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

Phase 1 & 2

Waitlist Available

Research Sponsored by Celsion

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients with the following histologic epithelial cell types are eligible: High grade serous adenocarcinoma, endometrioid adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, or adenocarcinoma not otherwise specified (N.O.S.).

Patients must be at least 18 years old.

Must not have

Patients with history or evidence upon physical examination of CNS disease.

Patients who have received prior radiotherapy to any portion of the abdominal cavity or pelvis are excluded.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up randomization to date of death, for up to 3 years from lpi

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new cancer treatment (GEN-1 plus NACT) to see if it is safe and effective.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include reactions related to intraperitoneal administration, typical chemotherapy-related issues like nausea, fatigue, hair loss, blood cell count changes leading to increased infection risk or bleeding problems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I am 18 years old or older.

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I have a suspected diagnosis of ovarian, fallopian tube, or peritoneal cancer confirmed by biopsy.

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My gynecological cancer is in an advanced stage (III or IV).

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My blood tests show my bone marrow is working well.

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I can take care of myself but may not be able to do heavy physical work.

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My liver tests are within the required limits.

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My kidney function is within the normal range.

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My nerve damage does not significantly affect my daily activities.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I have not had radiation therapy to my abdomen or pelvis.

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I have active hepatitis.

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I have not had chemotherapy for any abdominal or pelvic tumor.

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I have previously been treated with IMNN-001.

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I haven't taken steroids or immunosuppressants in the last 2 weeks.

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I am not pregnant, breastfeeding, and I use effective birth control.

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I am currently being treated for an autoimmune disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ randomization to date of death, for up to 3 years from lpi

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~randomization to date of death, for up to 3 years from lpi

This trial's timeline: 3 weeks for screening, Varies for treatment, and randomization to date of death, for up to 3 years from lpi for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

PFS

Secondary study objectives

Overall Survival

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Paclitaxel

2011

Completed Phase 4

~5450

IMNN-001

2015

Completed Phase 1

~20