~19 spots leftby Aug 2026

GEN-1 + Chemo + Bevacizumab for Ovarian Cancer

(MRD Trial)

Recruiting at 2 trial locations
Age: 18+
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1 & 2
Recruiting
Sponsor: Imunon
Must not be taking: Corticosteroids, Immunosuppressants
Disqualifiers: Autoimmune disease, HIV, Hepatitis, others
No Placebo Group
Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial requires that any hormonal therapy directed at the malignant tumor be stopped at least one week before the first treatment. However, hormone replacement therapy can continue. The protocol does not specify other medication restrictions, but you should discuss your current medications with the trial team.

What data supports the effectiveness of the drug combination GEN-1, Bevacizumab, and chemotherapy for ovarian cancer?

Research shows that combining Bevacizumab with chemotherapy drugs like paclitaxel and carboplatin can improve progression-free survival (the time during which the cancer does not get worse) in ovarian cancer patients. Bevacizumab has also shown antitumor activity in cases where the cancer is resistant to platinum-based treatments.12345

Is the combination of GEN-1, chemotherapy, and bevacizumab safe for treating ovarian cancer?

Bevacizumab, when combined with chemotherapy drugs like carboplatin and paclitaxel, has been studied for safety in treating ovarian cancer. Common side effects include high blood pressure, bleeding, and protein in the urine, which are usually mild and manageable, but there can be serious risks like blood clots and digestive system issues. These findings are based on studies of bevacizumab with chemotherapy in ovarian cancer patients.36789

What makes the drug combination of GEN-1, chemotherapy, and Bevacizumab unique for treating ovarian cancer?

This treatment is unique because it combines GEN-1, a novel agent, with chemotherapy and Bevacizumab, which targets blood vessel growth in tumors. Bevacizumab has shown to improve progression-free survival in ovarian cancer when added to standard chemotherapy, offering a new option for patients with advanced disease.1011121314

Research Team

AJ

Amir Jazaeri, MD

Principal Investigator

University of Texas MD Anderson Center

Eligibility Criteria

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.

Inclusion Criteria

I haven't had a serious illness, infection needing strong antibiotics, or COVID-19 in the last 4 weeks.
My ovarian cancer is a specific type called high grade serous adenocarcinoma.
Subjects must have satisfactory results for the baseline laboratory analyses and diagnostic procedures as specified in the protocol
See 7 more

Exclusion Criteria

I haven't had radiation in my abdomen or pelvis but may have had it for breast, head and neck, or skin cancer over three years ago without recurrence.
I have previously been treated with IMNN-001.
Subjects who have a history of allergic reactions attributed to compounds of similar chemical or biologic composition to IMNN-001 or other drugs used in this study
See 14 more

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Neoadjuvant Chemotherapy

Participants receive neoadjuvant chemotherapy with Paclitaxel and Carboplatin every 21 days for 4 to 6 cycles, with BEV included in certain cycles.

12-18 weeks

Interval Cytoreductive Surgery (ICS)

Interval cytoreductive surgery is performed 3-4 weeks after the last dose of neoadjuvant chemotherapy.

3-4 weeks

Adjuvant Chemotherapy

Participants receive adjuvant chemotherapy with Paclitaxel and Carboplatin, with BEV included in certain cycles, for 3 additional cycles.

9 weeks

Maintenance Therapy

BEV is administered every 3 weeks as a single agent until disease progression or unacceptable toxicity, for up to an additional 18 cycles.

54 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment.

8 months

Treatment Details

Interventions

  • Bevacizumab (Angiogenesis Inhibitor)
  • Carboplatin (Chemotherapy)
  • GEN1 (Gene Therapy)
  • Paclitaxel (Chemotherapy)
Trial OverviewThe 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.
Participant Groups
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.

Bevacizumab is already approved in Japan, Canada for the following indications:

🇯🇵
Approved in Japan as Avastin for:
  • Colorectal cancer
  • Non-small cell lung cancer
  • Breast cancer
  • Renal cell carcinoma
  • Ovarian cancer
🇨🇦
Approved in Canada as Avastin for:
  • Colorectal cancer
  • Non-small cell lung cancer
  • Breast cancer
  • Renal cell carcinoma
  • Ovarian cancer

Find a Clinic Near You

Who Is Running the Clinical Trial?

Imunon

Lead Sponsor

Trials
16
Recruited
1,600+

Breakthrough Cancer Research

Collaborator

Trials
2
Recruited
250+

Break Through Cancer Foundation

Collaborator

Trials
1
Recruited
50+

Findings from Research

In a study of 90 ovarian cancer patients, the combination of bevacizumab with paclitaxel and carboplatin significantly improved treatment outcomes, with higher remission and disease control rates compared to those receiving only paclitaxel and carboplatin.
The combined treatment also led to lower levels of tumor markers CA199, CEA, and CA242 without increasing the risk of adverse effects, indicating it is a safe and effective option for improving patient prognosis.
Effect of bevacizumab plus paclitaxel and carboplatin regimen on prognostic survival of ovarian cancer patients.Jiang, Q., Qian, H., Mei, L., et al.[2023]
Cytoreductive surgery followed by platinum-based chemotherapy, particularly with carboplatin, remains the standard treatment for advanced epithelial ovarian cancer, but most patients are not cured, highlighting the need for improved therapies.
Paclitaxel, a novel agent effective in platinum-resistant ovarian cancer, is being tested in combination with platinum compounds in clinical trials for previously untreated patients, aiming to enhance treatment efficacy.
Treatment of ovarian cancer: current status.Ozols, RF.[2015]
In a study of 299 patients with advanced ovarian cancer, combining bevacizumab with carboplatin/paclitaxel resulted in a median progression-free survival of 15.4 months, indicating its efficacy as a front-line treatment.
The treatment was generally safe, with 54% of patients experiencing grade 3/4 adverse events, primarily hypertension and neutropenia, and a 1-year overall survival rate of 94%, suggesting a favorable safety profile.
Role of front-line bevacizumab in advanced ovarian cancer: the OSCAR study.Hall, M., Bertelli, G., Li, L., et al.[2020]

References

Effect of bevacizumab plus paclitaxel and carboplatin regimen on prognostic survival of ovarian cancer patients. [2023]
Treatment of ovarian cancer: current status. [2015]
Role of front-line bevacizumab in advanced ovarian cancer: the OSCAR study. [2020]
Profile of bevacizumab in the treatment of platinum-resistant ovarian cancer: current perspectives. [2022]
Phase III trials of standard chemotherapy with or without bevacizumab for ovarian cancer: a meta-analysis. [2021]
Experience with bevacizumab in the management of epithelial ovarian cancer. [2015]
Paclitaxel (Taxol) treatment for refractory ovarian cancer: phase II clinical trial. [2019]
Arthralgia in patients with ovarian cancer treated with bevacizumab and chemotherapy. [2021]
Prospective non-interventional BELOVA/BGOG-ov16 study on safety of frontline bevacizumab in elderly patients with FIGO stage IV ovarian cancer: a study of the Belgian and Luxembourg Gynaecological Oncology Group. [2022]
Bevacizumab and ovarian cancer. [2021]
Bevacizumab with Chemotherapy as a First-Line Treatment for Advanced Ovarian Cancer in a Serbian Cohort. [2023]
Bevacizumab and its use in epithelial ovarian cancer. [2019]
Bevacizumab and platinum-based combinations for recurrent ovarian cancer: a randomised, open-label, phase 3 trial. [2022]
Bevacizumab combination therapy: a review of its use in patients with epithelial ovarian, fallopian tube, or primary peritoneal cancer. [2019]