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Oregovomab in Combination With Bevacizumab Plus Chemo in BRCA Wild Type Platinum Sensitive Recurrent Ovarian Cancer
Sponsor: CanariaBio Inc.
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.
Official title: Phase 1b/2, Single Arm Clinical Trial to Evaluate the Safety and Activity of Oregovomab and Bevacizumab, Paclitaxel Carboplatin as a Combinatorial Strategy in Subjects With BRCA-wild Type Platinum Sensitive Recurrent Ovarian Cancer
Key Details
Gender
FEMALE
Age Range
19 Years - Any
Study Type
INTERVENTIONAL
Enrollment
54
Start Date
2021-03-17
Completion Date
2026-08-31
Last Updated
2026-04-06
Healthy Volunteers
No
Interventions
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
Bevacizumab
15mg/Kg Day 1 (every 21 days) until progression
Paclitaxel
175 mg/m\^2, Day 1 x 6 cycles (every 21 days)
Carboplatin
AUC 5 IV Day 1 x 6 cycles (every 21 days)
Locations (6)
Korea Anam Hospital
Seoul, Seoul, South Korea
Asan Medical Hospital
Seoul, Seoul, South Korea
Seoul St. Mary's Hospital
Seoul, Seoul, South Korea
Kyungpook National University Chilgok Hospital
Daegu, South Korea
CHA Bundang Medical Center
Seongnam-si, South Korea
Severance Hospital
Seoul, South Korea