Access the full text.
Sign up today, get DeepDyve free for 14 days.
Glucocorticoid-Induced TNF Receptor-Related Protein Agonist Alone or With Nivolumab for Advanced Solid Tumors Original Investigation Research jamaoncology.com (Reprinted) JAMA Oncology
R. Geva, M. Voskoboynik, A. Beebe, J. Gwo, K. Dobrenkov, E. Chartash, G. Long (2018)
First-in-human phase 1 study of MK-1248, an anti-human glucocorticoid-induced tumor necrosis factor receptor (GITR) monoclonal antibody, as monotherapy or in combination with pembrolizumab in patients with advanced solid tumors.Journal of Clinical Oncology, 36
J. Larkin, F. Hodi, J. Wolchok (2015)
Combined Nivolumab and Ipilimumab or Monotherapy in Untreated Melanoma.The New England journal of medicine, 373 13
R. Herbst, P. Baas, Dong-Wan Kim, E. Felip, J. Pérez-Gracia, Ji-Youn Han, J. Molina, Joo‐Hang Kim, C. Arvis, M. Ahn, M. Majem, M. Fidler, G. Castro, M. Garrido, G. Lubiniecki, Shentu Yue, E. Im, M. Dolled-Filhart, E. Garon (2016)
Pembrolizumab versus docetaxel for previously treated, PD-L1-positive, advanced non-small-cell lung cancer (KEYNOTE-010): a randomised controlled trialThe Lancet, 387
A. Cohen, David Schaer, Cailian Liu, Yanyun Li, Daniel Hirschhorn-Cymmerman, Soochi Kim, A. Diab, G. Rizzuto, F. Duan, M. Perales, T. Merghoub, A. Houghton, J. Wolchok (2010)
Agonist Anti-GITR Monoclonal Antibody Induces Melanoma Tumor Immunity in Mice by Altering Regulatory T Cell Stability and Intra-Tumor AccumulationPLoS ONE, 5
D. Schadendorf, F. Hodi, C. Robert, J. Weber, K. Margolin, O. Hamid, D. Patt, Tai-Tsang Chen, D. Berman, J. Wolchok (2015)
Pooled Analysis of Long-Term Survival Data From Phase II and Phase III Trials of Ipilimumab in Unresectable or Metastatic Melanoma.Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 33 17
F. Teng, Xiangjiao Meng, L. Kong, Jinming Yu (2018)
Progress and challenges of predictive biomarkers of anti PD-1/PD-L1 immunotherapy: A systematic review.Cancer letters, 414
L. Siu, N. Steeghs, T. Meniawy, M. Joerger, J. Spratlin, S. Rottey, A. Nagrial, A. Cooper, R. Meier, X. Guan, P. Phillips, G. Bajaj, J. Gokemeijer, A. Korman, K. Aung, M. Carlino (2017)
Preliminary results of a phase I/IIa study of BMS-986156 (glucocorticoid-induced tumor necrosis factor receptor–related gene [GITR] agonist), alone and in combination with nivolumab in pts with advanced solid tumors.Journal of Clinical Oncology, 35
Lieping Chen, D. Flies (2013)
Molecular mechanisms of T cell co-stimulation and co-inhibitionNature Reviews Immunology, 13
R. Greenwald, G. Freeman, A. Sharpe (2005)
The B7 family revisited.Annual review of immunology, 23
P. Ott, F. Hodi, H. Kaufman, J. Wigginton, J. Wolchok (2017)
Combination immunotherapy: a road mapJournal for Immunotherapy of Cancer, 5
David Schaer, D. Hirschhorn-Cymerman, J. Wolchok (2014)
Targeting tumor-necrosis factor receptor pathways for tumor immunotherapyJournal for Immunotherapy of Cancer, 2
F. Hodi, S. O'Day, D. McDermott, R. Weber, J. Sosman, J. Haanen, R. Gonzalez, C. Robert, D. Schadendorf, Jessica Hassel, W. Akerley, A. Eertwegh, J. Lutzky, P. Lorigan, Julia Vaubel, G. Linette, D. Hogg, C. Ottensmeier, C. Lebbé, C. Peschel, I. Quirt, Joseph Clark, J. Wolchok, J. Weber, Jason Tian, M. Yellin, G. Nichol, A. Hoos, W. Urba (2010)
Improved survival with ipilimumab in patients with metastatic melanoma.The New England journal of medicine, 363 8
R. Motzer, N. Tannir, D. McDermott, O. Frontera, B. Melichar, T. Choueiri, E. Plimack, P. Barthélémy, C. Porta, S. George, T. Powles, F. Donskov, V. Neiman, C. Kollmannsberger, P. Salman, H. Gurney, R. Hawkins, A. Ravaud, M. Grimm, S. Bracarda, C. Barrios, Y. Tomita, D. Castellano, B. Rini, Allen Chen, S. Mekan, B. McHenry, M. Wind-Rotolo, J. Doan, P. Sharma, H. Hammers, B. Escudier (2018)
Nivolumab plus Ipilimumab versus Sunitinib in Advanced Renal‐Cell CarcinomaThe New England Journal of Medicine, 378
E. Eisenhauer, P. Therasse, J. Bogaerts, L. Schwartz, D. Sargent, R. Ford, J. Dancey, S. Arbuck, S. Gwyther, M. Mooney, Lawrence Rubinstein, L. Shankar, L. Dodd, Robert Kaplan, D. Lacombe, J. Verweij (2009)
