Status:
RECRUITING
Targeting Driver Oncogenes With a Peptide Vaccine Plus Durvalumab and Tremelimumab for Patients With Biliary Tract Cancers (BTC)
Lead Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborating Sponsors:
AstraZeneca
Private Philanthropic Funds
Conditions:
Biliary Tract Cancers
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 fol...
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.
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.
- 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.
Key Trial Info
Start Date :
May 27 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2029
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT06564623
Start Date
May 27 2025
End Date
May 1 2029
Last Update
December 5 2025
Active Locations (1)
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1
SKCCC Johns Hopkins Medical Institution
Baltimore, Maryland, United States, 21231