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Research

Phase 1

Seattle Cancer Care Alliance (SCCA) treats each patient with the best care possible. Sometimes, that involves a clinical trial. 

Our Phase 1 clinical trials offer an option to people with advanced cancer when conventional treatments no longer work. These trials, which study innovative new therapies in people for the first time, are critical to future patients, who may benefit from today’s breakthroughs, and to the health care industry, which is searching for tomorrow’s cures.

SCCA joins the leading researchers and cancer experts from Fred Hutchinson Cancer Research Center and the University of Washington Medical Center. One team devoted to your best possible outcome.

Phase 1 Program capabilities

SCCA provides the first academic-based Phase 1 program for cancer research in the Pacific Northwest. 

Phase I clinical trials require a high level of technical and scientific competencies, like those found at SCCA. Our program provides unique opportunities for correlative studies that take advantage of our consortium’s research strengths, such as world-class positron emission tomography (PET) imaging, proteomics, biomarkers and genomics cores.

Mission statement

The Phase I Program partners with patients and families to conduct-cutting edge cancer research for the advancement of science. Our clinical trial expertise allows us to inspire hope and provide compassionate care for those who face a lack of treatment options. We collaborate with our Cancer Consortium and leading industry partners to improve quality care for current and future generations.

Research services we provide

The Phase 1 Program provides a full range of research services to advance the development, implementation and successful completion of clinical trials.

  • The majority of trials in our Phase 1 Program are industry-sponsored (a pharmaceutical company oversees the study and analyzes the data we collect).
  • Regulatory review (such as for the safety of study participants) includes scientific committee review, radiation safety review, and institutional review board (IRB) review.
  • We have experience conducting outpatient trials at SCCA and inpatient trials at University of Washington Medical Center.

Examples of new treatments being tested in the Phase 1 Program include:

  • Immunotherapy
  • Targeted therapies
  • Angiogenesis inhibitors
  • Cytotoxic agents for hematologic and solid tumor cancers

Clinical Trials Unit

We created our Clinical Trials Unit with the highest level of quality and comfort for our patients. Features include:

  • A lounge with comfortable chairs, a flat-panel television and snacks to create a peaceful environment.
  • Four patient rooms where each patient can receive care in one place, with nursing staff and research coordinators close by.

The Clinical Trials Unit is open from Monday through Friday, 8 am to 10 pm. If an overnight stay is required, our patients stay at University of Washington Medical Center. 

Phase 1 Program team

Our highly skilled and devoted staff, nurses and physicians have extensive research experience and provide the exacting care and attention required to test potential breakthrough therapies.

Leadership

John A. Thompson, MD, Director, Phase 1 Clinical Trials Program; Clinical Research Division, Member, Fred Hutchinson Cancer Research Center; University of Washington Professor, Medical Oncology Division.

Bojana I. Askovich, PhD,  Phase 1, Program Administrator.

