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  • TP026/#1435 Phase 3 study of efficacy & safety of Olvi-Vec and platinum-doublet + bevacizumab compared to platinum-doublet + bevacizumab in platinum-resistant/refractory ovarian cancer (ONPRIME; GOG-3076) [NCT05281471]

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TP026/#1435 Phase 3 study of efficacy & safety of Olvi-Vec and platinum-doublet + bevacizumab compared to platinum-doublet + bevacizumab in platinum-resistant/refractory ovarian cancer (ONPRIME; GOG-3076) [NCT05281471]
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  1. Robert Holloway1,
  2. Premal Thaker2,
  3. Alberto Mendivil3,
  4. Sarfraz Ahmad1,
  5. Maria Bell4,
  6. Setsuko Chambers5,
  7. John K Chan6,
  8. Robert L Coleman7,
  9. Sarah Crafton8,
  10. Erin Crane9,
  11. Ramez Eskander10,
  12. Karen Finkelstein11,
  13. Whitney S Graybill12,
  14. Thomas Herzog13,
  15. Veena John14,
  16. Lisa Landrum15,
  17. Aliza Leiser16,
  18. Michael Mchale10,
  19. Rachel Miller17,
  20. Bradley Monk18,
  21. Kathleen Moore19,
  22. David O’Malley20,
  23. Thomas Reid21,
  24. Debra Richardson19,
  25. Dan-Arin Silasi22,
  26. Jan Sunde23 and
  27. Krishnansu Tewari24
  1. 1AdventHealth Cancer Institute, Gynecologic Oncology, Orlando, USA
  2. 2Washington University School of Medicine, Department of Gynecologic Oncology, St Louis, USA
  3. 3Hoag Cancer Center, Gynecologic Oncology, Newport Beach, USA
  4. 4Sanford Health, Sanford Gynecologic Oncology Clinic, Sioux Falls, USA
  5. 5University of Arizona Cancer Center, Gynecologic Oncology, Tucson, USA
  6. 6California Pacific Medical Center, Gynecologic Oncology, San Francisco, USA
  7. 7US Oncology Network/Research, Gynecologic Oncology Group (GOG), Gynecologic Oncology, The Woodlands, USA
  8. 8West Penn Hospital, Gynecologic Oncology, Pittsburgh, USA
  9. 9Atrium Health Carolinas Medical Center, Levine Cancer Institute, Gynecologic Oncology, Charlotte, USA
  10. 10University of California San Diego Moores Cancer Center, Division of Gynecologic Oncology, Department of Obstetrics, Gynecology and Reproductive Services, La Jolla, USA
  11. 11Southwest Women’s Oncology, Gynecologic Oncology, Optimal Clinical Research Group, Albuquerque, USA
  12. 12Medical University of South Carolina Hollings Cancer Center, Obstetrics and Gynecology, Charleston, USA
  13. 13University of Cincinnati Cancer Center, Gynecologic Oncology, Cincinnati, USA
  14. 14Northwell Health Cancer Institute, Hematology and Medical Oncology, Lake Success, USA
  15. 15Indiana University Health, Simon Comprehensive Cancer Center, Gynecologic Oncology, Indianapolis, USA
  16. 16Cancer Institute of New Jersey, Gynecologic Oncology, Brunswick, USA
  17. 17University of Kentucky, Gynecologic Oncology, Lexington, USA
  18. 18University of Arizona, Creighton University, Honorhealth Research Institute, Phoenix, USA
  19. 19Stephenson Cancer Center University of Oklahoma, Gynecologic Oncology, Oklahoma City, USA
  20. 20The Ohio State University, James Cancer Center, Division of Gynecologic Oncology, Columbus, USA
  21. 21Kettering Health, Gynecologic Oncology, Kettering, USA
  22. 22Mercy St. Louis/David C. Pratt Cancer Center, Gynecologic Oncology, St. Louis, USA
  23. 23Baylor College of Medicine, Gynecologic Oncology, Houston, USA
  24. 24Chao Family Comprehensive Cancer Center, University of California Irvine, Division of Gynecologic Oncology, Irvine, USA

Abstract

Objectives Olvi-Vec (olvimulogene nanivacirepvec, aka GL-ONC1, laboratory name: GLV-1h68) is an oncolytic vaccinia virus-based immunotherapy. This Phase 3 study aims to test the hypothesis that the combination of Olvi-Vec followed by further platinum-doublet chemotherapy is particularly effective against tumors by virus-mediated immune activation and re-sensitization of tumor cells to chemotherapy in heavily pre-treated patients with platinum-resistant/refractory ovarian cancer (PRROC) as shown in the Phase 2 VIRO-15 study (table 1). Primary objective is progression-free survival (PFS) by RECIST 1.1 in intent-to-treat population (ITT; all randomly assigned patients). Secondary objectives are: i) objective response rate (ORR) and duration of response (DOR) by RECIST 1.1, PFS by RECIST 1.1 (in modified ITT population), PFS by iRECIST, overall survival (OS), and safety; ii) to determine ORR by the Gynecological Cancer Intergroup (GCIG) CA-125 criteria, and Clinical Benefit Rate [CBR=(CR+PR+SD≥15 weeks)/total number of patients evaluated by RECIST 1.1 or iRECIST]. RECIST & iRECIST response will be assessed by blinded central imaging review (BICR). Additional analyses of efficacy endpoints in modified population are included.

Methods Phase 3 OnPrime Study design is summarized in figure 1. The study is enrolling and will have 30 sites in the USA [NCT05281471].

Results Trial in progress: there are no available results at the time of submission.

View this table:
Abstract TP026/#1435 Table 1

Previous phase 2 VIRO-15 study updated data in PRROC patients

Abstract TP026/#1435 Figure 1
Abstract TP026/#1435 Figure 1

Phase 3 OnPrime study design

Conclusions Trial in progress: there are no available conclusions at the time of submission.

https://doi.org/10.1136/ijgc-2022-igcs.535

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