PMID- 26014293 OWN - NLM STAT- MEDLINE DCOM- 20160429 LR - 20240104 IS - 1527-7755 (Electronic) IS - 0732-183X (Linking) VI - 33 IP - 25 DP - 2015 Sep 1 TI - Talimogene Laherparepvec Improves Durable Response Rate in Patients With Advanced Melanoma. PG - 2780-8 LID - 10.1200/JCO.2014.58.3377 [doi] AB - PURPOSE: Talimogene laherparepvec (T-VEC) is a herpes simplex virus type 1-derived oncolytic immunotherapy designed to selectively replicate within tumors and produce granulocyte macrophage colony-stimulating factor (GM-CSF) to enhance systemic antitumor immune responses. T-VEC was compared with GM-CSF in patients with unresected stage IIIB to IV melanoma in a randomized open-label phase III trial. PATIENTS AND METHODS: Patients with injectable melanoma that was not surgically resectable were randomly assigned at a two-to-one ratio to intralesional T-VEC or subcutaneous GM-CSF. The primary end point was durable response rate (DRR; objective response lasting continuously >/= 6 months) per independent assessment. Key secondary end points included overall survival (OS) and overall response rate. RESULTS: Among 436 patients randomly assigned, DRR was significantly higher with T-VEC (16.3%; 95% CI, 12.1% to 20.5%) than GM-CSF (2.1%; 95% CI, 0% to 4.5%]; odds ratio, 8.9; P < .001). Overall response rate was also higher in the T-VEC arm (26.4%; 95% CI, 21.4% to 31.5% v 5.7%; 95% CI, 1.9% to 9.5%). Median OS was 23.3 months (95% CI, 19.5 to 29.6 months) with T-VEC and 18.9 months (95% CI, 16.0 to 23.7 months) with GM-CSF (hazard ratio, 0.79; 95% CI, 0.62 to 1.00; P = .051). T-VEC efficacy was most pronounced in patients with stage IIIB, IIIC, or IVM1a disease and in patients with treatment-naive disease. The most common adverse events (AEs) with T-VEC were fatigue, chills, and pyrexia. The only grade 3 or 4 AE occurring in >/= 2% of T-VEC-treated patients was cellulitis (2.1%). No fatal treatment-related AEs occurred. CONCLUSION: T-VEC is the first oncolytic immunotherapy to demonstrate therapeutic benefit against melanoma in a phase III clinical trial. T-VEC was well tolerated and resulted in a higher DRR (P < .001) and longer median OS (P = .051), particularly in untreated patients or those with stage IIIB, IIIC, or IVM1a disease. T-VEC represents a novel potential therapy for patients with metastatic melanoma. CI - (c) 2015 by American Society of Clinical Oncology. FAU - Andtbacka, Robert H I AU - Andtbacka RH AD - Robert H.I. Andtbacka, Huntsman Cancer Institute, University of Utah, Salt Lake City, UT; Howard L. Kaufman, Rutgers Cancer Institute of New Jersey, New Brunswick, NJ; Frances Collichio, University of North Carolina Medical Center, Chapel Hill, NC; Thomas Amatruda, Minnesota Oncology, Fridley, MN; Neil Senzer, Mary Crowley Cancer Research Center, Dallas; Merrick Ross, University of Texas MD Anderson Cancer Center, Houston, TX; Jason Chesney, University of Louisville, Louisville, KY; Keith A. Delman, Winship Cancer Institute, Emory University School of Medicine, Atlanta, GA; Lynn E. Spitler, Northern California Melanoma Center, San Francisco; Gregory A. Daniels, University of California San Diego Medical Center, Moores Cancer Center, La Jolla; Yining Ye, Bin Yao, Ai Li, Ari Vander Walde, and Jennifer Gansert, Amgen, Thousand Oaks, CA; Igor Puzanov, Vanderbilt University, Nashville, TN; Sanjiv S. Agarwala, St Luke's University Hospital and Health Network, Bethlehem, and Temple University School of Medicine, Philadelphia, PA; Mohammed Milhem, University of Iowa Hospitals and Clinics, Iowa City, IA; Lee Cranmer, University of Arizona, Tucson, AZ; Brendan Curti, Earle A. Chiles Research Institute, Portland, OR; Karl Lewis, University of Colorado Cancer Center, Aurora, CO; Troy Guthrie, Baptist Cancer Institute, Jacksonville; Jonathan S. Zager, Moffitt Cancer Center, Tampa, FL; Gerald P. Linette, Washington University School of Medicine, St Louis, MO; Kevin Harrington, Institute of Cancer Research, Royal Marsden Hospital, London; Mark R. Middleton, National Institute for Health Research Biomedical Research Centre, Oxford, United Kingdom; Wilson H. Miller Jr, McGill University, Montreal, Quebec, Canada; and Susan Doleman and Robert S. Coffin, Amgen, Woburn, MA. FAU - Kaufman, Howard L AU - Kaufman HL AD - Robert H.I. Andtbacka, Huntsman Cancer Institute, University of Utah, Salt Lake City, UT; Howard L. Kaufman, Rutgers Cancer Institute of New Jersey, New Brunswick, NJ; Frances Collichio, University of North Carolina Medical Center, Chapel Hill, NC; Thomas Amatruda, Minnesota Oncology, Fridley, MN; Neil Senzer, Mary Crowley Cancer Research Center, Dallas; Merrick Ross, University of Texas MD Anderson Cancer Center, Houston, TX; Jason Chesney, University of Louisville, Louisville, KY; Keith A. Delman, Winship Cancer Institute, Emory University School of Medicine, Atlanta, GA; Lynn E. Spitler, Northern California Melanoma Center, San Francisco; Gregory A. Daniels, University of California San Diego Medical Center, Moores Cancer Center, La Jolla; Yining Ye, Bin Yao, Ai Li, Ari Vander Walde, and Jennifer Gansert, Amgen, Thousand Oaks, CA; Igor Puzanov, Vanderbilt University, Nashville, TN; Sanjiv S. Agarwala, St Luke's University Hospital and Health Network, Bethlehem, and Temple University School of Medicine, Philadelphia, PA; Mohammed Milhem, University of Iowa Hospitals and Clinics, Iowa City, IA; Lee Cranmer, University of Arizona, Tucson, AZ; Brendan Curti, Earle A. Chiles Research Institute, Portland, OR; Karl Lewis, University of Colorado Cancer Center, Aurora, CO; Troy Guthrie, Baptist Cancer Institute, Jacksonville; Jonathan S. Zager, Moffitt Cancer Center, Tampa, FL; Gerald P. Linette, Washington University School of Medicine, St Louis, MO; Kevin Harrington, Institute of Cancer Research, Royal Marsden Hospital, London; Mark R. Middleton, National Institute for Health Research Biomedical Research Centre, Oxford, United Kingdom; Wilson H. Miller Jr, McGill University, Montreal, Quebec, Canada; and Susan Doleman and Robert S. Coffin, Amgen, Woburn, MA. howard.kaufman@rutgers.edu. FAU - Collichio, Frances AU - Collichio F AD - Robert H.I. Andtbacka, Huntsman Cancer Institute, University of Utah, Salt Lake City, UT; Howard L. Kaufman, Rutgers Cancer Institute of New Jersey, New Brunswick, NJ; Frances Collichio, University of North Carolina Medical Center, Chapel Hill, NC; Thomas Amatruda, Minnesota Oncology, Fridley, MN; Neil Senzer, Mary Crowley Cancer Research Center, Dallas; Merrick Ross, University of Texas MD Anderson Cancer Center, Houston, TX; Jason Chesney, University of Louisville, Louisville, KY; Keith A. Delman, Winship Cancer Institute, Emory University School of Medicine, Atlanta, GA; Lynn E. Spitler, Northern California Melanoma Center, San Francisco; Gregory A. Daniels, University of California San Diego Medical Center, Moores Cancer Center, La Jolla; Yining Ye, Bin Yao, Ai Li, Ari Vander Walde, and Jennifer Gansert, Amgen, Thousand Oaks, CA; Igor Puzanov, Vanderbilt University, Nashville, TN; Sanjiv S. Agarwala, St Luke's University Hospital and Health Network, Bethlehem, and Temple University School of