NCT02759588

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P50-P75 for phase_1 ovarian-cancer

Timeline
Completed

Started May 2016

Longer than P75 for phase_1 ovarian-cancer

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 25, 2016

Completed
6 days until next milestone

Study Start

First participant enrolled

May 1, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 3, 2016

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

January 5, 2023

Status Verified

January 1, 2023

Enrollment Period

5.7 years

First QC Date

April 25, 2016

Last Update Submit

January 3, 2023

Conditions

Ovarian CancerPeritoneal CarcinomatosisFallopian Tube Cancer

Keywords

GL-ONC1oncolytic virusvirotherapyViral therapyimmunotherapyimmune therapyvacciniavaccinia virusGeneluxovarian cancerplatinum resistantplatinum refractoryperitoneal carcinomatosisfallopian cancercancerabdominal cancerimagingcarcinomaDNA virusneoplasmsneoplasms by histological typeneoplasms, Glandular and EpithelialPoxviridae infectionsVirus diseasesrecurrent ovarian cancerintermediate platinum-sensitive

Outcome Measures

Primary Outcomes (4)

  • Incidence of Treatment-emergent Adverse Events [Safety and Tolerability] (Phase 1b)

    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)

    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)

    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)

    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 Outcomes (6)

  • Evaluation of Tumor Response to Treatment (Phase 1b)

    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

    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)

    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)

    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

    By medical chart review until death or 3 years from the date of last treatment which ever comes first.

  • +1 more secondary outcomes

Study Arms (1)

GL-ONC1

EXPERIMENTAL
Biological: GL-ONC1 alone, or in combination with chemotherapy with or without bevacizumab

Interventions

GL-ONC1 alone, or in combination with chemotherapy with or without bevacizumabBIOLOGICAL

GL-ONC1 is a genetically-engineered oncolytic vaccinia virus, which is administered via intraperitoneal infusion as multiple doses.

GL-ONC1

Eligibility Criteria

Age21 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Gynecologic Oncology Associates

Newport Beach, California, 92663, United States

Location

AdventHealth Cancer Institute

Orlando, Florida, 32804, United States

Location

Related Publications (1)

  • Holloway RW, Mendivil AA, Kendrick JE, Abaid LN, Brown JV, LeBlanc J, McKenzie ND, Mori KM, Ahmad S. Clinical Activity of Olvimulogene Nanivacirepvec-Primed Immunochemotherapy in Heavily Pretreated Patients With Platinum-Resistant or Platinum-Refractory Ovarian Cancer: The Nonrandomized Phase 2 VIRO-15 Clinical Trial. JAMA Oncol. 2023 Jul 1;9(7):903-908. doi: 10.1001/jamaoncol.2023.1007.

    PMID: 37227734DERIVED

Related Links

MeSH Terms

Conditions

Ovarian NeoplasmsPeritoneal NeoplasmsFallopian Tube NeoplasmsVacciniaNeoplasmsCarcinomaNeoplasms by Histologic TypeNeoplasms, Glandular and EpithelialPoxviridae InfectionsVirus Diseases

Interventions

Drug TherapyBevacizumab

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal DisordersAbdominal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesPeritoneal DiseasesFallopian Tube DiseasesDNA Virus InfectionsInfections

Intervention Hierarchy (Ancestors)

TherapeuticsAntibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 25, 2016

First Posted

May 3, 2016

Study Start

May 1, 2016

Primary Completion

December 31, 2021

Study Completion

December 31, 2022

Last Updated

January 5, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

US(2)