Clinical Publications
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
Int J Gynecol Cancer. 2023 Sep 4;33(9):1458-1463. doi: 10.1136/ijgc-2023-004812.
Robert W Holloway, Premal Thaker, Alberto A Mendivil, Sarfraz Ahmad, Ahmed N Al-Niaimi, James Barter, Tiffany Beck, Setsuko K Chambers, Robert L Coleman, Sarah M Crafton, Erin Crane, Eskander Ramez, Sharad Ghamande, Whitney Graybill, Thomas Herzog, Megan Dr Indermaur, Veena S John, Lisa Landrum, Peter C Lim, Joseph A Lucci, Michael McHale, Bradley J Monk, Kathleen Nadine Moore, Robert Morris, David M O’Malley, Thomas J Reid, Debra Richardson, Peter G Rose, Jennifer M Scalici, Dan-Arin Silasi, Krishnansu Tewari, Edward W Wang.
>Abstract.
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 Oncology. 2023;9(7):903-908. doi:10.1001/jamaoncol.2023.1007
Robert W. Holloway, Alberto A. Mendivil, James E. Kendrick, Lisa N. Abaid, John V. Brown, Jane LeBlanc, Nathalie D. McKenzie, Kristina M. Mori, Sarfraz Ahmad.
>Article.
Vaccinia (Smallpox) for the Treatment of Ovarian Cancer-Turning an Old Foe Into a Friend?
JAMA Oncology. 2023 Jul 1;9(7):894-896. doi: 10.1001/jamaoncol.2023.0983.
Erica S. Tsang, Pamela N. Munster.
>Editorial.
Correlative analysis from a phase I clinical trial of intrapleural administration of oncolytic vaccinia virus (Olvi-vec) in patients with malignant pleural mesothelioma
Frontiers in Immunology. 2023 Feb 16;14:1112960.
Navin K. Chintala, Jennie K. Choe, Erin McGee, Rebecca Bellis, Jasmeen K. Saini, Srijita Banerjee, Andre L. Moreira, Marjorie G. Zauderer, Prasad S. Adusumilli, Valerie W. Rusch.
>Abstract.
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]
International Journal of Gynecologic Cancer 2022;32:A236.
Robert Holloway, Premal Thaker, Alberto Mendivil, Sarfraz Ahmad, Maria Bell, Setsuko Chambers, John K Chan, Robert L Coleman, Sarah Crafton, Erin Crane, Ramez Eskander, Karen Finkelstein, Whitney S Graybill, Thomas Herzog, Veena John, Lisa Landrum, Aliza Leiser, Michael Mchale, Rachel Miller, Bradley Monk, Kathleen Moore, David O’Malley, Thomas Reid, Debra Richardson, Dan-Arin Silasi, Jan Sunde, Krishnansu Tewari.
>Poster.
Oncolytic viral therapy engenders a clinical response in a recurrent ovarian cancer patient
Anticancer Drugs. 2022 Jun 1;33(5):513-516.
John Micha, Mark Rettenmaier, Peter Giuliano, Randy Bohart, Bram Goldstein.
>Abstract.
A phase 1b study of intraperitoneal oncolytic viral immunotherapy in platinum-resistant or refractory ovarian cancer
Gynecologic Oncology 2021, Volume 163, Issue 3, P481-489.
Madhavi Manyam, Amanda J. Stephens, Jessica A. Kennard, Jane LeBlanc, Sarfraz Ahmad, James E. Kendrick, Robert W. Holloway
>Abstract.
Phase 2 Trial of Oncolytic Vaccinia Virus Primed Immunochemotherapy in Platinum-Resistant/Refractory Ovarian Cancer (PRROC) (NCT02759588)
European Society for Medical Oncology (ESMO) Virtual Congress 2020
Robert W. Holloway, Alberto A. Mendivil, James E. Kendrick, Lisa N. Abaid, John V. Brown, Christine K. Fitzsimmons, Jessica A. Kennard, Monica King, Jane LeBlanc, Katrina Lopez, Madhavi Manyam, Nathalie D. McKenzie, Kristina M. Mori, Amanda J. Stephens, Sarfraz Ahmad
>Poster.
Phase 2 Trial of Oncolytic Vaccinia Virus Primed Immunochemotherapy in Platinum-Resistant/Refractory Ovarian Cancer (PRROC) (NCT02759588)
Annals of Oncology (2020) 31 (suppl_4): S551-S589.