Medicine, Philadelphia, PA; Mohammed Milhem, University of Iowa Hospitals and Clinics, Iowa City, IA; Lee Cranmer, University of Arizona, Tucson, AZ; Brendan Curti, Earle A. Chiles Research Institute, Portland, OR; Karl Lewis, University of Colorado Cancer Center, Aurora, CO; Troy Guthrie, Baptist Cancer Institute, Jacksonville; Jonathan S. Zager, Moffitt Cancer Center, Tampa, FL; Gerald P. Linette, Washington University School of Medicine, St Louis, MO; Kevin Harrington, Institute of Cancer Research, Royal Marsden Hospital, London; Mark R. Middleton, National Institute for Health Research Biomedical Research Centre, Oxford, United Kingdom; Wilson H. Miller Jr, McGill University, Montreal, Quebec, Canada; and Susan Doleman and Robert S. Coffin, Amgen, Woburn, MA. FAU - Amatruda, Thomas AU - Amatruda T AD - Robert H.I. Andtbacka, Huntsman Cancer Institute, University of Utah, Salt Lake City, UT; Howard L. Kaufman, Rutgers Cancer Institute of New Jersey, New Brunswick, NJ; Frances Collichio, University of North Carolina Medical Center, Chapel Hill, NC; Thomas Amatruda, Minnesota Oncology, Fridley, MN; Neil Senzer, Mary Crowley Cancer Research Center, Dallas; Merrick Ross, University of Texas MD Anderson Cancer Center, Houston, TX; Jason Chesney, University of Louisville, Louisville, KY; Keith A. Delman, Winship Cancer Institute, Emory University School of Medicine, Atlanta, GA; Lynn E. Spitler, Northern California Melanoma Center, San Francisco; Gregory A. Daniels, University of California San Diego Medical Center, Moores Cancer Center, La Jolla; Yining Ye, Bin Yao, Ai Li, Ari Vander Walde, and Jennifer Gansert, Amgen, Thousand Oaks, CA; Igor Puzanov, Vanderbilt University, Nashville, TN; Sanjiv S. Agarwala, St Luke's University Hospital and Health Network, Bethlehem, and Temple University School of Medicine, Philadelphia, PA; Mohammed Milhem, University of Iowa Hospitals and Clinics, Iowa City, IA; Lee Cranmer, University of Arizona, Tucson, AZ; Brendan Curti, Earle A. Chiles Research Institute, Portland, OR; Karl Lewis, University of Colorado Cancer Center, Aurora, CO; Troy Guthrie, Baptist Cancer Institute, Jacksonville; Jonathan S. Zager, Moffitt Cancer Center, Tampa, FL; Gerald P. Linette, Washington University School of Medicine, St Louis, MO; Kevin Harrington, Institute of Cancer Research, Royal Marsden Hospital, London; Mark R. Middleton, National Institute for Health Research Biomedical Research Centre, Oxford, United Kingdom; Wilson H. Miller Jr, McGill University, Montreal, Quebec, Canada; and Susan Doleman and Robert S. Coffin, Amgen, Woburn, MA. FAU - Senzer, Neil AU - Senzer N AD - Robert H.I. Andtbacka, Huntsman Cancer Institute, University of Utah, Salt Lake City, UT; Howard L. Kaufman, Rutgers Cancer Institute of New Jersey, New Brunswick, NJ; Frances Collichio, University of North Carolina Medical Center, Chapel Hill, NC; Thomas Amatruda, Minnesota Oncology, Fridley, MN; Neil Senzer, Mary Crowley Cancer Research Center, Dallas; Merrick Ross, University of Texas MD Anderson Cancer Center, Houston, TX; Jason Chesney, University of Louisville, Louisville, KY; Keith A. Delman, Winship Cancer Institute, Emory University School of Medicine, Atlanta, GA; Lynn E. Spitler, Northern California Melanoma Center, San Francisco; Gregory A. Daniels, University of California San Diego Medical Center, Moores Cancer Center, La Jolla; Yining Ye, Bin Yao, Ai Li, Ari Vander Walde, and Jennifer Gansert, Amgen, Thousand Oaks, CA; Igor Puzanov, Vanderbilt University, Nashville, TN; Sanjiv S. Agarwala, St Luke's University Hospital and Health Network, Bethlehem, and Temple University School of Medicine, Philadelphia, PA; Mohammed Milhem, University of Iowa Hospitals and Clinics, Iowa City, IA; Lee Cranmer, University of Arizona, Tucson, AZ; Brendan Curti, Earle A. Chiles Research Institute, Portland, OR; Karl Lewis, University of Colorado Cancer Center, Aurora, CO; Troy Guthrie, Baptist Cancer Institute, Jacksonville; Jonathan S. Zager, Moffitt Cancer Center, Tampa, FL; Gerald P. Linette, Washington University School of Medicine, St Louis, MO; Kevin Harrington, Institute of Cancer Research, Royal Marsden Hospital, London; Mark R. Middleton, National Institute for Health Research Biomedical Research Centre, Oxford, United Kingdom; Wilson H. Miller Jr, McGill University, Montreal, Quebec, Canada; and Susan Doleman and Robert S. Coffin, Amgen, Woburn, MA. FAU - Chesney, Jason AU - Chesney J AD - Robert H.I. Andtbacka, Huntsman Cancer Institute, University of Utah, Salt Lake City, UT; Howard L. Kaufman, Rutgers Cancer Institute of New Jersey, New Brunswick, NJ; Frances Collichio, University of North Carolina Medical Center, Chapel Hill, NC; Thomas Amatruda, Minnesota Oncology, Fridley, MN; Neil Senzer, Mary Crowley Cancer Research Center, Dallas; Merrick Ross, University of Texas MD Anderson Cancer Center, Houston, TX; Jason Chesney, University of Louisville, Louisville, KY; Keith A. Delman, Winship Cancer Institute, Emory University School of Medicine, Atlanta, GA; Lynn E. Spitler, Northern California Melanoma Center, San Francisco; Gregory A. Daniels, University of California San Diego Medical Center, Moores Cancer Center, La Jolla; Yining Ye, Bin Yao, Ai Li, Ari Vander Walde, and Jennifer Gansert, Amgen, Thousand Oaks, CA; Igor Puzanov, Vanderbilt University, Nashville, TN; Sanjiv S. Agarwala, St Luke's University Hospital and Health Network, Bethlehem, and Temple University School of Medicine, Philadelphia, PA; Mohammed Milhem, University of Iowa Hospitals and Clinics, Iowa City, IA; Lee Cranmer, University of Arizona, Tucson, AZ; Brendan Curti, Earle A. Chiles Research Institute, Portland, OR; Karl Lewis, University of Colorado Cancer Center, Aurora, CO; Troy Guthrie, Baptist Cancer Institute, Jacksonville; Jonathan S. Zager, Moffitt Cancer Center, Tampa, FL; Gerald P. Linette, Washington University School of Medicine, St Louis, MO; Kevin Harrington, Institute of Cancer Research, Royal Marsden Hospital, London; Mark R. Middleton, National Institute for Health Research Biomedical Research Centre, Oxford, United Kingdom; Wilson H. Miller Jr, McGill University, Montreal, Quebec, Canada; and Susan Doleman and Robert S. Coffin, Amgen, Woburn, MA. FAU - Delman, Keith A AU - Delman KA AD - Robert H.I. Andtbacka, Huntsman Cancer Institute, University of Utah, Salt Lake City, UT; Howard L. Kaufman, Rutgers Cancer Institute of New Jersey, New Brunswick, NJ; Frances Collichio, University of North Carolina Medical Center, Chapel Hill, NC; Thomas Amatruda, Minnesota Oncology, Fridley, MN; Neil Senzer, Mary Crowley Cancer Research Center, Dallas; Merrick Ross, University of Texas MD Anderson Cancer Center, Houston, TX; Jason Chesney, University of Louisville, Louisville, KY; Keith A. Delman, Winship Cancer Institute, Emory University School of Medicine, Atlanta, GA; Lynn E. Spitler, Northern California Melanoma Center, San Francisco; Gregory A. Daniels, University of California San Diego Medical Center, Moores Cancer Center, La Jolla; Yining Ye, Bin Yao, Ai Li, Ari Vander Walde, and Jennifer Gansert, Amgen, Thousand Oaks, CA; Igor Puzanov, Vanderbilt