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ACTIVE NOT RECRUITING
NCT04938583
PHASE1/PHASE2

Oregovomab in Combination With Bevacizumab Plus Chemo in BRCA Wild Type Platinum Sensitive Recurrent Ovarian Cancer

Sponsor: CanariaBio Inc.

View on ClinicalTrials.gov

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

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

Bevacizumab

15mg/Kg Day 1 (every 21 days) until progression

DRUG

Paclitaxel

175 mg/m\^2, Day 1 x 6 cycles (every 21 days)

DRUG

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