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Safety profile of avelumab in patients with advanced solid tumors: A pooled analysis of data from the phase 1 JAVELIN solid tumor and phase 2 JAVELIN Merkel 200 clinical trials.

Kelly K, Infante JR, Taylor MH, Patel MR, Wong DJ, Iannotti N, Mehnert JM, Loos AH, Koch H, Speit I, Gulley JL.

Cancer. 2018 Feb 22. doi: 10.1002/cncr.31293. [Epub ahead of print]


Phase I Trial of M7824 (MSB0011359C), a Bifunctional Fusion Protein Targeting PD-L1 and TGFβ, in Advanced Solid Tumors.

Strauss J, Heery CR, Schlom J, Madan RA, Cao L, Kang Z, Lamping E, Marté JL, Donahue RN, Grenga I, Cordes L, Christensen O, Mahnke L, Helwig C, Gulley JL.

Clin Cancer Res. 2018 Mar 15;24(6):1287-1295. doi: 10.1158/1078-0432.CCR-17-2653. Epub 2018 Jan 3.


Avelumab demonstrates promise in advanced NSCLC.

Marciscano AE, Gulley JL.

Oncotarget. 2017 Nov 13;8(61):102767-102768. doi: 10.18632/oncotarget.22418. eCollection 2017 Nov 28. No abstract available.


Checkpoint and PARP inhibitors, for whom and when.

Lee JM, Gulley JL.

Oncotarget. 2017 Sep 12;8(56):95036-95037. doi: 10.18632/oncotarget.20852. eCollection 2017 Nov 10. No abstract available.


Avelumab in metastatic urothelial carcinoma after platinum failure (JAVELIN Solid Tumor): pooled results from two expansion cohorts of an open-label, phase 1 trial.

Patel MR, Ellerton J, Infante JR, Agrawal M, Gordon M, Aljumaily R, Britten CD, Dirix L, Lee KW, Taylor M, Schöffski P, Wang D, Ravaud A, Gelb AB, Xiong J, Rosen G, Gulley JL, Apolo AB.

Lancet Oncol. 2018 Jan;19(1):51-64. doi: 10.1016/S1470-2045(17)30900-2. Epub 2017 Dec 5.


Combining immunotherapies for the treatment of prostate cancer.

Redman JM, Gulley JL, Madan RA.

Urol Oncol. 2017 Dec;35(12):694-700. doi: 10.1016/j.urolonc.2017.09.024. Review.


A novel bifunctional anti-PD-L1/TGF-β Trap fusion protein (M7824) efficiently reverts mesenchymalization of human lung cancer cells.

David JM, Dominguez C, McCampbell KK, Gulley JL, Schlom J, Palena C.

Oncoimmunology. 2017 Jul 13;6(10):e1349589. doi: 10.1080/2162402X.2017.1349589. eCollection 2017.


Analyses of functions of an anti-PD-L1/TGFβR2 bispecific fusion protein (M7824).

Jochems C, Tritsch SR, Pellom ST, Su Z, Soon-Shiong P, Wong HC, Gulley JL, Schlom J.

Oncotarget. 2017 Sep 8;8(43):75217-75231. doi: 10.18632/oncotarget.20680. eCollection 2017 Sep 26.


Phase I Study of a Poxviral TRICOM-Based Vaccine Directed Against the Transcription Factor Brachyury.

Heery CR, Palena C, McMahon S, Donahue RN, Lepone LM, Grenga I, Dirmeier U, Cordes L, Marté J, Dahut W, Singh H, Madan RA, Fernando RI, Hamilton DH, Schlom J, Gulley JL.

Clin Cancer Res. 2017 Nov 15;23(22):6833-6845. doi: 10.1158/1078-0432.CCR-17-1087. Epub 2017 Aug 30.


Avelumab for the treatment of metastatic Merkel cell carcinoma.

Cordes LM, Gulley JL.

Drugs Today (Barc). 2017 Jul;53(7):377-383. doi: 10.1358/dot.2017.53.7.2654888. Review.


Highlights of the 31st annual meeting of the Society for Immunotherapy of Cancer (SITC), 2016.

Gulley JL, Repasky EA, Wood LS, Butterfield LH.

