malignant pleural mesothelioma
Conditions
Interventions
Continue to administer the combination therapy of cisplatin, pemetrexed and nivolumab and the maintenance therapy of nivolumab to a patient until the patient correspond to the withdrawal criteria for
Sponsors
Okayama Rosai Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Age: more than 20 years old at the date of informed consent 2) Pathologically confirmed pleural malignant mesothelioma 3) Advanced or metastatic malignant pleural mesothelioma which is untreated and unresectable 4) Patients who have a measurable lesion designated by Modified RECIST criteira 5) Available tumor sample for testing of PD-L1 expression 6) Eastern Cooperative Oncology Group performance status (ECOG PS) is 0 or 1 7) Life expectancy is >= 90 days 8) SpO2 measured by pulse oximeter within 7 days is >= 94% 9) Meet the defined lab value criteria 10) Females of childbearing potential who agree to prevent pregnancy and lactating to at least 5 months after last administration of nivolumab 11) Males who agree to contraception at least 7 months after last administration of nivolumab 12) Patients who understand the study contents and give a written consent at their free will
Exclusion criteria
Exclusion criteria: 1) Patients with history of anaphylaxis induced by other drugs 2) Autoimmune disease 3) Double cancer 4) Metastasis to brain or meninges 5) Interstitial lung disease or pulmonary fibrosis 6) Diverticulitis or peptic ulcer 7) Pleural effusion necessary for emission every 2 weeks or more 8) Treating pericardial effusion or ascites 9) Uncontrollable tumor pain 10) Transient ischemic attack, cerebrovascular accident, thrombosis or thromboembolism within 180 days 11) Uncontrollable severe cardiovascular disease 12) Anticoagulant therapy 13) Uncontrollable diabetes 14) Treating systemic infection 15) Transplantation therapy 16) Obviously positive to HIV infection 17) HTLV-1 antibody positive, HBs antigen positive or HCV antibody positive. Either HBs antigen positive or HBc antibody positive and HBV-DNA detection although HBs antigen is negative. 18) History of treatment for T cell regulation 19) Surgery with local or surface anesthesia within 14 days 20) Surgery with general anesthesia within 28 days 21) Pleurodesis within 14 days 22) Pleurodesis using picibanil within 28 days 23) Adhesions surgery of pericardium or peritoneum 24) Radiation therapy for pain relief within 14 days 25) Radiopharmaceutical therapy within 56 days 26) Administration of unapproved drugs within 28 days or unapproved antibody within 90 days 27) Administration of systemic adrenal cortical hormone or immunosuppressive agents 28) Females who are or may be pregnant or lactating 29) Patients who are incapable of giving consent (for example, dementia) 30) Any other inadequacy for this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Centrally reviewed, overall response rate based on Modified RECIST criteria: to last administration | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety: adverse event, laboratory test, vital sign, body weight, 12-lead electrocardiogram, chest X-ray, ECOG Performance Status Efficacy: 1) Response rate (assessment by local institution, Modified RECIST criteria) 2) Disease control rate (central review, Modified RECIST criteria) 3) Overall survival 4) Progression-free survival (central review, Modified RECIST criteria) 5) Duration of response (central review, Modified RECIST criteria) 6) Time to response (central review, Modified RECIST criteria) 7) best overall response (central review, Modified RECIST criteria) 8) The rate of change of the sum of the target lesion length (assessment by local institution, Modified RECIST criteria) QOL: EQ-5D, LCSS-Meso | — |
Countries
Japan
Contacts
Public ContactTatsushi Goto
Fiverings Co.,Ltd. Medical team
Outcome results
None listed