NL-OMON46045已完成2 期
Ipilimumab and Nivolumab in the Treatment of malignant Pleural Mesothelioma: a Phase II study - Ipilimumab and Nivolumab in malignant Pleural Mesothelioma: INITIATE
Antoni van Leeuwenhoek Ziekenhuis0 个研究点目标入组 33 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 33
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
- •* Signed informed consent form
- •* Age * 18 years
- •* WHO-ECOG performance status 0 or 1
- •* Able to comply with the study protocol, in the investigator*s judgment
- •* Patients with histologically confirmed diagnosis of the recurrence of MPM. Any pleural MPM subtype is permitted for inclusion in the study
- •* Progressive disease after at least one prior systemic treatment with a platinum-based doublet (both cisplatin and carboplatin are allowed) for unresectable MPM. All prior cytotoxic toxicities must have resolved to grade * 1 prior to registration
- •* Measurable disease on CT scan, according to modified RECIST Criteria for Mesothelioma
- •* Life expectancy * 12 weeks
- •* Adequate hematologic and organ function, defined by the following laboratory results, obtained within 14 days prior to the first study treatment:
- •- Absolute neutrophil count (ANC) * 1500 cells/µL (without granulocyte colony-stimulating factor support within 2 weeks prior to Cycle 1, Day 1)
- •- WBC count * 3000 cells/µL
- •- Lymphocyte count * 250 cells/µL
- •- Platelet count * 100.000/µL (without transfusion within 2 weeks prior to Cycle 1, Day 1)
- •- Hemoglobin * 5.6 mmol/L
- •- Serum albumin * 25 gr/L
- •- AST, ALT and alkaline phosphatase * 2.5 x ULN, with the following exceptions: patients with documented liver or bone metastases: alkaline phosphatase * 5 x ULN
- •- Serum bilirubin * 1.5 x ULN
- •Patients with known Gilbert disease who have serum bilirubin level * 3 x ULN may be enrolled
- •- INR and aPTT * 1.5 x ULN
- •Patients receiving therapeutic anticoagulation should be on a stable dose
- •- Creatinine clearance * 45 mL/min
- •Cockcroft-Gault, Chronic Kidney Disease Epidemiology Collaboration or Modification of Diet in Renal Disease formulae may be used; 24-hour urine collection is not required
- •* Women who are not postmenopausal (* 12 months of non-therapy*induced amenorrhea) or surgically sterile (absence of ovaries and/or uterus) and men with partners of childbearing potential, must agree to use adequate contraception (double barrier birth control) for the whole duration of study treatment and for 3 months after the last dose of therapy
- •* Women of childbearing potential must have a negative serum or urine pregnancy test within 48 hours prior the first dose of treatment
排除标准
- •* Medical or psychological impediment to comply with the protocol
- •* Patients with only peritoneal MPM
- •* Prior malignancy except adequately treated basal cell or squamous cell skin cancer, superficial or in-situ cancer of the bladder or other cancer for which the patient has been disease-free for at least five years
- •* Concomitant participation in another clinical trial (by the investigator*s judgement)
- •* Uncontrolled pleural/peritoneal effusion, pericardial effusion or ascites requiring recurrent drainage procedures (once monthly or more frequently)
- •* Uncontrolled tumor-related pain
- •Patients requiring pain medication must be on a stable regimen at study entry.
- •Symptomatic lesions amenable to palliative radiotherapy should be treated prior to enrolment.
- •* Previous treatment with any checkpoint inhibitor
- •* Pregnant or lactating women
- •* Patients with brain metastases
- •* History of or active autoimmune disease (e.g. pneumonitis; rheumatoid arthritis; severe form of psoriasis; uncontrolled type I diabetes or hypothyroidism)
- •* History of idiopathic pulmonary fibrosis (including pneumonitis) or unresolved drug-induced pneumonitis, organizing pneumonia, or active pneumonitis on screening chest CT scan
- •* History of relevant gastrointestinal disease, including, but not limited to, Crohn*s disease, ulcerative colitis, recurrent diverticulitis
- •* Prior allogenic bone marrow transplantation or prior solid organ transplantation
- •* History of HIV
- •* Patients with history of HBV infection are eligible if serological profile is compatible with past/resolved infection (defined as negative HBsAg test and positive antibody to HBV core antigen [anti-HBc] antibody test) and HBsAg test and HBV-DNA are both negative prior to Cycle 1, Day 1
- •* Patients with history of HCV infection must be screened for HCV-RNA PCR test prior to Cycle 1, Day 1, and are eligible if the test turns negative
- •* Other serious concomitant disease, including:
- •- Active tuberculosis
- •- Severe infections within 4 weeks prior to Cycle 1, Day 1
- •- Significant cardiovascular disease (NYHA class III or IV), myocardial infarction within the previous 6 months, unstable angina, or unstable arrhythmias
- •- Significant pulmonary (asthma or COPD) or hepatic disease or other illness considered by the investigator to constitute an unwarranted high risk for investigational treatment
- •* Major surgical procedures within 28 days prior to Cycle 1, Day 1
- •* Concurrent medications:
- •- Treatment with systemic immunosuppressive medications, including but not limited to prednisone (with specific exceptions; see below), cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti*tumor necrosis factor [anti-TNF] agents) within 2 weeks prior to Cycle 1, Day 1.
- •- The use of inhaled corticosteroids and mineralocorticoids (e.g., fludrocortisone) is allowed.
- •- The use of systemic prednisone at the dosage of 10 mg/day or lower (or equivalent) is allowed.
- •* Administration of a live, attenuated vaccine within 4 weeks before Cycle 1, Day 1
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