University, Nashville, TN; Sanjiv S. Agarwala, St Luke's University Hospital and Health Network, Bethlehem, and Temple University School of Medicine, Philadelphia, PA; Mohammed Milhem, University of Iowa Hospitals and Clinics, Iowa City, IA; Lee Cranmer, University of Arizona, Tucson, AZ; Brendan Curti, Earle A. Chiles Research Institute, Portland, OR; Karl Lewis, University of Colorado Cancer Center, Aurora, CO; Troy Guthrie, Baptist Cancer Institute, Jacksonville; Jonathan S. Zager, Moffitt Cancer Center, Tampa, FL; Gerald P. Linette, Washington University School of Medicine, St Louis, MO; Kevin Harrington, Institute of Cancer Research, Royal Marsden Hospital, London; Mark R. Middleton, National Institute for Health Research Biomedical Research Centre, Oxford, United Kingdom; Wilson H. Miller Jr, McGill University, Montreal, Quebec, Canada; and Susan Doleman and Robert S. Coffin, Amgen, Woburn, MA. FAU - Spitler, Lynn E AU - Spitler LE AD - Robert H.I. Andtbacka, Huntsman Cancer Institute, University of Utah, Salt Lake City, UT; Howard L. Kaufman, Rutgers Cancer Institute of New Jersey, New Brunswick, NJ; Frances Collichio, University of North Carolina Medical Center, Chapel Hill, NC; Thomas Amatruda, Minnesota Oncology, Fridley, MN; Neil Senzer, Mary Crowley Cancer Research Center, Dallas; Merrick Ross, University of Texas MD Anderson Cancer Center, Houston, TX; Jason Chesney, University of Louisville, Louisville, KY; Keith A. Delman, Winship Cancer Institute, Emory University School of Medicine, Atlanta, GA; Lynn E. Spitler, Northern California Melanoma Center, San Francisco; Gregory A. Daniels, University of California San Diego Medical Center, Moores Cancer Center, La Jolla; Yining Ye, Bin Yao, Ai Li, Ari Vander Walde, and Jennifer Gansert, Amgen, Thousand Oaks, CA; Igor Puzanov, Vanderbilt University, Nashville, TN; Sanjiv S. Agarwala, St Luke's University Hospital and Health Network, Bethlehem, and Temple University School of Medicine, Philadelphia, PA; Mohammed Milhem, University of Iowa Hospitals and Clinics, Iowa City, IA; Lee Cranmer, University of Arizona, Tucson, AZ; Brendan Curti, Earle A. Chiles Research Institute, Portland, OR; Karl Lewis, University of Colorado Cancer Center, Aurora, CO; Troy Guthrie, Baptist Cancer Institute, Jacksonville; Jonathan S. Zager, Moffitt Cancer Center, Tampa, FL; Gerald P. Linette, Washington University School of Medicine, St Louis, MO; Kevin Harrington, Institute of Cancer Research, Royal Marsden Hospital, London; Mark R. Middleton, National Institute for Health Research Biomedical Research Centre, Oxford, United Kingdom; Wilson H. Miller Jr, McGill University, Montreal, Quebec, Canada; and Susan Doleman and Robert S. Coffin, Amgen, Woburn, MA. FAU - Puzanov, Igor AU - Puzanov I AD - Robert H.I. Andtbacka, Huntsman Cancer Institute, University of Utah, Salt Lake City, UT; Howard L. Kaufman, Rutgers Cancer Institute of New Jersey, New Brunswick, NJ; Frances Collichio, University of North Carolina Medical Center, Chapel Hill, NC; Thomas Amatruda, Minnesota Oncology, Fridley, MN; Neil Senzer, Mary Crowley Cancer Research Center, Dallas; Merrick Ross, University of Texas MD Anderson Cancer Center, Houston, TX; Jason Chesney, University of Louisville, Louisville, KY; Keith A. Delman, Winship Cancer Institute, Emory University School of Medicine, Atlanta, GA; Lynn E. Spitler, Northern California Melanoma Center, San Francisco; Gregory A. Daniels, University of California San Diego Medical Center, Moores Cancer Center, La Jolla; Yining Ye, Bin Yao, Ai Li, Ari Vander Walde, and Jennifer Gansert, Amgen, Thousand Oaks, CA; Igor Puzanov, Vanderbilt University, Nashville, TN; Sanjiv S. Agarwala, St Luke's University Hospital and Health Network, Bethlehem, and Temple University School of Medicine, Philadelphia, PA; Mohammed Milhem, University of Iowa Hospitals and Clinics, Iowa City, IA; Lee Cranmer, University of Arizona, Tucson, AZ; Brendan Curti, Earle A. Chiles Research Institute, Portland, OR; Karl Lewis, University of Colorado Cancer Center, Aurora, CO; Troy Guthrie, Baptist Cancer Institute, Jacksonville; Jonathan S. Zager, Moffitt Cancer Center, Tampa, FL; Gerald P. Linette, Washington University School of Medicine, St Louis, MO; Kevin Harrington, Institute of Cancer Research, Royal Marsden Hospital, London; Mark R. Middleton, National Institute for Health Research Biomedical Research Centre, Oxford, United Kingdom; Wilson H. Miller Jr, McGill University, Montreal, Quebec, Canada; and Susan Doleman and Robert S. Coffin, Amgen, Woburn, MA. FAU - Agarwala, Sanjiv S AU - Agarwala SS AD - Robert H.I. Andtbacka, Huntsman Cancer Institute, University of Utah, Salt Lake City, UT; Howard L. Kaufman, Rutgers Cancer Institute of New Jersey, New Brunswick, NJ; Frances Collichio, University of North Carolina Medical Center, Chapel Hill, NC; Thomas Amatruda, Minnesota Oncology, Fridley, MN; Neil Senzer, Mary Crowley Cancer Research Center, Dallas; Merrick Ross, University of Texas MD Anderson Cancer Center, Houston, TX; Jason Chesney, University of Louisville, Louisville, KY; Keith A. Delman, Winship Cancer Institute, Emory University School of Medicine, Atlanta, GA; Lynn E. Spitler, Northern California Melanoma Center, San Francisco; Gregory A. Daniels, University of California San Diego Medical Center, Moores Cancer Center, La Jolla; Yining Ye, Bin Yao, Ai Li, Ari Vander Walde, and Jennifer Gansert, Amgen, Thousand Oaks, CA; Igor Puzanov, Vanderbilt University, Nashville, TN; Sanjiv S. Agarwala, St Luke's University Hospital and Health Network, Bethlehem, and Temple University School of Medicine, Philadelphia, PA; Mohammed Milhem, University of Iowa Hospitals and Clinics, Iowa City, IA; Lee Cranmer, University of Arizona, Tucson, AZ; Brendan Curti, Earle A. Chiles Research Institute, Portland, OR; Karl Lewis, University of Colorado Cancer Center, Aurora, CO; Troy Guthrie, Baptist Cancer Institute, Jacksonville; Jonathan S. Zager, Moffitt Cancer Center, Tampa, FL; Gerald P. Linette, Washington University School of Medicine, St Louis, MO; Kevin Harrington, Institute of Cancer Research, Royal Marsden Hospital, London; Mark R. Middleton, National Institute for Health Research Biomedical Research Centre, Oxford, United Kingdom; Wilson H. Miller Jr, McGill University, Montreal, Quebec, Canada; and Susan Doleman and Robert S. Coffin, Amgen, Woburn, MA. FAU - Milhem, Mohammed AU - Milhem M AD - Robert H.I. Andtbacka, Huntsman Cancer Institute, University of Utah, Salt Lake City, UT; Howard L. Kaufman, Rutgers Cancer Institute of New Jersey, New Brunswick, NJ; Frances Collichio, University of North Carolina Medical Center, Chapel Hill, NC; Thomas Amatruda, Minnesota Oncology, Fridley, MN; Neil Senzer, Mary Crowley Cancer Research Center, Dallas; Merrick Ross, University of Texas MD Anderson Cancer Center, Houston, TX; Jason Chesney, University of Louisville, Louisville, KY; Keith A. Delman, Winship Cancer Institute, Emory University School of Medicine, Atlanta, GA; Lynn E. Spitler, Northern California Melanoma Center, San Francisco; Gregory A. Daniels, University of California San Diego Medical