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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
NameTimeMethod
Progression Free Survival (PFS)Until disease progression or up to 5 years after the enrollment
Secondary Outcome Measures
NameTimeMethod
Disease Recurrence RateAt 2 years after the enrollment

Trial Locations

Locations (1)

Mackay Memorial Hospital

🇨🇳

Taipei, Taiwan

Mackay Memorial Hospital
🇨🇳Taipei, Taiwan
Fiona Chen
Contact
886-2-25433535
fionaeg0528@gmail.com
Chih-Lung Chang, MD
Sub Investigator
Yuh-Cheng Yang, MD
Principal Investigator

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