IMNN-001 + Chemotherapy for Ovarian Cancer

(OVATION-3 Trial)

Recruiting at 2 trial locations

Overseen By Lauren Musso

Age: 18+

Sex: Female

Trial Phase: Phase 3

Sponsor: Imunon

Must not be taking: Corticosteroids, Immunosuppressants, Bevacizumab, others

Disqualifiers: Pregnancy, Active infection, Autoimmune, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 6

500 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

Premal H Thaker, M.D.

Principal Investigator

Washington University School of Medicine

Are You a Good Fit for This Trial?

This trial is for patients with advanced epithelial ovarian, fallopian tube, or peritoneal cancer at Stage IIIC or IV. They must be able to receive neoadjuvant chemotherapy and have good organ function (bone marrow, kidney, liver) and controlled neuropathy. A negative pregnancy test and effective contraception are required for those of childbearing potential.

Inclusion Criteria

I am not pregnant, using birth control, and not breastfeeding if that applies to me.

I am able to care for myself and up and about more than 50% of my waking hours.

My nerve damage (neuropathy) is mild or not present.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Neoadjuvant Chemotherapy

Participants receive neoadjuvant chemotherapy with paclitaxel and carboplatin, with IMNN-001 administered in the experimental arm

9 weeks

3 cycles, every 3 weeks

Interval Debulking Surgery

Interval debulking surgery is performed after 3 cycles of neoadjuvant chemotherapy

1 week

Adjuvant Chemotherapy

Participants receive adjuvant chemotherapy with paclitaxel and carboplatin, with IMNN-001 administered in the experimental arm

9 weeks

3 cycles, every 3 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

Maintenance Therapy

Participants receive standard of care maintenance therapy

13 months

What Are the Treatments Tested in This Trial?

Interventions

• IMNN-001

Trial Overview The trial tests IMNN-001 combined with standard chemotherapy versus chemotherapy alone in treating these cancers. It's a phase 3 study where participants are randomly assigned to either the new treatment group or the control group receiving only chemo.

How Is the Trial Designed?

Group I: Experimental Arm: IMNN-001 + SOC Chemotherapy + SOC Maintenance Therapy Experimental Treatment 5 Interventions

IMNN-001 in combination with standard neoadjuvant and adjuvant chemotherapy followed by standard of care maintenance therapy

Group II: Control Arm: SOC Chemotherapy + SOC Maintenance Therapy Active Control 4 Interventions

Standard neoadjuvant and adjuvant chemotherapy followed by standard of care maintenance therapy.

Who Is Running the Clinical Trial?

Imunon

Lead Sponsor

Trials

16

Recruited

1,600+