The Phase 1 Team

Research team

Clinical research group
  • Erica Peters, CCRC, PM, Senior Research Coordinator
  • Hannah Lee, CCRC, Research Manager
  • Brittany Healy, CCRP, Senior Research Coordinator
  • Jeniece Hensel, CCRP, Senior Research Data Manager
  • Meghan Laurie, CCRP, Principal Data Coordinator
  • Kelsey Brewster, Data Coordinator
  • Nesha Hyde, Data Coordinator
  • Megan Healy, Data Coordinator
  • Saralynn Chen, Data Coordinator
  • Grace Neal, Research Coordinator
  • Anu Chinnadurai, Research Coordinator
  • Katie Kim, Research Coordinator
  • Harini Ramachandran, Research Coordinator
  • Olga Tsvetkova, Research Coordinator
  • Jennie Huang, Research Coordinator
  • Liana Doma, Research Coordinator
Regulatory Affairs
  • Reina Hibbert, CCRC, Regulatory Affairs Manager
  • Erin Shaw, CCRP, Regulatory Affairs Coordinator
  • Patrick Toler, Regulatory Affairs Coordinator
  • Jordan Cooper, Regulatory Affairs Coordinator 
  • Felipe Contreras Pizarro, Regulatory Student Assistant
Financials/Administrative Support
  • Ji Won Kang, Finance Manager
  • Cassie Kim, Programs Operations Specialist
  • Kristina Vucheva, Fiscal Specialist
  • Gergana Bozhilova-Deneva, Fiscal Specialist
  • Leanna Tri, Fiscal Specialist II
  • Amanda Nguyen, Budget Fiscal Analyst
  • Nina Lee, CCRP, Research Consultant
Faculty and investigators
  • Shailender Bhatia, MD (melanoma, renal)
  • Gabi Chiorean, MD (gastrointestinal)
  • Andrew Coveler, MD (gastrointestinal)
  • Barbara Goff, MD (gynecological)
  • Ajay Gopal, MD (hematology)
  • Heidi Gray, MD (gynecological)
  • Hannah Linden, MD (breast)
  • John B. Liao, MD, PhD (gynecological)
  • Rafael Santana-Davila, MD (head, neck and lung)
  • Michael Schweizer, MD (genitourinary)
  • Stephen Smith, MD (lymphoma, chronic lymphocytic leukemia, small lymphocytic lymphoma)
  • Jennifer Specht, MD (breast)
  • John Thompson, MD (melanoma and renal)
  • Shaveta Vinayak, MD (breast)
  • Kit Wong, MD (gastrointestinal)  
Phase 1 mid-levels
  • Annie Alidina, ARNP
  • Susan Ottemiller, ARNP
Phase 1 clinic support
  • Candace Mencias, RN
  • Kim Sheppard, RN
  • Fetenech Chage, LPN
  • Jana Ffitch, LPN
  • Michael Peters, Laboratory Scientist
  • Josh Willard, Laboratory Scientist
  • Danika Anderson, Laboratory Scientist
  • Sara Vasquez, Program Coordinator
  • Peter Phrydas, Team Coordinator
CTU staff
  • Luningning Mayor-Talmadge, RN CTU Charge Nurse

