GEN-1 + NACT for Ovarian Cancer
(OVATION 2 Trial)

Recruiting in Palo Alto (17 mi)

+23 other locations

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Celsion

No Placebo Group

Trial Summary

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.

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.

+11 more

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.

+9 more

Participant Groups

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.

2Treatment groups

Experimental Treatment

Active Control

Group I: NACT + IMNN-001Experimental Treatment3 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 AloneActive Control2 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.