Robert W. Holloway, Alberto A. Mendivil, James E. Kendrick, Lisa N. Abaid, John V. Brown, Christine K. Fitzsimmons, Jessica A. Kennard, Monica King, Jane LeBlanc, Katrina Lopez, Madhavi Manyam, Nathalie D. McKenzie, Kristina M. Mori, Amanda J. Stephens, Sarfraz Ahmad
Oncolytic Vaccinia (Olvi-Vec) Primed Immunochemotherapy in Platinum-Resistant/Refractory Ovarian Cancer
Global Annual Meeting of the International Gynecologic Cancer Society (IGCS) 2020
Robert W. Holloway, Alberto A. Mendivil, James E. Kendrick, Lisa N. Abaid, John V. Brown, Christine K. Fitzsimmons, Jessica A. Kennard, Monica King, Jane LeBlanc, Katrina Lopez, Madhavi Manyam, Nathalie D. McKenzie, Kristina M. Mori, Amanda J. Stephens, Sarfraz Ahmad
>Watch Oral Plenary Presentation. (video)
Oncolytic Vaccinia (Olvi-Vec) Primed Immunochemotherapy in Platinum-Resistant/Refractory Ovarian Cancer
Global Annual Meeting of the International Gynecologic Cancer Society (IGCS) 2020
Robert W. Holloway, Alberto A. Mendivil, James E. Kendrick, Lisa N. Abaid, John V. Brown, Christine K. Fitzsimmons, Jessica A. Kennard, Monica King, Jane LeBlanc, Katrina Lopez, Madhavi Manyam, Nathalie D. McKenzie, Kristina M. Mori, Amanda J. Stephens, Sarfraz Ahmad
>Abstract 12. (page 23)
Phase 2 VIRO-15 Trial of OlvimulogeneNanivacirepvec (Olvi-Vec)-Primed Immunochemotherapy in Platinum-Resistant/Refractory Ovarian Cancer
Society Of Gynecologic Oncology 2020 Annual Meeting
Robert W. Holloway, Alberto A. Mendivil, James E. Kendrick, Lisa N. Abaid, John V. Brown, Christine K. Fitzsimmons, Jessica A. Kennard, Monica King, Jane LeBlanc, Katrina Lopez, Madhavi Manyam, Nathalie D. McKenzie, Kristina M. Mori, Jamie L. Smith, Amanda J. Stephens, Sarfraz Ahmad
Pronounced clinical response following the oncolytic vaccinia virus GL-ONC1 and chemotherapy in a heavily pretreated ovarian cancer patient
Anti-Cancer Drugs 2019, 30:1064–1066
Kristina M. Mori, Peter D. Giuliano, Katrina L. Lopez, Monica M. King, Randy Bohart and Bram H. Goldstein
Factors associated with extended survival for patients with platinum-resistant ovarian cancer treated with modified vaccinia oncolytic virotherapy
J Clin Oncol 37, 2019 (suppl; abstr e17070)
Madhavi Manyam, Amanda J. Stephens, Jessica A. Kennard, Christine K. Fitzsimmons, James Erasmus Kendrick, Nathalie Dauphin McKenzie, Jane LeBlanc, Jamie L. Smith, Sarfraz Ahmad, Robert W. Holloway
Phase I study of oncolytic vaccinia virus GL-ONC1 in patients with peritoneal carcinomatosis
Clin Cancer Res 2018 Sep 15;24(18):4388-4398.
Ulrich M. Lauer, Martina Schell, Julia Beil, Susanne Berchtold, Ursula Koppenhöfer, Jörg Glatzle, Alfred Königsrainer, Robert Möhle, Dominik Nann, Falko Fend, Christina Pfannenberg, Michael Bitzer, Nisar P. Malek
Phase 1b Study of Oncolytic Vaccinia Virus GL-ONC1 in recurrent ovarian cancer [Poster]
American Society of Clinical Oncology 2018 Annual Meeting
Robert W Holloway, James E Kendrick, Amanda J Stephens, Jessica A Kennard, Jeremy Burt, Jane LeBlanc, Karen Sellers, Jamie Smith, and Susan Coakley
Phase 1b study of oncolytic vaccinia virus GL-ONC1 in recurrent ovarian cancer
Journal of Clinical Oncology 36, no.15_suppl (May 20, 2018) 5577-5577
Robert W Holloway, James E Kendrick, Amanda J Stephens, Jessica A Kennard, Jeremy Burt, Jane LeBlanc, Karen Sellers, Jamie Smith, and Susan Coakley
Phase I Trial of Intravenous Oncolytic Vaccinia Virus (GL-ONC1) with Cisplatin and Radiotherapy in Patients with Locoregionally Advanced Head and Neck Carcinoma
Clin Cancer Res; 23(19) October 1, 2017
