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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.).
Any hormonal therapy directed at the malignant tumor must be discontinued at least one week prior to the first treatment. Continuation of hormone replacement therapy is permitted.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up the primary analysis for pfs will be conducted after at least 80 events have been observed or after all patients have been followed for at least 16 months, whichever is later.
Awards & highlights

OVATION 2 Trial 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.Check my eligibility
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.See study design
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.

OVATION 2 Trial 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 stopped any cancer-related hormone therapy at least a week ago.
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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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I haven't needed IV antibiotics or had a serious illness in the last 4 weeks.
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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.

OVATION 2 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~the primary analysis for pfs will be conducted after at least 80 events have been observed or after all patients have been followed for at least 16 months, whichever is later.
This trial's timeline: 3 weeks for screening, Varies for treatment, and the primary analysis for pfs will be conducted after at least 80 events have been observed or after all patients have been followed for at least 16 months, whichever is later. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
PFS

OVATION 2 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
IMNN-001
2015
Completed Phase 1
~20
Carboplatin
2014
Completed Phase 3
~6670
Paclitaxel
2011
Completed Phase 4
~5380

Find a Location

Who is running the clinical trial?

CelsionLead Sponsor
13 Previous Clinical Trials
1,334 Total Patients Enrolled
ImunonLead Sponsor
15 Previous Clinical Trials
1,458 Total Patients Enrolled
1 Trials studying Ovarian Cancer
50 Patients Enrolled for Ovarian Cancer
Premal H. Thaker, M.DStudy ChairWashington University School of Medicine

Media Library

NACT + IMNN-001 Clinical Trial Eligibility Overview. Trial Name: NCT03393884 — Phase 1 & 2
Ovarian Cancer Research Study Groups: NACT Alone, NACT + IMNN-001
Ovarian Cancer Clinical Trial 2023: NACT + IMNN-001 Highlights & Side Effects. Trial Name: NCT03393884 — Phase 1 & 2
NACT + IMNN-001 2023 Treatment Timeline for Medical Study. Trial Name: NCT03393884 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What medical conditions has GEN-1 been proven most effective in treating?

"GEN-1 is a standard treatment for melanoma, but it can also be used to manage the spread of neoplasms, sarcoma, and lymphoma."

Answered by AI

Are there a lot of North American medical clinics participating in this research?

"There are 23 recruiting patients for this trial such as University of Alabama Birmingham in Birmingham, Women's Care Florida in Saint Petersburg, and Monter Cancer Center in Lake Success, as well as 20 other locations."

Answered by AI

What is the evidence base for GEN-1?

"GEN-1 was first researched in 1997 by the City of Hope Comprehensive Cancer Center. As of now, there have been 1546 completed studies. Out of these, 1228 are actively recruiting patients. Many of these trials are based in Birmingham, Alabama."

Answered by AI
~16 spots leftby Dec 2024