Center, Moores Cancer Center, La Jolla; Yining Ye, Bin Yao, Ai Li, Ari Vander Walde, and Jennifer Gansert, Amgen, Thousand Oaks, CA; Igor Puzanov, Vanderbilt University, Nashville, TN; Sanjiv S. Agarwala, St Luke's University Hospital and Health Network, Bethlehem, and Temple University School of Medicine, Philadelphia, PA; Mohammed Milhem, University of Iowa Hospitals and Clinics, Iowa City, IA; Lee Cranmer, University of Arizona, Tucson, AZ; Brendan Curti, Earle A. Chiles Research Institute, Portland, OR; Karl Lewis, University of Colorado Cancer Center, Aurora, CO; Troy Guthrie, Baptist Cancer Institute, Jacksonville; Jonathan S. Zager, Moffitt Cancer Center, Tampa, FL; Gerald P. Linette, Washington University School of Medicine, St Louis, MO; Kevin Harrington, Institute of Cancer Research, Royal Marsden Hospital, London; Mark R. Middleton, National Institute for Health Research Biomedical Research Centre, Oxford, United Kingdom; Wilson H. Miller Jr, McGill University, Montreal, Quebec, Canada; and Susan Doleman and Robert S. Coffin, Amgen, Woburn, MA. FAU - Cranmer, Lee AU - Cranmer L AD - Robert H.I. Andtbacka, Huntsman Cancer Institute, University of Utah, Salt Lake City, UT; Howard L. Kaufman, Rutgers Cancer Institute of New Jersey, New Brunswick, NJ; Frances Collichio, University of North Carolina Medical Center, Chapel Hill, NC; Thomas Amatruda, Minnesota Oncology, Fridley, MN; Neil Senzer, Mary Crowley Cancer Research Center, Dallas; Merrick Ross, University of Texas MD Anderson Cancer Center, Houston, TX; Jason Chesney, University of Louisville, Louisville, KY; Keith A. Delman, Winship Cancer Institute, Emory University School of Medicine, Atlanta, GA; Lynn E. Spitler, Northern California Melanoma Center, San Francisco; Gregory A. Daniels, University of California San Diego Medical Center, Moores Cancer Center, La Jolla; Yining Ye, Bin Yao, Ai Li, Ari Vander Walde, and Jennifer Gansert, Amgen, Thousand Oaks, CA; Igor Puzanov, Vanderbilt University, Nashville, TN; Sanjiv S. Agarwala, St Luke's University Hospital and Health Network, Bethlehem, and Temple University School of Medicine, Philadelphia, PA; Mohammed Milhem, University of Iowa Hospitals and Clinics, Iowa City, IA; Lee Cranmer, University of Arizona, Tucson, AZ; Brendan Curti, Earle A. Chiles Research Institute, Portland, OR; Karl Lewis, University of Colorado Cancer Center, Aurora, CO; Troy Guthrie, Baptist Cancer Institute, Jacksonville; Jonathan S. Zager, Moffitt Cancer Center, Tampa, FL; Gerald P. Linette, Washington University School of Medicine, St Louis, MO; Kevin Harrington, Institute of Cancer Research, Royal Marsden Hospital, London; Mark R. Middleton, National Institute for Health Research Biomedical Research Centre, Oxford, United Kingdom; Wilson H. Miller Jr, McGill University, Montreal, Quebec, Canada; and Susan Doleman and Robert S. Coffin, Amgen, Woburn, MA. FAU - Curti, Brendan AU - Curti B AD - Robert H.I. Andtbacka, Huntsman Cancer Institute, University of Utah, Salt Lake City, UT; Howard L. Kaufman, Rutgers Cancer Institute of New Jersey, New Brunswick, NJ; Frances Collichio, University of North Carolina Medical Center, Chapel Hill, NC; Thomas Amatruda, Minnesota Oncology, Fridley, MN; Neil Senzer, Mary Crowley Cancer Research Center, Dallas; Merrick Ross, University of Texas MD Anderson Cancer Center, Houston, TX; Jason Chesney, University of Louisville, Louisville, KY; Keith A. Delman, Winship Cancer Institute, Emory University School of Medicine, Atlanta, GA; Lynn E. Spitler, Northern California Melanoma Center, San Francisco; Gregory A. Daniels, University of California San Diego Medical Center, Moores Cancer Center, La Jolla; Yining Ye, Bin Yao, Ai Li, Ari Vander Walde, and Jennifer Gansert, Amgen, Thousand Oaks, CA; Igor Puzanov, Vanderbilt University, Nashville, TN; Sanjiv S. Agarwala, St Luke's University Hospital and Health Network, Bethlehem, and Temple University School of Medicine, Philadelphia, PA; Mohammed Milhem, University of Iowa Hospitals and Clinics, Iowa City, IA; Lee Cranmer, University of Arizona, Tucson, AZ; Brendan Curti, Earle A. Chiles Research Institute, Portland, OR; Karl Lewis, University of Colorado Cancer Center, Aurora, CO; Troy Guthrie, Baptist Cancer Institute, Jacksonville; Jonathan S. Zager, Moffitt Cancer Center, Tampa, FL; Gerald P. Linette, Washington University School of Medicine, St Louis, MO; Kevin Harrington, Institute of Cancer Research, Royal Marsden Hospital, London; Mark R. Middleton, National Institute for Health Research Biomedical Research Centre, Oxford, United Kingdom; Wilson H. Miller Jr, McGill University, Montreal, Quebec, Canada; and Susan Doleman and Robert S. Coffin, Amgen, Woburn, MA. FAU - Lewis, Karl AU - Lewis K AD - Robert H.I. Andtbacka, Huntsman Cancer Institute, University of Utah, Salt Lake City, UT; Howard L. Kaufman, Rutgers Cancer Institute of New Jersey, New Brunswick, NJ; Frances Collichio, University of North Carolina Medical Center, Chapel Hill, NC; Thomas Amatruda, Minnesota Oncology, Fridley, MN; Neil Senzer, Mary Crowley Cancer Research Center, Dallas; Merrick Ross, University of Texas MD Anderson Cancer Center, Houston, TX; Jason Chesney, University of Louisville, Louisville, KY; Keith A. Delman, Winship Cancer Institute, Emory University School of Medicine, Atlanta, GA; Lynn E. Spitler, Northern California Melanoma Center, San Francisco; Gregory A. Daniels, University of California San Diego Medical Center, Moores Cancer Center, La Jolla; Yining Ye, Bin Yao, Ai Li, Ari Vander Walde, and Jennifer Gansert, Amgen, Thousand Oaks, CA; Igor Puzanov, Vanderbilt University, Nashville, TN; Sanjiv S. Agarwala, St Luke's University Hospital and Health Network, Bethlehem, and Temple University School of Medicine, Philadelphia, PA; Mohammed Milhem, University of Iowa Hospitals and Clinics, Iowa City, IA; Lee Cranmer, University of Arizona, Tucson, AZ; Brendan Curti, Earle A. Chiles Research Institute, Portland, OR; Karl Lewis, University of Colorado Cancer Center, Aurora, CO; Troy Guthrie, Baptist Cancer Institute, Jacksonville; Jonathan S. Zager, Moffitt Cancer Center, Tampa, FL; Gerald P. Linette, Washington University School of Medicine, St Louis, MO; Kevin Harrington, Institute of Cancer Research, Royal Marsden Hospital, London; Mark R. Middleton, National Institute for Health Research Biomedical Research Centre, Oxford, United Kingdom; Wilson H. Miller Jr, McGill University, Montreal, Quebec, Canada; and Susan Doleman and Robert S. Coffin, Amgen, Woburn, MA. FAU - Ross, Merrick AU - Ross M AD - Robert H.I. Andtbacka, Huntsman Cancer Institute, University of Utah, Salt Lake City, UT; Howard L. Kaufman, Rutgers Cancer Institute of New Jersey, New Brunswick, NJ; Frances Collichio, University of North Carolina Medical Center, Chapel Hill, NC; Thomas Amatruda, Minnesota Oncology, Fridley, MN; Neil Senzer, Mary Crowley Cancer Research Center, Dallas; Merrick Ross, University of Texas MD Anderson Cancer Center, Houston, TX; Jason Chesney, University of Louisville, Louisville, KY; Keith A. Delman, Winship Cancer Institute, Emory University School of Medicine, Atlanta, GA; Lynn