NCT04498117

Oregovomab Plus Chemo in Newly Diagnosed Patients With Advanced Epithelial Ovarian Cancer Following Optimal Debulking Surgery

A Multicenter Phase 3, Double-Blind, Placebo-Controlled Study Comparing Chemo-Immunotherapy (Paclitaxel-Carboplatin- Oregovomab) vs Chemotherapy (Paclitaxel-Carboplatin- Placebo) in Patients With Advanced Epithelial Ovarian, Fallopian Tube or Peritoneal Carcinoma

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 615 (actual)
• Sponsor: CanariaBio Inc. · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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).

Conditions

• Carcinoma, Ovarian Epithelial
• Ovarian Neoplasms
• Ovarian Cancer
• Ovarian Serous Adenocarcinoma
• Fallopian Tube Neoplasms
• Fallopian Tube Adenocarcinoma
• Fallopian Tube Serous Adenocarcinoma
• Peritoneal Cancer
• Peritoneal Carcinoma
• Peritoneal Neoplasms

Interventions

Type	Name	Description
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 ± 5 minutes
DRUG	Paclitaxel	175 mg/m\^2, every 3 weeks
DRUG	Carboplatin	AUC 6 IV Day 1 x 6 cycles (every 21 days)
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 ± 5 minutes
DRUG	Carboplatin	AUC 5-6 IV Day 1 x 6 cycles (every 21 days)

Timeline

• Start date: 2020-08-25
• Primary completion: 2026-12-26
• Completion: 2028-08-26
• First posted: 2020-08-04
• Last updated: 2026-04-01

Locations

148 sites across 14 countries: United States, Argentina, Belgium, Brazil, Canada, Chile, Czechia, Hungary, India, Italy, Mexico, South Korea, Spain, Taiwan

Regulatory

• FDA-regulated drug study