Ivosidenib Plus Durvalumab and Gemcitabine/Cisplatin as First-Line Therapy in Participants With Locally Advanced or Metastatic Cholangiocarcinoma With an IDH1 Mutation
This research is looking at a new combination of medicines for a type of cancer that starts in the bile ducts, called cholangiocarcinoma. This is for people whose cancer has a specific genetic change called an IDH1 mutation and is locally advanced, unresectable, or has spread to other parts of the body. The study combines ivosidenib, durvalumab, and standard chemotherapy (gemcitabine/cisplatin). We want to find out if this combination is safe, what the right dose is, and how well it works as a first treatment option. The study runs in two main parts, first checking safety and dosage, then expanding to see its effectiveness. Regular hospital visits, tests, and follow-up will be part of taking part.
Överblick
Vad handlar denna studie om?
This study is investigating a new way to treat a specific type of cancer called cholangiocarcinoma, which affects the bile ducts. This cancer is quite rare and can be challenging to treat, especially when it's advanced. The focus of this research is on patients whose cancer cells have a particular genetic error, known as an IDH1 mutation. This mutation can affect how cancer cells grow, and certain medicines are designed to target it.
The study combines several different treatments: ivosidenib, which specifically targets the IDH1 mutation; durvalumab, a type of immunotherapy that helps your body's immune system fight cancer; and standard chemotherapy drugs (gemcitabine and cisplatin). The aim is to see if using these treatments together can be more effective than current approaches, by attacking the cancer from different angles. This is being explored as an initial (first-line) treatment option for patients before they've had other therapies for advanced disease.
This research is important because it could lead to better treatment options for people with this specific type of bile duct cancer. By understanding if this combination is safe and effective, doctors can potentially offer new hope and improved outcomes for patients with IDH1-mutated cholangiocarcinoma.
Viktiga punkter
- Tests a new combination of treatments for bile duct cancer with a specific genetic change (IDH1 mutation).
- Aims to find out if this combination is safe and effective as a first treatment.
- Involves regular hospital visits for treatment and monitoring.
- Includes a mix of oral medication, immunotherapy, and chemotherapy.
- Follow-up will continue for several months after treatment ends.
- Deltagande är frivilligt, och du kan dra dig ur när som helst.
Vem kan vara berättigad?
To join this study, you must have a confirmed diagnosis of bile duct cancer (cholangiocarcinoma) that is locally advanced, cannot be removed by surgery, or has spread. Importantly, your cancer cells must show a specific genetic change called an IDH1 mutation.
You also need to be at least 18 years old and generally well enough to take part, with normal bone marrow, liver, and kidney function. This means your body needs to be able to handle the treatments involved. Doctors will check these things with blood tests.
There are also reasons you might not be able to join. For example, if you've already had many treatments for your advanced bile duct cancer, or if you've previously received certain types of immunotherapy. You also shouldn't have any other serious medical conditions that might make taking part risky.
Kan denna studie passa dig?
Svara på dessa snabba frågor för att se om du kan vara berättigad. Detta är endast en vägledning — forskarteamet fattar det slutgiltiga beslutet.
- Do you have a confirmed diagnosis of advanced bile duct cancer?
- Has your doctor confirmed your cancer has the IDH1 genetic mutation?
- Är du 18 år eller äldre?
- Are you generally well, with good blood counts, liver, and kidney function?
- Have you had limited or no prior treatment for your advanced cancer?
Vad innebär deltagande?
If you join this study, you will receive a combination of medicines: ivosidenib, durvalumab, gemcitabine, and cisplatin. The first 8 treatment cycles will combine all these medicines, with durvalumab continuing after that. Each treatment cycle for the first 8 cycles lasts 21 days, and then subsequent cycles will be 28 days long.
During your treatment, you'll have regular hospital visits. In the first cycle, you'll visit on days 1, 8, and 15. For cycles 2 to 8, you'll visit on days 1 and 8. After that, you'll visit on day 1 of each new cycle. These visits will involve various checks, including blood tests, heart readings (ECG), measuring your vital signs (like blood pressure and temperature), and a physical examination to monitor your health and how the treatment is working.
After your treatment period finishes, you'll have follow-up safety visits approximately 30 and 90 days later. Following these, doctors will continue to check in with you about your survival every three months for an extended period. The study involves two phases: a first phase to find the best and safest dose of the medicine combination, followed by an expansion phase to see how well that dose works.
Potentiella risker och fördelar
Platser (38)
- Cancer and Blood Speciality Clinic - Los AlamitosVerifierat postnummerLos Alamitos, USA· Rekrytering
- Usc Norris Comprehensive Cancer CenterVerifierat postnummerLos Angeles, USA· Rekrytering
- Northwestern MedicineVerifierat postnummerChicago, USA· Rekrytering
- Memorial Sloan Kettering Cancer CenterVerifierat postnummerNew York, USA· Rekrytering
- Duke UniversityVerifierat postnummerDurham, USA· Rekrytering
- Gibbs Cancer CenterVerifierat postnummerSpartanburg, United States· Rekrytering
- Tennesse Oncology - Elliston Place PlazaVerifierat postnummerNashville, USA· Rekrytering
- The University of Texas Md Anderson Cancer CenterVerifierat postnummerHouston, USA· Rekrytering
- Alfred HealthVerifierat postnummerMelbourne, Australien· Rekrytering
- Hospital de Amor - BarretosVerifierat postnummerBarretos, Brasilien· Rekrytering
- Oncoclinicas MgVerifierat postnummerBelo Horizonte, Brasilien· Rekrytering
- CIONCVerifierat postnummerCuritiba, Brasilien· Rekrytering
Vanliga frågor
What is an IDH1 mutation?
It's a specific genetic change in your cancer cells that can make them grow. This study's treatment is designed to target this change.
What does 'first-line therapy' mean?
This means the study drugs would be the first treatment you receive for your advanced bile duct cancer, before other main treatments.
Vilka typer av tester kommer jag att ha?
You'll have regular blood tests, heart checks (ECGs), vital sign measurements, and physical examinations during your hospital visits.
Hur länge kommer jag att vara med i studien?
The treatment period varies, but you'll have follow-up visits for safety for about 3 months after treatment, and then survival checks every three months.
Kan jag lämna studien när som helst?
Yes, you can choose to stop participating in the study at any point, and this won't affect your ongoing medical care.
Hur du får reda på mer
Institut de Recherches Internationales Servier (I.R.I.S.) Clinical Studies Department
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