EUCTR2016-001599-31-NL进行中（未招募）1 期
Ipilimumab and Nivolumab in the Treatment of malignant Pleural Mesothelioma: a Phase II study
Stichting Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis0 个研究点开始时间: 2016年8月22日最近更新:
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研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
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 (Byrne MJ, 2004)
- •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
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 16
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 17
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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