Study of IMNN-001 (Also Known as GEN-1) With NACT for Treatment of Ovarian Cancer (OVATION 2)

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Imunon
Study ID
NCT03393884
Phase
PHASE1/PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

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

Interventions

  • IMNN-001 — BIOLOGICAL
    IL-12 Plasmid Formulated with PEG-PEI-Cholesterol Lipopolymer
  • Carboplatin — DRUG
    AUC 6 IV over 1 hour on Day 1 of each cycle
  • Paclitaxel — DRUG
    175 mg/m2 IV over 3 hours on Day 1 of each cycle

Study Details

This is a randomized, open label, multicenter trial to evaluate the safety, dosing, efficacy and biological activity of intraperitoneal IMNN-001 plus NACT compared to NACT alone.

Key Dates

Start date
Sep 5, 2018
Status verified
May 2026
Primary completion
Jul 25, 2024
Completion
May 30, 2026

Study Design

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

Arms

  • Experimental: NACT + IMNN-001
    The NACT regimen will be paclitaxel 175 mg/m2 IV over 3 hours followed by carboplatin AUC 6 IV over 1 hour on Day 1. This will be repeated every 3 weeks for 6 cycles. IMNN-001 100 mg/m2 IP will be administered on Days 8 and 15 of the first NACT cycle and then on Days 1, 8, and 15 of the subsequent 21 day NACT cycles for a total of 17 treatments.
  • Active Comparator: NACT Alone
    The NACT regimen will be paclitaxel 175 mg/m2 IV over 3 hours followed by carboplatin AUC 6 IV over 1 hour on Day 1. This will be repeated every 3 weeks for 6 cycles.

Primary Outcome Measure

PFS [ Time Frame: The primary analysis for PFS will be conducted after at least 80 events have been observed or after all patients have been followed for at least 16 months, whichever is later. ]

Locations (20)

FacilityCityStateZIPSite coordinators
University of Alabama BirminghamBirminghamAlabama35233-
Mitchell Cancer Institute (University of South Alabama)MobileAlabama36604-
Gynecologic Oncology Associates (Hoag Hospital)Newport BeachCalifornia92663-
Innovative Clinical ResearchWhittierCalifornia90603-
Advent HealthOrlandoFlorida32803-
Women's Care FloridaSt. PetersburgFlorida33701-
Massachusetts General HospitalBostonMassachusetts02114-
Washington University School of Medicine in St. LouisSt LouisMissouri63110-
MD Anderson at CooperCamdenNew Jersey08105-
Hackensack University Medical CenterHackensackNew Jersey07601-
Monter Cancer CenterLake SuccessNew York11042-
NYU Langone, Long IslandMineolaNew York11501-
NYU LangoneNew YorkNew York10016-
Stephenson Cancer Center - Oklahoma UniversityOklahoma CityOklahoma73104-
Providence Cancer InstitutePortlandOregon97213-
Sanford HealthSioux FallsSouth Dakota57104-
Chattanooga Women's HealthChattanoogaTennessee37403-
The West ClinicGermantownTennessee38138-
Providence Health CareSpokaneWashington99204-
Medical College of WisconsinMilwaukeeWisconsin53226-

Find similar trials in Birmingham, AL

By condition
Ovarian cancer
By specialty
OncologyGynecologic oncologyWomen's health
By research site
University of Alabama Birmingham· Birmingham, ALMitchell Cancer Institute (University of South Alabama)· Mobile, ALGynecologic Oncology Associates (Hoag Hospital)· Newport Beach, CAInnovative Clinical Research· Whittier, CAAdvent Health· Orlando, FLWomen's Care Florida· St. Petersburg, FL

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