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MP0317+ Gemcitabine+ Cisplatine+ Durvalumab · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| MP0317 + Gemcitabine + Cisplatin + Durvalumab | EXPERIMENTAL | MP0317- Gemcitabine+ Cisplatin + Durvalumab |
| Gemcitabine + Cisplatin + Durvalumab | ACTIVE_COMPARATOR | Gemcitabine + Cisplatin + Durvalumab |
| Name | Type | Description |
|---|---|---|
| MP0317 + Gemcitabine + Cisplatine + Durvalumab | DRUG | * MP0317: 3 mg/kg IV(intraveinous), day 1, every 3 weeks for a maximum of 5 administrations * Immuno-chemotherapy (ICT): cycle 1-5 * Durvalumab 1500 mg IV, day 8 every 3 weeks * Gemcitabine 1000 mg/m² IV, days 8 and 15 every 3 weeks * Cisplatin 25 mg/m² IV, days 8 and 15 every 3 weeks * Immuno-chemotherapy (ICT): cycle 6-8 * Durvalumab 1500 mg IV every 3 weeks * Gemcitabine 1000 mg/m² at day 1, 8 every 21 days * Cisplatin 25 mg/m² at day 1, 8 every 21 days * Then durvalumab (1500 mg IV) will be administrated in monotherapy maintenance every 4 weeks until progression or unacceptable toxicity. |
| CT-Scan | PROCEDURE | at baseline, every 6 weeks (± 1 week) for the first 24 weeks and then every 8 weeks until progression, at end of treatment visit, At each follow-up visit : Only for patients who have not progressed during treatment phase |
| Gemcitabine + Cisplatin + Durvalumab | DRUG | * Immuno-chemotherapy (ICT) for 8 cycles : * Durvalumab 1500 mg IV, day 1 every 3 weeks * Gemcitabine 1000 mg/m² IV, days 1 and 8 every 3 weeks * Cisplatin 25 mg/m² IV, days 1 and 8 every 3 weeks * Then durvalumab (1500 mg IV) will be administrated in monotherapy maintenance every 4 weeks until progression or unacceptable toxicity. |
Inclusion Criteria: 1. Signed and dated informed consent 2. Histologically confirmed biliary tract carcinoma: intra/extrahepatic cholangiocarcinoma (note that gallbladder carcinoma are not eligible) 3. Locally advanced unresectable or metastatic 4. Patient who had not previously received systemic a...
MP0317 + Gemcitabine + Cisplatine + Durvalumab is an investigational combination therapy being studied for the first-line treatment of advanced biliary tract carcinoma. It combines the investigational agent MP0317 with the chemotherapy drugs gemcitabine and cisplatin, plus the immunotherapy durvalumab. The combination is currently in Phase 2 clinical development.
Molecular Partners AG (ticker: MOLN) is developing MP0317 + Gemcitabine + Cisplatine + Durvalumab. The company is conducting a Phase 2 clinical trial of this combination therapy for advanced biliary tract carcinoma. The trial is actively recruiting participants in France.
MP0317 + Gemcitabine + Cisplatine + Durvalumab is in Phase 2 clinical development. It is an investigational combination therapy and has not been approved by regulatory authorities. The ongoing Phase 2 trial is evaluating the combination in patients with advanced biliary tract carcinoma.
MP0317 + Gemcitabine + Cisplatine + Durvalumab is being studied in one active clinical trial, NCT07036380. This Phase 2 trial is titled 'MP0317 in Combination With Chemoimmunotherapy in First Line Treatment for Patients With Advanced Biliary Tract Carcinoma' and is recruiting 75 participants in France.
Yes, MP0317 + Gemcitabine + Cisplatine + Durvalumab is also known as MP0317 + Gemcitabine + Cisplatine + Durvalumab. These names refer to the same combination therapy being developed by Molecular Partners AG for advanced biliary tract carcinoma.