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

Mackay Memorial Hospital

Status and phase: Unknown; Phase 2

Conditions: Ovarian Cancer

Treatments: Biological: OPT-822/OPT-821

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02132988

MMH-OPT822-OC001

Details and patient eligibility

About

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.

Enrollment: 110 estimated patients

Sex: Female

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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110 participants in 1 patient group

OPT-822/OPT-821

Experimental group

Treatment:

Biological: OPT-822/OPT-821