In Memoriam
Dana Snyder, CCRC, Senior Research Coordinator

Abstracts
  1. E. T. Rodler, J. R. Infante, L. L. Siu, D. C. Smith, D. Sullivan, G. Vlahovic, J. Gomez-Navarro, G. Liu, S. Blakemore, J. A. Thompson. First-in-human phase I dose-escalation study of investigational drug MLN9708, a second-generation proteasome inhibitor, in advanced non-hematologic malignancies. Journal of Clinical Oncology 28, no. 15_suppl (May 2010) 3071-3071.
  2. Ansell, SM, Thompson, J, Infante, S, Heath, E, Whiting, N.C., Zhao, B and Forero-Torres, A. Targeting CD70 in Non-Hodgkin Lymphoma and Renal Cell Carcinoma: A Phase 1 Study of the Antibody-Drug conjugate SGN-75.  Annals of Oncology, Volume 21, Issue suppl_8, p532P. (October 2010).
  3. Bhatia S, Hamid O, Pavlick AC, Mulligan G, Smith PG, Pickard MD, Shultz M, Walker RM, Dezube B, O'Day S, MLN4924, an investigational NEDD8-activating enzyme inhibitor, in patients with metastatic melanoma: results of a phase 1 study, 2011, J Clin Oncol 29, abstr 8529.
  4. Konopleva M, Borthakur G, Thall PF, Yi CA,  Coveler A, Bueso-Ramos C, Benito J, Konoplev S, Gu Y, Ravandi F, Jabbour E, Faderl S, Thomas D, Cortes J, Kadia T, Kornblau S, Daver N, Pemmaraju N, Nguyen HQ, Feliu J, Lu H, Wei C, Wilson WR, Melink TJ, Gutheil JC, Andreeff M, Estey EH, Kantarjian H.Phase I/II Study of PR104 in Subjects with Refractory/Relapsed Acute Leukemia using Adaptive Dose Selection. 53 Annual ASH Meeting. 2011.
  5. Munster PN, van der Noll R, Voest EE, Dees EC, Tan AR, Specht JM, Falchook GS, Daud A, Lolkema MP, Grilley-Olson JE, Yu EY, Fu S, Bergeland EK, Kleha J, Peng S, Smith DA, Lampkin TA, Schellens JHM, Morris SR, Kurzrock R, Phase 1 first-in-human study of the PI3 kinase inhibitor GSK2126458 (GSK458) in patients with advanced solid tumors, 2011, J Clin Oncol 29, abstr 3018.
  6. Thompson JA, Forero-Torres A, Heath EI, Ansell SM, Pal SK, Infante JR, De Vos S, Hamlin PA, Zhao B, Klussman K, Whiting NC, The effect of SGN-75, a novel antibody–drug conjugate (ADC), in treatment of patients with renal cell carcinoma (RCC) or non-Hodgkin lymphoma (NHL): A phase I study, 2011, J Clin Oncol 29, abstr 3071.
  7. Rodler ET, Specht JM, Gadi VK, Kurland BF, Griffin MJ, Hammond JJ, Gralow JR, Phase 1 Study of PARP Inhibitor ABT-888 (Veliparib) in Combination with Cisplatin and Vinorelbine for Patients with Advanced Triple Negative Breast Cancer and/or BRCA-Mutation Associated Breast Cancer, 2011, Cancer Res 71; p1-17-04.
  8. Brentuximab Vedotin (SGN-35) Treatment in Relapsed CD30-positive Hodgkin Lymphoma Patients Following Allogeneic Stem Cell Transplant:  A Multicenter Case Series. AK Gopal, R. Ramchandren, RB Berryman, RH Advani, R Chen, SE Smith,  M Cooper, A Engert, J Matous, J Zain, LE Grove, NN Hunder, OA O’Connor. 37th Annual Meeting of the European Group for Blood and Marrow Transplantation. Paris, April 3-6, 2011.
  9. Falchook GS, Goff BA, Kurzrock R, Gray HJ, Martin LP, Coleman RL, Liu H, Zhou X, Benaim E, Schilder R, Phase I/II study of weekly paclitaxel with or without MLN8237 (alisertib), an investigational aurora A kinase inhibitor, in patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer (OC), or breast cancer (BrC): Phase 1 results, 2012, J Clin Oncol 30, abstr 5021.
  10. Smith DC, Sullivan D, Infante JR, Kauh JS, Siu LL, Vlahovic G, Thompson JA, Gupta J, De Bacco A, Liu G, Kalebic T, MLN9708, an investigational proteasome inhibitor, in patients (pts) with solid tumors: Updated phase I results, 2012, J Clin Oncol 30, abstr e13603.