J Immunother Cancer. 2017 Jul 18;5(1):55. doi: 10.1186/s40425-017-0262-1. Review.


Immunotherapy of Prostate Cancer: Facts and Hopes.

Bilusic M, Madan RA, Gulley JL.

Clin Cancer Res. 2017 Nov 15;23(22):6764-6770. doi: 10.1158/1078-0432.CCR-17-0019. Epub 2017 Jun 29. Review.


Immunotherapy biomarkers 2016: overcoming the barriers.

Gulley JL, Berzofsky JA, Butler MO, Cesano A, Fox BA, Gnjatic S, Janetzki S, Kalavar S, Karanikas V, Khleif SN, Kirsch I, Lee PP, Maccalli C, Maecker H, Schlom J, Seliger B, Siebert J, Stroncek DF, Thurin M, Yuan J, Butterfield LH.

J Immunother Cancer. 2017 Mar 21;5(1):29. doi: 10.1186/s40425-017-0225-6.


Prostate cancer immunotherapy: the path forward.

Madan RA, Gulley JL.

Curr Opin Support Palliat Care. 2017 Sep;11(3):225-230. doi: 10.1097/SPC.0000000000000278.


Prostate cancer: Better VISTAs ahead? Potential and pitfalls of immunotherapy.

Madan RA, Gulley JL.

Nat Rev Urol. 2017 Aug;14(8):455-456. doi: 10.1038/nrurol.2017.75. Epub 2017 May 23. No abstract available.


ADCC employing an NK cell line (haNK) expressing the high affinity CD16 allele with avelumab, an anti-PD-L1 antibody.

Jochems C, Hodge JW, Fantini M, Tsang KY, Vandeveer AJ, Gulley JL, Schlom J.

Int J Cancer. 2017 Aug 1;141(3):583-593. doi: 10.1002/ijc.30767. Epub 2017 May 19.


Role of Antigen Spread and Distinctive Characteristics of Immunotherapy in Cancer Treatment.

Gulley JL, Madan RA, Pachynski R, Mulders P, Sheikh NA, Trager J, Drake CG.

J Natl Cancer Inst. 2017 Apr 1;109(4). doi: 10.1093/jnci/djw261. Review.


Avelumab, an Anti-Programmed Death-Ligand 1 Antibody, In Patients With Refractory Metastatic Urothelial Carcinoma: Results From a Multicenter, Phase Ib Study.

Apolo AB, Infante JR, Balmanoukian A, Patel MR, Wang D, Kelly K, Mega AE, Britten CD, Ravaud A, Mita AC, Safran H, Stinchcombe TE, Srdanov M, Gelb AB, Schlichting M, Chin K, Gulley JL.

J Clin Oncol. 2017 Jul 1;35(19):2117-2124. doi: 10.1200/JCO.2016.71.6795. Epub 2017 Apr 4.


Avelumab for metastatic or locally advanced previously treated solid tumours (JAVELIN Solid Tumor): a phase 1a, multicohort, dose-escalation trial.

Heery CR, O'Sullivan-Coyne G, Madan RA, Cordes L, Rajan A, Rauckhorst M, Lamping E, Oyelakin I, Marté JL, Lepone LM, Donahue RN, Grenga I, Cuillerot JM, Neuteboom B, Heydebreck AV, Chin K, Schlom J, Gulley JL.

Lancet Oncol. 2017 May;18(5):587-598. doi: 10.1016/S1470-2045(17)30239-5. Epub 2017 Mar 31.


Avelumab for patients with previously treated metastatic or recurrent non-small-cell lung cancer (JAVELIN Solid Tumor): dose-expansion cohort of a multicentre, open-label, phase 1b trial.

Gulley JL, Rajan A, Spigel DR, Iannotti N, Chandler J, Wong DJL, Leach J, Edenfield WJ, Wang D, Grote HJ, Heydebreck AV, Chin K, Cuillerot JM, Kelly K.

Lancet Oncol. 2017 May;18(5):599-610. doi: 10.1016/S1470-2045(17)30240-1. Epub 2017 Mar 31.


Analyses of the peripheral immunome following multiple administrations of avelumab, a human IgG1 anti-PD-L1 monoclonal antibody.

Donahue RN, Lepone LM, Grenga I, Jochems C, Fantini M, Madan RA, Heery CR, Gulley JL, Schlom J.

