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Efficacy & Safety of Olvi-Vec and Platinum-doublet + Bevacizumab Compared to Platinum-doublet + Bevacizumab in Platinum-Resistant/Refractory Ovarian Cancer (OnPrime, GOG-3076)

Primary Purpose

Platinum-resistant Ovarian Cancer, Platinum-refractory Ovarian Cancer, Fallopian Tube Cancer

Status
Recruiting
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
olvimulogene nanivacirepvec
Platinum chemotherapy: carboplatin (preferred) or cisplatin
Non-platinum chemotherapy: Physician's Choice of gemcitabine, taxane (paclitaxel, docetaxel or nab-paclitaxel) or pegylated liposomal doxorubicin
Bevacizumab (or biosimilar)
Sponsored by
Genelux Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Platinum-resistant Ovarian Cancer focused on measuring olvimulogene nanivacirepvec, GL-ONC1, GLV-1h68, oncolytic virus, virotherapy, viral therapy, immunotherapy, immunochemotherapy, combination therapy, vaccinia virus, ovarian cancer, fallopian tube cancer, primary peritoneal cancer, platinum resistant, platinum refractory, recurrent ovarian cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.
  • Time from Last Platinum of 3-15 months since the last dose of platinum in the most recent platinum-based line of therapy (excluding using platinum as a radiosensitizer) until consent into this trial.
  • 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.

Sites / Locations

  • University of Arizona Cancer CenterRecruiting
  • City of HopeRecruiting
  • Hoag Gynecologic OncologyRecruiting
  • UCI Health Chao Family Comprehensive Cancer CenterRecruiting
  • AdventHealth Cancer InstituteRecruiting
  • Indiana University Simon Comprehensive Cancer CenterRecruiting
  • Holy Cross HospitalRecruiting
  • Karmanos Cancer InstituteRecruiting
  • Mercy Hospital St. LouisRecruiting
  • Kettering HealthRecruiting
  • Oklahoma University Health Stephenson Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Olvi-Vec + Platinum-doublet & bevacizumab

Platinum-doublet & bevacizumab

Arm Description

Olvi-Vec: A total of 2 consecutive days of intraperitoneal catheter infusions in Week 0 Platinum-doublet & bevacizumab (or biosimilar) administered beginning in Week 4 (preferred), but no later than Week 5

Platinum-doublet & bevacizumab (or biosimilar) administered beginning in Week 0

Outcomes

Primary Outcome Measures

Progression-free survival (PFS) by RECIST 1.1 in the Intention-to-Treat (ITT) population (all randomized participants regardless of whether they received any dose of treatment)
To assess progression-free survival from time of randomization until first documented disease progression based on radiological assessment or death from any cause.

Secondary Outcome Measures

Incidence of Treatment-emergent Adverse Events in the ITT population
Determine safety and tolerability of administering multiple doses of Olvi-Vec via intraperitoneal catheter in combination with platinum-doublet and bevacizumab (or biosimilar) as assessed by CTCAE v. 5.0 following initiation of study treatment until end of study participation.
Duration of Response (DOR) by RECIST 1.1 in the ITT population
Time from date of first response until the first date of progressive disease based on radiological assessment.
PFS by RECIST 1.1 in the modified ITT (mITT) population (participants who received at least 1 dose of treatment in either Arm)
Time from randomization to first documented disease progression based on radiological assessment or death from any cause.
PFS by iRECIST in the ITT population
Time from randomization to first documented disease progression with confirmatory imaging scan performed 4-8 weeks after unconfirmed disease progression or death from any cause.
Overall Response Rate (ORR) by RECIST 1.1 in the ITT population
Ratio of the sum of CR & PR divided by the number of ITT participants from start of treatment to confirmation of response.
Overall Survival in the ITT population
Time from randomization until date of death from any cause.

