Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01616303 | A Controlled Study of the Effectiveness of Oregovomab (Antibody) Plus Chemotherapy in Advanced Ovarian Cancer | PHASE2 | COMPLETED | 97 | — | — | Jun 15, 2012 | Oct 12, 2018 | Sep 14, 2020 | 2 | United States |
Change from baseline CA125 ELISPOT assay after stimulation with oregovomab (MAb-B43.13 against CA125) measured at approximately 12 weeks and 25 weeks after the start of first-line chemotherapy
| Arm | Type | Description |
|---|---|---|
| carboplatin & paclitaxel | ACTIVE_COMPARATOR | first-line chemotherapy for ovarian cancer |
| carboplatin & paclitaxel & oregovomab | EXPERIMENTAL | first-line chemotherapy for ovarian cancer plus oregovomab |
| Name | Type | Description |
|---|---|---|
| Carboplatin | DRUG | carboplatin (area under the curve (AUC) 6, administered intravenously in a single day for 6 cycles every three weeks \[21 days\]) |
| Paclitaxel | DRUG | Paclitaxel (175 mg / square meter, intravenously over three hours in one day to be repeated for 6 cycles every three weeks \[21 days\]) |
| oregovomab | BIOLOGICAL | oregovomab (2 mg infused intravenously jointly during the 1st, 3rd and 5th chemotherapy cycle and 12 weeks after the 5th cycle). |
Inclusion Criteria: * have newly diagnosed epithelial adenocarcinoma of ovarian, tubal or peritoneal origin and French Fédération Internationale de Gynécologie et d'Obstétrique (FIGO) Stage III/IV disease. * have preoperative CA125 levels \> 50 U/mL * have optimal cytoreduction (RT\<1) * be anticip...