NL-OMON56232招募中不适用
Combining anti-PD-L1 immune checkpoint inhibitor durvalumab with TLR-3 agonist rintatolimod in patients with metastatic pancreatic ductal adenocarcinoma for therapy efficacy. DURIPANC study. - DURIPANC
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 43
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Histologically or cytologically (Bethesda 5 or 6) confirmed metastatic
- •pancreatic cancer, as indicated by a definite cytology/histology report.
- •Stable disease according to RECIST criteria version 1.1 after at least 8
- •cycles of chemotherapy (FOLFIRINOX).
- •Inclusion <= 6 weeks after stopping FOLFIRINOX.
- •An accessible metastatic lesion for histological tissue collection.
- •SIII<900 (Systemic Immune-Inflammation Index = ((absolute neutrophil count *
- •platelet count) / absolute lymphocyte count)).
- •CA 19.9 <1000kU/L.
- •Age >= 18 years at time of study entry.
- •Body weight >30 kg.
- •WHO performance status of 0-1.
- •Adequate renal function (eGFR > 40 ml/min).
- •Adequate liver tests (bilirubin <= 1.5 times normal; ALAT/ASAT <= 5 times
- •Adequate bone marrow function (WBC > 3.0 x 109/L, platelets > 75 x 109/L ,
- •absolute neutrophil count (ANC) >=1.0 × 109 /L and hemoglobin > 5.6 mmol/L.
- •Effective contraceptive methods.
- •Patient must have a life expectancy of at least 12 weeks.
- •Patient is willing and able to comply with the protocol for the duration of
- •the study including undergoing treatment and scheduled visits and examinations
- •including follow up.
- •Capable of giving signed informed consent which includes compliance with the
- •requirements and restrictions listed in the informed consent form (ICF) and in
- •this protocol. Written informed consent and any locally required authorization
- •(e.g., European Union Data Privacy Directive) obtained from the patient/legal
- •representative prior to performing any protocol-related procedures, including
- •screening evaluations.
排除标准
- •Child-Pugh Classification grade B/C.
- •Current treatment with immunotherapeutic drugs.
- •Previous malignancy (excluding non-melanoma skin cancer, pancreatic
- •neuroendocrine tumor (pNET) <2cm, and gastrointestinal stromal tumor (GIST)
- •<2cm), unless no evidence of disease and diagnosed more than 3 years before
- •diagnosis of pancreatic cancer, or with a life expectancy of more than 5 years
- •from date of inclusion.
- •Malignant ascites or pleural effusion.
- •Female patients who are pregnant or breastfeeding or male or female patients
- •of reproductive potential who are not willing to employ effective birth control
- •from screening to 90 days after the last dose of durvalumab monotherapy.
- •Known allergy or hypersensitivity to any of the study drugs or any of the
- •study drug excipients.
- •An active autoimmune disease that has required systemic treatment in past 2
- •years (i.e. with use of disease modifying agents, corticosteroids or other
- •immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or
- •physiologic corticosteroid replacement therapy for adrenal or pituitary
- •insufficiency, etc.) is not considered a form of systemic treatment. Active or
- •prior documented autoimmune or inflammatory disorders (including inflammatory
- •bowel disease [e.g., colitis or Crohn's disease], diverticulitis [with the
- •exception of diverticulosis], systemic lupus erythematosus, Sarcoidosis
- •syndrome, or Wegener syndrome [granulomatosis with polyangiitis, Graves'
- •disease, rheumatoid arthritis, hypophysitis, uveitis, etc.]). The following are
- •exceptions to this criterion:
- •A. Patients with vitiligo or alopecia;
- •B. Patients with hypothyroidism (e.g., following Hashimoto syndrome) stable on
- •hormone replacement;
- •C. Any chronic skin condition that does not require systemic therapy;
- •D. Patients without active disease in the last 5 years may be included but only
- •after consultation with the study physician;
- •E. Patients with celiac disease controlled by diet alone.
- •Diagnosis of immunodeficiency or receiving systemic steroid therapy or any
- •other form of immunosuppressive therapy within 14 days prior to the planned
- •first dose of the study. The following are exceptions to this criterion: 1)
- •Intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra
- •articular injection), 2) Systemic corticosteroids at physiologic doses not to
- •exceed 10 mg/day of prednisone or its equivalent and 3) Steroids as
- •premedication for hypersensitivity reactions (e.g., CT scan premedication).
- •Receipt of live attenuated vaccine within 30 days prior to the first dose of
- •IP. Note: Patients, if enrolled, should not receive live vaccine whilst
- •receiving IP and up to 30 days after the last dose of IP.
- •Prior randomisation or treatment in a previous durvalumab clinical study
- •regardless of treatment arm assignment.
- •Participation in another clinical study with an investigational product
- •during the last 3 months.
- •Concurrent enrolment in another clinical study, unless it is an observational
- •(non-interventional) clinical study or during the follow-up period of an
- •interventional study.
- •Receipt of the last dose of anticancer therapy (chemotherapy, immunotherapy,
- •endocrine therapy, targeted therapy, biologic therapy, tumor embolization,
- 另有 1 项未显示
研究者
相似试验
招募中
1 期
Combining anti-PD-L1 immune checkpoint inhibitor durvalumab with TLR-3 agonist rintatolimod in patients with metastatic pancreatic ductal adenocarcinoma for therapy efficacy. DURIPANC StudyCTIS2024-514597-42-00Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)43
已完成
不适用
Combination therapy of immuno checkpoint inhibitors and radiosensitization treatment for metastatic melanomaJPRN-UMIN000026925Kochi University, Kochi Medical School5
尚未招募
不适用
Administration of immune checkpoint inhibitors through an elastomeric pump. A patient preference study and cost analysis.Solid tumors for which nivolumab or pembrolizumab monotherapy has an EMA approved indication. This includes (but is not limited to) melanoma, renal-cell cancer, NSCLC and head and neck cancer.NL-OMON25676Erasmus MC390
进行中（未招募）
1 期
Patient preference for administration of cancer immunotherapy via an elastomeric pump. A patient preference study and an economic analysis.Solid tumors for which nivolumab or pembrolizumab monotherapy is an EMA approved indication. This includes (but is not limited to) melanoma, renal-cell cancer, NSCLC and head and neck cancer.EUCTR2021-000058-24-NLErasmus MC Cancer Institute390
招募中
4 期
Administration of immune checkpoint inhibitors through an elastomeric pump. A patient preference study and cost analysis.NSCLC and head and neck cancerrenal-cell cancerSolid or hematological tumors for which Nivolumab or Pembrolizumab monotherapy have an EMA approved indication. This includes (but is not limited to) melanomaVarious forms of cancer for which Nivolumab or Pembrolizumab monotherapy are prescribed as treatment10027656NL-OMON54425Erasmus MC, Universitair Medisch Centrum Rotterdam390