IMNN-001 + Chemotherapy for Ovarian Cancer

(OVATION-3 Trial)

Recruiting at 4 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 trial tests a new treatment called IMNN-001, an experimental therapy, combined with chemotherapy to determine if it is more effective than chemotherapy alone for advanced ovarian, fallopian tube, or peritoneal cancer. Researchers aim to assess whether adding IMNN-001 can enhance the safety and effectiveness of standard cancer treatments. Women with advanced, high-grade ovarian cancer who are scheduled to receive chemotherapy might be suitable candidates for this study. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to potentially groundbreaking advancements in cancer treatment.

Will I have to stop taking my current medications?

The trial requires that any hormonal therapy directed at the malignant tumor be stopped at least one week before the first treatment. However, hormone replacement therapy can continue. The protocol does not specify other medication restrictions, so it's best to discuss your current medications with the trial team.

Is there any evidence suggesting that IMNN-001 plus chemotherapy is likely to be safe for humans?

Research has shown that IMNN-001 is generally well-tolerated. Trials have demonstrated its safety for patients, with few unexpected or severe side effects reported. Specifically, these studies found potential survival benefits alongside minimal serious side effects. This suggests that IMNN-001 helps patients while maintaining a favorable safety profile. So far, patients have managed the treatment well, indicating its safety in humans. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for ovarian cancer?

Most treatments for ovarian cancer involve standard chemotherapy, which targets rapidly dividing cells. But IMNN-001 works differently, aiming to enhance the body's immune response against cancer cells. Researchers are excited about IMNN-001 because it could potentially boost the effectiveness of existing chemotherapy, leading to better outcomes for patients. This approach might not only improve survival rates but also reduce the likelihood of cancer returning.

What evidence suggests that IMNN-001 plus chemotherapy could be an effective treatment for ovarian cancer?

In this trial, participants in the experimental arm will receive IMNN-001 with standard neoadjuvant and adjuvant chemotherapy, followed by standard care maintenance therapy. Studies have shown that IMNN-001 could be very effective in treating ovarian cancer. Specifically, it has increased survival rates and improved the area around tumors, enhancing the fight against cancer. Research indicates that patients treated with IMNN-001 lived longer, particularly those with certain genetic conditions (HRD+). Additionally, the treatment has been well-tolerated, indicating it is generally safe for patients. Overall, these findings suggest that IMNN-001 could be a promising option for treating ovarian cancer. ^{1 2 4 5 6}

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+

Citations

1. investors.imunon.com investors.imunon.com/news-releases/news-release-details/imunon-presents-imnn-001-phase-2-translational-data-advanced

IMUNON Presents IMNN-001 Phase 2 Translational Data in ... IMNN-001 has shown significant therapeutic potential in clinical trials thus far, and the robust survival benefits and favorable safety profile ...

2. targetedonc.com targetedonc.com/view/imnn-001-continues-to-show-favorable-responses-in-ovarian-cancer

IMNN-001 Continues to Show Favorable Responses in ... IMNN-001 shows promising results in enhancing the tumor microenvironment and improving survival rates in advanced ovarian cancer treatment.

3. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.16_suppl.5516

Updated survival analysis from OVATION-2 trial. IMNN-001 demonstrated trends towards material improvement in overall survival and acceptable safety in advanced EOC, especially in HRD+ patients.

4. sciencedirect.com sciencedirect.com/science/article/pii/S0090825825007978

OVATION-2: A randomized phase I/II study evaluating the ... A randomized, controlled, open label phase 1/2 study, evaluated the safety and efficacy of IMNN-001, an IL-12 immune gene therapy, with neo/adjuvant ...

5. onclive.com onclive.com/view/ovation-3-trial-of-imnn-001-seeks-to-confirm-feasibility-of-targeting-il-12-to-boost-immune-responses-in-ovarian-cancer

OVATION-3 Trial of IMNN-001 Seeks to Confirm Feasibility ... Initial early-phase data with IMNN-001 previously demonstrated a favorable safety profile and initial signals of efficacy when administered ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06915025

Study Details | NCT06915025 | Phase 3 Trial Evaluating ... This is a randomized, adaptive, open label, multicenter trial to evaluate the safety and efficacy of intraperitoneal (IP) IMNN-001 plus chemotherapy compared to ...