Phase II trial of nivolumab in patients with unresectable or recurrent thymic carcinoma; PRIMER trial
- Conditions
- thymic carcinoma
- Registration Number
- JPRN-UMIN000022007
- Lead Sponsor
- ational Cancer Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 15
Not provided
1)Patients with active double cancer (except for completely resected basal cell cancer, stage I squamous cell cancer, carcinoma in situ, intramucosal cancer, superficial bladder cancer, or gastrointestinal cancer resected by ESD or EMR, or other cancer free of relapse for 5 years) 2)Patients who have an infection requiring systematic therapy 3)Patients with active gastrointestinal ulceration 4)Patients with current or previous pneumonitis or pulmonary fibrosis diagnosed based on imaging or clinical findings 5)Patients with a current or previous severe hypersensitive reaction to an antibody product 6)Patients with a current or chronic and recurrent auto immune disease (Patients could be enrolled if they had type 1 diabetes mellitus, hypothyroidism requiring only hormone replacement therapy, skin disorder requiring no systematic therapy, or an auto immune disease predicted to remain free of disease in the absence of external factors) 7)Patients who are HIV antibody-positive, HBsAg-positive, or HCV antibody-positive (even though a patient was HCV antibody-positive, the patient could be enrolled if the patient was HCV-RNA-negative) 8)Patients who are HBsAg-negative, but HBs antibody-positive or HBc antibody-positive, and HCV-DNA quantitative test is positive 9)Pregnant or breast-feeding women, or women suspected of being pregnant 10)Patients with a psychiatric disease or psychological symptoms
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method response rate
- Secondary Outcome Measures
Name Time Method