Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT06564623

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

Led by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Updated on 2026-05-08

25

Participants Needed

1

Research Sites

196 weeks

Total Duration

On this page

Sponsors

S

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Lead Sponsor

A

AstraZeneca

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Histologically or cytologically confirmed biliary tract cancer previously treated with gemcitabine, cisplatin, and anti-PD(L)1 therapy
  • Evidence of radiological disease and willingness to have tumor biopsy at baseline and during treatment
  • Sufficient archival tumor tissue available for next-generation sequencing and immune-phenotyping
  • Biliary tract cancer containing at least one oncogenic mutation targeted by the vaccine
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Body weight greater than 30 kg
  • Adequate organ and marrow function as defined by study laboratory tests
  • Controlled chronic or acute hepatitis B or C infection prior to enrollment
  • Negative pregnancy test for women of childbearing potential
  • Use of acceptable birth control methods for both women and men during the study
  • Life expectancy of at least 12 weeks
  • Ability to understand and willingness to sign informed consent
Not Eligible

You will not qualify if you...

  • Participation in another clinical study with investigational product within 2 weeks prior to this study
  • Expected need for other systemic or localized cancer treatments during this study
  • Use of systemic or topical immunosuppressive steroids above specified doses within 2 weeks prior to treatment, with some exceptions
  • Recent palliative or adjuvant radiation or gamma knife radiosurgery within 2 weeks
  • Use of chemotherapy or checkpoint inhibitors targeting anti-PD1/PD-L1 within 2 weeks
  • Use of investigational cytotoxic drugs, devices, live-virus vaccines, allergen therapy, growth factors, or major surgery within 4 weeks prior to treatment
  • Unresolved toxicity grade 2 or higher from previous cancer therapy, except certain conditions
  • Grade 2 or higher neuropathy without physician consultation
  • Unresolved adverse events from prior immunotherapy
  • History of grade 3 or higher immune-related or neurologic/ocular adverse events from prior immunotherapy
  • Prior treatment with anti-PD-1 or anti-PD-L1 drugs
  • Severe hypersensitivity to monoclonal antibodies or related compounds
  • History of leptomeningeal carcinomatosis or brain metastases
  • Active or suspected autoimmune disease requiring systemic therapy in last 5 years
  • History of interstitial lung disease or pneumonitis requiring steroids
  • Pulse oximetry below 92% on room air or need for home oxygen
  • Known HIV/AIDS infection
  • Active co-infection with hepatitis viruses
  • Uncontrolled illnesses that may limit compliance
  • Diagnosis of another cancer requiring systemic therapy within past 5 years
  • Immunodeficiency diagnosis
  • Presence of tissue or organ allograft or history of hematopoietic stem cell transplant
  • Substance abuse or illicit drug use history within last year
  • Inability or unwillingness to follow study schedule
  • Pregnancy or breastfeeding
  • Women of childbearing potential and men with female partners not willing to use contraception
  • Clinical ascites requiring paracentesis within last 4 weeks
  • History of malignant bowel obstruction

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

SKCCC Johns Hopkins Medical Institution

Baltimore, Maryland, United States, 21231

Actively Recruiting

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Research Team

C

Colleen Apostol, RN

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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