A Phase II trial of immunotherapy with an anti-PD-1 antibody in advanced / relapsed, Platinum - resistant Ovarian Cancer

Phase 2

• Conditions: ovarian cancer

• Registration Number: JPRN-UMIN000005714
• Lead Sponsor: Department of Gynecology and Obstetrics, Kyoto University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-09-15
• Study Completion: 2014-12-26
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: Female
• Target Recruitment: 20

Inclusion Criteria

Not provided

Exclusion Criteria

1) Patients with histories of severe hypersensitive reactions to other antibody drugs. 2) Patients with adverse drug reactions caused by pre-treatment or impacts of complications of surgery or radiation, which are judged to affect the safety assessment of study drug by principle/sub-investigator. 3) Patients with synchronous multiple cancers. 4) Patients with complications of autoimmune disease, histories of chronic and recurrent autoimmune disease or other diseases which require systemic steroid therapy or immune suppressor. 5) Patients with positive test results for HBV, HCV, HIV-1, HIV-2 and HLV-1 antibodies. 6) Patients who are pregnant, nursing or possibly pregnant, or do not agree with contraception until 300 days from the last administration of study drug after informed consent. 7) Patients who received any other study drug or anti-PD-1 antibody within 4 weeks prior to the study drug administration. 8) Patients whom principle/sub-investigator judged ineligible to participate in this study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified