib.
How long will I be in the study?
Treatment can last for about one year if your cancer was removed, or up to two years if it wasn't fully removed or had spread. You'll have regular follow-up appointments during and after this time.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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