Targeting Driver Oncogenes With a Peptide Vaccine Plus Durvalumab and Tremelimumab for Patients W… (NCT06564623) | Clinical Trial Compass
RecruitingPhase 1
Targeting Driver Oncogenes With a Peptide Vaccine Plus Durvalumab and Tremelimumab for Patients With Biliary Tract Cancers (BTC)
United States25 participantsStarted 2025-05-27
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion 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.
Exclusion Criteria:
* 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 …
What they're measuring
1
Number of participants experiencing grade 3 or above drug-related toxicities
Timeframe: 20 Months
2
Maximum percentage change in interferon-producing mutant-specific cluster of differentiation 8 (CD8) and cluster of differentiation 4 (CD4) T cells.
Timeframe: Baseline to 20 weeks post vaccination (baseline, 20 weeks)
Trial details
NCT IDNCT06564623
SponsorSidney Kimmel Comprehensive Cancer Center at Johns Hopkins