J Immunother Cancer. 2017 Feb 21;5:20. doi: 10.1186/s40425-017-0220-y. eCollection 2017.


The Society for Immunotherapy of Cancer consensus statement on immunotherapy for the treatment of prostate carcinoma.

McNeel DG, Bander NH, Beer TM, Drake CG, Fong L, Harrelson S, Kantoff PW, Madan RA, Oh WK, Peace DJ, Petrylak DP, Porterfield H, Sartor O, Shore ND, Slovin SF, Stein MN, Vieweg J, Gulley JL.

J Immunother Cancer. 2016 Dec 20;4:92. doi: 10.1186/s40425-016-0198-x. eCollection 2016.


The IDO1 selective inhibitor epacadostat enhances dendritic cell immunogenicity and lytic ability of tumor antigen-specific T cells.

Jochems C, Fantini M, Fernando RI, Kwilas AR, Donahue RN, Lepone LM, Grenga I, Kim YS, Brechbiel MW, Gulley JL, Madan RA, Heery CR, Hodge JW, Newton R, Schlom J, Tsang KY.

Oncotarget. 2016 Jun 21;7(25):37762-37772. doi: 10.18632/oncotarget.9326.


Developing immunotherapy strategies in the treatment of prostate cancer.

Gulley JL, Madan RA.

Asian J Urol. 2016 Oct;3(4):278-285. doi: 10.1016/j.ajur.2016.08.008. Epub 2016 Aug 30. Review.


Revised Overall Survival Analysis of a Phase II, Randomized, Double-Blind, Controlled Study of PROSTVAC in Men With Metastatic Castration-Resistant Prostate Cancer.

Kantoff PW, Gulley JL, Pico-Navarro C.

J Clin Oncol. 2017 Jan;35(1):124-125. doi: 10.1200/JCO.2016.69.7748. Epub 2016 Sep 30. No abstract available.


TARP vaccination is associated with slowing in PSA velocity and decreasing tumor growth rates in patients with Stage D0 prostate cancer.

Wood LV, Fojo A, Roberson BD, Hughes MS, Dahut W, Gulley JL, Madan RA, Arlen PM, Sabatino M, Stroncek DF, Castiello L, Trepel JB, Lee MJ, Parnes HL, Steinberg SM, Terabe M, Wilkerson J, Pastan I, Berzofsky JA.

Oncoimmunology. 2016 Jul 1;5(8):e1197459. doi: 10.1080/2162402X.2016.1197459. eCollection 2016 Aug.


Predicting clinical outcomes in chordoma patients receiving immunotherapy: a comparison between volumetric segmentation and RECIST.

Fenerty KE, Folio LR, Patronas NJ, Marté JL, Gulley JL, Heery CR.

BMC Cancer. 2016 Aug 23;16(1):672. doi: 10.1186/s12885-016-2699-x.


Samarium-153-EDTMP (Quadramet®) with or without vaccine in metastatic castration-resistant prostate cancer: A randomized Phase 2 trial.

Heery CR, Madan RA, Stein MN, Stadler WM, Di Paola RS, Rauckhorst M, Steinberg SM, Marté JL, Chen CC, Grenga I, Donahue RN, Jochems C, Dahut WL, Schlom J, Gulley JL.

Oncotarget. 2016 Oct 18;7(42):69014-69023. doi: 10.18632/oncotarget.10883.


Analyses of Pretherapy Peripheral Immunoscore and Response to Vaccine Therapy.

Farsaci B, Donahue RN, Grenga I, Lepone LM, Kim PS, Dempsey B, Siebert JC, Ibrahim NK, Madan RA, Heery CR, Gulley JL, Schlom J.

Cancer Immunol Res. 2016 Sep 2;4(9):755-65. doi: 10.1158/2326-6066.CIR-16-0037. Epub 2016 Aug 2.


Radium-223 in prostate cancer: emitting the right signals.

Madan RA, Gulley JL, Dahut WL.

Lancet Oncol. 2016 Sep;17(9):1186-7. doi: 10.1016/S1470-2045(16)30248-0. Epub 2016 Jul 26. No abstract available.


Immunotherapy in genitourinary malignancies.

Wattenberg MM, Fong L, Madan RA, Gulley JL.

