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Cancer-Killing virus shows promise in tough ovarian cancer trial

NCT ID NCT05281471

Disease control Sponsor: Genelux Corporation Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Aug 27, 2026 · Updated 4 times

Summary

This Phase 3 study tests whether a modified virus called Olvi-Vec, given with chemotherapy and bevacizumab, can help women with ovarian cancer that no longer responds to platinum drugs. About 186 participants will receive either the virus combination or standard chemotherapy. The goal is to see if the virus can make the cancer sensitive to platinum again and slow disease progression.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Olvi-Vec (a modified virus that targets and kills cancer cells), followed by platinum chemotherapy and bevacizumab
What this could lead to
If successful, this could offer a new treatment option for women with hard-to-treat ovarian cancer that has stopped responding to platinum-based chemotherapy.
What could go wrong
This is an early Phase 3 trial with only 186 participants, so results may not apply to all patients. The virus-based therapy may cause side effects or fail to improve outcomes compared to current treatments.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 186 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2022

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Histologically confirmed (from prior treatment) non-resectable ovarian, fallopian tube or primary peritoneal cancer. * High-grade serous \[including malignant mixed Mullerian tumor (MMMT) with metastasis that contains high-grade epithelial carcinoma, FIGO grades 2 \& 3 allowed\], endometrioid, or clear-cell ovarian cancer. * Performance status ECOG of 0 or 1. * Life expectancy of at least 6 months. * Received a minimum of 3 prior lines (including the 1st line) of systemic therapy with no maximal limit. * Platinum-resistant or -refractory disease based on platinum-free interval (PFI) from the last dose of the most recent. platinum-based line of therapy (must have received a minimum of 2 doses of platinum in that line) to subsequent disease progression based on radiological assessment. Platinum-refractory: PFI of \< 1 month (including disease progression while on platinum-based therapy). Platinum-resistant: PFI of 1-6 months. * Received prior bevacizumab (or biosimilar) treatment. * No contraindication to receive carboplatin, cisplatin or bevacizumab (or biosimilar). * Have disease progression after last prior line of therapy based on radiological assessment prior to randomization. * At least 1 measurable target lesion per RECIST 1.1 based on abdominal/pelvis imaging scan at screening. * Evidence by CT and/or PET scans or physical exam of abdominal/pelvis region likely having disease in the peritoneal cavity (i.e., peritoneal carcinomatosis). * Adequate renal, hepatic, bone marrow function, adequate coagulation tests, adequate immune function by lymphocyte count. Exclusion Criteria: * Tumors of mucinous, low-grade serous, squamous cell, small cell neuroendocrine subtypes, MMMT tumors absent an epithelial component on recent biopsy, or non-epithelial ovarian cancers (e.g., germ cell tumors, Sex-cord tumors). * Bowel obstruction within last 3 months prior to screening. * Active urinary tract infection, pneumonia, other systemic infections. * Active gastrointestinal bleeding. * Known current central nervous system (CNS) metastasis. * Inflammatory diseases of the bowel. * History of HIV infection. * Active hepatitis B virus or hepatitis C virus within 4 weeks prior to study. * History of thromboembolic event within the prior 3 months. * Contraindications for intraperitoneal (IP) catheter placement: Bowel obstruction with distended abdomen, rigid abdomen with bulky anterior wall carcinomatosis, abdominal wall hernia mesh that precludes laparoscopic entry to abdomen. * Clinically significant cardiac disease at screening (New York Heart Association Class III/IV). * Acute cerebrovascular event(s) such as cerebrovascular accident (CVA) or transient ischemic attack (TIA) in previous 6 months. * Oxygen saturation \<90%. * Received prior virus-based gene therapy or therapy with cytolytic virus of any type. * Receiving concurrent antiviral agent. * Prior malignancy of other histology active within previous 3 years except for locally curable cancers apparently cured such as basal/squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of cervix or breast, any other stage I/II local malignancies. * Received chemotherapy, radiotherapy, other anti-cancer biologic therapies within 4 weeks prior to planned treatment. * Underwent surgery within 4 weeks, or have insufficient recovery from surgical-related trauma or wound healing, prior to first study treatment in either Arm. * Receiving immunosuppressive therapy or steroids (except acute concurrent corticosteroid of no more than 20 mg per day for medical management with prednisolone equivalent. * Symptomatic malignant ascites or pleural effusions defined as rapidly progressive ascites with abdominal distension and gastrointestinal dysfunction, pleural effusions with respiratory difficulties requiring frequent paracentesis \> once every 14 days. * Known hypersensitivity to gentamicin.

