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  • A phase III, multicenter, randomized study of olvimulogene nanivacirepvec followed by platinum-doublet chemotherapy and bevacizumab compared with platinum-doublet chemotherapy and bevacizumab in women with platinum-resistant/refractory ovarian cancer

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Clinical trial
A phase III, multicenter, randomized study of olvimulogene nanivacirepvec followed by platinum-doublet chemotherapy and bevacizumab compared with platinum-doublet chemotherapy and bevacizumab in women with platinum-resistant/refractory ovarian cancer
  1. Robert W Holloway1,
  2. Premal Thaker2,
  3. Alberto A Mendivil3,
  4. Sarfraz Ahmad1,
  5. Ahmed N Al-Niaimi4,
  6. James Barter5,
  7. Tiffany Beck3,
  8. Setsuko K Chambers6,
  9. Robert L Coleman7,
  10. Sarah M Crafton8,
  11. Erin Crane9,
  12. Ramez Eskander10,
  13. Sharad Ghamande11,
  14. Whitney Graybill12,
  15. Thomas Herzog13,
  16. Megan Dr Indermaur14,
  17. Veena S John15,
  18. Lisa Landrum16,
  19. Peter C Lim17,
  20. Joseph A Lucci18,
  21. Michael McHale19,
  22. Bradley J Monk20,
  23. Kathleen Nadine Moore21,
  24. Robert Morris22,
  25. David M O’Malley23,
  26. Thomas J Reid24,
  27. Debra Richardson25,
  28. Peter G Rose26,
  29. Jennifer M Scalici27,
  30. Dan-Arin Silasi28,
  31. Krishnansu Tewari29 and
  32. Edward W Wang30
  1. 1 AdventHealth Cancer Institute, Orlando, Florida, USA
  2. 2 Obstetrics and Gynecology, Washington University in Saint Louis, Saint Louis, Missouri, USA
  3. 3 Hoag Cancer Center, Newport Beach, California, USA
  4. 4 Banner MD Anderson Cancer Center, Gilbert, Arizona, USA
  5. 5 Holy Cross Hospital, Silver Spring, Maryland, USA
  6. 6 University of Arizona Cancer Center, Tucson, Arizona, USA
  7. 7 US Oncology Network, The Woodlands, Texas, USA
  8. 8 West Penn Hospital, Allegheny Health Network, Pittsburgh, Pennsylvania, USA
  9. 9 Levine Cancer Institution, Atrium Health, Charlotte, North Carolina, USA
  10. 10 Moores Cancer Center, University of California San Diego, La Jolla, California, USA
  11. 11 Augusta University Medical College of Georgia, Augusta, Georgia, USA
  12. 12 Hollings Cancer Center, Medical University of South Carolina, Charleston, South Carolina, USA
  13. 13 Cancer Center, University of Cincinnati, Cincinnati, Ohio, USA
  14. 14 Women’s Cancer Associates, St Petersburg, Florida, USA
  15. 15 Northwell Health Cancer Institute, Lake Success, New York, USA
  16. 16 Indiana University Simon Comprehensive Cancer Center, Indianapolis, Indiana, USA
  17. 17 Center of Hope, Reno, Nevada, USA
  18. 18 McGovern Medical School, University of Texas Health Sciences Center at Houston, Houston, Texas, USA
  19. 19 Obstetrics, Gynecology, and Reproductive Sciences, University of California San Diego, La Jolla, California, USA
  20. 20 University of Arizona and Creighton University School of Medicine, HonorHealth Research Institute, Phoenix, Arizona, USA
  21. 21 Stephenson Cancer Center, University of Oklahoma, Oklahoma City, Oklahoma, USA
  22. 22 Karmanos Cancer Center, Detroit, Michigan, USA
  23. 23 James Cancer Center, The Ohio State University, Columbus, Ohio, USA
  24. 24 Kettering Health, Kettering, Ohio, USA
  25. 25 Stephenson Cancer Center, University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, USA
  26. 26 Gynecology Oncology Desk A-81, Cleveland Clinic Foundation, Cleveland, Ohio, USA
  27. 27 Mitchell Cancer Institute, University of South Alabama, Mobile, Alabama, USA
  28. 28 Mercy St Louis/Diavid C Pratt Cancer Center, St Louis, Missouri, USA
  29. 29 Chao Family Comprehensive Cancer Center, University of California Irvine, Irvine, California, USA
  30. 30 City of Hope, Duarte, California, USA
  1. Correspondence to Professor Sarfraz Ahmad, AdventHealth Cancer Institute, Orlando, USA; sarfraz.ahmad{at}AdventHealth.com; Dr Robert W Holloway, Gynecologic Oncology Program, AdventHealth Cancer Institute, Orlando, FL, USA; robhollowaymd{at}gmail.com

Abstract

Background Treatment options for patients with platinum-resistant/refractory ovarian cancers are limited and only marginally effective. The development of novel, more effective therapies addresses a critical unmet medical need. Olvimulogene nanivacirepvec (Olvi-Vec), with its strong immune modulating effect on the tumor microenvironment, may provide re-sensitization to platinum and clinically reverse platinum resistance or refractoriness in platinum-resistant/refractory ovarian cancer.

Primary Objective The primary objective is to evaluate the efficacy of intra-peritoneal Olvi-Vec followed by platinum-based chemotherapy and bevacizumab in patients with platinum-resistant/refractory ovarian cancer.

Study Hypothesis This phase III study investigates Olvi-Vec oncolytic immunotherapy followed by platinum-based chemotherapy and bevacizumab as an immunochemotherapy evaluating the hypothesis that such sequential combination therapy will prolong progression-free survival (PFS) and bring other clinical benefits compared with treatment with platinum-based chemotherapy and bevacizumab.

Trial Design This is a multicenter, prospective, randomized, and active-controlled phase III trial. Patients will be randomized 2:1 into the experimental arm treated with Olvi-Vec followed by platinum-doublet chemotherapy and bevacizumab or the control arm treated with platinum-doublet chemotherapy and bevacizumab.

Major Inclusion/Exclusion Criteria Eligible patients must have recurrent, platinum-resistant/refractory, non-resectable high-grade serous, endometrioid, or clear-cell ovarian, fallopian tube, or primary peritoneal cancer. Patients must have had ≥3 lines of prior chemotherapy.

Primary Endpoint The primary endpoint is PFS in the intention-to-treat population.

Sample Size Approximately 186 patients (approximately 124 patients randomized to the experimental arm and 62 to the control arm) will be enrolled to capture 127 PFS events.

Estimated Dates for Completing Accrual and Presenting Results Expected complete accrual in 2024 with presentation of primary endpoint results in 2025.

Trial Registration NCT05281471.

  • Ovarian Cancer
  • Surgical Oncology
  • Carcinoma, Ovarian Epithelial
  • Gynecology

Data availability statement

There are no data in this work.

https://doi.org/10.1136/ijgc-2023-004812

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    Data availability statement

    There are no data in this work.

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    Footnotes

    • Twitter @cvs225, @DebbieRic23, @jscalici

    • Correction notice This article has been corrected since it was first published to correct author name Ramez Eskander.

    • Contributors RWH, PT, and AAM performed the study design, protocol development, and manuscript writing. All authors participated in patient recruitment, data analysis and interpretation, and manuscript writing. All authors approved the final report. RWH and SA are responsible for the overall content as guarantor.

    • Funding This study is funded by Genelux Corporation, Westlake Village, California, USA.

    • Competing interests None declared.

    • Provenance and peer review Commissioned; internally peer reviewed.