A Study of Rilvegostomig or Durvalumab Plus Chemotherapy for First-Line Treatment of Biliary Tract Cancer (ARTEMIDE-Biliary02)
This important study, called ARTEMIDE-Biliary02, is for people with advanced bile duct cancer (also known as biliary tract cancer) that has spread or can't be removed by surgery. It aims to find the best first treatment for this type of cancer. Researchers are comparing two different drug combinations: one includes a new drug called rilvegostomig alongside standard chemotherapy (gemcitabine and cisplatin), and the other uses durvalumab, another immune-boosting drug, with the same chemotherapy. The main goal is to see which combination is more effective at treating the cancer and how safe each treatment is for patients. This could help improve future treatments for bile duct cancer.
At a glance
What is this study about?
This study is about finding better treatments for a type of cancer called biliary tract cancer, often known as bile duct cancer. This cancer starts in the tubes that carry bile from the liver. When it's advanced, it means the cancer has spread or can't be removed with surgery. For these patients, doctors are always looking for new ways to help.
In this study, called ARTEMIDE-Biliary02, researchers are testing two different treatment approaches as a first step for advanced bile duct cancer. Both approaches use standard chemotherapy drugs, gemcitabine and cisplatin, which are common treatments for this type of cancer. What's different is the addition of another drug to these chemotherapy drugs. One group will receive a drug called rilvegostomig, and another will receive a drug called durvalumab. Both rilvegostomig and durvalumab are types of immunotherapy, which means they work by helping your own immune system fight the cancer.
The main aim of the study is to compare these two combinations. Doctors want to see if one combination is better at shrinking the cancer, stopping it from growing, or helping people live longer. They also want to understand the side effects of each treatment to make sure they are safe. By taking part, patients are helping doctors learn more about the best ways to treat advanced bile duct cancer, which could help future patients.
Key takeaways
- This study is testing two new combinations of drugs for advanced bile duct cancer.
- It aims to find out which combination is safer and more effective as a first treatment.
- Both combinations include standard chemotherapy plus an immunotherapy drug.
- Participation involves regular medical checks and scans to monitor your health and the cancer.
- The study is for patients whose bile duct cancer has spread or cannot be removed by surgery.
- You can stop taking part in the study at any time if you wish.
Who may be eligible?
To join this study, your doctor would need to confirm you have a specific type of bile duct cancer (adenocarcinoma) that has been identified through a tissue sample. The cancer must be advanced, meaning it has either spread to other parts of your body or can't be removed surgically, and you must not have had any previous treatment for this advanced stage of your cancer.
You also need to be generally well enough to take part, as measured by a doctor's assessment (called an ECOG Performance Status of 0 or 1). Your body's organs, like your blood, liver, and kidneys, need to be working well. Additionally, your doctor will need a recent scan showing that your cancer can be measured accurately.
There are also some reasons why you might not be able to join. For example, if you have a specific type of bile duct cancer called ampullary carcinoma, you wouldn't be eligible. Also, if you have had certain immune system disorders, serious gut problems causing diarrhea, or active skin conditions requiring strong ongoing treatment, or certain lung conditions, you wouldn't 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 I have a confirmed diagnosis of bile duct cancer (adenocarcinoma)?
- Has my cancer spread or can it not be fully removed by surgery?
- Have I had any previous drug treatments for this advanced cancer already?
- Am I generally well enough to be active most of the time?
- Do my blood tests and organ function appear to be healthy enough for treatment?
- Do I have any serious immune system problems or certain long-term gut or lung conditions?
What does participation involve?
If you decide to join this study, you will be given one of the two treatment combinations. Doctors will monitor your health closely throughout. This will involve regular visits to the clinic for medical examinations, blood tests, and scans (like CT or MRI) to see how the treatment is working and check for any side effects. You will receive the study medication as prescribed by the research team. The total length of your participation will depend on how you respond to the treatment and the study plan, but you will have follow-up appointments even after active treatment ends. The research team will explain the full schedule of visits and assessments to you.
Potential risks and benefits
Locations (168)
- Research SiteVerified postcodeBirmingham, United States· Not yet recruiting
- Research SiteVerified postcodePhoenix, United States· Not yet recruiting
- Research SiteVerified postcodeTucson, United States· Not yet recruiting
- Research SiteVerified postcodeDuarte, United States· Recruiting
- Research SiteVerified postcodeOrange, United States· Not yet recruiting
- Research SiteVerified postcodeSanta Monica, United States· Not yet recruiting
- Research SiteVerified postcodeStanford, United States· Not yet recruiting
- Research SiteVerified postcodeAurora, United States· Not yet recruiting
- Research SiteVerified postcodeHartford, United States· Not yet recruiting
- Research SiteVerified postcodeNew Haven, United States· Not yet recruiting
- Research SiteVerified postcodeWashington D.C., United States· Not yet recruiting
- Research SiteVerified postcodeWashington D.C., United States· Not yet recruiting
Common questions
What is biliary tract cancer?
Biliary tract cancer is a type of cancer that starts in the bile ducts, which are tubes that carry digestive fluid (bile) from the liver.
What does 'advanced' cancer mean in this study?
It means the cancer has spread from where it started to other parts of the body, or it's located in a way that surgery can't remove it.
What are rilvegostomig and durvalumab?
These are drugs called immunotherapies. They work by boosting your body's own immune system to help it fight cancer cells.
Will I know which treatment I am getting?
In studies like this, patients are usually assigned to a treatment group by chance, like flipping a coin. Sometimes you and your doctors might know, and sometimes you might not. The study team will explain this to you.
Can I stop participating if I want to?
Yes, you have the right to withdraw from the study at any time, for any reason. Your decision will not affect your ongoing medical care.
How to find out more
AstraZeneca Clinical Study Information Center
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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