Loren K. Mell, Kevin T. Brumund, Gregory A. Daniels, Sunil J. Advani,Kaveh Zakeri, Mary E. Wright, Sara-Jane Onyeama, Robert A. Weisman,Parag R. Sanghvi, Peter J. Martin, and Aladar A. Szalay
Phase I Trial of Intravenously Delivered Attenuated Vaccinia Virus (GL-ONC1) with Chemoradiotherapy for Locoregionally Advanced Head/Neck Cancer [Poster]
American Society Of Clinical Oncology 2015 Annual Meeting
Loren K. Mell, Tony Yu, Kevin T. Brumund, Gregory A. Daniels, Sunil J. Advani, Parag Sanghvi, Mary E Wright, Sara-Jane Onyeama, Anu Põld, Terry Chamberlin, Peter Martin, Robert Weisman, Aladar A. Szalay
Phase I study of intra-pleural administration of GL-ONC1, an oncolytic vaccinia virus, in patients with malignant pleural effusion [Poster]
American Society Of Clinical Oncology 2015 Annual Meeting
L.M. Krug, M.G. Zauderer, P. Adusumilli, E. McGee, K. Sepkowitz, M. Klang, Y.A. Yu, P. Scigalla, V.A. Rusch
Phase I trial of intravenous attenuated vaccinia virus (GL-ONC1) with concurrent chemoradiotherapy (CRT) for locoregionally advanced head and neck carcinoma
Journal of Clinical Oncology 33, no.15_suppl (May 20, 2015) 6026-6026
Loren K. Mell , Yong A. Yu , Kevin T. Brumund , Gregory A. Daniels , Sunil J. Advani , Robert A. WeismanParag R. Sanghvi , Peter J. Martin , Mary E. Wright , Sara-Jane Onyeama , Qian Zhang , Anu Pold , Terry Chamberlin , Alexa Frentzen , Aladar A Szalay
Phase I study of intra-pleural administration of GL-ONC1, an oncolytic vaccinia virus, in patients with malignant pleural effusion
Journal of Clinical Oncology 33, no.15_suppl (May 20, 2015) 7559-7559
Lee M. Krug , Marjorie Glass Zauderer , Prasad S. Adusumili , Erin McGee , Kent Sepkowitz , Mark KlangYong A. Yu , Paul Scigalla , Valerie W. Rusch
Phase I Trial of Intravenously Delivered Attenuated Vaccinia (GL-ONC1) with Chemoradiotherapy for Locoregionally Advanced Head/Neck Cancer [Poster]
American Society Of Clinical Oncology 2014 Annual Meeting
Loren K. Mell, Tony Yu, Kevin T. Brumund, Gregory A. Daniels, Sunil J. Advani, Parag Sanghvi, Sara-Jane Onyeama, Peter Martin, Robert Weisman, AladarA. Szalay
Phase 1 Trial of Attenuated Vaccinia Virus (GL-ONC1) Delivered Intravenously With Concurrent Cisplatin and Radiation Therapy in Patients With Locoregionally Advanced Head-and-Neck Carcinoma Definitive Management of Head-and-Neck Squamous Cell Carcinoma
International Journal of Radiation Oncology 88(2)2014:477-8
L.K. Mell, Y.A. Yu, K.T. Brumund, S.J. Advani, S. Onyeama, G.A. Daniels, R.A. Weisman, P. Martin, A.A. Szalay
Results on the First Study on Intraperitoneal Virotherapy Employing a Recombinant Vaccinia Virus Genetically Engineered to Selectively Replicate in and Destroy Cancer Cells
Zeitschrift für Gastroenterologie 52(08) August 2014
UM Lauer, J Beil, S Berchtold, M Zimmermann, U Koppenhöfer, M Bitzer, NP Malek, J Glatzle, A Königsrainer, R Möhle, F Fend, C Pfannenberg, T Auth, T Yu, AA Szalay
Tracking of tumor cell colonization, in-patient replication, and oncolysis by GL-ONC1 employed in a phase I/II virotherapy study on patients with peritoneal carcinomatosis [Poster]
Oncolytic Virus Conference Oxford 2014
Ulrich M Lauer, Julia Beil, Susanne Berchtold, Martina Zimmermann, Ursula Koppenhoefer, Michael Bitzer, Nisar P Malek, Joerg Glatzle, Alfred Koenigsrainer, Robert Moehle, Falko Fend, Christina Pfannenberg, Tanja Auth, Tony Yu, Aladar A Szalay
Tracking of tumor cell colonization, in-patient replication, and oncolysis by GL-ONC1 employed in a phase I/II virotherapy study on patients with peritoneal carcinomatosis
Oncolytic Virus Conference Oxford 2014
Ulrich M Lauer, Julia Beil, Susanne Berchtold, Martina Zimmermann, Ursula Koppenhoefer, Michael Bitzer, Nisar P Malek, Joerg Glatzle, Alfred Koenigsrainer, Robert Moehle, Falko Fend, Christina Pfannenberg, Tanja Auth, Tony Yu, Aladar A Szalay
