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

NCT04498117 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 615

Last updated 2026-04-01

No results posted yet for this study

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.

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

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)

Sponsors & Collaborators

  • Gynecologic Oncology Group

    collaborator NETWORK

  • Iqvia Pty Ltd

    collaborator INDUSTRY

  • CanariaBio Inc.

    lead INDUSTRY

Principal Investigators

  • Sunil Gupta, MD, FRCPC · CanariaBio Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-25
Primary Completion
2026-12-26
Completion
2028-08-26
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Belgium
  • Brazil
  • Canada
  • Chile
  • Czechia
  • Hungary
  • India
  • Italy
  • Mexico
  • South Korea
  • Spain
  • Taiwan

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04498117 on ClinicalTrials.gov