Study of Cabozantinib Alone or in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors
This research is looking at two anti-cancer medicines, cabozantinib and atezolizumab, which can be used alone or in combination. It's for people with several types of advanced cancers, including cancers of the bladder, kidney, lung, prostate, breast, ovary, womb, liver, stomach, bowel, and head and neck, as well as thyroid cancer. The main goals are to find a safe dose for using these drugs together, understand their side effects, and see how well they might shrink tumours or stop them from growing. This is an early-stage study, meaning it's one of the first times this combination is being tested in a larger group of people with these cancers.
At a glance
What is this study about?
This study is designed to explore new ways of treating several types of advanced solid cancers that have spread or cannot be removed by surgery. It focuses on two specific anti-cancer drugs: cabozantinib and atezolizumab. These drugs work differently to fight cancer – cabozantinib targets certain signals that help cancer cells grow and spread, while atezolizumab helps your body's immune system recognise and attack cancer cells.
The study has two main parts. The first part, called the 'Dose Escalation Stage', focuses on finding the safest and most effective dose of cabozantinib to use when it's given alongside a standard dose of atezolizumab. Once this dose is determined, the study will move to the 'Expansion Stage'. In this stage, more patients with specific types of cancer will receive the combination treatment to get a better idea of how well it works and to further monitor its side effects. Some patients might also receive one of the drugs on its own at first, and then switch to the combination if their cancer progresses.
By carefully studying how these two drugs work together or alone, researchers hope to improve treatment options for people living with these advanced cancers. This kind of research is crucial for developing future treatments and helping more patients.
Key takeaways
- Tests new drug combinations for advanced cancers.
- Investigates cabozantinib and atezolizumab.
- Aims to find safe doses and assess effectiveness.
- Includes many cancer types, like bladder, lung, and breast cancer.
- Involves regular hospital visits for treatment and monitoring.
- You can withdraw from the study at any time.
Who may be eligible?
To join this study, you generally need to have a confirmed diagnosis of certain types of advanced cancer that cannot be surgically removed or has spread. Your doctors will need to be able to measure your cancer, for example, on scans, and you'll need to provide a sample of your tumour tissue.
You must be 18 years or older and generally in good health, meaning you can carry out most of your daily activities without much trouble. Your blood tests for organ function and bone marrow should also be within acceptable limits.
There are also some reasons why you might not be able to join. For example, if you've already had either cabozantinib or certain other types of anti-cancer treatments that boost your immune system, or if you have certain brain metastases that aren't well-controlled. People who are pregnant or breastfeeding, or who are taking certain steroid medications or blood thinners, would also not be able to participate.
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 you have advanced cancer that has spread or can't be operated on?
- Are you 18 years old or older?
- Do your doctors believe your general health is good enough for a study?
- Have you *not* had certain specific anti-cancer drugs before, such as cabozantinib or similar immune therapies (unless specifically allowed for your cancer type)?
- Are you able to attend regular appointments for treatment and monitoring?
- Are you not pregnant, breastfeeding, or on certain blood thinners or steroid medications?
What does participation involve?
If you decide to take part in this study, you will receive either cabozantinib or atezolizumab, or a combination of both, depending on the stage of the study and your cancer type. Cabozantinib is usually given as tablets, and atezolizumab is given as an infusion into a vein, typically every three weeks. The study involves regular visits to the hospital for check-ups, blood tests, and scans to monitor your health and how your cancer is responding to the treatment. The total duration of your participation will depend on how you respond to the treatment and the specific part of the study you are in, but it will involve ongoing assessments and follow-up.
Potential risks and benefits
Locations (124)
- Exelixis Clinical Site #53Verified postcodeGilbert, United States
- Exelixis Clinical Site #18Verified postcodePhoenix, United States
- Exelixis Clinical Site #1Verified postcodeDuarte, United States
- Exelixis Clinical Site #20Verified postcodeLa Jolla, United States
- Exelixis Clinical Site #46Verified postcodeLos Angeles, United States
- Exelixis Clinical Site #51Verified postcodeNewport Beach, United States
- Exelixis Clinical Site #62Verified postcodeSanta Monica, United States
- Exelixis Clinical Site #21Verified postcodeStanford, United States
- Exelixis Clinical Site #34Verified postcodeDenver, United States
- Exelixis Clinical Site #50Verified postcodeDenver, United States
- Exelixis Clinical Site #42Verified postcodeNew Haven, United States
- Exelixis Clinical Site #48Verified postcodeWashington D.C., United States
Common questions
What is the main purpose of this study?
The main purpose is to find a safe dose for a new combination of two anti-cancer drugs and see how well they work against different advanced cancers.
What kinds of cancers is this study for?
It's for many types of advanced cancer, including bladder, kidney, lung, prostate, breast, ovary, womb, liver, stomach, bowel, head and neck, and thyroid cancer.
What are cabozantinib and atezolizumab?
They are different types of anti-cancer medicines. Cabozantinib helps stop cancer cells from growing, while atezolizumab helps your body's immune system fight the cancer.
Will I definitely receive both drugs?
Some parts of the study will involve receiving both drugs. In other parts, you might receive one drug first and then move to the combination later, depending on your situation.
How long will I be in the study?
Your time in the study will depend on how you respond to the treatment and your specific cancer, but it will involve regular appointments and check-ups with the study team.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.