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.
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.
Participation in another clinical study with an investigational product during the last 2 weeks.
Patient is expected to require any other form of systemic or localized antineoplastic therapy while on study.
Intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra articular injection)
Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or its equivalent
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Lead sponsor
AstraZeneca
Collaborator
Private Philanthropic Funds
Collaborator