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

Conditions

• Biliary Tract Cancers

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• mBTC vax [0.3 - 2.4 mg peptide + 0.5 mg Poly-ICLC (Hiltonol)] — DRUG
  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.
• Durvalumab — DRUG
  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.
• Tremelimumab — DRUG
  Patients will receive treatment on C1D1. Tremelimumab (300 mg) will be administered IV as a single dose on Day 1 of Cycle 1.

Study Details

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.

Key Dates

Start date

May 27, 2025

Status verified

May 2026

Primary completion

Mar 31, 2029

Completion

Mar 31, 2029

Study Design

Enrollment

25 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Arm A - mBTCvax, Durvalumab and Tremelimumab

Primary Outcome Measure

Number of participants experiencing grade 3 or above drug-related toxicities [ Time Frame: 20 Months ]

Central Contacts

• Colleen Apostol, RN
  410-614-3644
  [email protected]

Locations (1)

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