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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
54
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
15mg/Kg Day 1 (every 21 days) until progression
175 mg/m\^2, Day 1 x 6 cycles (every 21 days)
Kyungpook National University Chilgok Hospital
Daegu, South Korea
RECRUITINGCHA Bundang Medical Center
Seongnam-si, South Korea
RECRUITINGKorea Anam Hospital
Seoul, South Korea
Safety and Tolerability
Assessment of Dose Limiting toxicity (DLT) based on incidences and severity of adverse events will be measured according to CTCAE v5.0
Time frame: 1cycle (21days)
Efficacy based on overall response rate (ORR)
Overall response rate measured as the Percentage of Participants with a Complete Response (CR) or Partial Response (PR), as Determined by the Investigator According to Response Evaluation Criteria in Solid Tumors (RECISTv1.1)
Time frame: Every 6 weeks (each cycle is 21 days)
Progression Free Survival (PFS)
PFS, defined as date of first study treatment to the date of event defined as the first documented progression as per RECIST v1.1 or death due to any cause
Time frame: Date of randomization up until date of first documented disease progression or date of death from any cause, whichever comes first
Overall Survival (OS)
OS, defined as date of first study treatment to date of death due to any cause
Time frame: Date of randomization up until date of death from any cause
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
AUC 5 IV Day 1 x 6 cycles (every 21 days)
Severance Hospital
Seoul, South Korea
RECRUITINGAsan Medical Hospital
Seoul, South Korea
RECRUITINGSeoul St. Mary's Hospital
Seoul, South Korea
RECRUITING