MedTrace Logo

Oregovomab Plus Chemotherapy in Neo-adjuvant Setting in Newly Diagnosed Patients With Advanced Epithelial Ovarian Cancer

NCT05605535 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 88

Last updated 2026-04-01

No results posted yet for this study

Summary

A clinical study to compare the efficacy and safety of five administrations of oregovomab versus placebo, infused in schedule dependent sequence with specific cycles of a standard six-cycle chemotherapy regimen (paclitaxel and carboplatin), for the treatment of patients with newly diagnosed advanced ovarian cancer who are planned to receive neoadjuvant treatment followed by interval debulking surgery (IDS) and adjuvant treatment.

Conditions

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

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 5 or 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

Sponsors & Collaborators

  • Raptim Research

    collaborator OTHER

  • CanariaBio Inc.

    lead INDUSTRY

Principal Investigators

  • Jada Srinivasa Rao, PhD · CanariaBio Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-07
Primary Completion
2026-10-15
Completion
2027-09-15
FDA Drug
Yes

Countries

  • India

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 NCT05605535 on ClinicalTrials.gov