CTRI

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, 372 subjects randomized in a 1:1 ratio (i.e., chemotherapy with oregovomab or chemotherapy with placebo). For Cohort 2 - NACT + Interval Surgery, 230 subjects will be randomized in a 1:1 ratio (i.e., chemotherapy with oregovomab or chemotherapy and placebo).

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).

Intervention/Treatment

Biological: Oregovomab

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 Â± 5 minutes

Other Name: MAb-B43.13

Drug: Paclitaxel

175 mg/m^2, every 3 weeks

Other Name: Taxol

Drug: Carboplatin

AUC 6 IV Day 1 x 6 cycles (every 21 days)

Other Name: Paraplatin

Placebo Comparator: Cohort 1 - Primary Surgery Control

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).

Drug: Paclitaxel

175 mg/m^2, every 3 weeks

Other Name: Taxol

Drug: Carboplatin

AUC 6 IV Day 1 x 6 cycles (every 21 days)

Other Name: Paraplatin

Biological: Placebo

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 Â± 5 minutes

Experimental: Cohort 2 - NACT + Interval Surgery Active

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).

Biological: Oregovomab

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 Â± 5 minutes

Other Name: MAb-B43.13

Drug: Paclitaxel

175 mg/m^2, every 3 weeks

Other Name: Taxol

Drug: Carboplatin

AUC 6 IV Day 1 x 6 cycles (every 21 days)

Other Name: Paraplatin

Placebo Comparator: Cohort 2 - NACT + Interval Surgery Control

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).

Drug: Paclitaxel

175 mg/m^2, every 3 weeks

Other Name: Taxol

Drug: Carboplatin

AUC 6 IV Day 1 x 6 cycles (every 21 days)

Other Name: Paraplatin

Biological: Placebo

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 Â± 5 minutes