Oregovomab Plus Chemo in Newly Diagnosed Patients With Advanced Epithelial Ovarian Cancer Following Optimal Debulking Surgery
Gynecologic Cancers
Ovarian Cancer
Primary Peritoneal Cancer
18 Years and older, Female
QPT-ORE-005 (primary)
NCI-2020-08028
FLORA5
FLORA-5
GOG 3035
GOG-3035
Summary
Study to compare the safety and efficacy of oregovomab versus placebo, administered in
combination with specific cycles of a standard six-cycle chemotherapy regimen (paclitaxel and
carboplatin), for the treatment of subjects with newly diagnosed advanced ovarian cancer who
have undergone optimal debulking.
Objectives
Phase 3 double-blind, placebo-controlled, multi-center study to compare the safety and
efficacy of four administrations of oregovomab 2 mg IV versus placebo, administered in
combination with specific cycles of a standard six-cycle chemotherapy regimen (paclitaxel and
carboplatin), for the treatment of subjects with newly diagnosed ovarian cancer who have
undergone optimal debulking surgery and are either pending initiation of chemotherapy (Cohort
1 - Primary Surgery) or resumption of another three cycles of chemotherapy, having already
completed three cycles of neoadjuvant chemotherapy (Cohort 2 - NACT + Interval Surgery).
For Cohort 1 - Primary Surgery, approximately 372 subjects randomized in a 1:1 ratio (i.e.,
chemotherapy with oregovomab or chemotherapy with placebo). For Cohort 2 - NACT + Interval
Surgery, approximately 230 subjects will be randomized in a 1:1 ratio (i.e., chemotherapy
with oregovomab or chemotherapy and placebo).
Eligibility
- Adults 18 years old or older.
- Newly diagnosed epithelial adenocarcinoma of ovarian, fallopian tube or peritoneal origin FIGO Stage III or IV disease.
- Histologic epithelial cell types: high grade serous adenocarcinoma, high grade endometrioid adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, or adenocarcinoma not otherwise specified (N.O.S.).
- Completed debulking surgery (either primary debulking surgery or interval debulking surgery at the discretion of the investigator). Debulking surgery must be optimal, R1 or R0 (defined as R1, macroscopic less than 1 cm in diameter, or R0, microscopic or no evidence of tumor). Assessment of debulking surgery will be determined at the time of the surgical procedure, not by post-surgical imaging.
- For Cohort 1, subject will undergo primary debulking surgery. Subject must receive initial dose of paclitaxel 175 mg/m^2 given intravenously and carboplatin AUC 6 IV every 3 weeks for 6 cycles. Carboplatin total dose given as 5 consecutive daily pulse doses, for subjects who experiences significant grade 3 or higher emesis. Subsequent dose modifications will be instituted per protocol. Cycle 1 of chemotherapy ± oregovomab/placebo must be anticipated to occur within 6 weeks after primary debulking surgery
- For Cohort 2, subject will undergo interval debulking surgery (IDS). Prior to IDS, subjects must have receive 3 cycles of paclitaxel and carboplatin as neoadjuvant treatment. After IDS, subjects must receive paclitaxel 175 mg/m^2 IV and carboplatin AUC 5-6 IV every 3 weeks, starting cycle 4. Cycle 4 of chemotherapy ± oregovomab/placebo must be anticipated to occur within 6 weeks after IDS.
- Suitable venous access for the study-required procedures
- Preoperative serum CA-125 levels = 50 U/mL for Cohort 1, serum CA-125 levels = 50 U/mL prior to first neoadjuvant chemotherapy for Cohort 2.
- Adequate bone marrow function:
- Absolute neutrophil count (ANC) = 1,500/µL
- Platelets = 100,000/µL
- Hemoglobin = 8.0 g/dL (Note: Blood transfusion is permitted up to 48 hours before first dose of study treatment).
- Adequate liver function:
- Bilirubin < 1.5 times upper limit normal (ULN)
- Lactate Dehydrogenase (LDH), SGOT/AST and SGPT/ALT < 2.5 times ULN
- Adequate renal function: a. Creatinine = 1.5 times ULN
- ECOG Performance Status of 0 or 1.
- For women of childbearing potential, must be willing to avoid pregnancy by using highly effective method of contraception from the first dose of study treatment to 6 months after last dose of study treatment as defined per protocol. Belgium and South Korea only: Use of a highly effective method of contraception from 28 days before first dose.
- Signed informed consent and authorization permitting release of personal health information.
- Willingness and ability to complete patient quality of life questionnaires.
Treatment Sites in Georgia
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