Health Condition 1: - Health Condition 2: C569- Malignant neoplasm of unspecifiedovary
Conditions
Interventions
Intervention1: Oregovomab & Placebo
Biological/Ovarian cancer
Chemical Name: MAb-B43.13: Investigational Product: oregovomab (MAb-B43.13)
â?¢ Dosage Form: Lyophilized Powder for injection
â?¢ Dose: Ea
Sponsors
OncoQuest Pharmaceuticals Inc
Star Genomics India Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: Major Inclusion Criteria: 1. Adults 18 years old or older. 2. Subjects with newly diagnosed epithelial adenocarcinoma of ovarian, fallopian tube or peritoneal origin FIGO Stage III or IV disease. 3. Eligible 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.). 4. Completed debulking surgery (either primary debulking surgery or interval debulking surgery at the discretion of the investigator), as defined below: a. For subjects who undergo primary debulking surgery (Cohort 1 - Primary Surgery): i. Cycle 1 of chemotherapy ± oregovomab/placebo must be anticipated to occur within 6 weeks after primary debulking surgery, and ii. The primary debulking surgery is optimal, R1 or R0 (defined as R1, macroscopic no greater than 1 cm in diameter, or R0, microscopic or no evidence of tumor). b. For subjects who will undergo interval debulking surgery (Cohort 2 â?? NACT/Interval Surgery): i. Subject must have received neoadjuvant treatment with 3 cycles of paclitaxel 175 mg/m2 IV over 3 hours every approximately 3 weeks (21 Days), followed by carboplatin area under the curve (AUC) 5-6 administered intravenously (IV) approximately every 3 weeks (21 Days), and ii. Cycle 4 of chemotherapy ± oregovomab/placebo must be anticipated to occur within 6 weeks after interval debulking surgery, and iii. The interval debulking surgery is optimal, R1 or R0 (defined as R1, macroscopic no greater than 1 cm in diameter, or R0, microscopic or no evidence of tumor). 5. Suitable venous access for the study-required procedures. 6. Cohort 1 â?? Primary Surgery: Preoperative serum CA-125 levels >= 50 U/mL, or Cohort 2 â?? NACT + Interval Surgery: serum CA-125 levels >= 50 U/mL prior to first pre-operative chemotherapy (chemotherapy cycle #1). 7. Adequate bone marrow function: a. Absolute neutrophil count (ANC) >= 1,500/μL. b. Platelets >= 100,000/μL. 8. Hemoglobin >= 8.0 g/dL (Note: Blood transfusion is permitted up to 48 hours before first dose of study treatment). 9. Adequate liver function: a. Bilirubin b. Lactate Dehydrogenase (LDH), SGOT/AST and SGPT/ALT c. Albumin >3.5 g/dL. 10. Adequate renal function: a. Creatinine 11. ECOG Performance Status of 0 or 1. 12. For women of childbearing potential, must be willing to avoid pregnancy by using a highly effective method of contraception from the first dose of study treatment to 60 days after last dose of study treatment. Adequate contraception is defined in Section 8.2.5). 13. Sign informed consent and authorization permitting release of personal health information. 14. Willingness and ability to complete patient quality of life questionnaires.
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Outcome Measures : Investigator Assessed Progression Free Survival Date of randomization to radiographically-confirmed disease progression according to RECIST v1.1 as determined by the investigator or deathTimepoint: [ Time Frame: Date of randomization until date of first documented disease progression or date of death from any cause, whichever comes first, at up to approximately 4 years. ] | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Outcome Measures : Overall Survival [ Time Frame: Date of randomization up until date of death from any cause, up to approximately 8 years ] Date of randomization to the date of death Date of randomization to the date of death Date of randomization to the date of deathTimepoint: Time Frame: Date of randomization up until date of death from any cause, up to approximately 8 years | — |
Countries
Argentina, Belgium, Brazil, Canada, Chile, China, Czech Republic, Democratic People's Republic of Korea, Hungary, India, Italy, Mexico, Poland, Romania, Spain, Taiwan, United States of America
Contacts
Public ContactShiv Raman Dugal
Institute of Clinical Research India (ICRI)
Outcome results
None listed