Full Information

First Posted
March 7, 2022
Last Updated
September 14, 2023
Sponsor
Genelux Corporation
Collaborators
GOG Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT05281471
Brief Title
Efficacy & Safety of Olvi-Vec and Platinum-doublet + Bevacizumab Compared to Platinum-doublet + Bevacizumab in Platinum-Resistant/Refractory Ovarian Cancer (OnPrime, GOG-3076)
Official Title
A Randomized Phase 3 Study Assessing the Efficacy and Safety of Olvi-Vec Followed by Platinum-doublet Chemotherapy and Bevacizumab Compared With Platinum-doublet Chemotherapy and Bevacizumab in Women With Platinum-Resistant/Refractory Ovarian Cancer (OnPrime, GOG-3076)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 31, 2022 (Actual)
Primary Completion Date
August 2024 (Anticipated)
Study Completion Date
October 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Genelux Corporation
Collaborators
GOG Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The OnPrime study is a multi-center, randomized open-label phase 3 study evaluating the safety and efficacy of Olvi-Vec followed by platinum-doublet chemotherapy and bevacizumab compared to the Active Comparator Arm with platinum-doublet chemotherapy and bevacizumab in women diagnosed with platinum-resistant/refractory ovarian cancer (includes fallopian tube cancer and primary peritoneal cancer).
Detailed Description
Olvi-Vec (olvimulogene nanivacirepvec, aka GL-ONC1, laboratory name: GLV-1h68) is an oncolytic vaccinia virus-based immunotherapy. This study is to test the hypothesis that the combination of Olvi-Vec followed by further chemotherapy is particularly effective against established tumors by virus-mediated immune activation and re-sensitization of tumor cells to chemotherapy. Participant population includes histologically confirmed non-resectable platinum-resistant/refractory ovarian cancer (PRROC). Determination of progression-free survival, safety and overall survival are key objectives. Participants randomized into the Experimental Arm will receive a single-cycle (2 infusions on two consecutive days) of Olvi-Vec through an intraperitoneal catheter. The catheter is then removed, and patients receive systemically administered platinum-doublet chemotherapy and bevacizumab. The control arm receives the same platinum-doublet chemotherapy and bevacizumab at the same dose and schedule. Biological samples will be obtained from some Experimental Arm participants for virus-shedding testing. Assessment of response to treatment in both arms will be by RECIST 1.1 and iRECIST. Maintenance/continued treatment with non-platinum chemotherapy and bevacizumab is dependent on a participant being clinically stable until confirmed progressive disease by iRECIST or can no longer tolerate therapy. Dr. Robert W. Holloway (AdventHealth Cancer Institute, Orlando, FL) will serve as the National Principal Investigator for this Phase 3 study in PRROC.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Platinum-resistant Ovarian Cancer, Platinum-refractory Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer, High-grade Serous Ovarian Cancer, Endometrioid Ovarian Cancer, Ovarian Clear Cell Carcinoma
Keywords
olvimulogene nanivacirepvec, GL-ONC1, GLV-1h68, oncolytic virus, virotherapy, viral therapy, immunotherapy, immunochemotherapy, combination therapy, vaccinia virus, ovarian cancer, fallopian tube cancer, primary peritoneal cancer, platinum resistant, platinum refractory, recurrent ovarian cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Randomization (2:1) is either into the Experimental Arm which is Olvi-Vec followed by platinum-doublet chemotherapy and bevacizumab or into the Active Comparator Arm which is platinum-doublet chemotherapy and bevacizumab.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
186 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Olvi-Vec + Platinum-doublet & bevacizumab
Arm Type
Experimental
Arm Description
Olvi-Vec: A total of 2 consecutive days of intraperitoneal catheter infusions in Week 0 Platinum-doublet & bevacizumab (or biosimilar) administered beginning in Week 4 (preferred), but no later than Week 5
Arm Title
Platinum-doublet & bevacizumab
Arm Type
Active Comparator
Arm Description
Platinum-doublet & bevacizumab (or biosimilar) administered beginning in Week 0
Intervention Type
Biological
Intervention Name(s)
olvimulogene nanivacirepvec
