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RecruitingBiliary Tract Cancers

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

Eligible age

18+ yrs

Accepts

All genders

Locations

1 state

Healthy volunteers

No

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About this study

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.

Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

You may qualify if…

  • ✓ 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.
  • ✓ Have a BTC containing at least one of the oncogenic mutation/alterations targeted by the vaccine.
  • ✓ Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
  • ✓ Must have body weight of \>30 kg.
  • ✓ Patients must have adequate organ and marrow function defined by study-specified laboratory tests.

You may not qualify if…

  • ✕ 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.
  • ✕ Any of the following procedures or medications within 2 weeks prior to initiation of study treatment:
  • ✕ Systemic or topical steroids at immunosuppressive doses (\> 10 mg/day of prednisone or equivalent). The following are exceptions to this criterion:
  • ✕ 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
  • ✕ Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication)
  • ✕ Palliative or adjuvant radiation or gamma knife radiosurgery.

Where it's recruiting

Maryland

Baltimore

Source: ClinicalTrials.gov · NCT06564623 · last updated 2026-05-08