Trial of Active Immunotherapy With Globo H-KLH (OPT-822/821) in Women Who Have Non-Progressive Ovarian Cancer
Phase 2
- Conditions
- Ovarian Cancer
- Registration Number
- NCT02132988
- Lead Sponsor
- Mackay Memorial Hospital
- Brief Summary
The purpose of this study is to evaluate the effect of OPT-822/OPT-821 on improving Progression-Free Survival (PFS) in subjects who have non-progressive epithelial ovarian, fallopian tube, or primary peritoneal cancer after cytoreductive surgery and platinum-based chemotherapy as initial treatment for primary disease or as salvage treatment for first relapse.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 110
Inclusion Criteria
- Female subjects ≥ 21 years of age with histologically confirmed ≥ stage II epithelial ovarian, fallopian tube, and primary peritoneal cancer at diagnosis
- Who have not progressed after initial treatment with cytoreductive surgery and at least 4 cycles of platinum-based chemotherapy.
OR
- Female subjects ≥ 21 years of age with first relapsed epithelial ovarian, fallopian tube, and primary peritoneal cancer (regardless of stage at diagnosis)
- Who have not progressed after received at least 4 additional cycles of platinum-based chemotherapy with or without having undergone secondary cytoreductive surgery .
Exclusion Criteria
- Subjects with evidence of disease progression according to the GCIG CA125 criteria or RECIST 1.1 criteria.
- Subjects who are currently receiving any other concomitant anticancer therapy.
- Subjects with evidence of extra-abdominal metastasis.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Progression Free Survival (PFS) Until disease progression or up to 5 years after the enrollment
- Secondary Outcome Measures
Name Time Method Disease Recurrence Rate At 2 years after the enrollment
Trial Locations
- Locations (1)
Mackay Memorial Hospital
🇨🇳Taipei, Taiwan
Mackay Memorial Hospital🇨🇳Taipei, TaiwanFiona ChenContact886-2-25433535fionaeg0528@gmail.comChih-Lung Chang, MDSub InvestigatorYuh-Cheng Yang, MDPrincipal Investigator