Efficacy and Safety of Zanidatamab With Standard-of-care Therapy Against Standard-of-care Therapy for Advanced HER2-positive Biliary Tract Cancer
This study is looking at a new treatment called Zanidatamab for adults with advanced biliary tract cancer that has a specific marker known as HER2-positive. It aims to find out if adding Zanidatamab to current standard treatments (which include Cisplatin, Gemcitabine, and sometimes Pembrolizumab or Durvalumab) works better and is safe for patients. Biliary tract cancer affects the bile ducts, which are tubes that carry digestive fluid. This study is for people whose cancer has spread or cannot be removed by surgery. It's in a late stage of testing, meaning it has already been looked at in earlier studies with smaller groups of people.
At a glance
What is this study about?
Imagine your body is like a lock and key, and sometimes cancer cells have too many 'HER2' locks on their surface, making them grow faster. This study is testing a new medicine called Zanidatamab, which is designed to block these HER2 'locks' specifically. Doctors want to see if adding Zanidatamab to the usual treatments helps people with advanced biliary tract cancer that has a lot of these HER2 locks.
The usual treatments for this type of cancer often include a combination of chemotherapy drugs like Cisplatin and Gemcitabine. Sometimes, an additional type of medicine, like Pembrolizumab or Durvalumab, which helps the body's own immune system fight cancer, is also used. This study will compare giving Zanidatamab along with these standard treatments versus just giving the standard treatments alone. The main goal is to find out if the Zanidatamab combination is more effective at shrinking the cancer or stopping it from growing, and importantly, whether it's safe for patients.
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. It involves a larger group of patients to confirm the results from earlier studies. By taking part, you could be helping researchers find new and better ways to treat biliary tract cancer in the future.
Key takeaways
- Tests a new drug (Zanidatamab) for HER2-positive biliary tract cancer.
- Compares new drug with standard treatment versus standard treatment alone.
- For advanced cancer that cannot be removed by surgery or has spread.
- Aims to see if Zanidatamab combination is more effective and safe.
- Participation involves regular hospital visits for treatment and checks.
Who may be eligible?
To be considered for this study, you must have biliary tract cancer that has been confirmed by a doctor, and it must be HER2-positive. This means your cancer cells have a lot of a specific protein called HER2. Your cancer should also be advanced, meaning it cannot be removed by surgery or has spread to other parts of your body.
You can't have had previous treatment with a HER2-targeting drug, and you should not have received more than two cycles of chemotherapy with Cisplatin and Gemcitabine (with or without Pembrolizumab or Durvalumab) for your advanced cancer. Certain types of biliary tract cancer are not included in this study, such as small cell cancer or neuroendocrine tumours. You also can't have certain other health conditions, like severe infections, active autoimmune diseases, or cancer that has spread to your brain.
All participants must be at least 18 years old and in good general health, as judged by a doctor. If you are female and could become pregnant, you'll need to have a negative pregnancy test and agree to use two reliable methods of birth control during the study. Males with partners who could become pregnant also need to use birth control.
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 biliary tract cancer confirmed by a doctor?
- Is my cancer HER2-positive?
- Is my cancer advanced (cannot be surgically removed or has spread)?
- Have I had no or very limited previous chemotherapy for my advanced cancer?
- Am I at least 18 years old and generally in good health?
What does participation involve?
If you join this study, you will receive either the new drug Zanidatamab along with standard treatments (Cisplatin and Gemcitabine, and possibly Pembrolizumab or Durvalumab), or just the standard treatments alone. You won't get to choose which group you are in; this is decided randomly, like flipping a coin. You will have regular visits to the hospital or clinic for treatments, check-ups, and tests like blood tests and scans, to see how you are responding to the treatment.
The exact schedule and number of visits will depend on the treatment you receive and how your body responds. Doctors will carefully monitor you for any side effects. You'll continue treatment for as long as it's helping and the side effects are manageable, or until the study doctors decide it's no longer the best option for you. After stopping treatment, there will be follow-up visits to track your health. The total duration of your participation will vary but can last for several months or even longer, including follow-up care.
Potential risks and benefits
Locations (185)
- City of Hope(City of Hope National Medical Center, City of Hope Medical Center)Verified postcodeDuarte, United States· Recruiting
- Rocky Mountain Cancer Centers, LLPVerified postcodeLone Tree, United States· Withdrawn
- AdventHealth Hematology and OncologyVerified postcodeOrlando, United States· Recruiting
- Winship Cancer InstituteVerified postcodeAtlanta, United States· Recruiting
- The University of Kansas Cancer Center - WestwoodVerified postcodeWestwood, United States· Withdrawn
- Norton Cancer Institute - AudubonVerified postcodeLouisville, United States· Recruiting
- Ochsner Clinic FoundationVerified postcodeNew Orleans, United States· Recruiting
- Tufts Medical CenterVerified postcodeBoston, United States· Active not recruiting
- University of Michigan HospitalVerified postcodeAnn Arbor, United States· Recruiting
- Henry Ford Health SystemVerified postcodeDetroit, United States· Recruiting
- Minnesota Oncology Hematology, P.A.Verified postcodeMaple Grove, United States· Active not recruiting
- Atlantic Health System/Morristown Medical CenterVerified postcodeMorristown, United States· Active not recruiting
Common questions
What is HER2-positive cancer?
HER2-positive means cancer cells have too much of a protein called HER2, which helps them grow. This study focuses on biliary tract cancer with this specific feature.
What are the standard treatments being used?
The standard treatments typically include chemotherapy drugs Cisplatin and Gemcitabine, sometimes with additional immune-boosting drugs like Pembrolizumab or Durvalumab.
Will I get the new drug Zanidatamab?
You might. Participants are randomly assigned to either receive Zanidatamab plus standard treatment or standard treatment alone. It's like drawing straws, so you won't know beforehand.
What does a Phase 3 study mean?
Phase 3 is one of the last steps in testing a new drug. It involves more people than earlier phases to confirm if the drug is effective and safe before it can be widely used.
How long will I be in the study if I join?
The time you spend in the study can vary. It involves receiving treatment for as long as it's beneficial and then having regular follow-up visits, potentially lasting for many months.
How to find out more
Clinical Trial Disclosure & Transparency
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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