Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07036380 | MP0317 in Combination With Chemoimmunotherapy in First Line Treatment for Patients With Advanced Biliary Tract Carcinoma | PHASE2 | RECRUITING | 75 | — | — | Dec 22, 2025 | Nov 1, 2029 | Jun 1, 2026 | 11 | France |
| 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...