Phase I Clinical Study on the Combination Therapy of CHP-NY-ESO-1 Cancer Vaccine and MIS416 for the Treatment of Patients with NY-ESO-1 expressing Refractory Urothelial or Prostate Cancer
Phase 1
- Conditions
- Refractory Urothelial or Prostate Cancer
- Registration Number
- JPRN-UMIN000005246
- Lead Sponsor
- Mie University Graduate School of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 12
Inclusion Criteria
Not provided
Exclusion Criteria
1)Past history of severe hypersensitivity. 2)Positive for HBs antigen, HCV antibody or HIV antibody. 3)Experience of autoimmune disease requiring treatment during 6 months preceding the day of consent. 4)Active multiple primaries. Simultaneous or metachronous with disease-free interval of 5 years or more. 5)Patient with disease requiring emergent radiotherapy. 6)Use of steroids (more than 20 mg equivalent of prednisolone/day) or immunosup-pressive drugs. 7)Patients with severe complication(s). 8)History of other NY-ESO-1-related immunotherapy. 9)Pregnant, lactating, or unprotected female. 10)Any other cases that the attending doctor judges not appropriate to enroll to this study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method