  11. Tykodi SS, Brahmer JR, Hwu WJ, Chow LQ, Topalian SL, Hwu P, Odunsi K, Camacho LH, Kauh JS, Pitot HC, Hamid O, Pardoll DM, Agrawal S, Parker S, Goldberg S, Gubta AK, Wigginton J, PD-1/PD-L1 pathway as a target for cancer immunotherapy: Safety and clinical activity of BMS-936559, an anti-PD-L1 antibody, in patients with solid tumors, 2012, J Clin Oncol 30, abstr 2510.
  12. Alessandra Di Bacco, Allison Berger, Neeraj Gupta, Feng Gao, Stephen Blakemore, Mark Qian, Susan Chen, Bradley Stringer, Yu Yang, Ray Liu, Stephen Tirrell Doug Bowman, David C. Smith, Daniel Sullivan, Jeffrey R. Infante, John S. Kauh, Lillian L. Siu, Gordana Vlahovic, John A. Thompson, Thea Kalebic.Tumor drug distribution and target engagement of MLN9708, an investigational proteasome inhibitor, in patients with advanced solid tumors.Journal of Clinical Oncology 30, no. 15_suppl (May 2012) 3077-3077.
  13. Chow LQ, Infante JR, Siu LL, Sullivan D, Kauh JS, DiBacco A, Gupta N, Kalebic T, Smith DC, Thompson JA. MLN9708, an investigational proteasome inhibitor, in patients with solid tumors: Updated phase 1 results.  Poster Presentation at the Multidisciplinary Head and Neck Symposium, Phoenix, AZ, 2012.
  14. Bell-McGuinn KM, Gray HJ, Fleming GF, Cristea MC, Medina DM, Xiong H, Dudley MW, Dunbar M, Giranda VL, Luo Y, McKee MD, Martin LP, A Phase I Study of ABT-888 in Combination with Carboplatin and Gemcitabine in Subjects with Advanced Solid Tumors, J Clin Oncol 31, 2013, abstr 2584.
  15. Coveler AL, Van Hoff DD, Ko AH, Whiting NC, Zhao B, Wolpin BM. A phase 1 study of ASG-5ME, a novel antibody:drug conjugate, in pancreatic ductal adenocarcinoma, 2013, J Clin Oncol 31, abstr 176
  16. Hingorani SR, Harris WP, Beck JT, Berdov BA, Wagner SA, Pshevlotsky EM, Tjulandin S, Gladkov O, Holcombe RF, Jiang P, Maneval DC, Zhu J, Devoe CE, A phase 1b study of gemcitibine plus PDGPH2 (pegylated recombinant human hyaluronidase) in patients with stage IV previously untreated pancreatic cancer, 2013, J Clin Oncol 31, abstr 4010.
  17. Shaw AT, Mehra R, Kim DW, Felip E, Chow LQM, Camidge DR, Tan DSW, Vansteenkiste JF, Sharam S, De Pas T, Wolf J, Katayama R, Lau YYY, Goldwasser M, Boral A, Engelman JA, Clinical activity of the ALK inhibitor LDK378 in advanced ALK-positive NSCLC, 2013, J Clin Oncol 31, abstr 8010.
  18. Thompson JA, Forrero A, Heath EI, Pal SK, Ansell SM, Infante JR, De Vos S, Hamlin PA, Whiting NC, Zhao B, Tannir NM, SGN-75 in the treatment of patients with CD70-positive malignancies including metastatic renal cell carcinoma, 2013, J Clin Oncol 31, abstr 368.
  19. Laura Quan Man Chow, Michael S. Gordon, Theodore F. Logan, Scott J. Antonia, Shailender Bhatia, John A. Thompson, Julie R. Brahmer, Gretchen Solberg, Rachel Bittner, David Fontana, Joseph Grosso, Lewis J. Cohen, Christoph Matthias Ahlers, Jon M. Wigginton, Charles G. Drake. Phase I dose escalation study of recombinant interleukin-21 (rIL-21; BMS-982470) in combination with nivolumab (anti-PD-1; BMS-936558; ONO-4538) in patients (pts) with advanced or metastatic solid tumors.2013, Journal of Clinical Oncology 31, no. 15_supp.