Curr Opin Urol. 2016 Nov;26(6):501-7. doi: 10.1097/MOU.0000000000000331.


A Phase II Clinical Trial of TRC105 (Anti-Endoglin Antibody) in Adults With Advanced/Metastatic Urothelial Carcinoma.

Apolo AB, Karzai FH, Trepel JB, Alarcon S, Lee S, Lee MJ, Tomita Y, Cao L, Yu Y, Merino MJ, Madan RA, Parnes HL, Steinberg SM, Rodriguez BW, Seon BK, Gulley JL, Arlen PM, Dawson NA, Figg WD, Dahut WL.

Clin Genitourin Cancer. 2017 Feb;15(1):77-85. doi: 10.1016/j.clgc.2016.05.010. Epub 2016 May 27.


Perspectives on sipuleucel-T: Its role in the prostate cancer treatment paradigm.

Gulley JL, Mulders P, Albers P, Banchereau J, Bolla M, Pantel K, Powles T.

Oncoimmunology. 2015 Dec 10;5(4):e1107698. eCollection 2016 Apr. Review.


Nivolumab, anti-programmed death-1 (PD-1) monoclonal antibody immunotherapy: Role in advanced cancers.

Rajan A, Kim C, Heery CR, Guha U, Gulley JL.

Hum Vaccin Immunother. 2016 Sep;12(9):2219-31. doi: 10.1080/21645515.2016.1175694. Epub 2016 May 2. Review.


Cognitive testing of tobacco use items for administration to patients with cancer and cancer survivors in clinical research.

Land SR, Warren GW, Crafts JL, Hatsukami DK, Ostroff JS, Willis GB, Chollette VY, Mitchell SA, Folz JN, Gulley JL, Szabo E, Brandon TH, Duffy SA, Toll BA.

Cancer. 2016 Jun 1;122(11):1728-34. doi: 10.1002/cncr.29964. Epub 2016 Mar 28.


Considerations for the combination of anticancer vaccines and immune checkpoint inhibitors.

Strauss J, Madan RA, Gulley JL.

Expert Opin Biol Ther. 2016 Jul;16(7):895-901. doi: 10.1517/14712598.2016.1170805. Epub 2016 Apr 8. Review.


The evolving role of immunotherapy in prostate cancer.

Cordes LM, Gulley JL, Madan RA.

Curr Opin Oncol. 2016 May;28(3):232-40. doi: 10.1097/CCO.0000000000000281. Review.


Analyses of 123 Peripheral Human Immune Cell Subsets: Defining Differences with Age and between Healthy Donors and Cancer Patients Not Detected in Analysis of Standard Immune Cell Types.

Lepone LM, Donahue RN, Grenga I, Metenou S, Richards J, Heery CR, Madan RA, Gulley JL, Schlom J.

J Circ Biomark. 2016 Mar 10;5:5. doi: 10.5772/62322. eCollection 2016 Jan-Dec.


Prospective Study Evaluating Na18F PET/CT in Predicting Clinical Outcomes and Survival in Advanced Prostate Cancer.

Apolo AB, Lindenberg L, Shih JH, Mena E, Kim JW, Park JC, Alikhani A, McKinney YY, Weaver J, Turkbey B, Parnes HL, Wood LV, Madan RA, Gulley JL, Dahut WL, Kurdziel KA, Choyke PL.

J Nucl Med. 2016 Jun;57(6):886-92. doi: 10.2967/jnumed.115.166512. Epub 2016 Jan 21.


Phase II trial of docetaxel, bevacizumab, lenalidomide and prednisone in patients with metastatic castration-resistant prostate cancer.

Madan RA, Karzai FH, Ning YM, Adesunloye BA, Huang X, Harold N, Couvillon A, Chun G, Cordes L, Sissung T, Beedie SL, Dawson NA, Theoret MR, McLeod DG, Rosner I, Trepel JB, Lee MJ, Tomita Y, Lee S, Chen C, Steinberg SM, Arlen PM, Gulley JL, Figg WD, Dahut WL.

BJU Int. 2016 Oct;118(4):590-7. doi: 10.1111/bju.13412. Epub 2016 Feb 19.


