Targeting Biliary Tract Cancers with a Peptide Vaccine and Immunotherapy
This study is for people with advanced biliary tract cancers (BTC) that have been previously treated with gemcitabine/cisplatin/anti-PD(L)1 therapy. It is testing a combination of treatments: a personalized peptide vaccine called mBTC vax, along with two immunotherapy drugs, durvalumab and tremelimumab. The main goals are to see how safe this combination is (looking at side effects) and how it affects your immune system (specifically, certain T cells that fight cancer). You must be at least 18 years old and have evidence of cancer that can be seen on scans, and you will need a tumor biopsy. The study plans to enroll 25 participants.
- Study design
- This is an interventional study with an unclear phase, planning to enroll 25 participants. It is testing a combination of a vaccine and two immunotherapy drugs.
- What's involved
- You will receive the mBTC vax weekly for the first month, then every 8 weeks. Durvalumab will be given every 4 weeks, and tremelimumab will be given as a single dose at the start of the study. You will also have tumor biopsies at the beginning and during treatment.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study will measure drug-related toxicities for 20 months and immune responses from baseline to 20 weeks after vaccination.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT06564623
Targeting Driver Oncogenes With a Peptide Vaccine Plus Durvalumab and Tremelimumab for Patients With Biliary Tract Cancers (BTC)
Recruiting
PHASE1Ages 18+InterventionalTreatmentSidney Kimmel Comprehensive Cancer Center at Johns HopkinsInvestigator-initiated
~25 participants
Updated 2026-05-08 on ClinicalTrials.gov
What's tested:mBTC vax [0.3 - 2.4 mg peptide + 0.5 mg Poly-ICLC (Hiltonol)]DurvalumabTremelimumab
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of participants experiencing grade 3 or above drug-related toxicities
Measured over 20 Months
+1 more outcome measured
Conditions
NCT06564623
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
SKCCC Johns Hopkins Medical Institution
Baltimore, Marylandstudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Marina Baretti, MD · PRINCIPAL_INVESTIGATOR · SKCCC Johns Hopkins Medical Institution
Who to contact
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Eligibility criteria
Inclusion
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.
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.
Known history of interstitial lung disease or of (non-infectious) pneumonitis that required steroids or current pneumonitis.
Has a pulse oximetry \< 92% on room air.
Requires the use of home oxygen.
Has a known history of Human Immunodeficiency Virus (HIV)/AIDS
Has active co-infection with HBV (hepatitis B virus) and HCV (hepatitis C virus) or coinfected with HBV and hepatitis delta virus (HDV)
Uncontrolled intercurrent illness including, but not limited to, uncontrolled infection, symptomatic congestive heart failure, unstable angina, cardiac arrhythmia, metastatic cancer, or psychiatric illness/social situations that would limit compliance with study requirements.
Patients who have been diagnosed with another cancer or myeloproliferative disorder in the past 5 years requiring systemic therapy or expected to require active therapy within the clinical study period.
Has a diagnosis of immunodeficiency.
Presence of any tissue or organ allograft, regardless of need for immunosuppression, including corneal allograft. Patients with a history of allogeneic hematopoietic stem cell transplant will be excluded.
Any other sound medical, psychiatric, and/or social reason as determined by the Investigator.
Patient is at the time of signing informed consent a regular user (including "recreational use") of any illicit drugs or had a recent history (within the last year) of substance abuse (including alcohol).
Patient is unwilling or unable to follow the study schedule for any reason.
Pregnant or breastfeeding.
WOCBP and men with female partners (WOCBP) who are not willing to use contraception.
Evidence of clinical ascites requiring paracentesis in the last 4 weeks.
History of malignant bowel obstruction.
Exclusion
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.
What this trial measures
- Number of participants experiencing grade 3 or above drug-related toxicities20 Months
When calculating the incidence of Adverse Events (AE), each AE (as defined by NCI CTCAE v5.0) will be counted only once for a given subject.
- Maximum percentage change in interferon-producing mutant-specific cluster of differentiation 8 (CD8) and cluster of differentiation 4 (CD4) T cells.Baseline to 20 weeks post vaccination (baseline, 20 weeks)
Evaluated by the maximal percent change in interferon-producing mutant-specific CD8 and CD4 T cells within 20 weeks post-vaccination compared to pre-vaccination baseline.