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Angiogenesis Inhibitor

GEN-1 + Chemo + Bevacizumab for Ovarian Cancer (MRD Trial)

Phase 1 & 2
Recruiting
Research Sponsored by Imunon
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subjects must have a suspected diagnosis of high grade epithelial ovarian, fallopian tube, or primary peritoneal carcinoma with histologic confirmation to be obtained by diagnostic laparoscopy
Subjects must have an International Federation of Gynecology and Obstetrics (FIGO) stage of III or IV who based on standard of care clinical considerations have been recommended to undergo neoadjuvant therapy per standard clinical determination by their oncology provider
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights

MRD Trial Summary

This trial tests if adding a drug to chemo + Bev can better treat cancer.

Who is the study for?
This trial is for adults with advanced ovarian, fallopian tube, or primary peritoneal cancer at FIGO stage III or IV. They must be recommended for neoadjuvant therapy and have high grade serous adenocarcinoma confirmed by laparoscopy. Participants need proper organ function, no severe illnesses including recent COVID-19, no hormonal cancer therapies within a week before the trial starts, and an ECOG performance status of 0-1. Women must not be pregnant or breastfeeding and agree to use contraception.Check my eligibility
What is being tested?
The study tests adding IMNN-001 (GEN-1) to standard chemotherapy with Bevacizumab versus chemotherapy with Bevacizumab alone in patients with newly diagnosed advanced ovarian-related cancers. It's a phase I/II randomized open-label trial assessing safety, dosing efficacy, and biological activity.See study design
What are the potential side effects?
Possible side effects include those common to chemotherapy such as nausea, fatigue, hair loss; Bevacizumab may cause high blood pressure or bleeding issues; GEN-1 related side effects are under investigation but could involve immune system reactions similar to other gene therapies.

MRD Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am suspected to have advanced ovarian, fallopian tube, or peritoneal cancer, awaiting confirmation via laparoscopy.
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My cancer is at an advanced stage and my doctor recommends starting treatment before surgery.
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I am fully active or restricted in physically strenuous activity but can do light work.

MRD Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Minimal Residual Disease
Secondary outcome measures
OS
PFS

MRD Trial Design

2Treatment groups
Experimental Treatment
Group I: Chemotherapy + BEV + IMNN-001 (Experimental)Experimental Treatment4 Interventions
Chemotherapy (neoadjuvant and adjuvant): Paclitaxel 175 mg/m2 IV followed by carboplatin AUC 5-6 IV starting on C1D1. During the neoadjuvant period, there will be from 4 to 6 cycles repeated every 21 days. BEV 15 mg/kg IV administration will be included with each cycle except during the cycles around time of surgery. During maintenance, BEV will be administered every 3 weeks as a single agent until disease progression or unacceptable toxicity for a maximum of an additional 18 cycles. In total, BEV may be administered up to 24 cycles. FDA approved BEV biosimilars may be used in this study in place of BEV. IMNN-001 80 mg/m2 IP will be administered weekly beginning C1D15 and continue weekly through the last cycle of adjuvant therapy. At the conclusion of chemotherapy, GEN-1 will be administered every 21 days with BEV in subjects who are BRCA-/HRP until disease progression or unacceptable toxicity for up to an additional 18 cycles.
Group II: Chemotherapy + BEV (Control)Experimental Treatment3 Interventions
Chemotherapy (neoadjuvant and adjuvant): Paclitaxel 175 mg/m2 IV followed by carboplatin AUC 5-6 IV starting on C1D1. During the neoadjuvant period, there will be from 4 to 6 cycles (at the Investigator's discretion, having an additional C4+1 and C4+2) repeated every 21 days. BEV 15 mg/kg IV administration will be included with each cycle EXCEPT the following cycles: [1] Cycle 1, [2] the last cycle of neoadjuvant therapy immediately preceding ICS, and [3] the first cycle of adjuvant chemotherapy (i.e., first cycle after ICS). During the maintenance phase, BEV 15 mg/kg will be administered every 3 weeks as a single agent until disease progression or unacceptable toxicity for a maximum of an additional 18 cycles. In total, BEV may be administered up to 24 cycles. FDA approved BEV biosimilars may be used in this study in place of BEV.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bevacizumab
2013
Completed Phase 4
~5280
Paclitaxel
2011
Completed Phase 4
~5380
Carboplatin
2014
Completed Phase 3
~6670
IMNN-001
2015
Completed Phase 1
~20

Find a Location

Who is running the clinical trial?

ImunonLead Sponsor
15 Previous Clinical Trials
1,538 Total Patients Enrolled
Break Through Cancer FoundationUNKNOWN
Amir Jazaeri, MDStudy ChairUniversity of Texas MD Anderson Center
3 Previous Clinical Trials
102 Total Patients Enrolled
2 Trials studying Ovarian Cancer
71 Patients Enrolled for Ovarian Cancer

Media Library

Bevacizumab (Angiogenesis Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05739981 — Phase 1 & 2
Ovarian Cancer Research Study Groups: Chemotherapy + BEV + IMNN-001 (Experimental), Chemotherapy + BEV (Control)
Ovarian Cancer Clinical Trial 2023: Bevacizumab Highlights & Side Effects. Trial Name: NCT05739981 — Phase 1 & 2
Bevacizumab (Angiogenesis Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05739981 — Phase 1 & 2

Frequently Asked Questions

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

Does the FDA sanction combination treatment of Chemotherapy, BEV, and GEN-1?

"Safety ratings for the combination of Chemotherapy + BEV + GEN-1 (Experimental) were assessed at 2, as there was prior evidence backing its safety profile yet no data to support efficacy."

Answered by AI

How many individuals have been recruited for this experiment?

"Affirmative. As per the clinicaltrials.gov page, this investigation is still recruiting individuals to take part in it. The trial was announced on February 10th 2023 and its details were most recently revised as of February 13th 2023. It seeks 50 participants at one medical facility."

Answered by AI

Are there any opportunities left to enroll in this clinical experiment?

"As visible from the clinicaltrials.gov page, potential participants are being sought for this trial. This investigation was originally posted on February 10th, 2023 and recently updated on February 13th of that same year."

Answered by AI
~33 spots leftby Aug 2026