E. Spitler, Northern California Melanoma Center, San Francisco; Gregory A. Daniels, University of California San Diego Medical Center, Moores Cancer Center, La Jolla; Yining Ye, Bin Yao, Ai Li, Ari Vander Walde, and Jennifer Gansert, Amgen, Thousand Oaks, CA; Igor Puzanov, Vanderbilt University, Nashville, TN; Sanjiv S. Agarwala, St Luke's University Hospital and Health Network, Bethlehem, and Temple University School of Medicine, Philadelphia, PA; Mohammed Milhem, University of Iowa Hospitals and Clinics, Iowa City, IA; Lee Cranmer, University of Arizona, Tucson, AZ; Brendan Curti, Earle A. Chiles Research Institute, Portland, OR; Karl Lewis, University of Colorado Cancer Center, Aurora, CO; Troy Guthrie, Baptist Cancer Institute, Jacksonville; Jonathan S. Zager, Moffitt Cancer Center, Tampa, FL; Gerald P. Linette, Washington University School of Medicine, St Louis, MO; Kevin Harrington, Institute of Cancer Research, Royal Marsden Hospital, London; Mark R. Middleton, National Institute for Health Research Biomedical Research Centre, Oxford, United Kingdom; Wilson H. Miller Jr, McGill University, Montreal, Quebec, Canada; and Susan Doleman and Robert S. Coffin, Amgen, Woburn, MA. FAU - Guthrie, Troy AU - Guthrie T AD - Robert H.I. Andtbacka, Huntsman Cancer Institute, University of Utah, Salt Lake City, UT; Howard L. Kaufman, Rutgers Cancer Institute of New Jersey, New Brunswick, NJ; Frances Collichio, University of North Carolina Medical Center, Chapel Hill, NC; Thomas Amatruda, Minnesota Oncology, Fridley, MN; Neil Senzer, Mary Crowley Cancer Research Center, Dallas; Merrick Ross, University of Texas MD Anderson Cancer Center, Houston, TX; Jason Chesney, University of Louisville, Louisville, KY; Keith A. Delman, Winship Cancer Institute, Emory University School of Medicine, Atlanta, GA; Lynn E. Spitler, Northern California Melanoma Center, San Francisco; Gregory A. Daniels, University of California San Diego Medical Center, Moores Cancer Center, La Jolla; Yining Ye, Bin Yao, Ai Li, Ari Vander Walde, and Jennifer Gansert, Amgen, Thousand Oaks, CA; Igor Puzanov, Vanderbilt University, Nashville, TN; Sanjiv S. Agarwala, St Luke's University Hospital and Health Network, Bethlehem, and Temple University School of Medicine, Philadelphia, PA; Mohammed Milhem, University of Iowa Hospitals and Clinics, Iowa City, IA; Lee Cranmer, University of Arizona, Tucson, AZ; Brendan Curti, Earle A. Chiles Research Institute, Portland, OR; Karl Lewis, University of Colorado Cancer Center, Aurora, CO; Troy Guthrie, Baptist Cancer Institute, Jacksonville; Jonathan S. Zager, Moffitt Cancer Center, Tampa, FL; Gerald P. Linette, Washington University School of Medicine, St Louis, MO; Kevin Harrington, Institute of Cancer Research, Royal Marsden Hospital, London; Mark R. Middleton, National Institute for Health Research Biomedical Research Centre, Oxford, United Kingdom; Wilson H. Miller Jr, McGill University, Montreal, Quebec, Canada; and Susan Doleman and Robert S. Coffin, Amgen, Woburn, MA. FAU - Linette, Gerald P AU - Linette GP AD - Robert H.I. Andtbacka, Huntsman Cancer Institute, University of Utah, Salt Lake City, UT; Howard L. Kaufman, Rutgers Cancer Institute of New Jersey, New Brunswick, NJ; Frances Collichio, University of North Carolina Medical Center, Chapel Hill, NC; Thomas Amatruda, Minnesota Oncology, Fridley, MN; Neil Senzer, Mary Crowley Cancer Research Center, Dallas; Merrick Ross, University of Texas MD Anderson Cancer Center, Houston, TX; Jason Chesney, University of Louisville, Louisville, KY; Keith A. Delman, Winship Cancer Institute, Emory University School of Medicine, Atlanta, GA; Lynn E. Spitler, Northern California Melanoma Center, San Francisco; Gregory A. Daniels, University of California San Diego Medical Center, Moores Cancer Center, La Jolla; Yining Ye, Bin Yao, Ai Li, Ari Vander Walde, and Jennifer Gansert, Amgen, Thousand Oaks, CA; Igor Puzanov, Vanderbilt University, Nashville, TN; Sanjiv S. Agarwala, St Luke's University Hospital and Health Network, Bethlehem, and Temple University School of Medicine, Philadelphia, PA; Mohammed Milhem, University of Iowa Hospitals and Clinics, Iowa City, IA; Lee Cranmer, University of Arizona, Tucson, AZ; Brendan Curti, Earle A. Chiles Research Institute, Portland, OR; Karl Lewis, University of Colorado Cancer Center, Aurora, CO; Troy Guthrie, Baptist Cancer Institute, Jacksonville; Jonathan S. Zager, Moffitt Cancer Center, Tampa, FL; Gerald P. Linette, Washington University School of Medicine, St Louis, MO; Kevin Harrington, Institute of Cancer Research, Royal Marsden Hospital, London; Mark R. Middleton, National Institute for Health Research Biomedical Research Centre, Oxford, United Kingdom; Wilson H. Miller Jr, McGill University, Montreal, Quebec, Canada; and Susan Doleman and Robert S. Coffin, Amgen, Woburn, MA. FAU - Daniels, Gregory A AU - Daniels GA AD - Robert H.I. Andtbacka, Huntsman Cancer Institute, University of Utah, Salt Lake City, UT; Howard L. Kaufman, Rutgers Cancer Institute of New Jersey, New Brunswick, NJ; Frances Collichio, University of North Carolina Medical Center, Chapel Hill, NC; Thomas Amatruda, Minnesota Oncology, Fridley, MN; Neil Senzer, Mary Crowley Cancer Research Center, Dallas; Merrick Ross, University of Texas MD Anderson Cancer Center, Houston, TX; Jason Chesney, University of Louisville, Louisville, KY; Keith A. Delman, Winship Cancer Institute, Emory University School of Medicine, Atlanta, GA; Lynn E. Spitler, Northern California Melanoma Center, San Francisco; Gregory A. Daniels, University of California San Diego Medical Center, Moores Cancer Center, La Jolla; Yining Ye, Bin Yao, Ai Li, Ari Vander Walde, and Jennifer Gansert, Amgen, Thousand Oaks, CA; Igor Puzanov, Vanderbilt University, Nashville, TN; Sanjiv S. Agarwala, St Luke's University Hospital and Health Network, Bethlehem, and Temple University School of Medicine, Philadelphia, PA; Mohammed Milhem, University of Iowa Hospitals and Clinics, Iowa City, IA; Lee Cranmer, University of Arizona, Tucson, AZ; Brendan Curti, Earle A. Chiles Research Institute, Portland, OR; Karl Lewis, University of Colorado Cancer Center, Aurora, CO; Troy Guthrie, Baptist Cancer Institute, Jacksonville; Jonathan S. Zager, Moffitt Cancer Center, Tampa, FL; Gerald P. Linette, Washington University School of Medicine, St Louis, MO; Kevin Harrington, Institute of Cancer Research, Royal Marsden Hospital, London; Mark R. Middleton, National Institute for Health Research Biomedical Research Centre, Oxford, United Kingdom; Wilson H. Miller Jr, McGill University, Montreal, Quebec, Canada; and Susan Doleman and Robert S. Coffin, Amgen, Woburn, MA. FAU - Harrington, Kevin AU - Harrington K AD - Robert H.I. Andtbacka, Huntsman Cancer Institute, University of Utah, Salt Lake City, UT; Howard L. Kaufman, Rutgers Cancer Institute of New Jersey, New Brunswick, NJ; Frances Collichio, University of North Carolina Medical Center, Chapel Hill, NC; Thomas Amatruda, Minnesota Oncology, Fridley, MN; Neil Senzer, Mary Crowley Cancer Research Center, Dallas; Merrick Ross, University of Texas MD Anderson Cancer