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

NCT02132988 | Unknown Phase 2

• 1 other identifier: MMH-OPT822-OC001
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Ovarian Cancer

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival (PFS)

  Until disease progression or up to 5 years after the enrollment

Secondary Outcomes (1)

• Disease Recurrence Rate

  At 2 years after the enrollment

Study Arms (1)

OPT-822/OPT-821

EXPERIMENTAL

Biological: OPT-822/OPT-821

Interventions

OPT-822/OPT-821 BIOLOGICAL

OPT-822/OPT-821

Eligibility Criteria

• Age: 21 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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 .

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mackay Memorial Hospital: lead
• OBI Pharma, Inc: collaborator

Study Sites (1)

Mackay Memorial Hospital

Taipei, 104, Taiwan

RECRUITING

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Central Study Contacts

Fiona Chen

CONTACT

886-2-25433535; fionaeg0528@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2014
• First Posted: May 7, 2014
• Study Start: November 1, 2013
• Primary Completion: November 1, 2017
• Study Completion: November 1, 2018
• Last Updated: May 7, 2014

Record last verified: 2014-05

Locations

TW (1)