New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1).European journal of cancer, 45 2
Byrne reported having stock and other ownership interests in CARP Pharmaceuticals
D. O’Callaghan, E. Rexhepaj, K. Gately, L. Coate, D. Delaney, D. O'Donnell, E. Kay, F. O'Connell, W. Gallagher, K. O'Byrne (2015)
Tumour islet Foxp3+ T-cell infiltration predicts poor outcome in nonsmall cell lung cancerEuropean Respiratory Journal, 46
Novartis, and Foundation Medicine; receiving research funding from AstraZeneca/MedImmune, and Bristol-Myers Squibb
D. Knee, B. Hewes, J. Brogdon (2016)
Rationale for anti-GITR cancer immunotherapy.European journal of cancer, 67
Stefanie Linch, M. Mcnamara, William Redmond (2015)
OX40 Agonists and Combination Immunotherapy: Putting the Pedal to the MetalFrontiers in Oncology, 5
C. Denlinger, J. Infante, R. Aljumaily, A. Naing, A. Chintakuntlawar, N. Rizvi, H. Ross, M. Gordon, R. Kumar, M. Ma, L. Yan, P. Vicini, N. Standifer, J. Cann, A. Perera, N. Durham, S. Krishnan, A. Balmanoukian (2018)
A phase I study of MEDI1873, a novel GITR agonist, in advanced solid tumors.Annals of oncology : official journal of the European Society for Medical Oncology, 29 Suppl 8
Liisa Chang, Minna Chang, Hanna Chang, F. Chang (2017)
Microsatellite Instability: A Predictive Biomarker for Cancer ImmunotherapyApplied Immunohistochemistry & Molecular Morphology, 26
Novartis Pharmaceuticals. Phase I/Ib study of GWN323 alone and in combination with PDR001 in patients with advanced malignancies and lymphomas
K. Papadopoulos, K. Autio, T. Golan, K. Dobrenkov, E. Chartash, Xiaoyun Li, R. Wnek, G. Long (2019)
Phase 1 study of MK-4166, an anti-human glucocorticoid-induced tumor necrosis factor receptor (GITR) antibody, as monotherapy or with pembrolizumab (pembro) in patients (pts) with advanced solid tumors.Journal of Clinical Oncology
S. Harris, Jessica Brown, Juanita Lopez, T. Yap (2016)
Immuno-oncology combinations: raising the tail of the survival curveCancer Biology & Medicine, 13
Dr Curigliano reported being an expert advisory board member for Bristol-Myers Squibb
Versione, Francesco Grossi (2020)
Common Terminology Criteria for Adverse EventsDefinitions
B. Tran, R. Carvajal, A. Marabelle, S. Patel, P. LoRusso, E. Rasmussen, Gloria Juan, V. Upreti, C. Beers, G. Ngarmchamnanrith, P. Schöffski (2018)
Dose escalation results from a first-in-human, phase 1 study of glucocorticoid-induced TNF receptor–related protein agonist AMG 228 in patients with advanced solid tumorsJournal for Immunotherapy of Cancer, 6
Samantha Arnett, J. Teillaud, T. Wurch, J. Reichert, Cameron Dunlop, Michael Huber (2011)
IBC's 21st Annual Antibody Engineering and 8th Annual Antibody Therapeutics International Conferences and 2010 Annual Meeting of The Antibody SocietymAbs, 3
Robert Ferris, G. Blumenschein, J. Fayette, J. Guigay, A. Colevas, L. Licitra, K. Harrington, S. Kasper, E. Vokes, C. Even, F. Worden, Nabil Saba, L. Docampo, R. Haddad, T. Rordorf, N. Kiyota, M. Tahara, M. Monga, M. Lynch, W. Geese, J. Kopit, James Shaw, Maura Gillison (2016)
Nivolumab for Recurrent Squamous-Cell Carcinoma of the Head and Neck.The New England journal of medicine, 375 19
Dr Schilder reported receiving a grant from Bristol-Myers Squibb; and personal fees from Incyte, Immunogen, Celsion, and FlatIron outside the submitted work
J. Brahmer, C. Drake, I. Wollner, J. Powderly, J. Picus, W. Sharfman, E. Stankevich, A. Pons, Theresa Salay, T. McMiller, Marta Gilson, Changyu Wang, M. Selby, J. Taube, R. Anders, Lieping Chen, A. Korman, D. Pardoll, I. Lowy, S. Topalian (2010)
Phase I study of single-agent anti-programmed death-1 (MDX-1106) in refractory solid tumors: safety, clinical activity, pharmacodynamics, and immunologic correlates.Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 28 19
An open-label, dose-escalation, safety study of INCAGN01876 in subjects with advanced or metastatic solid tumors
