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Biliary Tract CancersPhase 1NCT06564623

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

A Phase 1 study testing mBTC vax [0.3 - 2.4 mg peptide + 0.5 mg Poly-ICLC (Hiltonol)], Durvalumab and Tremelimumab in people with Biliary Tract Cancers, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Biliary Tract Cancers
What is being tested?
mBTC vax [0.3 - 2.4 mg peptide + 0.5 mg Poly-ICLC (Hiltonol)], Durvalumab and Tremelimumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
1 siteUnited States
Study dates
27 May 2025to Mar 2029
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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
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  • 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.
  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Colleen Apostol, RN contact

410-614-3644

GIClinicalTrials@jhmi.edu

United States1 site, 1 recruiting

  • SKCCC Johns Hopkins Medical Institution

    Baltimore, Maryland, 21231

    Colleen Apostol, RN, 410-614-3644, GIClinicalTrials@jhmi.edu

    Marina Baretti, MD

    Recruiting

Other trials in United States

About this study

Official title: A Pilot Study of Targeting Driver Oncogenes With a Peptide Vaccine Plus Durvalumab and Tremelimumab for Patients With Biliary Tract Cancers

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.

Being tested
mBTC vax [0.3 - 2.4 mg peptide + 0.5 mg Poly-ICLC (Hiltonol)], Durvalumab, Tremelimumab
Keywords
Biliary Tract Cancer, Duvalumab, Tremelimumab, Immunotherapy, mBTCvax (peptide vaccine + Poly-ICLC (Hiltonol)), Anti PD-L1, Anti-Cytotoxic T-lymphocyte antigen 4 (CTLA-4), Hiltonol, Carcinoma
Medical subject headings
Biliary Tract Neoplasms, Diabetes Mellitus, Insulin-Dependent, 12, Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • mBTC vax [0.3 - 2.4 mg peptide + 0.5 mg Poly-ICLC (Hiltonol)]Drug

    Also called Peptide + Poly-ICLC (Hiltonol)

    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.

  • DurvalumabDrug

    Also called IMFINZI®

    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.

  • TremelimumabDrug

    Also called IMJUDO®

    Patients will receive treatment on C1D1. Tremelimumab (300 mg) will be administered IV as a single dose on Day 1 of Cycle 1.

Study groups in NCT06564623
Study groupRoleWhat they receive
Arm A - mBTCvax, Durvalumab and TremelimumabExperimentalNot described
Receives: Drug: mBTC vax [0.3 - 2.4 mg peptide + 0.5 mg Poly-ICLC (Hiltonol)]; Drug: Durvalumab; Drug: Tremelimumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of participants experiencing grade 3 or above drug-related toxicities

    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.

    Measured: 20 Months

  2. Maximum percentage change in interferon-producing mutant-specific cluster of differentiation 8 (CD8) and cluster of differentiation 4 (CD4) T cells.

    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.

    Measured: Baseline to 20 weeks post vaccination (baseline, 20 weeks)

Secondary outcomes (2)

  1. Progression Free Survival (PFS)

    PFS is defined as the number of months from the date of first vaccine dose until the date of disease progression using RECIST 1.1 criteria or death due to any cause, whichever occurs first, for BTC patients. PFS will be censored at the date of the last scan for subjects without documentation of disease progression at the time of analysis. Per RECIST 1.1 criteria, Complete Response (CR) = disappearance of all target lesions, Partial Response (PR) is =>30percent decrease in sum of diameters of target lesions, Progressive Disease (PD) is >20percent increase in sum of diameters of target lesions, Stable Disease (SD) is <30percent decrease or <20percent increase in sum of diameters of target lesions. Estimation based on the Kaplan-Meier curve.

    Measured: 4 years

  2. Overall Survival (OS)

    OS will be defined as the number of months from the date of first vaccine dose until date of death due to any cause. OS will be censored on the date the subject was last known to be alive for subjects without documentation of death at time of analysis. Estimation based on the Kaplan-Meier curve.

    Measured: 4 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Aug 2024
  2. Study start27 May 2025
  3. Primary completionMar 2029 (estimated)
  4. Study completionMar 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
25 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06564623
Sponsor's protocol ID
J2477
Other IDs
IRB00416341
Status last verified
May 2026
First submitted
19 Aug 2024
Last updated
8 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing mBTC vax [0.3 - 2.4 mg peptide + 0.5 mg Poly-ICLC (Hiltonol)], Durvalumab and Tremelimumab in people with Biliary Tract Cancers, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 41 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Colleen Apostol, RN (410-614-3644, GIClinicalTrials@jhmi.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants experiencing grade 3 or above drug-related toxicities (time frame: 20 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06564623.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2026.

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