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

Recruiting now · Phase 1

Conditions studied: Biliary Tract Cancers

In brief

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 facts

Study ID

NCT06564623

Run by

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

People needed

25

Starts

2025-05-27

Expected to finish

2029-03-01

Last updated by the study team

2026-05-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.
• Patients with chronic or acute hepatitis B virus (HBV) or hepatitis C virus (HCV) infection must have disease controlled prior to enrollment.
• Women of childbearing potential (WOCBP) must have a negative urine or serum pregnancy test.
• For both Women and Men, must use acceptable form of birth control while on study.
• Must have a life expectancy of at least 12 weeks.
• Ability to understand and willingness to sign a written informed consent document.

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.
• Chemotherapy or checkpoint inhibitor targeting anti-Pd1/PD-L1.
• Within 4 weeks prior to initiation of study treatment:
• Any investigational cytotoxic drug.
• Any investigational device.
• Non-oncology vaccines containing live virus.
• Allergen hyposensitization therapy.
• Growth factors, e.g. granulocyte-colony stimulating factor (G-CSF), granulocyte macrophage-colony stimulating factor (GM-CSF), erythropoietin.
• Major surgery.
• Any unresolved toxicity NCI CTCAE Grade ≥2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria.
• Patients with Grade ≥2 neuropathy will be evaluated on a case-by-case basis after consultation with the Study Physician.
• All AEs while receiving prior immunotherapy must have completely resolved or resolved to baseline prior to screening for this study.
• Must not have experienced a ≥Grade 3 immune related AE or an immune related neurologic or ocular AE of any grade while receiving prior immunotherapy.
• Patients with a history of prior treatment with anti-PD-1 and anti-PD-L1.
• History of severe hypersensitivity reaction to any monoclonal antibodies or related compounds or to any of its components.
• History of leptomeningeal carcinomatosis.
• Patient has a known history or evidence of brain metastases.
• Has an active known or suspected autoimmune disease or which has required systemic therapy in the last 5 years.

Where it is running

• SKCCC Johns Hopkins Medical Institution — Baltimore, Maryland, United States (enrolling)

Full record on ClinicalTrials.gov

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