Targeting Driver Oncogenes With a Peptide Vaccine Plus Durvalumab and Tremelimumab for Patients With Biliary Tract Cancers (BTC)

PHASE1RecruitingINTERVENTIONAL
Enrollment

25

Participants

Timeline

Start Date

May 27, 2025

Primary Completion Date

May 31, 2029

Study Completion Date

May 31, 2029

Conditions
Biliary Tract Cancers
Interventions
DRUG

mBTC 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.

DRUG

Durvalumab

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.

DRUG

Tremelimumab

Patients will receive treatment on C1D1. Tremelimumab (300 mg) will be administered IV as a single dose on Day 1 of Cycle 1.

Trial Locations (1)

21231

RECRUITING

SKCCC Johns Hopkins Medical Institution, Baltimore

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

AstraZeneca

INDUSTRY

collaborator

Private Philanthropic Funds

OTHER

lead

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

OTHER