Approval Probability
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Oregovomab · 1 trial · 10 indications
Date of randomization to radiographically-confirmed disease progression according to RECIST v1.1 as determined by the investigator or death
| Arm | Type | Description |
|---|---|---|
| Cohort 1- Surgery Active | EXPERIMENTAL | Six (6) 21-day cycles of chemotherapy with oregovomab given at four (4) cycles (Cycle 1, Cycle 3, Cycle 5, and Cycle 5 plus 12 weeks). |
| Cohort 1 - Primary Surgery Control | PLACEBO_COMPARATOR | Six (6) 21-day cycles of chemotherapy with placebo comparator given with chemotherapy at four (4) cycles (Cycle 1, Cycle 3, Cycle 5, and Cycle 5 plus 12 weeks). |
| Cohort 2 - NACT + Interval Surgery Active | EXPERIMENTAL | In Cohort 2 - NACT + Interval Surgery, subjects must already have received three (3) cycles of paclitaxel and carboplatin neoadjuvant therapy. Subjects in Cohort 2 - NACT + Interval Surgery will receive three (3) cycles of chemotherapy with oregovomab given at four (4) cycles (Cycle 4, Cycle 6, Cycle 6 plus 6 weeks and Cycle 6 plus 18 weeks). |
| Cohort 2 - NACT + Interval Surgery Control | PLACEBO_COMPARATOR | In Cohort 2 - NACT + Interval Surgery, subjects must already have received three (3) cycles of paclitaxel and carboplatin neoadjuvant therapy. Subjects in Cohort 2 - NACT + Interval Surgery will receive three (3) cycles of chemotherapy with placebo comparator given at four (4) cycles (Cycle 4, Cycle 6, Cycle 6 plus 6 weeks and Cycle 6 plus 18 weeks). |
| Name | Type | Description |
|---|---|---|
| Oregovomab | BIOLOGICAL | 2 mg, 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 |
| Paclitaxel | DRUG | 175 mg/m\^2, every 3 weeks |
| Carboplatin | DRUG | AUC 6 IV Day 1 x 6 cycles (every 21 days) |
| Placebo | BIOLOGICAL | 2 mg, 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 |
Inclusion Criteria: 1. Adults 18 years old or older. 2. Newly diagnosed epithelial adenocarcinoma of ovarian, fallopian tube or peritoneal origin FIGO Stage III or IV disease. 3. Histologic epithelial cell types: high grade serous adenocarcinoma, high grade endometrioid adenocarcinoma, undifferenti...
Oregovomab is an investigational monoclonal antibody being studied for the treatment of advanced epithelial ovarian cancer. It is being evaluated in newly diagnosed patients following optimal debulking surgery, in combination with chemotherapy. The drug targets MUC16, a tumor-associated antigen expressed on ovarian cancer cells.
Oregovomab targets MUC16, a cell surface glycoprotein also known as CA-125, which is highly expressed on ovarian cancer cells. By binding to MUC16, the antibody is designed to elicit an immune response against the tumor. This mechanism is being investigated in the context of advanced epithelial ovarian cancer.
Oregovomab is being developed by IQVIA Holdings, Inc., a company publicly traded under the ticker symbol IQV. The drug is currently in Phase 3 clinical development for the treatment of advanced epithelial ovarian cancer.
Oregovomab is currently in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The ongoing Phase 3 trial is evaluating its efficacy and safety in patients with newly diagnosed advanced epithelial ovarian cancer.
Oregovomab is being studied in a single Phase 3 clinical trial registered as NCT04498117. This randomized, double-blind, placebo-controlled trial enrolls approximately 615 female patients aged 18 years and older with newly diagnosed advanced epithelial ovarian cancer following optimal debulking surgery. The trial is active but not recruiting participants.
Oregovomab is a distinct monoclonal antibody with the ChEMBL identifier CHEMBL2107917. No alternative names for this drug have been reported in the available clinical trial information. It is being studied specifically for its potential role in treating advanced epithelial ovarian cancer.