Study of IMNN-001 with Chemotherapy for Treating Ovarian Cancer (OVATION 2)

Sponsor: Imunon

Sponsor score: 0

ClinicalTrials ID:NCT03393884

This clinical trial is testing a new treatment called IMNN-001, combined with standard chemotherapy, to see if it is safe and effective for patients with ovarian cancer. The study compares this combination to chemotherapy alone.

Patient Parameters

Program Overview

The purpose of this study is to evaluate the safety and effectiveness of a new treatment, IMNN-001, when used with standard chemotherapy for ovarian cancer. Researchers want to see if this combination can improve outcomes compared to chemotherapy alone. The study involves multiple centers and is open to eligible patients who meet specific criteria.

Eligibility Criteria

Inclusion Criteria

  • Have a suspected diagnosis of certain types of ovarian, fallopian tube, or primary peritoneal cancer confirmed by a biopsy.
  • Have advanced cancer classified as stage III or IV according to the International Federation of Gynecology and Obstetrics (FIGO).
  • Have specific types of cancer cells, such as high-grade serous adenocarcinoma or endometrioid adenocarcinoma.
  • Have adequate bone marrow, kidney, liver, and nerve function as determined by specific medical tests.
  • Be free of active infections or serious uncontrolled medical conditions within four weeks before starting the study.
  • Stop any hormonal therapy for the cancer at least one week before the first treatment, but hormone replacement therapy is allowed.
  • Have a performance status score of 0, 1, or 2, indicating the ability to carry out daily activities with some limitations.
  • Women of childbearing potential must have a negative pregnancy test and use effective contraception. Breastfeeding must be stopped before joining the study.
  • Have satisfactory results from initial lab tests and diagnostic procedures.
  • Sign an informed consent form and agree to the release of personal health information.
  • Be at least 18 years old.

Exclusion Criteria

  • Have previously received the IMNN-001 treatment.
  • Have allergies to similar compounds or other study drugs.
  • Have used corticosteroids or need ongoing immunosuppressive therapy within two weeks before the study.
  • Have active autoimmune diseases requiring treatment, such as lupus or rheumatoid arthritis.
  • Have had other invasive cancers within the last three years, except for certain skin cancers.
  • Have had radiation therapy to the abdomen or pelvis, unless it was for specific cancers and completed over three years ago.
  • Have had chemotherapy for abdominal or pelvic tumors, unless it was for breast cancer and completed over three years ago.
  • Have active hepatitis.
  • Have severe medical problems unrelated to cancer that would interfere with the study.
  • Are pregnant, breastfeeding, or not using adequate contraception.
  • Have brain-related conditions, such as uncontrolled seizures or recent strokes.
  • Have conditions that would interfere with the placement of the catheter needed for the study treatment, such as recent abdominal surgery or intestinal issues.

Locations

FACILITYZIPCITYSTATE
University of Alabama Birmingham35233BirminghamAlabama
Mitchell Cancer Institute (University of South Alabama)36604MobileAlabama
Gynecologic Oncology Associates (Hoag Hospital)92663Newport BeachCalifornia
Innovative Clinical Research90603WhittierCalifornia
Advent Health32803OrlandoFlorida
Women's Care Florida33701St. PetersburgFlorida
Massachusetts General Hospital02114BostonMassachusetts
Washington University School of Medicine in St. Louis63110St LouisMissouri
MD Anderson at Cooper08105CamdenNew Jersey
Hackensack University Medical Center07601HackensackNew Jersey

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