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

Part of paid clinical trials in Orlando, Florida.

Sponsor
Imunon
Study ID
NCT06915025
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • IMNN-001 (IL-12 Plasmid Formulated with PEG-PEI-Cholesterol Lipopolymer) — DRUG
    100 mg/m2 IP given weekly during frontline treatment
  • Paclitaxel — DRUG
    175 mg/m2 IV given every 21 days for 6 cycles during frontline treatment
  • Carboplatin — DRUG
    AUC 6 IV given every 21 days for 6 cycles during frontline treatment
  • Olaparib — DRUG
    Olaparib (300 mg orally every 12 hours for 2 years) for patients with somatic or germline BRCAmut.
  • Niraparib — DRUG
    Niraparib (200-300 mg orally daily for 3 years; dosing based on participant's weight and platelet counts) for either HRD/BRCAmut \& HRD/BRCAwt.

Study Details

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.

Key Dates

Start date
Jul 9, 2025
Status verified
Jun 2026
Primary completion
Oct 31, 2032
Completion
Oct 31, 2032

Study Design

Enrollment
500 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Experimental Arm: IMNN-001 + SOC Chemotherapy + SOC Maintenance Therapy
    IMNN-001 in combination with standard neoadjuvant and adjuvant chemotherapy followed by standard of care maintenance therapy
  • Active Comparator: Control Arm: SOC Chemotherapy + SOC Maintenance Therapy
    Standard neoadjuvant and adjuvant chemotherapy followed by standard of care maintenance therapy.

Primary Outcome Measure

Overall Survival [ Time Frame: 48 months ]

Central Contacts

Locations (7)

FacilityCityStateZIPSite coordinators
Advent HealthOrlandoFlorida32804
Karla Hernandez-Cruz
[email protected]
Robert Holloway, MD (PRINCIPAL_INVESTIGATOR)
Washington University School of Medicine in St. LouisSt LouisMissouri63110
Missy Bradlo
[email protected]
Andrea Hagemann, MD (PRINCIPAL_INVESTIGATOR)
Providence Cancer InstitutePortlandOregon97213
Christopher Darus, MD (PRINCIPAL_INVESTIGATOR)
Sanford HealthSioux FallsSouth Dakota57104
Ashley Johnson
[email protected]
Maria Bell, MD (PRINCIPAL_INVESTIGATOR)
Erlanger HealthChattanoogaTennessee37403
Kimberly Donelson
[email protected]
Lorraine Christensen
[email protected]
Stephen DePasquale, MD (PRINCIPAL_INVESTIGATOR)
Providence Sacred Heart Medical Center & Children's HospitalSpokaneWashington99204
Jodie Mactagone
[email protected]
Melanie Bergman, MD (PRINCIPAL_INVESTIGATOR)
Froedtert and The Medical College of WisconsinMilwaukeeWisconsin53226
Maia Terashvili
[email protected]
William Bradley, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Orlando, FL

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By specialty
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By research site
Advent Health· Orlando, FLWashington University School of Medicine in St. Louis· St Louis, MOProvidence Cancer Institute· Portland, ORSanford Health· Sioux Falls, SDErlanger Health· Chattanooga, TNProvidence Sacred Heart Medical Center & Children's Hospital· Spokane, WA

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