RecruitingPhase 1NCT06564623

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

A Pilot Study of Targeting Driver Oncogenes With a Peptide Vaccine Plus Durvalumab and Tremelimumab for Patients With Biliary Tract Cancers


Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Enrollment

25 participants

Start Date

May 27, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a personalized cancer vaccine — designed based on your tumor's specific mutations — combined with the immunotherapy drug durvalumab, for patients with bile duct or gallbladder cancer (biliary tract cancer) that has already been treated with standard therapy including gemcitabine, cisplatin, and an anti-PD-1 drug. **You may be eligible if...** - You are 18 or older with a confirmed diagnosis of biliary tract cancer - Your cancer was previously treated with gemcitabine, cisplatin, and an immunotherapy drug - Your tumor has at least one specific mutation that the vaccine can target (confirmed by genetic testing) - You have measurable disease visible on imaging and are willing to have a tumor biopsy - You are in good general health (ECOG 0–1) - Your weight is above 30 kg and your organ function is adequate **You may NOT be eligible if...** - You have received other investigational therapy within the past 2 weeks - You need other forms of cancer treatment while on this study - You are pregnant or breastfeeding - You have uncontrolled autoimmune disease - You have active, uncontrolled hepatitis B or C Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.


Locations(1)

SKCCC Johns Hopkins Medical Institution

Baltimore, Maryland, United States

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NCT06564623