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Phase 3 Trial Evaluating the Safety & Efficacy of IMNN-001 Administered in Combination w/ Standard NACT & Adjuvant Chemotherapy in Newly Diagnosed Patients w/ Advanced EOC, Fallopian Tube or Primary Peritoneal Cancer

NCT06915025 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 500

Last updated 2026-05-04

No results posted yet for this study

Summary

This is a randomized, adaptive, open label, multicenter trial to evaluate the safety and efficacy of intraperitoneal (IP) IMNN-001 plus chemotherapy compared to chemotherapy alone.

Conditions

Interventions

DRUG

IMNN-001 (IL-12 Plasmid Formulated with PEG-PEI-Cholesterol Lipopolymer)

100 mg/m2 IP given weekly during frontline treatment

DRUG

Paclitaxel

175 mg/m2 IV given every 21 days for 6 cycles during frontline treatment

DRUG

Carboplatin

AUC 6 IV given every 21 days for 6 cycles during frontline treatment

DRUG

Olaparib

Olaparib (300 mg orally every 12 hours for 2 years) for patients with somatic or germline BRCAmut.

DRUG

Niraparib

Niraparib (200-300 mg orally daily for 3 years; dosing based on participant's weight and platelet counts) for either HRD/BRCAmut \& HRD/BRCAwt.

Sponsors & Collaborators

  • Imunon

    lead INDUSTRY

Principal Investigators

  • Premal H Thaker, M.D. · Washington University School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-09
Primary Completion
2032-10-31
Completion
2032-10-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT06915025 on ClinicalTrials.gov