NCT06564623招募中1 期
A Pilot Study of Targeting Driver Oncogenes With a Peptide Vaccine Plus Durvalumab and Tremelimumab for Patients With Biliary Tract Cancers
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins2 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2025年5月27日最近更新:
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Number of participants experiencing grade 3 or above drug-related toxicities
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •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.
排除标准
- •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-L
- •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-L
- •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.
研究组 & 干预措施
Arm A - mBTCvax, Durvalumab and Tremelimumab
Experimental
干预措施: Durvalumab (Drug)
Arm A - mBTCvax, Durvalumab and Tremelimumab
Experimental
干预措施: Tremelimumab (Drug)
Arm A - mBTCvax, Durvalumab and Tremelimumab
Experimental
干预措施: mBTC vax [0.3 - 2.4 mg peptide + 0.5 mg Poly-ICLC (Hiltonol)] (Drug)
结局指标
主要结局
Number of participants experiencing grade 3 or above drug-related toxicities
时间窗: 20 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.
时间窗: 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.
次要结局
- Progression Free Survival (PFS)(4 years)
- Overall Survival (OS)(4 years)
研究者
研究点 (2)
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