Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
mBTC vax · 1 trial · 1 indication
When calculating the incidence of Adverse Events (AE), each AE (as defined by NCI CTCAE v5.0) will be counted only once for a given subject.
Evaluated by the maximal percent change in interferon-producing mutant-specific CD8 and CD4 T cells within 20 weeks post-vaccination compared to pre-vaccination baseline.
| Arm | Type | Description |
|---|---|---|
| Arm A - mBTCvax, Durvalumab and Tremelimumab | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| mBTC vax [0.3 - 2.4 mg peptide + 0.5 mg Poly-ICLC (Hiltonol)] | DRUG | Patients will receive treatment on Day 1, 8, 15 and 22 of cycle 1 and on day 1 of remaining cycles (C2-C4) in Prime Phase. In the Boost Phase - every 2 cycles (8 weeks) beginning from C6D1. |
| Durvalumab | DRUG | Patients will receive treatment on Day 1 of each cycle. Durvalumab (1500 mg) will be administered IV every 4 weeks in both the Prime and Boost Phase. |
| Tremelimumab | DRUG | Patients will receive treatment on C1D1. Tremelimumab (300 mg) will be administered IV as a single dose on Day 1 of Cycle 1. |
Inclusion Criteria: * Age ≥18 years * Must have a histologically- or cytologically, proven biliary tract cancer (BTC) previously treated with gemcitabine/cisplatin/anti-PD(L)1 therapy. * Must have evidence of radiological disease, must accept to have a tumor biopsy of an accessible lesion at baseli...