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

May 6, 2014 updated by: Mackay Memorial Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

110

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan, 104
        • Recruiting
        • Mackay Memorial Hospital
        • Contact:
        • Sub-Investigator:
          • Chih-Lung Chang, MD
        • Principal Investigator:
          • Yuh-cheng Yang, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progression Free Survival (PFS)
Time Frame: Until disease progression or up to 5 years after the enrollment
Until disease progression or up to 5 years after the enrollment

Secondary Outcome Measures

Outcome Measure
Time Frame
Disease Recurrence Rate
Time Frame: At 2 years after the enrollment
At 2 years after the enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mackay Memorial Hospital

Collaborators

OBI Pharma, Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2013

Primary Completion (Anticipated)

November 1, 2017

Study Completion (Anticipated)

November 1, 2018

Study Registration Dates

First Submitted

May 6, 2014

First Submitted That Met QC Criteria

May 6, 2014

First Posted (Estimate)

May 7, 2014

Study Record Updates

Last Update Posted (Estimate)

May 7, 2014

Last Update Submitted That Met QC Criteria

May 6, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MMH-OPT822-OC001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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