Center, Houston, TX; Jason Chesney, University of Louisville, Louisville, KY; Keith A. Delman, Winship Cancer Institute, Emory University School of Medicine, Atlanta, GA; Lynn E. Spitler, Northern California Melanoma Center, San Francisco; Gregory A. Daniels, University of California San Diego Medical Center, Moores Cancer Center, La Jolla; Yining Ye, Bin Yao, Ai Li, Ari Vander Walde, and Jennifer Gansert, Amgen, Thousand Oaks, CA; Igor Puzanov, Vanderbilt University, Nashville, TN; Sanjiv S. Agarwala, St Luke's University Hospital and Health Network, Bethlehem, and Temple University School of Medicine, Philadelphia, PA; Mohammed Milhem, University of Iowa Hospitals and Clinics, Iowa City, IA; Lee Cranmer, University of Arizona, Tucson, AZ; Brendan Curti, Earle A. Chiles Research Institute, Portland, OR; Karl Lewis, University of Colorado Cancer Center, Aurora, CO; Troy Guthrie, Baptist Cancer Institute, Jacksonville; Jonathan S. Zager, Moffitt Cancer Center, Tampa, FL; Gerald P. Linette, Washington University School of Medicine, St Louis, MO; Kevin Harrington, Institute of Cancer Research, Royal Marsden Hospital, London; Mark R. Middleton, National Institute for Health Research Biomedical Research Centre, Oxford, United Kingdom; Wilson H. Miller Jr, McGill University, Montreal, Quebec, Canada; and Susan Doleman and Robert S. Coffin, Amgen, Woburn, MA. FAU - Middleton, Mark R AU - Middleton MR AD - Robert H.I. Andtbacka, Huntsman Cancer Institute, University of Utah, Salt Lake City, UT; Howard L. Kaufman, Rutgers Cancer Institute of New Jersey, New Brunswick, NJ; Frances Collichio, University of North Carolina Medical Center, Chapel Hill, NC; Thomas Amatruda, Minnesota Oncology, Fridley, MN; Neil Senzer, Mary Crowley Cancer Research Center, Dallas; Merrick Ross, University of Texas MD Anderson Cancer Center, Houston, TX; Jason Chesney, University of Louisville, Louisville, KY; Keith A. Delman, Winship Cancer Institute, Emory University School of Medicine, Atlanta, GA; Lynn E. Spitler, Northern California Melanoma Center, San Francisco; Gregory A. Daniels, University of California San Diego Medical Center, Moores Cancer Center, La Jolla; Yining Ye, Bin Yao, Ai Li, Ari Vander Walde, and Jennifer Gansert, Amgen, Thousand Oaks, CA; Igor Puzanov, Vanderbilt University, Nashville, TN; Sanjiv S. Agarwala, St Luke's University Hospital and Health Network, Bethlehem, and Temple University School of Medicine, Philadelphia, PA; Mohammed Milhem, University of Iowa Hospitals and Clinics, Iowa City, IA; Lee Cranmer, University of Arizona, Tucson, AZ; Brendan Curti, Earle A. Chiles Research Institute, Portland, OR; Karl Lewis, University of Colorado Cancer Center, Aurora, CO; Troy Guthrie, Baptist Cancer Institute, Jacksonville; Jonathan S. Zager, Moffitt Cancer Center, Tampa, FL; Gerald P. Linette, Washington University School of Medicine, St Louis, MO; Kevin Harrington, Institute of Cancer Research, Royal Marsden Hospital, London; Mark R. Middleton, National Institute for Health Research Biomedical Research Centre, Oxford, United Kingdom; Wilson H. Miller Jr, McGill University, Montreal, Quebec, Canada; and Susan Doleman and Robert S. Coffin, Amgen, Woburn, MA. FAU - Miller, Wilson H Jr AU - Miller WH Jr AD - Robert H.I. Andtbacka, Huntsman Cancer Institute, University of Utah, Salt Lake City, UT; Howard L. Kaufman, Rutgers Cancer Institute of New Jersey, New Brunswick, NJ; Frances Collichio, University of North Carolina Medical Center, Chapel Hill, NC; Thomas Amatruda, Minnesota Oncology, Fridley, MN; Neil Senzer, Mary Crowley Cancer Research Center, Dallas; Merrick Ross, University of Texas MD Anderson Cancer Center, Houston, TX; Jason Chesney, University of Louisville, Louisville, KY; Keith A. Delman, Winship Cancer Institute, Emory University School of Medicine, Atlanta, GA; Lynn E. Spitler, Northern California Melanoma Center, San Francisco; Gregory A. Daniels, University of California San Diego Medical Center, Moores Cancer Center, La Jolla; Yining Ye, Bin Yao, Ai Li, Ari Vander Walde, and Jennifer Gansert, Amgen, Thousand Oaks, CA; Igor Puzanov, Vanderbilt University, Nashville, TN; Sanjiv S. Agarwala, St Luke's University Hospital and Health Network, Bethlehem, and Temple University School of Medicine, Philadelphia, PA; Mohammed Milhem, University of Iowa Hospitals and Clinics, Iowa City, IA; Lee Cranmer, University of Arizona, Tucson, AZ; Brendan Curti, Earle A. Chiles Research Institute, Portland, OR; Karl Lewis, University of Colorado Cancer Center, Aurora, CO; Troy Guthrie, Baptist Cancer Institute, Jacksonville; Jonathan S. Zager, Moffitt Cancer Center, Tampa, FL; Gerald P. Linette, Washington University School of Medicine, St Louis, MO; Kevin Harrington, Institute of Cancer Research, Royal Marsden Hospital, London; Mark R. Middleton, National Institute for Health Research Biomedical Research Centre, Oxford, United Kingdom; Wilson H. Miller Jr, McGill University, Montreal, Quebec, Canada; and Susan Doleman and Robert S. Coffin, Amgen, Woburn, MA. FAU - Zager, Jonathan S AU - Zager JS AD - Robert H.I. Andtbacka, Huntsman Cancer Institute, University of Utah, Salt Lake City, UT; Howard L. Kaufman, Rutgers Cancer Institute of New Jersey, New Brunswick, NJ; Frances Collichio, University of North Carolina Medical Center, Chapel Hill, NC; Thomas Amatruda, Minnesota Oncology, Fridley, MN; Neil Senzer, Mary Crowley Cancer Research Center, Dallas; Merrick Ross, University of Texas MD Anderson Cancer Center, Houston, TX; Jason Chesney, University of Louisville, Louisville, KY; Keith A. Delman, Winship Cancer Institute, Emory University School of Medicine, Atlanta, GA; Lynn E. Spitler, Northern California Melanoma Center, San Francisco; Gregory A. Daniels, University of California San Diego Medical Center, Moores Cancer Center, La Jolla; Yining Ye, Bin Yao, Ai Li, Ari Vander Walde, and Jennifer Gansert, Amgen, Thousand Oaks, CA; Igor Puzanov, Vanderbilt University, Nashville, TN; Sanjiv S. Agarwala, St Luke's University Hospital and Health Network, Bethlehem, and Temple University School of Medicine, Philadelphia, PA; Mohammed Milhem, University of Iowa Hospitals and Clinics, Iowa City, IA; Lee Cranmer, University of Arizona, Tucson, AZ; Brendan Curti, Earle A. Chiles Research Institute, Portland, OR; Karl Lewis, University of Colorado Cancer Center, Aurora, CO; Troy Guthrie, Baptist Cancer Institute, Jacksonville; Jonathan S. Zager, Moffitt Cancer Center, Tampa, FL; Gerald P. Linette, Washington University School of Medicine, St Louis, MO; Kevin Harrington, Institute of Cancer Research, Royal Marsden Hospital, London; Mark R. Middleton, National Institute for Health Research Biomedical Research Centre, Oxford, United Kingdom; Wilson H. Miller Jr, McGill University, Montreal, Quebec, Canada; and Susan Doleman and Robert S. Coffin, Amgen, Woburn, MA. FAU - Ye, Yining AU - Ye Y AD - Robert H.I. Andtbacka, Huntsman Cancer Institute, University of Utah, Salt Lake City, UT; Howard L. Kaufman, Rutgers Cancer Institute of New Jersey, New Brunswick, NJ; Frances Collichio, University of North Carolina Medical Center, Chapel Hill, NC; Thomas Amatruda, Minnesota