Other Intervention Name(s)
GL-ONC1 and GLV-1h68
Intervention Description
Olvi-Vec is an engineered oncolytic vaccinia virus
Intervention Type
Drug
Intervention Name(s)
Platinum chemotherapy: carboplatin (preferred) or cisplatin
Intervention Description
Administered according to local practice
Intervention Type
Drug
Intervention Name(s)
Non-platinum chemotherapy: Physician's Choice of gemcitabine, taxane (paclitaxel, docetaxel or nab-paclitaxel) or pegylated liposomal doxorubicin
Intervention Description
Administered according to local practice
Intervention Type
Drug
Intervention Name(s)
Bevacizumab (or biosimilar)
Intervention Description
Administered according to local practice
Primary Outcome Measure Information:
Title
Progression-free survival (PFS) by RECIST 1.1 in the Intention-to-Treat (ITT) population (all randomized participants regardless of whether they received any dose of treatment)
Description
To assess progression-free survival from time of randomization until first documented disease progression based on radiological assessment or death from any cause.
Time Frame
From date of randomization up to 12 months
Secondary Outcome Measure Information:
Title
Incidence of Treatment-emergent Adverse Events in the ITT population
Description
Determine safety and tolerability of administering multiple doses of Olvi-Vec via intraperitoneal catheter in combination with platinum-doublet and bevacizumab (or biosimilar) as assessed by CTCAE v. 5.0 following initiation of study treatment until end of study participation.
Time Frame
From date of first study treatment until death or study completion; assessed up to 36 months
Title
Duration of Response (DOR) by RECIST 1.1 in the ITT population
Description
Time from date of first response until the first date of progressive disease based on radiological assessment.
Time Frame
From date of randomization up to 12 months
Title
PFS by RECIST 1.1 in the modified ITT (mITT) population (participants who received at least 1 dose of treatment in either Arm)
Description
Time from randomization to first documented disease progression based on radiological assessment or death from any cause.
Time Frame
From date of randomization up to 12 months
Title
PFS by iRECIST in the ITT population
Description
Time from randomization to first documented disease progression with confirmatory imaging scan performed 4-8 weeks after unconfirmed disease progression or death from any cause.
Time Frame
From date of randomization up to 12 months
Title
Overall Response Rate (ORR) by RECIST 1.1 in the ITT population
Description
Ratio of the sum of CR & PR divided by the number of ITT participants from start of treatment to confirmation of response.
Time Frame
From date of randomization up to 12 months
Title
Overall Survival in the ITT population
Description
Time from randomization until date of death from any cause.
Time Frame
From date of randomization until death or study completion; assessed up to 36 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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. Time from Last Platinum of 3-15 months since the last dose of platinum in the most recent platinum-based line of therapy (excluding using platinum as a radiosensitizer) until consent into this trial. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert W Holloway, MD
Organizational Affiliation
OnPrime Study
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Arizona Cancer Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85719
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Claudia Al Khairi
Phone
520-626-0975
Email
calkhairi@arizona.edu
First Name & Middle Initial & Last Name & Degree
Setsuko K. Chambers, MD
Facility Name
City of Hope
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Edward Wang, MD, PhD
Phone
877-467-3411
Email
edwang@coh.org
First Name & Middle Initial & Last Name & Degree
Edward Wang, MD, PhD
Facility Name
Hoag Gynecologic Oncology
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Esmeralda Martinez
Phone
949-764-5827
Email
Esmeralda.Martinez@hoag.org
First Name & Middle Initial & Last Name & Degree
Alberto Mendivil, MD, FACOG, FACS
Facility Name
UCI Health Chao Family Comprehensive Cancer Center
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Krishnansu S. Tewari, MD
Phone
714-456-7971
Email
ktewari@hs.uci.edu
First Name & Middle Initial & Last Name & Degree
Krishnansu S. Tewari, MD
