Spots Global Cancer Trial Database for Oregovomab in Combination With Bevacizumab Plus Chemo in BRCA Wild Type Platinum Sensitive Recurrent Ovarian Cancer
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Trial Identification
Brief Title: Oregovomab in Combination With Bevacizumab Plus Chemo in BRCA Wild Type Platinum Sensitive Recurrent Ovarian Cancer
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
Study ID: NCT04938583
Study Description
Brief 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.
Detailed Description: This study is an open-label, single arm, phase 1b/II, multicenter study. In phase 1b part, the recommended phase 2 dose of oregovomab combined with bevacizumab, paclitaxel and carboplatin will be examined. Approximately 3 to 12 subjects("3+3" dose finding design) will be enrolled in phase 1b trial with starting dose of 2mg oregovmab. In Phase II trial, response rate of combination with oregovomab and bevacizumab, paclitaxel will be examined. Based on Simon's two stage model, 8 patients will be enrolled in first stage, after review of efficacy (response rate) of study treatment, 30 additional subjects for second stage of phase 2 will be enrolled. Considering 10% of screening failure rate, overall 42 patients will be enrolled in phase 2 trial.
Eligibility
Minimum Age: 19 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Kyungpook National University Chilgok Hospital, Daegu, , Korea, Republic of
CHA Bundang Medical Center, Seongnam-si, , Korea, Republic of
Korea Anam Hospital, Seoul, , Korea, Republic of
Severance Hospital, Seoul, , Korea, Republic of
Asan Medical Hospital, Seoul, , Korea, Republic of
Seoul St. Mary's Hospital, Seoul, , Korea, Republic of
Contact Details
Name: Dr Jung KH, MD
Affiliation: Asan Medical Hospital
Role: PRINCIPAL_INVESTIGATOR
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