A Pilot Study of Targeting Driver Oncogenes With a Peptide Vaccine Plus Durvalumab and Tremelimumab for Patients With Biliary Tract Cancers
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Summary
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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. *…
Interventions
- DrugmBTC vax [0.3 - 2.4 mg peptide + 0.5 mg Poly-ICLC (Hiltonol)]
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.
- DrugDurvalumab
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.
- DrugTremelimumab
Patients will receive treatment on C1D1. Tremelimumab (300 mg) will be administered IV as a single dose on Day 1 of Cycle 1.
Location
- SKCCC Johns Hopkins Medical InstitutionBaltimore, Maryland