Oregovomab in Combination With Bevacizumab Plus Chemo in BRCA Wild Type Platinum Sensitive Recurrent Ovarian Cancer
NCT04938583 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 54
Last updated 2026-04-06
Summary
This is a single arm phase 1b/2 evaluation of the combination of oregovomab, and bevacizumab, paclitaxel carboplatin in adult subjects with CA125-associated, advanced recurrent epithelial ovarian, fallopian tube or peritoneal carcinoma (FIGO Stage III/IV) with BRCA-wild type, previously treated with 1 prior lines of therapy, and with platinum free intervals of \>6 months since last platinum-based treatment.
Conditions
- Ovarian Cancer by FIGO Stage
- Ovarian Cancer Stage III
- Ovarian Cancer Stage IV
Interventions
- BIOLOGICAL
-
Oregovomab
Oregovomab will be administered on day1 cycle 1, 3, 5, and 9. A minimum of 3 patients will be enrolled into each cohort (2 mg or 1 mg). 2 mg (starting dose), dissolved in 2 mL of 0.9% Sodium Chloride Injection USP, then added to 50 mL of Sodium Chloride Injection USP infused over 20 ± 5 minutes
- DRUG
-
15mg/Kg Day 1 (every 21 days) until progression
- DRUG
-
175 mg/m\^2, Day 1 x 6 cycles (every 21 days)
- DRUG
-
AUC 5 IV Day 1 x 6 cycles (every 21 days)
Sponsors & Collaborators
-
Korean Cancer Study Group
collaborator OTHER -
CanariaBio Inc.
lead INDUSTRY
Principal Investigators
-
Dr Jung KH, MD · Asan Medical Hospital
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 19 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-03-17
- Primary Completion
- 2025-10-30
- Completion
- 2026-08-31
- FDA Drug
- Yes
Countries
- South Korea
Study Locations
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