What side effects are associated with this type of intervention?

Common treatments for ovarian cancer, such as chemotherapy and antiangiogenic agents like bevacizumab, often have several side effects. Chemotherapy can cause nausea, vomiting, hair loss, fatigue, and an increased risk of infection due to lowered white blood cell counts. Bevacizumab, an antiangiogenic agent, can lead to hypertension, proteinuria, bleeding, and gastrointestinal perforations. These treatments aim to manage the disease but come with significant side effects that need to be monitored and managed by healthcare providers.

What prior FDA approvals exist?

The FDA has approved several treatments for ovarian cancer that involve chemotherapy and targeted therapies. Bevacizumab, an angiogenesis inhibitor, is approved for use in combination with chemotherapy for the treatment of advanced ovarian cancer. Additionally, PARP inhibitors such as niraparib, olaparib, and rucaparib have been approved for maintenance therapy in patients with recurrent ovarian cancer who have responded to platinum-based chemotherapy. These treatments aim to improve progression-free survival and are often used in combination with other chemotherapeutic agents.

What other types of research exist?

Promising novel alternatives to IMNN-001 for ovarian cancer patients include PARP inhibitors such as Olaparib and Rucaparib. Olaparib has shown improvement in progression-free survival (PFS) and a modest improvement in overall survival (OS) in patients with platinum-sensitive relapsed disease. Rucaparib has also demonstrated efficacy as both maintenance therapy and monotherapy for recurrent, platinum-sensitive ovarian cancer.

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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

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing if adding a new drug, IMNN-001, to standard cancer treatments can make the treatment more effective for patients. The standard treatments include chemotherapy and Bevacizumab, which are commonly used for various cancers such as colorectal, lung, and ovarian cancers.

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.

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.

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years

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

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

Primary study objectives

Minimal Residual Disease

Secondary study objectives

PFS

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

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

Paclitaxel

2011

Completed Phase 4

~5450

IMNN-001

2015

Completed Phase 1

~20

Carboplatin

2014

Completed Phase 3

~6120

Bevacizumab

2013

Completed Phase 4

~5540

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for ovarian cancer include chemotherapy and targeted therapies. Chemotherapy agents work by damaging the DNA of cancer cells or inhibiting their ability to divide, leading to cell death. Targeted therapies, such as bevacizumab, inhibit angiogenesis, which is the formation of new blood vessels that supply the tumor, thereby starving the cancer cells. The IMNN-001 trial combines these approaches, aiming to maximize the destruction of cancer cells while preventing tumor growth. Understanding these mechanisms helps patients appreciate how their treatments are designed to control cancer progression and improve survival rates.

Therapeutic Management of Rare Primary Ovarian Neoplasms: Carcinosarcoma, Leiomyosarcoma, Melanoma and Carcinoid.Integrative network analysis identifies potential targets and drugs for ovarian cancer.Defining the molecular response to trastuzumab, pertuzumab and combination therapy in ovarian cancer.