GL-ONC1 Oncolytic Immunotherapy in Patients With Recurrent or Refractory Ovarian Cancer
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|ClinicalTrials.gov Identifier: NCT02759588|
Recruitment Status : Completed
First Posted : May 3, 2016
Last Update Posted : January 5, 2023
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|Condition or disease||Intervention/treatment||Phase|
|Ovarian Cancer Peritoneal Carcinomatosis Fallopian Tube Cancer||Biological: GL-ONC1 alone, or in combination with chemotherapy with or without bevacizumab||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||46 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase 1b & 2 Study With GL-ONC1 Oncolytic Immunotherapy in Patients With Recurrent or Refractory Ovarian Cancer (VIRO-15)|
|Study Start Date :||May 2016|
|Actual Primary Completion Date :||December 31, 2021|
|Actual Study Completion Date :||December 31, 2022|
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.
- 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.
- 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
- 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.
- 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.
- 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).
- 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).
- 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.
- 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.
- 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.
- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||21 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||Female|
|Accepts Healthy Volunteers:||No|
- 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).
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02759588
|United States, California|
|Gynecologic Oncology Associates|
|Newport Beach, California, United States, 92663|
|United States, Florida|
|AdventHealth Cancer Institute|
|Orlando, Florida, United States, 32804|
|Responsible Party:||Genelux Corporation|
|Other Study ID Numbers:||
|First Posted:||May 3, 2016 Key Record Dates|
|Last Update Posted:||January 5, 2023|
|Last Verified:||January 2023|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
neoplasms by histological type
neoplasms, Glandular and Epithelial
recurrent ovarian cancer
Carcinoma, Ovarian Epithelial
Fallopian Tube Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Genital Neoplasms, Female
Endocrine System Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Fallopian Tube Diseases
Digestive System Neoplasms
Digestive System Diseases
Antineoplastic Agents, Immunological
Angiogenesis Modulating Agents
Physiological Effects of Drugs