Resources Required for Semi-Automatic Volumetric Measurements in Metastatic Chordoma: Is Potentially Improved Tumor Burden Assessment Worth the Time Burden?

Fenerty KE, Patronas NJ, Heery CR, Gulley JL, Folio LR.

J Digit Imaging. 2016 Jun;29(3):357-64. doi: 10.1007/s10278-015-9846-9.


Prospects for the future of prostate cancer vaccines.

Madan RA, Gulley JL.

Expert Rev Vaccines. 2016;15(3):271-4. doi: 10.1586/14760584.2015.1118348. Epub 2015 Dec 7.


The generation and analyses of a novel combination of recombinant adenovirus vaccines targeting three tumor antigens as an immunotherapeutic.

Gabitzsch ES, Tsang KY, Palena C, David JM, Fantini M, Kwilas A, Rice AE, Latchman Y, Hodge JW, Gulley JL, Madan RA, Heery CR, Balint JP Jr, Jones FR, Schlom J.

Oncotarget. 2015 Oct 13;6(31):31344-59. doi: 10.18632/oncotarget.5181.


ABO blood type correlates with survival on prostate cancer vaccine therapy.

Muthana SM, Gulley JL, Hodge JW, Schlom J, Gildersleeve JC.

Oncotarget. 2015 Oct 13;6(31):32244-56. doi: 10.18632/oncotarget.4993.


Docetaxel Alone or in Combination With a Therapeutic Cancer Vaccine (PANVAC) in Patients With Metastatic Breast Cancer: A Randomized Clinical Trial.

Heery CR, Ibrahim NK, Arlen PM, Mohebtash M, Murray JL, Koenig K, Madan RA, McMahon S, Marté JL, Steinberg SM, Donahue RN, Grenga I, Jochems C, Farsaci B, Folio LR, Schlom J, Gulley JL.

JAMA Oncol. 2015 Nov;1(8):1087-95. doi: 10.1001/jamaoncol.2015.2736. Erratum in: JAMA Oncol. 2015 Nov;1(8):1171-2.


The impact of leukapheresis on immune-cell number and function in patients with advanced cancer.

Gulley JL, Marté J, Heery CR, Madan RA, Steinberg SM, Leitman SF, Tsang KY, Schlom J.

Cancer Immunol Immunother. 2015 Nov;64(11):1429-35. doi: 10.1007/s00262-015-1738-9. Epub 2015 Aug 5.


Phase I Trial of a Yeast-Based Therapeutic Cancer Vaccine (GI-6301) Targeting the Transcription Factor Brachyury.

Heery CR, Singh BH, Rauckhorst M, Marté JL, Donahue RN, Grenga I, Rodell TC, Dahut W, Arlen PM, Madan RA, Schlom J, Gulley JL.

Cancer Immunol Res. 2015 Nov;3(11):1248-56. doi: 10.1158/2326-6066.CIR-15-0119. Epub 2015 Jun 30.


Randomized phase II trial of docetaxel with or without PSA-TRICOM vaccine in patients with castrate-resistant metastatic prostate cancer: A trial of the ECOG-ACRIN cancer research group (E1809).

McNeel DG, Chen YH, Gulley JL, Dwyer AJ, Madan RA, Carducci MA, DiPaola RS.

Hum Vaccin Immunother. 2015;11(10):2469-74. doi: 10.1080/21645515.2015.1062190.


Antibody-Dependent Cellular Cytotoxicity Activity of a Novel Anti-PD-L1 Antibody Avelumab (MSB0010718C) on Human Tumor Cells.

Boyerinas B, Jochems C, Fantini M, Heery CR, Gulley JL, Tsang KY, Schlom J.

Cancer Immunol Res. 2015 Oct;3(10):1148-1157. doi: 10.1158/2326-6066.CIR-15-0059. Epub 2015 May 26.


Detection and Characterization of Circulating Tumour Cells from Frozen Peripheral Blood Mononuclear Cells.

Lu D, Graf RP, Harvey M, Madan RA, Heery C, Marte J, Beasley S, Tsang KY, Krupa R, Louw J, Wahl J, Bales N, Landers M, Marrinucci D, Schlom J, Gulley JL, Dittamore R.

J Circ Biomark. 2015 May 13;4:4. doi: 10.5772/60745. eCollection 2015 Jan-Dec.

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