M. Overman, S. Lonardi, K. Wong, H. Lenz, F. Gelsomino, M. Aglietta, M. Morse, E. Cutsem, R. McDermott, A. Hill, M. Sawyer, A. Hendlisz, Bart, Neyns, M. Svrcek, R. Moss, J. Ledeine, Z. Cao, S. Kamble, S. Kopetz, T. André (2018)
Durable Clinical Benefit With Nivolumab Plus Ipilimumab in DNA Mismatch Repair-Deficient/Microsatellite Instability-High Metastatic Colorectal Cancer.Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 36 8
Peter-Christian Klöhn, Ulrich Wuellner, Nora Zizlsperger, Yu Zhou, Daniel Tavares, Sven Berger, K. Zettlitz, Gabriele Proetzel, May Yong, Richard Begent, J. Reichert (2011)
IBC’s 22nd Annual Antibody Engineering and 9th Annual Antibody Therapeutics International Conferences and the 2011 Annual Meeting of The Antibody Society, December 5–8, 2011, San Diego, CAmAbs, 4
H. Koon, D. Shepard, T. Merghoub, David Schaer, C. Sirard, J. Wolchok (2016)
First-in-human phase 1 single-dose study of TRX-518, an anti-human glucocorticoid-induced tumor necrosis factor receptor (GITR) monoclonal antibody in adults with advanced solid tumors.Journal of Clinical Oncology, 34
H. Borghaei, L. Paz-Ares, L. Horn, D. Spigel, M. Steins, N. Ready, L. Chow, E. Vokes, E. Felip, E. Holgado, F. Barlesi, M. Kohlhäufl, O. Arrieta, M. Burgio, J. Fayette, H. Léna, E. Poddubskaya, D. Gerber, S. Gettinger, C. Rudin, N. Rizvi, L. Crinò, G. Blumenschein, S. Antonia, C. Dorange, C. Harbison, F. Finckenstein, J. Brahmer (2015)
Nivolumab versus Docetaxel in Advanced Nonsquamous Non-Small-Cell Lung Cancer.The New England journal of medicine, 373 17
Larkin (2015)
Combined nivolumab and ipilimumab or monotherapy in untreated melanoma.N Engl J Med, 373
J. Brahmer, K. Reckamp, P. Baas, L. Crinò, W. Eberhardt, E. Poddubskaya, S. Antonia, A. Płużański, E. Vokes, E. Holgado, D. Waterhouse, N. Ready, J. Gainor, O. Frontera, L. Havel, M. Steins, M. Garassino, J. Aerts, M. Dómine, L. Paz-Ares, M. Reck, C. Baudelet, C. Harbison, B. Lestini, D. Spigel (2015)
Nivolumab versus Docetaxel in Advanced Squamous-Cell Non-Small-Cell Lung Cancer.The New England journal of medicine, 373 2
Kortnye Smith, J. Desai (2018)
Nivolumab for the treatment of colorectal cancerExpert Review of Anticancer Therapy, 18
Jianjun Gao, C. Bernatchez, P. Sharma, L. Radvanyi, P. Hwu (2013)
Advances in the development of cancer immunotherapies.Trends in immunology, 34 2
Key PointsQuestionIs the glucocorticoid-induced tumor necrosis factor receptor–related protein agonist BMS-986156 treatment with or without nivolumab tolerable and clinically active in patients with advanced solid tumors? FindingsIn this open-label, phase 1/2a study of 292 treated patients with advanced solid tumors (69 completed initial treatment), BMS-986156 therapy had a tolerable safety profile; combination therapy had a similar safety profile to that of nivolumab. No responses were seen with monotherapy; however, in combination therapy, response rates were comparable to those historically observed with nivolumab (<15% across tumor types). MeaningThis study represents the largest data set on glucocorticoid-induced tumor necrosis factor receptor–related protein agonism with or without nivolumab to our knowledge; a clear signal has not emerged demonstrating that glucocorticoid-induced tumor necrosis factor receptor–related protein agonism may be an effective therapeutic strategy in a broad patient population.
JAMA Oncology – American Medical Association
Published: Jan 7, 2020
Read and print from thousands of top scholarly journals.
Already have an account? Log in
Bookmark this article. You can see your Bookmarks on your DeepDyve Library.
To save an article, log in first, or sign up for a DeepDyve account if you don’t already have one.
Copy and paste the desired citation format or use the link below to download a file formatted for EndNote
Access the full text.
Sign up today, get DeepDyve free for 14 days.
All DeepDyve websites use cookies to improve your online experience. They were placed on your computer when you launched this website. You can change your cookie settings through your browser.