Study on the Effectiveness and Safety of Olvi-Vec with Chemotherapy and Bevacizumab for Platinum-Resistant Ovarian Cancer

Sponsor: Genelux Corporation

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT05281471

Provider View

This clinical trial is comparing a new treatment using Olvi-Vec with chemotherapy and bevacizumab to the usual chemotherapy and bevacizumab in women with ovarian cancer that has not responded to platinum-based treatments.

Patient Parameters

Program Overview

The OnPrime study is a large, multi-center trial testing a new treatment approach for women with ovarian cancer that has not responded to platinum-based chemotherapy. The study is comparing the safety and effectiveness of Olvi-Vec, a virus-based therapy, followed by chemotherapy and bevacizumab, against the standard treatment chosen by doctors. This trial builds on earlier research that showed promising results in patients with difficult-to-treat ovarian cancer. The study aims to see if this new combination can help shrink tumors and improve survival in these patients.

Description

Olvi-Vec is a type of immunotherapy that uses a virus to help the immune system attack cancer cells. This study is testing whether Olvi-Vec, followed by chemotherapy, is effective in treating ovarian cancer that has not responded to platinum-based treatments. Women participating in the study will be randomly assigned to one of two groups. One group will receive Olvi-Vec through a catheter into the abdomen, followed by chemotherapy and bevacizumab. The other group will receive the standard chemotherapy and bevacizumab treatment chosen by their doctor. The study will measure how long patients live without the cancer getting worse and overall survival. Some participants will also provide samples to check for virus shedding. The response to treatment will be assessed using specific criteria by an independent review. Dr. Robert W. Holloway is leading this study at the AdventHealth Cancer Institute in Orlando, FL.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with non-resectable ovarian, fallopian tube, or primary peritoneal cancer.
  • High-grade serous, endometrioid, or clear-cell ovarian cancer.
  • Good overall health with a performance status of 0 or 1.
  • Life expectancy of at least 6 months.
  • Previously received at least 3 lines of systemic therapy.
  • Time from last platinum treatment is 24 months or less.
  • Cancer is resistant or refractory to platinum-based treatments.
  • Previously treated with bevacizumab.
  • No contraindications to receiving carboplatin, cisplatin, or bevacizumab.
  • Disease progression after the last treatment.
  • At least one measurable tumor.
  • Evidence of disease in the abdominal/pelvis area.
  • Adequate kidney, liver, bone marrow function, and immune function.

Exclusion Criteria

  • Certain types of ovarian cancer, such as mucinous or low-grade serous.
  • Recent bowel obstruction.
  • Active infections like urinary tract infection or pneumonia.
  • Active gastrointestinal bleeding.
  • Cancer spread to the brain.
  • Inflammatory bowel diseases.
  • History of HIV infection.
  • Active hepatitis B or C.
  • Recent blood clots.
  • Conditions preventing catheter placement.
  • Severe heart disease.
  • Recent stroke or mini-stroke.
  • Low oxygen levels.
  • Previous virus-based gene therapy.
  • Taking antiviral medications.
  • Recent other cancers, except for certain skin or localized cancers.
  • Recent chemotherapy or surgery.
  • Taking immunosuppressive drugs or steroids.
  • Symptomatic fluid buildup in the abdomen or lungs.
  • Allergy to gentamicin.

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