  20. Shailender Bhatia, Brendan D. Curti, Michael S. Gordon, Jason Chesney, Theodore Logan, John A. Thompson, Nels Royer, Rachel Bittner, David Fontana, Joseph Grosso, Pamela L. Clemens, Lewis J. Cohen, Christoph Matthias Ahlers, Jon M. Wigginton, Patrick Hwu. Phase I dose escalation study of recombinant interleukin-21 (rIL-21, BMS-982470) in combination with ipilimumab (Ipi) in patients (pts) with advanced or metastatic melanoma (MM). 2013 Journal of Clinical Oncology 31, no. 15_suppl.DOI: 10.1200/jco.2013.31.15_suppl.tps3109.
  21. Segal NH, Gopal AK, Bhatia S, Kohrt HE, Levy R, Pishvaian MJ, Houot R, Bartlett N, Nghiem P, Kronenberg SA, Thall AD, Mugundu G, Huang B, Davis C, A phase 1 study of PF-05082566 (anti-4-1BB) in patients with advanced cancer, 2014, J Clin Oncol 32:5s, abstr 3007.
  22. Seiwert TY, Burtness B, Weiss J, Gluck I, Eder JP, Pai SI, Dolled-Filhart M, Emancipator K, Pathiraja K, Gause C, Iannone R, Brown H, Houp J, Cheng JD, Chow LQM, A phase 1b study of MK-3475 in patients with human papillovirus (HPV)-associated and non-HPV-associated head and neck (H/N) cancer, 2014, J Clin Oncol 32:5s, abstr 6011.
  23. Forero-Torres A, Modi S, Specht J, Miller K, Weise A, Burris III H, Liu M, Krop I, Pusztai L, Kostic A, Li M and Mita M. SGN-LIV1: A Phase 1 study evaluating a novel antibody-drug conjugate in patients with LIV-1 positive breast cancer. 2014 San Antonio Breast Cancer Symposium.Publication Number: OT2-3-01.
  24. Chihiro Morishima, Douglas G McNeel, Manish R Patel, Holbrook Kohrt, Thomas A Waldmann, John A Thompson, Kevin Conlon, Paul M Sondel, Heather Wakelee, Mary L Disis, Stephen P Creekmore and Jeffrey S Miller.CITN11-02 interim trial results: subcutaneous administration of recombinant human IL-15 (rhil-15) is associated with robust expansion of peripheral blood CD56+ NK cells.Journal for ImmunoTherapy of Cancer20142(Suppl 3):P80.
  25. E. Felip; D. Kim; R. Mehra; D.S.W. Tan; L.Q. Chow; D.R. Camidge; J.F. Vansteenkiste; S. Sharma; T. De Pas; G.J. Riely; B. Solomon; J. Wolf; M. Thomas; M. Schuler; G. Lui; A. Santoro; M. Geraldes; A.L. Boral; A. Yovine; A.T. Shaw. EFFICACY AND SAFETY OF CERITINIB IN PATIENTS (PTS) WITH ADVANCED ANAPLASTIC LYMPHOMA KINASE (ALK)-REARRANGED (ALK+) NON-SMALL CELL LUNG CANCER (NSCLC): AN UPDATE OF ASCEND-19. Ann Oncol (2014) 25 (suppl_4): iv456-iv457.
  26. A.T. Shaw; R. Mehra; D.S.W. Tan; E. Felip; L.Q. Chow; D.R. Camidge; J.F. Vansteenkiste; S. Sharma; T. De Pas; G.J. Riely; B. Solomon; J. Wolf; M. Thomas; M. Schuler; G. Liu; A. Santoro; M. Geraldes; A.L. Boral; A. Yovine; D. Kim .EVALUATION OF CERITINIB-TREATED PATIENTS (PTS) WITH ANAPLASTIC LYMPHOMA KINASE REARRANGED (ALK+) NON-SMALL CELL LUNG CANCER (NSCLC) AND BRAIN METASTASES IN THE ASCEND-1 STUDY.Ann Oncol (2014) 25 (suppl_4): iv455-iv456.
  27. Tan DS, Shaw AT, Mehra R, Felip E, Chow LQM, D. Camidge R, Vansteenkiste JF, Sharma S, De Pas T, Riely GJ, Solomon BJ, Wolf J, Thomas M, Schuler MH, Liu G, Santoro A, Geraldes M, Boral A, Yovine AJ, Kim DW. Ceritinib in Asian versus Caucasian patients (Pts) with advanced anaplastic lymphoma kinase (ALK)-rearranged (ALK+) NSCLC: Subgroup analysis of the ASCEND-1 trial. Journal of Clinical Oncology 32, no. 15_suppl (May 2014) 8078-8078.
  28. L.Q. Chow; B. Burtness; J. Weiss; R. Berger; J.P. Eder; E.J. Gonzalez; J. Pulini; J. Johnson; M. Dolled-Filhart; K. Emancipator; J.K. Lunceford; K. Pathiraja; C. Gause; J.D. Cheng; T. Seiwert. A PHASE IB STUDY OF PEMBROLIZUMAB (PEMBRO; MK-3475) IN PATIENTS (PTS) WITH HUMAN PAPIILLOMA VIRUS (HPV)-POSITIVE AND NEGATIVE HEAD AND NECK CANCER (HNC).Ann Oncol (2014) 25 (suppl_4): mdu438.32.
