RECRUITING

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

Conditions

Biliary Tract Cancers 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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-05-27

Study Completion:2029-05

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06564623

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* 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.	* 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.

Inclusion Criteria

Exclusion Criteria

* 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.

* 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.

Contacts and Locations

Study Contact

Colleen Apostol, RN

CONTACT

410-614-3644

GIClinicalTrials@jhmi.edu

Joann Santmyer, RN

CONTACT

410-614-3644

GIClinicalTrials@jhmi.edu

Principal Investigator

Marina Baretti, MD

PRINCIPAL_INVESTIGATOR

SKCCC Johns Hopkins Medical Institution

Study Locations (Sites)

SKCCC Johns Hopkins Medical Institution

Baltimore, Maryland, 21231

United States

Collaborators and Investigators

Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Marina Baretti, MD, PRINCIPAL_INVESTIGATOR, SKCCC Johns Hopkins Medical Institution

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-05-27

Study Completion Date2029-05

Study Record Updates

Study Start Date2025-05-27

Study Completion Date2029-05

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

Biliary Tract Cancers