GEN-1 + NACT for Ovarian Cancer

(OVATION 2 Trial)

Recruiting at 23 trial locations

Overseen By Beth J Llewellyn

Age: 18+

Sex: Female

Trial Phase: Phase 1 & 2

Sponsor: Celsion

Must not be taking: Corticosteroids, Immunosuppressants

Disqualifiers: Autoimmune disease, Other malignancies, Hepatitis, CNS disease, others

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

Compensation: Varies

Number of Visits: 6

Duration: 18 weeks

130 Participants Needed

Trial Summary

Do I need to stop taking my current medications for the trial?

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.

How does the GEN-1 + NACT treatment differ from other treatments for ovarian cancer?

The GEN-1 + NACT treatment is unique because it combines GEN-1, a novel therapy, with neoadjuvant chemotherapy (NACT), which is used before surgery to shrink tumors in advanced ovarian cancer. This combination aims to enhance the effectiveness of chemotherapy by potentially modulating the immune environment, which is not a standard approach in current ovarian cancer treatments. ^{1 2 3 4 5}

What is the purpose of this trial?

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.

Research Team

Premal H. Thaker, M.D

Principal Investigator

Washington University School of Medicine

Eligibility Criteria

This trial is for adults with ovarian, fallopian tube, or peritoneal cancer who haven't had prior treatments with IMNN-001 or chemotherapy/radiotherapy to the abdomen. They must have good organ function and performance status (able to carry out daily activities), not be pregnant or breastfeeding, and use effective contraception.

Inclusion Criteria

My cancer is one of the specified types of epithelial cell cancer.

I stopped any cancer-related hormone therapy at least a week ago.

Patients must have satisfactory results for the baseline laboratory analyses and diagnostic procedures as specified in the protocol.

Exclusion Criteria

Patients with concurrent severe medical problems unrelated to the malignancy that would significantly limit full compliance with the study or expose the patient to extreme risk or decreased life expectancy.

I have a history or signs of brain or spinal cord disease.

You have any condition that would make it difficult to place the catheter for giving the study drug.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive NACT regimen with or without IMNN-001. NACT involves paclitaxel and carboplatin administered every 3 weeks for 6 cycles. IMNN-001 is administered intraperitoneally on specific days of each cycle.

18 weeks

6 cycles with multiple visits per cycle

Follow-up

Participants are monitored for safety and effectiveness after treatment

16 months

Long-term follow-up

Participants are monitored for overall survival

Up to 3 years

Treatment Details

Interventions

• GEN-1

Trial Overview The study tests the safety and effectiveness of a new treatment called IMNN-001 when given through the abdomen along with standard chemotherapy (NACT) versus NACT alone in patients with advanced-stage ovarian-type cancers.

Participant Groups

Group I: NACT + IMNN-001 Experimental Treatment 3 Interventions

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.

Group II: NACT Alone Active Control 2 Interventions

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.

Who Is Running the Clinical Trial?

Celsion

Lead Sponsor

Trials

14

Recruited

1,500+

Imunon

Lead Sponsor

Trials

16

Recruited

1,600+

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Neoadjuvant Chemotherapy in Advanced Ovarian Cancer: A Single-Institution Experience and a Review of the Literature. [2017]

2. England pubmed.ncbi.nlm.nih.gov

Role of neoadjuvant chemotherapy in the management of stage IIIC-IV ovarian cancer: survey results from the members of the European Society of Gynecological Oncology. [2022]

3. China pubmed.ncbi.nlm.nih.gov

Neoadjuvant treatment for newly diagnosed advanced ovarian cancer: where do we stand and where are we going? [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Neoadjuvant Chemotherapy Modulates the Immune Microenvironment in Metastases of Tubo-Ovarian High-Grade Serous Carcinoma. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Use and Effectiveness of Neoadjuvant Chemotherapy for Treatment of Ovarian Cancer. [2022]