GL-ONC1 Oncolytic Immunotherapy in Patients With Recurrent or Refractory Ovarian Cancer

January 3, 2023 updated by: Genelux Corporation

Phase 1b & 2 Study With GL-ONC1 Oncolytic Immunotherapy in Patients With Recurrent or Refractory Ovarian Cancer (VIRO-15)

The purpose of this study is to determine if GL-ONC1 oncolytic immunotherapy is well tolerated with anti-tumor activity in patients diagnosed with recurrent or refractory ovarian cancer and peritoneal carcinomatosis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Ovarian cancer (OC) remains the most lethal gynecologic malignancy owing to late detection, intrinsic and acquired chemo-resistance and remarkable heterogeneity. There is an unmet medical need to develop new therapy modalities. In preclinical studies, GL-ONC1, has shown the ability to preferentially locate, colonize and destroy tumor cells in more than 30 different human tumors, including ovarian cancer. GL-ONC1 has been investigated in early stage clinical trials in the United States and Europe via systemic delivery as monotherapy and in combination with other therapies, and via regional delivery as monotherapy. GL-ONC1 treatment was well tolerated across different malignancies, routes of administration, and monotherapy as well as combination therapy protocols. The ability of GL-ONC1 to infect tumor tissue and kill tumor cells was demonstrated. In addition, virus-induced immune activation and favorable anti-tumor immune response have been observed. Evidences of anti-tumor efficacy and clinical benefits have also been documented.

Study Type

Interventional

Enrollment (Actual)

46

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Newport Beach, California, United States, 92663
        • Gynecologic Oncology Associates
    • Florida
      • Orlando, Florida, United States, 32804
        • AdventHealth Cancer Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Signed, written informed consent.
  • High-grade serous (including Malignant Mixed Mullerian Tumor (MMMT) with metastasis that contains high grade epithelial carcinoma), endometrioid, or clear-cell ovarian cancer which includes: (1) platinum-resistant (recurrence or progression in < 6 months) or (2) platinum-refractory (progression while on platinum-based therapy); patient must have failed either at least 2 consecutive therapies or are not eligible for additional cytotoxic therapies (exception is Phase 2 receiving chemotherapy with/without bevacizumab).
  • Intermediate platinum-sensitive patients (recurrence of disease 6 to 12 months from last platinum compound treatment): Recurrent ovarian carcinoma with at least four prior individual treatment regimens including at least two separate platinum-based therapies with recurrence from the last platinum-based regimen less than 12 months, who are unwilling or unable to undergo additional platinum-based cytotoxic therapy (this sub-population is not applicable for Phase 2 receiving chemotherapy with/without bevacizumab).
  • Performance status ECOG is at 0 or 1, and life expectancy of 6 months
  • Has either measurable disease in the peritoneal cavity as defined by RECIST 1.1 (Phase 1b & 2) or has non-measurable disease in the peritoneal cavity (Phase 1b) and can be confirmed by laparoscopy and/or elevated CA-125. Patients who have non-measurable disease that is not identifiable by PET/PET-CT scan, but who have elevated CA-125, and/or ascites, with visible disease confirmed by laparoscopy are also eligible.
  • Able to undergo IP injection.
  • Adequate renal, hepatic, bone marrow and immune functions.
  • Baseline tumor biopsy is required.
  • Documented progressive disease status at baseline (Phase 2).

Exclusion Criteria:

  • Tumors of mucinous subtypes, or non-epithelial ovarian cancers (e.g., Brenner tumors, Sex-cord tumors).
  • Unresolved bowel obstruction.
  • Known central nervous system (CNS) metastasis.
  • Known seropositivity for HIV or active hepatitis infection.
  • History of thromboembolic event within the last 3 months.
  • Pregnant or breast-feeding women.
  • Smallpox vaccination within 1 year of study treatment.
  • Clinically significant cardiac disease.
  • Received prior gene therapy or therapy with cytolytic virus of any type.
  • Receiving concurrent antiviral agent active against vaccinia virus.
  • Have known allergy to ovalbumin or other egg products.
  • Have clinically significant dermatological disorders (e.g., eczema, psoriasis, or unhealed skin wounds or ulcers) as assessed by the Investigator.
  • Symptomatic malignant ascites and non-manageable pleural effusion.
  • Known hypersensitivity to bevacizumab, uncontrolled hypertension, history of stroke, or clinical findings suggestive of excessive risk for GL perforation (uncontrolled peptic ulcer disease, partial small bowel obstruction, etc.) that would make risks of bevacizumab unacceptable in the opinion of the investigator.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: GL-ONC1
Biological: GL-ONC1 alone, or in combination with chemotherapy with or without bevacizumab
GL-ONC1 is a genetically-engineered oncolytic vaccinia virus, which is administered via intraperitoneal infusion as multiple doses.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Treatment-emergent Adverse Events [Safety and Tolerability] (Phase 1b)
Time Frame: Change from baseline during Treatment and for 30 days following last dose.
Determine safety and tolerability of administering multiple doses of GL-ONC1 via intraperitoneal catheter by the evaluation of the number of participants with treatment-emergent adverse events (type, frequency, and severity) as assessed by CTCAE 4.03.
Change from baseline during Treatment and for 30 days following last dose.
Determine Progression-free Survival following Treatment (Phase 2)
Time Frame: From date of registration until the date of first documented disease progression or date of death from any cause, whichever comes first, assessed up to 24 months.
To assess progression-free survival (PFS) from time of registration until disease
From date of registration until the date of first documented disease progression or date of death from any cause, whichever comes first, assessed up to 24 months.
Tumor Marker Cancer Antigen-125 (CA-125) (Phase 2)
Time Frame: Assessed pre-treatment, during treatment at 2- to 3-week intervals and post-treatment assessed up to 24 months.
To assess anti-tumor response.
Assessed pre-treatment, during treatment at 2- to 3-week intervals and post-treatment assessed up to 24 months.
Overall Response Rate (ORR) by RECIST 1.1 (Phase 2)
Time Frame: Assessed pre-treatment, during treatment at 6- to 12-week intervals and post-treatment assessed up to 24 months.
To assess anti-tumor response.
Assessed pre-treatment, during treatment at 6- to 12-week intervals and post-treatment assessed up to 24 months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of Tumor Response to Treatment (Phase 1b)
Time Frame: Assessed post-treatment at 6 to 12 week intervals or until disease progression or death from any cause, whichever comes first, assessed up to 24 months.
Evaluate participant's best overall response to treatment with therapeutic intent assessed by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. (i.e., complete response, partial response, stable disease, or progressive disease).
Assessed post-treatment at 6 to 12 week intervals or until disease progression or death from any cause, whichever comes first, assessed up to 24 months.
Evaluation of Immune-related Tumor Response
Time Frame: Assessed post-treatment at 6 to 12 week intervals or until disease progression or death from any cause, whichever comes first, assessed up to 24 months.
Evaluate participants' best overall response to treatment with oncolytic immunotherapy assessed by Immune-related Response Criteria (immune-related complete response, immune-related partial response, immune-related stable disease, or immune-related progressive disease).
Assessed post-treatment at 6 to 12 week intervals or until disease progression or death from any cause, whichever comes first, assessed up to 24 months.
CA-125 Response (Phase 1b)
Time Frame: Assessed pre-treatment, during treatment and post-treatment at 6 to 12 week intervals, assessed up to 24 months.
CA-125 according to the Gynecologic Cancer Intergroup (GCIG) is measured by at least a 50% reduction in CA-125 levels from pre-treatment sample which is confirmed and maintained for at least 28 days. Pre-treatment CA-125 sample must be at least twice the upper limit of normal and obtained within 2 weeks prior to starting treatment.
Assessed pre-treatment, during treatment and post-treatment at 6 to 12 week intervals, assessed up to 24 months.
Determine Progression-free Survival following Treatment (Phase 1b)
Time Frame: From date of registration until the date of first documented disease progression or date of death from any cause, whichever comes first, assessed up to 24 months.
To assess progression-free survival (PFS) in participant population.
From date of registration until the date of first documented disease progression or date of death from any cause, whichever comes first, assessed up to 24 months.
Overall Survival
Time Frame: By medical chart review until death or 3 years from the date of last treatment which ever comes first.
To determine overall survival (OS) in the participant population.
By medical chart review until death or 3 years from the date of last treatment which ever comes first.
Clinical Benefit Rate
Time Frame: Approximately 24 months
Defined as the percentage of patients who have achieved CR + PR + SD greater than or equal to 15 weeks.
Approximately 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Genelux Corporation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2016

Primary Completion (Actual)

December 31, 2021

Study Completion (Actual)

December 31, 2022

Study Registration Dates

First Submitted

April 25, 2016

First Submitted That Met QC Criteria

April 29, 2016

First Posted (Estimate)

May 3, 2016

Study Record Updates

Last Update Posted (Actual)

January 5, 2023

Last Update Submitted That Met QC Criteria

January 3, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GL-ONC1-015

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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