A clinical trial of nivolumab in patients with unresectable clear cell sarcoma and alveolar soft part sarcoma (NCCH1510,OSCAR trial)
- Conditions
- clear cell sarcoma and alveolar soft part sarcoma
- Registration Number
- JPRN-UMIN000023665
- Lead Sponsor
- ational Cancer Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 20
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Overall response rate (central review)
- Secondary Outcome Measures
Name Time Method Overall response rate (investigator's review) Progression-free survival Overall survival Adverse events