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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.
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 belowSelect...
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.
OVATION 2 Trial Timeline
Screening ~ 3 weeks3 visits
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.
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.
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
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.My cancer is one of the specified types of epithelial cell cancer.I stopped any cancer-related hormone therapy at least a week ago.I am 18 years old or older.I have a suspected diagnosis of ovarian, fallopian tube, or peritoneal cancer confirmed by biopsy.My gynecological cancer is in an advanced stage (III or IV).My blood tests show my bone marrow is working well.I can take care of myself but may not be able to do heavy physical work.I have not had radiation therapy to my abdomen or pelvis.I have active hepatitis.I haven't needed IV antibiotics or had a serious illness in the last 4 weeks.I have not had chemotherapy for any abdominal or pelvic tumor.I have previously been treated with IMNN-001.My liver tests are within the required limits.My kidney function is within the normal range.My nerve damage does not significantly affect my daily activities.I haven't taken steroids or immunosuppressants in the last 2 weeks.I am not pregnant, breastfeeding, and I use effective birth control.I haven't had any cancer except for non-melanoma skin cancer in the last 3 years.I am currently being treated for an autoimmune disease.
Research Study Groups:
This trial has the following groups:- Group 1: NACT Alone
- Group 2: NACT + IMNN-001
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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."
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