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

• Sponsor: Mackay Memorial Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02132988
• Collaborator: OBI Pharma, Inc (Industry)
• Enrollment: 110
• Location: 1
• Arm: 1
• Duration (Months): 60
• Patients Per Site Per Month: 1.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Ovarian Cancer	Biological: OPT-822/OPT-821	Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 110 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: An Open Labeled Phase II Trial of Active Immunotherapy With Globo H-KLH (OPT-822/821) in Women Who Have Non-Progressive Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
• Study Start Date: Nov 1, 2013
• Anticipated Primary Completion Date: Nov 1, 2017
• Anticipated Study Completion Date: Nov 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: OPT-822/OPT-821	Biological: OPT-822/OPT-821

Outcome Measures

Primary Outcome Measures

1. Progression Free Survival (PFS) [Until disease progression or up to 5 years after the enrollment]

Secondary Outcome Measures

1. Disease Recurrence Rate [At 2 years after the enrollment]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mackay Memorial Hospital	Taipei		Taiwan	104

Sponsors and Collaborators

• Mackay Memorial Hospital
• OBI Pharma, Inc

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Mackay Memorial Hospital
• ClinicalTrials.gov Identifier: NCT02132988
• Other Study ID Numbers: MMH-OPT822-OC001
• First Posted: May 7, 2014
• Last Update Posted: May 7, 2014
• Last Verified: May 1, 2014

• Additional relevant MeSH terms: Ovarian Neoplasms; Carcinoma, Ovarian Epithelial

Study Results

No Results Posted as of May 7, 2014