NCT06060405招募中2 期
Durvalumab and Oleclumab in Resectable PDAC: A Window of Opportunity Study (DORA Trial)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Percent change in CD8+ cell infiltration
研究概览
简要总结
This is a multi-site Canadian, window of opportunity study to evaluate the immune activity of durvalumab and oleclumab in resectable pancreatic ductal adenocarcinoma (PDAC) when given prior to surgery.
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
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •Weight ≥ 35 kg
- •Have a life expectancy ≥ 12 weeks
- •Have histologically or cytologically confirmed pancreatic ductal adenocarcinoma (PDAC).
- •Upfront resectable PDAC
- •Have adequate organ and marrow function required for the study
- •Baseline images taken prior to treatment must undergo central review
- •Participants must agree to use study approved methods to prevent pregnancy for study required period
排除标准
- •Receipt of any conventional or investigational anticancer therapy within 21 days or palliative radiotherapy within 14 days prior to the scheduled first dose of study treatment
- •Prior receipt of any immune-mediated therapy including, but not limited to, other anti CTLA-4, anti-PD-1, anti-PD-L1 including durvalumab antibodies and agents targeting CD73, CD39, or adenosine receptors, excluding therapeutic anticancer vaccines.
- •Concurrent enrolment in another therapeutic clinical study. Enrolment in observational studies will be allowed.
- •Have a history of Grade 3 or greater thromboembolic events in the prior 3 months or thromboembolic event of any grade with ongoing symptoms.
- •Have prior history of myocardial infarction, transient ischemic attack, congestive heart failure ≥ Class 3 based on New York Heart Association Functional Classification or stroke within the past 3 months prior to the scheduled first dose of study treatment.
- •Active or prior documented autoimmune disorders within the past 3 years prior to the scheduled first dose of study treatment with the following exceptions
- •Vitiligo or alopecia
- •Hypothyroidism not requiring systemic treatment or stable on hormone replacement
- •Psoriasis not requiring systemic treatment
- •Any chronic skin condition that does not require systemic therapy
- •Have known active hepatitis infection. Participants with a past or resolved Hepatitis B (HBV) infection are eligible. Participants positive for Hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA.
- •Known to have tested positive for human immunodeficiency virus (HIV) (positive HIV 1/2 antibodies) or active tuberculosis infection
- •Other invasive malignancy within 5 years.
- •Known allergy or hypersensitivity to investigational product formulations.
- •Active grade 3 or greater edema
- •Uncontrolled intercurrent illness
- •Current or prior use of immunosuppressive medication within 14 days prior to the scheduled first dose of study treatment with the following exceptions:
- •Intranasal, topical, inhaled corticosteroids or local steroid injections
- •Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or equivalent
- •Steroids as premedication for hypersensitivity reaction
- •Receipt of live, attenuated vaccine within 30 days prior to the scheduled first dose of study treatment
- •Major surgery within 28 days prior to scheduled first dose of study treatment or still recovering from prior surgery. Local are allowed, without needing to wait for the 28 day recovery period.
- •Are pregnant, lactating, or intend to become pregnant during their participation in the study
- •Any condition that, in the opinion of the investigator, would interfere with safe administration or evaluation of the investigational products or interpretation of subject safety or study results
研究组 & 干预措施
Durvalumab and Oleclumab
Experimental
Durvalumab, 1500 mg x 1 dose and oleclumab 3000 mg x 2 doses every 2 weeks prior to surgical resection.
干预措施: Durvalumab (Drug)
Durvalumab and Oleclumab
Experimental
Durvalumab, 1500 mg x 1 dose and oleclumab 3000 mg x 2 doses every 2 weeks prior to surgical resection.
干预措施: Oleclumab (Drug)
结局指标
主要结局
Percent change in CD8+ cell infiltration
时间窗: Baseline biopsy to surgical resection (35 days)
次要结局
- Percent change in CD3 cell population in blood(Baseline biopsy to surgical resection (35 days))
- Percent change in CD45RA cell population in tumour tissue(Baseline biopsy to surgical resection (35 days))
- Percent change in CD45RA cell population in blood(Baseline biopsy to surgical resection (35 days))
- Percent change in CD3 cell population in tumour tissue(Baseline biopsy to surgical resection (35 days))
- Percent change in RO T cell population in tumour tissue(Baseline biopsy to surgical resection (35 days))
- Percent change in RO T cell population in blood(Baseline biopsy to surgical resection (35 days))
- Percent change in M1 vs M2 macrophage population in tumour tissue(Baseline biopsy to surgical resection (35 days))
- Percent change in M1 vs M2 macrophage population in blood(Baseline biopsy to surgical resection (35 days))
研究者
研究点 (2)
Loading locations...
相似试验
已完成
2 期
Durvalumab Alone or in Combination With Novel Agents in Subjects With NSCLCStage III Non-small Cell Lung CancerUnresectableNCT03822351MedImmune LLC189
进行中（未招募）
1 期
A Study of Novel Anti-cancer Agents in Patients With Metastatic Triple Negative Breast CancerTriple Negative Breast NeoplasmsNCT03742102AstraZeneca243
招募中
2 期
Durvalumab With Consolidative Radiochemotherapy and Ablative Stereotactic Radiotherapy in Oligometastatic ES-SCLCExtensive-stage Small-cell Lung CancerNCT06223711Universität des Saarlandes43
终止
2 期
Neoadjuvant Immunotherapy With Durvalumab and Tremelimumab for Bladder Cancer Patients Ineligible for CisplatinMuscle-invasive Bladder CancerNCT03234153Insel Gruppe AG, University Hospital Bern6
Unknown
2 期
An Open Label, Multicenter Phase 2 Study of Durvalumab (MEDI4736) + Olaparib as Maintenance Therapy in ChineseDurvalumabLung CancerSmall Cell Lung CancerNCT05245994Li Zhang, MD60