  29. K. Muro; Y. Bang; V. Shankaran; R. Geva; D.V.T. Catenacci; S. Gupta; J.P. Eder; R. Berger; E.J. Gonzalez; J. Pulini; A.B. Ray; M. Dolled-Filhart; K. Emancipator; K. Pathiraja; X. Shu; M.R. Koshiji; J. Cheng; H.C. Chung. A PHASE 1B STUDY OF PEMBROLIZUMAB (PEMBRO; MK-3475) IN PATIENTS (PTS) WITH ADVANCED GASTRIC CANCER. Ann Oncol (2014) 25 (suppl_4): mdu438.15.
  30. Mufti, GJ; Estey, E; Popat, R; Mattison, R; Menne, T; Azar, J; Bloor, A., Gaymes, TJ, Khwaj, A., Juckett, M., Lennard A., Zhang C., Gallant, G. J. A., Gopal, A.K. RESULTS OF A PHASE 1 STUDY OF BMN 673, A POTENT AND SPECIFIC PARP-1/2 INHIBITOR, IN PATIENTS WITH ADVANCED HEMATOLOGICAL MALIGNANCIES.2014  proceedings of 19th Congress of the European-Hematology-Association. (pp. 33-34).
  31. Stein MN, Chow LQM, Smith DC, Shepard DR, Wang D, Powderly JD, Gao L, Lin Y, Koshiji M. Phase II study evaluating the effect of concomitant ramucirumab (IMC-1121B; RAM) on the pharmacokinetics (PK) of docetaxel (DOC) in patients (pts) with advanced malignant solid tumors. J Clin Oncol 32, 2014 (suppl; abstr e13539).
  32. Chow LQM, Smith DC, Tan AR, Denlinger CS, Wang D, Shepard DR, Chaudhary A, Lin Y, Koshiji M. Phase II study evaluating the effect of concomitant ramucirumab (IMC-1121B; RAM) on the pharmacokinetics (PK) of paclitaxel (PTX) and the PK of RAM as monotherapy in patients (pts) with advanced malignant solid tumors. J Clin Oncol 32, 2014 (suppl; abstr e13554).
  33. Thompson JA, Motzer R, Molina AM, Choueiri TK, Heath EI, Kollmannsberger CK, Redman BG, Sangha RS, Ernst DS, Pili R, Butturini A, Wiseman A, Trave F, Anand B, Huang Y, Reyno LM, Phase 1 studies of anti-ENPP3 antibody drug conjugates (ADCs) in advanced refractory renal cell carcinomas (RRCC), 2015, J Clin Oncol 33, abstr 2503.
  34. Atkins MB, Choueiri TK, Hodi FS, Thompson JA, Hwu WJ, McDermott DF, Brookes M, Tosolini A, Ebbinghaus S, Yang Z, Gause CK, Perini RF, Ribas A, Pembrolizumab (MK-3475) plus low-dose ipilimumab (IPI) in patients (pts) with advanced melanoma (MEL) or renal cell carcinoma (RCC): Data from the KEYNOTE-029 phase 1 study, J Clin Oncol 33, 2015, abstr 3009.
  35. Chawla SP, Schoffski P, Blay JY, Jones RL, Gelderblom H, Attia S, Chmielowski B, Van Tine BA, Trent JC, Patel S, Wagner AJ, Viele JK, Chugh R, Le Cesne A, Tinoco G, Sankhala KK, Falcone J, Schweizer C, Weil S, Maki RG, A Study of the Safety and Efficacy of the Combination of Gemcitabine and Docetaxel with ontuxizumab (MORAb-004) in Metastatic Soft Tissue Sarcoma, 2015, J Clin Oncol 33, abstr TPS10577.
  36. Gopal AK, Bartlett NL, Levy R, Houot R, Smith SD, Segal NH, Thall AD, Mugundu G, Huang B, Davis C, Kohrt HE, A phase 1 study of PF-05082566 (anti-4-1BB) + rituximab in patients with CD20+ NHL, 2015, J Clin Oncol 33, abstr 3004.
  37. Hingorani SR, Harris WP, Hendifar AE, Bullock AJ, Wu XW, Huang Y, Jiang P, High response rate and PFS with PEGPH230 added to nab-paclitaxel/gemcitabine in stage IV previously untreated pancreatic cancer patients with high-HA tumors: Interim results of a randomized phase II study, 2015, J Clin Oncol 33, abstr 4006.
  38. Hamid O, Chow LQM, Tavokkoli F, Marshall S, Gribbin MJ, Karakunnel JJ, Gray JE, Phase 1, open-label study of MEDI0680, an anti-programmed cell death-1 (PD-1) antibody, in combination with MEDI4736, an anti-programmed cell death ligand-1 (PD-L1) antibody, in patients with advanced malignancies, 2015, J Clin Oncol 33, abstr TPS3087.