Oncology, Fridley, MN; Neil Senzer, Mary Crowley Cancer Research Center, Dallas; Merrick Ross, University of Texas MD Anderson Cancer Center, Houston, TX; Jason Chesney, University of Louisville, Louisville, KY; Keith A. Delman, Winship Cancer Institute, Emory University School of Medicine, Atlanta, GA; Lynn E. Spitler, Northern California Melanoma Center, San Francisco; Gregory A. Daniels, University of California San Diego Medical Center, Moores Cancer Center, La Jolla; Yining Ye, Bin Yao, Ai Li, Ari Vander Walde, and Jennifer Gansert, Amgen, Thousand Oaks, CA; Igor Puzanov, Vanderbilt University, Nashville, TN; Sanjiv S. Agarwala, St Luke's University Hospital and Health Network, Bethlehem, and Temple University School of Medicine, Philadelphia, PA; Mohammed Milhem, University of Iowa Hospitals and Clinics, Iowa City, IA; Lee Cranmer, University of Arizona, Tucson, AZ; Brendan Curti, Earle A. Chiles Research Institute, Portland, OR; Karl Lewis, University of Colorado Cancer Center, Aurora, CO; Troy Guthrie, Baptist Cancer Institute, Jacksonville; Jonathan S. Zager, Moffitt Cancer Center, Tampa, FL; Gerald P. Linette, Washington University School of Medicine, St Louis, MO; Kevin Harrington, Institute of Cancer Research, Royal Marsden Hospital, London; Mark R. Middleton, National Institute for Health Research Biomedical Research Centre, Oxford, United Kingdom; Wilson H. Miller Jr, McGill University, Montreal, Quebec, Canada; and Susan Doleman and Robert S. Coffin, Amgen, Woburn, MA. FAU - Yao, Bin AU - Yao B AD - Robert H.I. Andtbacka, Huntsman Cancer Institute, University of Utah, Salt Lake City, UT; Howard L. Kaufman, Rutgers Cancer Institute of New Jersey, New Brunswick, NJ; Frances Collichio, University of North Carolina Medical Center, Chapel Hill, NC; Thomas Amatruda, Minnesota Oncology, Fridley, MN; Neil Senzer, Mary Crowley Cancer Research Center, Dallas; Merrick Ross, University of Texas MD Anderson Cancer Center, Houston, TX; Jason Chesney, University of Louisville, Louisville, KY; Keith A. Delman, Winship Cancer Institute, Emory University School of Medicine, Atlanta, GA; Lynn E. Spitler, Northern California Melanoma Center, San Francisco; Gregory A. Daniels, University of California San Diego Medical Center, Moores Cancer Center, La Jolla; Yining Ye, Bin Yao, Ai Li, Ari Vander Walde, and Jennifer Gansert, Amgen, Thousand Oaks, CA; Igor Puzanov, Vanderbilt University, Nashville, TN; Sanjiv S. Agarwala, St Luke's University Hospital and Health Network, Bethlehem, and Temple University School of Medicine, Philadelphia, PA; Mohammed Milhem, University of Iowa Hospitals and Clinics, Iowa City, IA; Lee Cranmer, University of Arizona, Tucson, AZ; Brendan Curti, Earle A. Chiles Research Institute, Portland, OR; Karl Lewis, University of Colorado Cancer Center, Aurora, CO; Troy Guthrie, Baptist Cancer Institute, Jacksonville; Jonathan S. Zager, Moffitt Cancer Center, Tampa, FL; Gerald P. Linette, Washington University School of Medicine, St Louis, MO; Kevin Harrington, Institute of Cancer Research, Royal Marsden Hospital, London; Mark R. Middleton, National Institute for Health Research Biomedical Research Centre, Oxford, United Kingdom; Wilson H. Miller Jr, McGill University, Montreal, Quebec, Canada; and Susan Doleman and Robert S. Coffin, Amgen, Woburn, MA. FAU - Li, Ai AU - Li A AD - Robert H.I. Andtbacka, Huntsman Cancer Institute, University of Utah, Salt Lake City, UT; Howard L. Kaufman, Rutgers Cancer Institute of New Jersey, New Brunswick, NJ; Frances Collichio, University of North Carolina Medical Center, Chapel Hill, NC; Thomas Amatruda, Minnesota Oncology, Fridley, MN; Neil Senzer, Mary Crowley Cancer Research Center, Dallas; Merrick Ross, University of Texas MD Anderson Cancer Center, Houston, TX; Jason Chesney, University of Louisville, Louisville, KY; Keith A. Delman, Winship Cancer Institute, Emory University School of Medicine, Atlanta, GA; Lynn E. Spitler, Northern California Melanoma Center, San Francisco; Gregory A. Daniels, University of California San Diego Medical Center, Moores Cancer Center, La Jolla; Yining Ye, Bin Yao, Ai Li, Ari Vander Walde, and Jennifer Gansert, Amgen, Thousand Oaks, CA; Igor Puzanov, Vanderbilt University, Nashville, TN; Sanjiv S. Agarwala, St Luke's University Hospital and Health Network, Bethlehem, and Temple University School of Medicine, Philadelphia, PA; Mohammed Milhem, University of Iowa Hospitals and Clinics, Iowa City, IA; Lee Cranmer, University of Arizona, Tucson, AZ; Brendan Curti, Earle A. Chiles Research Institute, Portland, OR; Karl Lewis, University of Colorado Cancer Center, Aurora, CO; Troy Guthrie, Baptist Cancer Institute, Jacksonville; Jonathan S. Zager, Moffitt Cancer Center, Tampa, FL; Gerald P. Linette, Washington University School of Medicine, St Louis, MO; Kevin Harrington, Institute of Cancer Research, Royal Marsden Hospital, London; Mark R. Middleton, National Institute for Health Research Biomedical Research Centre, Oxford, United Kingdom; Wilson H. Miller Jr, McGill University, Montreal, Quebec, Canada; and Susan Doleman and Robert S. Coffin, Amgen, Woburn, MA. FAU - Doleman, Susan AU - Doleman S AD - Robert H.I. Andtbacka, Huntsman Cancer Institute, University of Utah, Salt Lake City, UT; Howard L. Kaufman, Rutgers Cancer Institute of New Jersey, New Brunswick, NJ; Frances Collichio, University of North Carolina Medical Center, Chapel Hill, NC; Thomas Amatruda, Minnesota Oncology, Fridley, MN; Neil Senzer, Mary Crowley Cancer Research Center, Dallas; Merrick Ross, University of Texas MD Anderson Cancer Center, Houston, TX; Jason Chesney, University of Louisville, Louisville, KY; Keith A. Delman, Winship Cancer Institute, Emory University School of Medicine, Atlanta, GA; Lynn E. Spitler, Northern California Melanoma Center, San Francisco; Gregory A. Daniels, University of California San Diego Medical Center, Moores Cancer Center, La Jolla; Yining Ye, Bin Yao, Ai Li, Ari Vander Walde, and Jennifer Gansert, Amgen, Thousand Oaks, CA; Igor Puzanov, Vanderbilt University, Nashville, TN; Sanjiv S. Agarwala, St Luke's University Hospital and Health Network, Bethlehem, and Temple University School of Medicine, Philadelphia, PA; Mohammed Milhem, University of Iowa Hospitals and Clinics, Iowa City, IA; Lee Cranmer, University of Arizona, Tucson, AZ; Brendan Curti, Earle A. Chiles Research Institute, Portland, OR; Karl Lewis, University of Colorado Cancer Center, Aurora, CO; Troy Guthrie, Baptist Cancer Institute, Jacksonville; Jonathan S. Zager, Moffitt Cancer Center, Tampa, FL; Gerald P. Linette, Washington University School of Medicine, St Louis, MO; Kevin Harrington, Institute of Cancer Research, Royal Marsden Hospital, London; Mark R. Middleton, National Institute for Health Research Biomedical Research Centre, Oxford, United Kingdom; Wilson H. Miller Jr, McGill University, Montreal, Quebec, Canada; and Susan Doleman and Robert S. Coffin, Amgen, Woburn, MA. FAU - VanderWalde, Ari AU - VanderWalde A AD - Robert H.I. Andtbacka, Huntsman Cancer Institute, University of Utah, Salt Lake City, UT; Howard L. Kaufman, Rutgers Cancer Institute of New