clear cell sarcoma and alveolar soft part sarcoma
Conditions
Interventions
Nivolumab 240mg/body is administered intravenously biweekly.
Sponsors
National Cancer Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Histologically confirmed clear cell sarcoma and alveolar soft part sarcoma 2)Unresectable 3)As for alveolar soft part sarcoma, prior treatment of anti-angiogenic agents(ex.pazopanib,sunitinib) 4)Not having any of the followings;symptomatic brain metastasis at the time of registration,carcinomatous meningitis or spinal metastasis requiring surgical intervention 5)Not having any of the followings;pericardial fluid,pleural effusion or ascites requiring treatment 6)Aged 18 or above 7)Performance Status 0 or 1 8)One or more measurable lesions confirmed by contrast enhanced CT 9)No prior treatment with anti-PD-1 antibody(nivolumab,pembrolizumab etc.),anti-PD-L1 antibody(atezolizumab,avelumab etc.),anti-CTLA-4 antibody(ipilimumab etc.)or other treatment related to T cell regulation 10)Not received systematic corticosteroid at a daily dose of more than 10mg in prednisolone equivalent or immunosuppressant drug within 14days before registration 11)Not received anti-cancer therapy within 28 days before registration 12)Not received operation under general anesthesia within 28days before registration 13)Not received radiotherapy other than the site of lesion within 14days before registration 14)Not received radiotherapy or therapeutic radiopharmaceutical(except for diagnostic radiopharmaceutical)at the site of lesion within 56days before registration 15)Correspond to the following values in laboratory tests performed within 14 days a.Neutrophil count>=1000/mm3 b.Platelet count>=100000/mm3 c.Hemoglobin>=8.0g/dL d.AST(GOT)<=100U/L e.ALT(GPT)<=100U/L f.Total bilirubin<=1.5mg/dL g.Creatinine<=1.5mg/dL 16)>=92% of SpO2 under room air conditions within 14days before registration 17)Given consent to contraception 18)Written informed consent
Exclusion criteria
Exclusion criteria: 1)Active double cancer(except for completely resected basal cell carcinoma,stage I squamous cell carcinoma,carcinoma in situ,intramucosal cancer,superficial bladder cancer,gastrointestinal cancer resected by ESD or EMR,and other cancer free of relapse for >=5 years) 2)Infection requiring systematic therapy 3)Active gastrointestinal ulceration 4)Current or previous interstitial pneumonitis or pulmonary fibrosis diagnosed based on imaging or clinical findings 5)Interstitial pattern based on chest imaging or inflammatory change such as active radiation pneumonitis and infectious pneumonia 6)Current or previous severe hypersensitive reaction to antibody products 7)Currently active or previously chronic or recurrent auto immune diseases(except for type 1 diabetes mellitus,hypothyroidism requiring hormone replacement therapy only,skin disorder requiring no systematic therapy,and any autoimmune diseases expected not to relapse without external factors) 8)HIV antibody-positive or HBs-antigen-positive,or HCV antibody-positive:except for HCV-RNA-negative even if HCV antibody-positive 9)Though HBs antigen-negative,HBs antibody-positive or HBc antibody-positive,and HCV-DNA quantitative test positive 10)Pregnant or breast-feeding women or women suspected of being pregnant 11)Psychiatric diseases or psychological symptoms interfering taking part in the trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall response rate (central review) | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall response rate (investigator's review) Progression-free survival Overall survival Adverse events | — |
Countries
Japan
Contacts
Public ContactNaoko Matsui
National Cancer Center Hospital Clinical Trial Support Office
Outcome results
None listed