Targeting Driver Oncogenes With a Peptide Vaccine Plus Durvalumab and Tremelimumab for Patients With Biliary Tract Cancers (BTC)
Trial Parameters
Brief 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 Criteria
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. * Must have body weight of \>30 kg. * Patients must have adequate organ and marrow function defined by study-specified laboratory tests. * Patients with chronic or acute hepatitis B virus (HBV) or hepatitis C virus (HCV) infection must have disease controlled prior to enrollment. * Women of childbearing potential (WOCBP) must have a negative urine or serum pregnancy test. * For both Women and Men, mu