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Conditions

The condition(s) this trial relates to.

fallopian tube cancer fallopian tube neoplasm ovarian cancer ovarian carcinoma ovarian clear cell cancer ovarian endometrioid adenocarcinoma ovarian serous adenocarcinoma primary peritoneal carcinoma vaccinia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Endometrioid ovarian cancer Fallopian tube cancer High grade serous ovarian cancer Ovarian clear cell carcinoma Platinum-refractory ovarian cancer Platinum-resistant ovarian cancer Primary peritoneal cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    33 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • AHN West Penn Hospital

    RECRUITING

    Pittsburgh, Pennsylvania, 15224, United States

  • AdventHealth Cancer Institute

    RECRUITING

    Orlando, Florida, 32804, United States

  • Atrium Health Wake Forest Baptist, Comprehensive Cancer Center

    RECRUITING

    Winston-Salem, North Carolina, 27157-0001, United States

  • Baylor College of Medicine

    RECRUITING

    Houston, Texas, 77030, United States

  • Center of Hope

    RECRUITING

    Reno, Nevada, 89511, United States

  • City of Hope

    RECRUITING

    Duarte, California, 91010, United States

  • Cleveland Clinic

    RECRUITING

    Cleveland, Ohio, 44195, United States

  • East Carolina University

    RECRUITING

    Greenville, North Carolina, 27834, United States

  • Emory University

    RECRUITING

    Atlanta, Georgia, 30322, United States

  • Erlanger Health, Inc.

    RECRUITING

    Chattanooga, Tennessee, 37403, United States

  • Hoag Gynecologic Oncology

    RECRUITING

    Newport Beach, California, 92663, United States

  • Hollings Cancer Center

    RECRUITING

    Charleston, South Carolina, 29425, United States

  • Holy Cross Hospital

    RECRUITING

    Silver Spring, Maryland, 20910, United States

  • Indiana University Simon Comprehensive Cancer Center

    RECRUITING

    Indianapolis, Indiana, 46202, United States

  • Karmanos Cancer Institute

    RECRUITING

    Detroit, Michigan, 48201, United States

  • Kettering Health

    RECRUITING

    Kettering, Ohio, 45429, United States

  • Levine Cancer Institute

    RECRUITING

    Charlotte, North Carolina, 28204, United States

  • Mercy Hospital St. Louis

    RECRUITING

    St Louis, Missouri, 63141, United States

  • OhioHealth Research Institute

    RECRUITING

    Columbus, Ohio, 43214, United States

  • Oklahoma University Health Stephenson Cancer Center

    RECRUITING

    Oklahoma City, Oklahoma, 73104, United States

  • ProMedica Flower Hospital

    RECRUITING

    Sylvania, Ohio, 43560, United States

  • Providence Sacred Heart Medical Center & Children's Hospital

    RECRUITING

    Spokane, Washington, 99204, United States

  • Sarasota Memorial Healthcare System

    RECRUITING

    Sarasota, Florida, 34239, United States

    Contact Email: •••••@•••••

  • Stony Brook Cancer Center

    RECRUITING

    Stony Brook, New York, 11794, United States

  • The University of South Alabama, Mitchell Cancer Institute

    RECRUITING

    Mobile, Alabama, 36604, United States

  • UC San Diego Health - Moores Cancer Center

    RECRUITING

    La Jolla, California, 92093, United States

  • UCI Health Chao Family Comprehensive Cancer Center

    RECRUITING

    Orange, California, 92868, United States

  • University of Arizona Cancer Center

    RECRUITING

    Tucson, Arizona, 85719, United States

  • University of Michigan

    RECRUITING

    Ann Arbor, Michigan, 48109, United States

  • University of Texas Science Center at Houston, McGovern Medical School

    RECRUITING

    Houston, Texas, 77030, United States

  • Washington University School of Medicine

    RECRUITING

    St Louis, Missouri, 63110, United States

  • Women's Cancer Associates with Women's Care Florida

    RECRUITING

    St. Petersburg, Florida, 33713, United States

  • Women's Cancer Center of Nevada

    RECRUITING

    Las Vegas, Nevada, 89106, United States

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