Trial of Active Immunotherapy With Globo H-KLH (OPT-822/821) in Women Who Have Non-Progressive Ovarian Cancer

Phase 2

• Conditions: Ovarian Cancer
• Interventions: Biological: OPT-822/OPT-821

• 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

Study Timeline

• Study Start: 2013-11
• Status Verified: 2014-05
• Study First Submitted: 2014-05-06
• Study First Submitted QC: 2014-05-06
• Last Update Submitted: 2014-05-06
• Study First Posted: 2014-05-07
• Last Update Posted: 2014-05-07
• Primary Completion: 2017-11
• Study Completion: 2018-11

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

Arm && Interventions

Group	Intervention	Description
OPT-822/OPT-821	OPT-822/OPT-821	-

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