Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
The purpose of this study is to evaluate the safety and the immune response of personalized mutant peptide vaccine with poly-ICLC adjuvant (mBTCvax) in combination with durvalumab and tremelimumab following front-line treatment in patients with advanced stage BTC.
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 baseline and on treatment. * Must have sufficient archival tumor tissue for next-generation sequencing (NGS) and immune-phenotyping. * Have a BTC containing at least one of the oncogenic mutation/alterations targeted by the vaccine. * Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1. *…
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.
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.
Patients will receive treatment on C1D1. Tremelimumab (300 mg) will be administered IV as a single dose on Day 1 of Cycle 1.
Arctuva estimate
Verify or correct the compensation shown for this listing.