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.
Auf einen Blick
Worum geht es in dieser Studie?
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.
Wichtige Erkenntnisse
- 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.
- Die Teilnahme ist freiwillig, und Sie können jederzeit zurücktreten.
Wer könnte berechtigt sein?
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.
Könnte diese Studie für Sie geeignet sein?
Beantworten Sie diese kurzen Fragen, um zu sehen, ob Sie möglicherweise berechtigt sind. Dies ist nur ein Leitfaden – das Forschungsteam trifft die endgültige Entscheidung.
- Do you have a confirmed diagnosis of advanced bile duct cancer?
- Has your doctor confirmed your cancer has the IDH1 genetic mutation?
- Sind Sie 18 Jahre alt oder älter?
- Are you generally well, with good blood counts, liver, and kidney function?
- Have you had limited or no prior treatment for your advanced cancer?
Was beinhaltet die Teilnahme?
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.
Potenzielle Risiken und Vorteile
Locations (38)
- Cancer and Blood Speciality Clinic - Los AlamitosVerifizierte PostleitzahlLos Alamitos, Vereinigte Staaten· Rekrutierung
- Usc Norris Comprehensive Cancer CenterVerifizierte PostleitzahlLos Angeles, Vereinigte Staaten· Rekrutierung
- Northwestern MedicineVerifizierte PostleitzahlChicago, Vereinigte Staaten· Rekrutierung
- Memorial Sloan Kettering Cancer CenterVerifizierte PostleitzahlNew York, Vereinigte Staaten· Rekrutierung
- Duke UniversitätVerifizierte PostleitzahlDurham, Vereinigte Staaten· Rekrutierung
- Gibbs Cancer CenterVerifizierte PostleitzahlSpartanburg, Vereinigte Staaten· Rekrutierung
- Tennesse Oncology - Elliston Place PlazaVerifizierte PostleitzahlNashville, Vereinigte Staaten· Rekrutierung
- The University of Texas Md Anderson Cancer CenterVerifizierte PostleitzahlHouston, Vereinigte Staaten· Rekrutierung
- Alfred HealthVerifizierte PostleitzahlMelbourne, Australia· Rekrutierung
- Hospital de Amor - BarretosVerifizierte PostleitzahlBarretos, Brazil· Rekrutierung
- Oncoclinicas MgVerifizierte PostleitzahlBelo Horizonte, Brazil· Rekrutierung
- CIONCVerifizierte PostleitzahlCuritiba, Brazil· Rekrutierung
Häufige Fragen
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.
Welche Art von Tests werde ich haben?
You'll have regular blood tests, heart checks (ECGs), vital sign measurements, and physical examinations during your hospital visits.
Wie lange werde ich an der Studie teilnehmen?
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.
Kann ich die Studie jederzeit verlassen?
Yes, you can choose to stop participating in the study at any point, and this won't affect your ongoing medical care.
Wie Sie mehr erfahren können
Institut de Recherches Internationales Servier (I.R.I.S.) Clinical Studies Department
Sprechen Sie immer mit Ihrem Hausarzt oder Spezialisten, bevor Sie sich entscheiden, an einer Studie teilzunehmen.
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