Validation of Biomarkers of Intravenously Administered Oncolytic Vaccinia Virus in a Phase I Trial [Poster]
Oncolytic Virus Conference Quebec 2013
Mansfield D, Yu T, Chen N, Stritzker J, Szalay AA, Harrington KJ
Phase I/II clinical trial of a genetically modified and oncolytic vaccinia virus GL-ONC1 in patients with unresactable, chemotherapy-resistant peritoneal carcinomatosis
Journal of Clinical Oncology 31(15_suppl):3098-3098 May 2013
Ulrich Lauer, Martina Zimmermann, Julia Sturm, Ursula Koppenhoefer, Michael Bitzer, Nisar P Malek, JoergGlatzle, Alfred Koenigsrainer, Robert Moehle, Falko Fend, Christina Pfannenberg, Tanja Auth, Tony Yu, Aladar A Szalay
Phase I/II clinical trial of a genetically modified and oncolytic vaccinia virus GL-ONC1 in patients with unresactable, chemotherapy-resistant peritoneal carcinomatosis [Poster]
American Society of Clinical Oncology 2013 Annual Meeting
Ulrich Lauer, Martina Zimmermann, Julia Sturm, Ursula Koppenhoefer, Michael Bitzer, Nisar P Malek, JoergGlatzle, Alfred Koenigsrainer, Robert Moehle, Falko Fend, Christina Pfannenberg, Tanja Auth, Tony Yu, Aladar A Szalay
Phase I Clinical Trial of a Genetically Modified and Oncolytic Vaccinia Virus GL-ONC1 with Green Fluorescent Protein Imaging
American Society Of Clinical Oncology 2013 Annual Meeting
H. Khan, A. Young, J. Mateo, N. Tunariu, T. A. Yap, D.Tan, D. Mansfield, M. Wong, R. Riisnaes, K. J. Harrington, H.Pandha, J. S. deBono
Phase I Clinical Trial of a Genetically Modified and Oncolytic Vaccinia Virus GL-ONC1 with Green Fluorescent Protein Imaging
Journal of Clinical Oncology 30, no. 15_suppl (May, 2012):2530-2530
A Phase I clinical trial of a genetically modified and imageable oncolytic vaccinia virus GL-ONC1 with clinical green fluorescent protein (GFP) imaging [Poster]
American Society Of Clinical Oncology 2011 Annual Meeting
Joanna Vitfell-Pedersen, Elena Karapanagiotou, Andrea Biondo, Martina Puglisi, Katie Denholm, Nina Tunariu, Salem Sassi, David Mansfield, Timothy Yap, Johann De-Bono and Kevin Harrington
Phase I Clinical Trial of a Genetically Modified and Oncolytic Vaccinia Virus GL-ONC1 with Green Fluorescent Protein Imaging
Journal of Clinical Oncology 29, no.15_suppl (May 20, 2011) 2577-2577
J. V. Pedersen , E. M. Karapanagiotou , A. Biondo , N. Tunariu , M. Puglisi , K. A. DenholmS. Sassi , D. Mansfield , T. A. Yap , J. S. De Bono , K. J. Harrington
Phase I Clinical Trial of a Genetically Modified and Oncolytic Vaccinia Virus GL-ONC1 with Green Fluorescent Protein Imaging
2011 NCRI Conference
Corral, A. Biondo, J. V. Pedersen, S. Alam, E. M. Karapanagiotou, N. Tunariu, K. Shah, N. Simoes, D. Goswani, E.D. Mansfield, S. Sassi, T. A. Yap, J. S. de Bono, K. J. Harrington
Preliminary results of a Phase 1 study of intravenous administration of GL-ONC1 Vaccinia virus in patients with advanced solid cancer with real time imaging. [Poster]
European Society of Medical Oncology 2010
Joanna Vitfell Pedersen, Elena Karapanagiotou, Salma Alam, Martina Puglisi, Lauren Britton, Salem Sassi, David Mansfield, Timothy Yap, Johann De-Bono and Kevin Harrington
Preliminary results of a Phase 1 study of intravenous administration of GL-ONC1 Vaccinia virus in patients with advanced solid cancer with real time imaging. [Poster]
European Organisation for Research and Treatment of Cancer 2011
Joanna Vitfell Pedersen, Elena Karapanagiotou, Salma Alam, Martina Puglisi, Lauren Britton, Salem Sassi, David Mansfield, Timothy Yap, Johann De-Bono and Kevin Harrington