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

Ovarian Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02132988
• Other study ID #: MMH-OPT822-OC001
• Status: Recruiting
• Phase: Phase 2
• First received: May 6, 2014
• Last updated: May 6, 2014
• Start date: November 2013
• Est. completion date: November 2018

Study information

• Verified date: May 2014
• Source: Mackay Memorial Hospital
• Contact: Fiona Chen
• Phone: 886-2-25433535
• Email: fionaeg0528[@]gmail.com
• Is FDA regulated: No
• Health authority: Taiwan : Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 110
• Est. completion date: November 2018
• Est. primary completion date: November 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years and older

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ovarian Cancer
• Ovarian Neoplasms

Intervention

Biological:
• OPT-822/OPT-821

Locations

Country	Name	City	State
Taiwan	Mackay Memorial Hospital	Taipei

Sponsors (2)

Lead Sponsor	Collaborator
Mackay Memorial Hospital	OBI Pharma, Inc

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression Free Survival (PFS)		Until disease progression or up to 5 years after the enrollment	No
Secondary	Disease Recurrence Rate		At 2 years after the enrollment	No