Testing Ipilimumab and Nivolumab Combination With or Without Cabozantinib in People >= 18 Years Old With Advanced Soft Tissue Sarcoma
This study is testing new ways to treat advanced soft tissue sarcoma, a type of cancer that affects soft tissues like muscle or fat. We are looking at a combination of two immunotherapy drugs, ipilimumab and nivolumab. These drugs help your own immune system fight the cancer. The study will compare whether adding a third drug called cabozantinib improves treatment. Cabozantinib works by blocking signals that cancer cells need to grow and spread. By comparing these treatments, researchers hope to find a more effective way to slow down or stop the growth of soft tissue sarcoma in people aged 18 and over.
At a glance
What is this study about?
This study is for adults aged 18 or older who have advanced soft tissue sarcoma. This means the cancer has spread from where it started to nearby areas or other parts of the body, and it cannot be easily removed with surgery. Soft tissue sarcoma is a type of cancer that can develop in various soft tissues, such as muscles, fat, nerves, and blood vessels.
The main aim of this study is to compare two different treatment approaches. Both approaches use a combination of two immunotherapy drugs: ipilimumab and nivolumab. Immunotherapy works by boosting your body's natural immune system to recognise and fight cancer cells. One group of participants will receive these two immunotherapy drugs. The other group will receive these same two immunotherapy drugs plus an additional drug called cabozantinib. Cabozantinib is a different type of cancer drug that works by blocking specific signals that cancer cells use to grow and multiply, and it can also stop new blood vessels from forming that tumours need to survive. Researchers want to see if adding cabozantinib makes the treatment more effective than using ipilimumab and nivolumab alone.
By carefully comparing these treatment plans, researchers hope to identify which approach is better at slowing down or stopping the cancer's growth. This kind of research is crucial for developing new and improved treatments for soft tissue sarcoma, offering hope for better outcomes for patients in the future. The study will look at how long people live without their cancer getting worse, and how much the tumours shrink.
Key takeaways
- This study compares two different drug combinations for advanced soft tissue sarcoma.
- It tests two immunotherapy drugs, with or without an additional targeted drug (cabozantinib).
- Participation involves regular scans, blood tests, and physical exams.
- The goal is to find better ways to slow or stop cancer growth for these patients.
- Potential benefits include access to new treatments; potential risks include side effects.
Who may be eligible?
To join this study, you must be 18 years old or older and have a type of soft tissue sarcoma that has spread or cannot be removed by surgery. Specifically, the study is looking for people with types like undifferentiated pleomorphic sarcoma (UPS), extraskeletal myxoid chondrosarcoma, liposarcoma, or non-uterine leiomyosarcoma.
Your cancer must be measurable, meaning doctors can see and measure at least one tumour on scans like CT or MRI. You must also be generally well enough to take part, as measured by a doctor, and have healthy enough organ function (like your kidneys and liver).
If you have been treated with certain drugs before, such as cabozantinib or a combination of ipilimumab and nivolumab, you might not be able to join this particular study. However, previous treatment with other specific cancer drugs might be allowed. The study team will check all your medical details carefully to see if you are a good fit.
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 a type of soft tissue sarcoma that has spread or cannot be removed by surgery?
- Do doctors consider you generally well enough for a clinical trial?
- Have you not previously taken cabozantinib or a combination of ipilimumab and nivolumab for your cancer?
What does participation involve?
If you join this study, you will be randomly assigned to one of two treatment groups. This means it's like flipping a coin to decide which treatment you receive. Both groups will receive intravenous (given into a vein) infusions of nivolumab and ipilimumab. One group will also take cabozantinib, which is a tablet.
Initially, for the first few cycles, you'll receive both nivolumab and ipilimumab every 21 days. After these first cycles, you will continue with nivolumab every 28 days. The cabozantinib tablets, if you're in that group, will likely be taken daily. You will continue treatment as long as it is working for you and you are not experiencing severe side effects.
Throughout the study, you will have regular hospital visits for blood tests, physical examinations, and imaging scans like CT or MRI to check how the treatment is working and to monitor your health. You will also have biopsies (small tissue samples) taken before and during the study. This will help researchers understand more about your cancer and how it responds to treatment. The total duration of your participation will depend on how you respond to the treatment and your health, but regular follow-up will continue for some time even after you stop treatment.
Potential risks and benefits
Locations (27)
- City of Hope Comprehensive Cancer CenterVerified postcodeDuarte, United States
- UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory CareVerified postcodeIrvine, 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
- Smilow Cancer Hospital Care Center at Saint FrancisVerified postcodeHartford, United States
- Yale UniversityVerified postcodeNew Haven, United States
- Smilow Cancer Hospital Care Center-TrumbullVerified postcodeTrumbull, United States
- MedStar Georgetown University HospitalVerified postcodeWashington D.C., United States
- UF Health Cancer Institute - GainesvilleVerified postcodeGainesville, United States
Common questions
What is soft tissue sarcoma?
Soft tissue sarcoma is a rare type of cancer that forms in the tissues that connect, support, and surround other body parts, like muscle, fat, nerves, or blood vessels.
What are immunotherapy drugs (ipilimumab and nivolumab)?
These drugs work by helping your body's own immune system find and fight cancer cells more effectively. They're often called 'checkpoint inhibitors'.
How does cabozantinib work?
Cabozantinib is a different type of drug that blocks specific signals inside cancer cells, stopping them from growing and spreading. It also stops new blood vessels that tumours need to grow.
Will I know which treatment I'm getting?
Because this is a randomised study, you will be assigned to one of the treatment groups by chance. This helps researchers compare the treatments fairly. You will be told which treatment you are receiving.
What if the treatment doesn't work for me?
The study team will monitor your progress closely. If the treatment isn't working or if you experience severe side effects, your doctors will discuss other treatment options with you.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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