Facility Name
AdventHealth Cancer Institute
City
Orlando
State/Province
Florida
ZIP/Postal Code
32804
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alejandra C Ricaurte
Phone
407-303-7346
Email
Alejandra.Ricaurte@AdventHealth.com
First Name & Middle Initial & Last Name & Degree
Robert W Holloway, MD
Facility Name
Indiana University Simon Comprehensive Cancer Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cheri West, RN
Phone
317-278-3021
Email
chawest@iupui.edu
First Name & Middle Initial & Last Name & Degree
Lisa Landrum, MD
Facility Name
Holy Cross Hospital
City
Silver Spring
State/Province
Maryland
ZIP/Postal Code
20910
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lyudmila Igorevna Kalnitskaya, MBA, MS
Phone
301-754-7552
Email
kalnitsl@holycrosshealth.org
First Name & Middle Initial & Last Name & Degree
James F Barter, MD
Facility Name
Karmanos Cancer Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robert Morris, MD
Phone
313-576-9435
Email
rmorris@med.wayne.edu
First Name & Middle Initial & Last Name & Degree
Robert Morris, MD
Facility Name
Mercy Hospital St. Louis
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Crystal Tindall, BSN, RN
Phone
314-251-7058
Email
Crystal.tindall@mercy.net
First Name & Middle Initial & Last Name & Degree
Emily Hoven, BSN, RN
Phone
314-251-7061
Email
Emily.hoven@mercy.net
First Name & Middle Initial & Last Name & Degree
Dan-Arin Silasi, MD
Facility Name
Kettering Health
City
Kettering
State/Province
Ohio
ZIP/Postal Code
45429
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel Geyer
Phone
937-395-8379
Email
daniel.geyer@ketteringhealth.org
First Name & Middle Initial & Last Name & Degree
Tammy Schleich
Phone
937-395-8483
Email
tammy.schleich@ketteringhealth.org
First Name & Middle Initial & Last Name & Degree
Thomas J. Reid, MD
Facility Name
Oklahoma University Health Stephenson Cancer Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Debra Richardson, MD
Phone
405-271-8707
Ext
31839
Email
Debra-Richardson@ouhsc.edu
First Name & Middle Initial & Last Name & Degree
Ashma Acharya
Phone
405-271-8001
Ext
18001
Email
Ashma-Acharya@ouhsc.edu
First Name & Middle Initial & Last Name & Degree
Debra Richardson, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31567308
Citation
Mori KM, Giuliano PD, Lopez KL, King MM, Bohart R, Goldstein BH. Pronounced clinical response following the oncolytic vaccinia virus GL-ONC1 and chemotherapy in a heavily pretreated ovarian cancer patient. Anticancer Drugs. 2019 Nov;30(10):1064-1066. doi: 10.1097/CAD.0000000000000836.
Results Reference
background
PubMed Identifier
34686353
Citation
Manyam M, Stephens AJ, Kennard JA, LeBlanc J, Ahmad S, Kendrick JE, Holloway RW. A phase 1b study of intraperitoneal oncolytic viral immunotherapy in platinum-resistant or refractory ovarian cancer. Gynecol Oncol. 2021 Dec;163(3):481-489. doi: 10.1016/j.ygyno.2021.10.069. Epub 2021 Oct 20. Erratum In: Gynecol Oncol. 2022 May;165(2):401.
Results Reference
result
Citation
Holloway RW, Mendivil AA, Kendrick JE, Abaid LN, Brown JV, Fitzsimmons CK, Kennard JA, King M, LeBlanc J, Lopez K, Manyam M, McKenzie ND, Mori KM, Stephens AJ, Sarfraz A. 2020 International Gynecologic Cancer Society, Oral Plenary Session presentation of VIRO-15 Phase 2 Trial Data, Robert Holloway, AdventHealth Cancer Institute, Orlando, FL. International Journal of Gynecologic Cancer 2020;30:A9-A10
Results Reference
result
PubMed Identifier
37227734
Citation
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.
Results Reference
result
Links:
URL
http://www.genelux.com/
Description
Genelux Corporation's Sponsor website
URL
https://www.genelux.com/pre-clinical-publications/
Description
Genelux Corporation's preclinical publications
URL
http://www.genelux.com/clinical-publications/
Description
Genelux Corporation's clinical publications
URL
http://www.gog.org
Description
The GOG Foundation's Partner website
URL
https://ijgc.bmj.com/content/30/Suppl_3/A9
Description
IGCS 2020 Oral Plenary: Dr. Robert W. Holloway - Oncolytic vaccinia (Olvi-Vec) primed immunochemotherapy in platinum-resistant/refractory ovarian cancer

Learn more about this trial

Efficacy & Safety of Olvi-Vec and Platinum-doublet + Bevacizumab Compared to Platinum-doublet + Bevacizumab in Platinum-Resistant/Refractory Ovarian Cancer (OnPrime, GOG-3076)

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