Jersey, New Brunswick, NJ; Frances Collichio, University of North Carolina Medical Center, Chapel Hill, NC; Thomas Amatruda, Minnesota Oncology, Fridley, MN; Neil Senzer, Mary Crowley Cancer Research Center, Dallas; Merrick Ross, University of Texas MD Anderson Cancer Center, Houston, TX; Jason Chesney, University of Louisville, Louisville, KY; Keith A. Delman, Winship Cancer Institute, Emory University School of Medicine, Atlanta, GA; Lynn E. Spitler, Northern California Melanoma Center, San Francisco; Gregory A. Daniels, University of California San Diego Medical Center, Moores Cancer Center, La Jolla; Yining Ye, Bin Yao, Ai Li, Ari Vander Walde, and Jennifer Gansert, Amgen, Thousand Oaks, CA; Igor Puzanov, Vanderbilt University, Nashville, TN; Sanjiv S. Agarwala, St Luke's University Hospital and Health Network, Bethlehem, and Temple University School of Medicine, Philadelphia, PA; Mohammed Milhem, University of Iowa Hospitals and Clinics, Iowa City, IA; Lee Cranmer, University of Arizona, Tucson, AZ; Brendan Curti, Earle A. Chiles Research Institute, Portland, OR; Karl Lewis, University of Colorado Cancer Center, Aurora, CO; Troy Guthrie, Baptist Cancer Institute, Jacksonville; Jonathan S. Zager, Moffitt Cancer Center, Tampa, FL; Gerald P. Linette, Washington University School of Medicine, St Louis, MO; Kevin Harrington, Institute of Cancer Research, Royal Marsden Hospital, London; Mark R. Middleton, National Institute for Health Research Biomedical Research Centre, Oxford, United Kingdom; Wilson H. Miller Jr, McGill University, Montreal, Quebec, Canada; and Susan Doleman and Robert S. Coffin, Amgen, Woburn, MA. FAU - Gansert, Jennifer AU - Gansert J AD - Robert H.I. Andtbacka, Huntsman Cancer Institute, University of Utah, Salt Lake City, UT; Howard L. Kaufman, Rutgers Cancer Institute of New Jersey, New Brunswick, NJ; Frances Collichio, University of North Carolina Medical Center, Chapel Hill, NC; Thomas Amatruda, Minnesota Oncology, Fridley, MN; Neil Senzer, Mary Crowley Cancer Research Center, Dallas; Merrick Ross, University of Texas MD Anderson Cancer Center, Houston, TX; Jason Chesney, University of Louisville, Louisville, KY; Keith A. Delman, Winship Cancer Institute, Emory University School of Medicine, Atlanta, GA; Lynn E. Spitler, Northern California Melanoma Center, San Francisco; Gregory A. Daniels, University of California San Diego Medical Center, Moores Cancer Center, La Jolla; Yining Ye, Bin Yao, Ai Li, Ari Vander Walde, and Jennifer Gansert, Amgen, Thousand Oaks, CA; Igor Puzanov, Vanderbilt University, Nashville, TN; Sanjiv S. Agarwala, St Luke's University Hospital and Health Network, Bethlehem, and Temple University School of Medicine, Philadelphia, PA; Mohammed Milhem, University of Iowa Hospitals and Clinics, Iowa City, IA; Lee Cranmer, University of Arizona, Tucson, AZ; Brendan Curti, Earle A. Chiles Research Institute, Portland, OR; Karl Lewis, University of Colorado Cancer Center, Aurora, CO; Troy Guthrie, Baptist Cancer Institute, Jacksonville; Jonathan S. Zager, Moffitt Cancer Center, Tampa, FL; Gerald P. Linette, Washington University School of Medicine, St Louis, MO; Kevin Harrington, Institute of Cancer Research, Royal Marsden Hospital, London; Mark R. Middleton, National Institute for Health Research Biomedical Research Centre, Oxford, United Kingdom; Wilson H. Miller Jr, McGill University, Montreal, Quebec, Canada; and Susan Doleman and Robert S. Coffin, Amgen, Woburn, MA. FAU - Coffin, Robert S AU - Coffin RS AD - Robert H.I. Andtbacka, Huntsman Cancer Institute, University of Utah, Salt Lake City, UT; Howard L. Kaufman, Rutgers Cancer Institute of New Jersey, New Brunswick, NJ; Frances Collichio, University of North Carolina Medical Center, Chapel Hill, NC; Thomas Amatruda, Minnesota Oncology, Fridley, MN; Neil Senzer, Mary Crowley Cancer Research Center, Dallas; Merrick Ross, University of Texas MD Anderson Cancer Center, Houston, TX; Jason Chesney, University of Louisville, Louisville, KY; Keith A. Delman, Winship Cancer Institute, Emory University School of Medicine, Atlanta, GA; Lynn E. Spitler, Northern California Melanoma Center, San Francisco; Gregory A. Daniels, University of California San Diego Medical Center, Moores Cancer Center, La Jolla; Yining Ye, Bin Yao, Ai Li, Ari Vander Walde, and Jennifer Gansert, Amgen, Thousand Oaks, CA; Igor Puzanov, Vanderbilt University, Nashville, TN; Sanjiv S. Agarwala, St Luke's University Hospital and Health Network, Bethlehem, and Temple University School of Medicine, Philadelphia, PA; Mohammed Milhem, University of Iowa Hospitals and Clinics, Iowa City, IA; Lee Cranmer, University of Arizona, Tucson, AZ; Brendan Curti, Earle A. Chiles Research Institute, Portland, OR; Karl Lewis, University of Colorado Cancer Center, Aurora, CO; Troy Guthrie, Baptist Cancer Institute, Jacksonville; Jonathan S. Zager, Moffitt Cancer Center, Tampa, FL; Gerald P. Linette, Washington University School of Medicine, St Louis, MO; Kevin Harrington, Institute of Cancer Research, Royal Marsden Hospital, London; Mark R. Middleton, National Institute for Health Research Biomedical Research Centre, Oxford, United Kingdom; Wilson H. Miller Jr, McGill University, Montreal, Quebec, Canada; and Susan Doleman and Robert S. Coffin, Amgen, Woburn, MA. LA - eng SI - ClinicalTrials.gov/NCT00769704 PT - Clinical Trial, Phase III PT - Comparative Study PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't DEP - 20150526 PL - United States TA - J Clin Oncol JT - Journal of clinical oncology : official journal of the American Society of Clinical Oncology JID - 8309333 RN - 0 (Adjuvants, Immunologic) RN - 0 (Antineoplastic Agents) RN - 83869-56-1 (Granulocyte-Macrophage Colony-Stimulating Factor) SB - IM CIN - Nat Rev Clin Oncol. 2015 Aug;12(8):438. PMID: 26077044 CIN - Ann Surg Oncol. 2016 Dec;23(13):4126-4129. PMID: 27380046 CIN - Nature. 2018 May;557(7704):150-151. PMID: 29740143 MH - Adjuvants, Immunologic/administration & dosage/adverse effects/*therapeutic use MH - Adult MH - Aged MH - Aged, 80 and over MH - Antineoplastic Agents/administration & dosage/adverse effects/*therapeutic use MH - Chills/chemically induced MH - Fatigue/chemically induced MH - Female MH - Fever/chemically induced MH - Granulocyte-Macrophage Colony-Stimulating Factor/*drug effects/immunology MH - *Herpesvirus 1, Human MH - Humans MH - Immunotherapy/*methods MH - Injections, Intralesional MH - Male MH - Melanoma/*drug therapy/*immunology/mortality/prevention & control/secondary MH - Middle Aged MH - Neoplasm Staging MH - Odds Ratio MH - *Oncolytic Virotherapy MH - *Oncolytic Viruses MH - Skin Neoplasms/*drug therapy/*immunology/mortality/pathology/prevention & control MH - Survival Analysis MH - Time Factors MH - Treatment Outcome MH - United States/epidemiology EDAT- 2015/05/28 06:00 MHDA- 2016/04/30 06:00 CRDT- 2015/05/28 06:00 PHST- 2015/05/28 06:00 [entrez] PHST- 2015/05/28 06:00 [pubmed] PHST- 2016/04/30 06:00 [medline] AID - JCO.2014.58.3377 [pii] AID - 10.1200/JCO.2014.58.3377 [doi] PST - ppublish SO - J Clin Oncol. 2015 Sep 1;33(25):2780-8. doi: 10.1200/JCO.2014.58.3377. Epub 2015 May 26.