JPRN-UMIN000023665
Completed
Phase 2
A clinical trial of nivolumab in patients with unresectable clear cell sarcoma and alveolar soft part sarcoma (NCCH1510,OSCAR trial) - A clinical trial of nivolumab in patients with unresectable clear cell sarcoma and alveolar soft part sarcoma (NCCH1510,OSCAR trial)
ational Cancer Center0 sites20 target enrollmentAugust 18, 2016
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- clear cell sarcoma and alveolar soft part sarcoma
- Sponsor
- ational Cancer Center
- Enrollment
- 20
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
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
Outcomes
Primary Outcomes
Not specified
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