  39. Somaiah N, Block MS, Kim JW, Shapiro G, Hwu P, Eder JP, Jones RL, Gnjatic S, Lu H, Hsu FJ, Pollack S, Phase 1, first-in-human trial of LV305 in patients with advanced or metastatic cancer expressing NY-ESO-1, 2015, J Clin Oncol 33, abstr 3021.
  40. Forero A, Burris III H, Mita M, Specht J, Weise A, Liu MC C, Modi S, Pusztai L, Kostic A, Yang J, Li M, Hengel S and Miller K.Interim analysis of a phase 1 study of the antibody-drug conjugate SGN-LIV1A in patients with metastatic breast cancer.2015 San Antonio Breast Cancer Symposium.Publication Number: P3-14-05.
  41. Chihiro Morishima, Douglas G McNeel, Manish R Patel, Holbrook E Kohrt, Thomas A Waldmann, John A Thompson, Kevin C Conlon, Paul M Sondel, Heather A Wakelee, Minjun C Apodaca, Steven P Fling, Mary L Disis, Stephen P Creekmore and Jeffrey S Miller. CITN11-02 interim trial results: subcutaneous administration of recombinant human IL-15 (rhIL-15) is associated with expansion of peripheral blood CD56+ NK cells and CD8+ T cells.Journal for ImmunoTherapy of Cancer20153(Suppl 2):P203.
  42. L. Buisseret; J. Specht; E.C. Dees; R. Berger; S. Gupta; R. Geva; L. Pusztai; C.K. Gause; V. Karantza; R. Nanda. KEYNOTE-012: A phase Ib study of pembrolizumab (MK-3475) in patients (pts) with metastatic triple-negative breast cancer (mTNBC).Ann Oncol (2015) 26 (suppl_3): iii6.
  43. A. Hendifar; S. Hingorani; W. Harris; T. Seery; D. Sigal; W. Wu; S. Dychter; P. Jiang. High Response Rate and PFS with PEGPH20 added to Nab-Paclitaxel/Gemcitabine in Stage IV Previously Untreated Pancreatic Cancer Patients with High-HA Tumors: Interim Results of a Randomized Phase 2 Study. Ann Oncol (2015) 26. (suppl_4): iv117.
  44. Y-J. Bang; H.C. Chung; V. Shankaran; R. Geva; D. Catenacci; S. Gupta; J.P. Eder; R. Berger; K. Emancipator; K. Pathiraja; T. McClanahan; M. Ayers; J. Lunceford; J. Cheng; M. Koshiji; K. Muro.Clinical outcomes and their correlation with gene expression in patients with advanced gastric cancer treated with pembrolizumab (MK-3475): KEYNOTE-012.Ann Oncol (2015) 26 (suppl_4): iv118.
  45. Rita Nanda, Laura Q Chow, E Claire Dees, Raanan Berger, Shilpa Gupta, Ravit Geva, Lajos Pusztai, Marisa Dolled-Filhart, Kenneth Emancipator, Edward J Gonzalez, Jennifer Houp, Kumudu Pathiraja, Vassiliki Karantza, Robert Iannone, Christine K Gause, Johnathan D Cheng, and Laurence Buisseret. A phase Ib study of pembrolizumab (MK-3475) in patients with advanced triple-negative breast cancer.Cancer Res 2015;75(9 Suppl):Abstract nr S1-09.
  46. R.L. Jones, J.C. Bendell, D.C. Smith, K. Deifenbach, J. Lettieri, O. Boix, A.C. Lockhart, C.L. O'Bryant, K.N. Moore. A Phase I open-label trial evaluating the cardiovascular safety of regorafenib in patients with advanced cancer. European journal of cancer. Volume 51, Supplement 3, Pages S336–S337.
  47. Chow LQM, Mehra R, Haddad R, Gupta S, Weiss J, Berger R, Burtness B, Thara M, Keam B, Le D, Cheng J, Health K, Pathiraja K, Seiwert T. Antitumor activity of the Anti-PD-1 antibody pembrolizumab in subgroups of patients with recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC): Exploratory analyses from KEYNOTE-012. Poster Presentation at the European Cancer Congress, Vienna, Austria. September 2015.
  48. Peter H. O'Donnell, Elizabeth R. Plimack, Joaquim Bellmunt, Raanan Berger, Robert B. Montgomery, Karl Heath, Marisa Dolled-Filhart, Kumudu Pathiraja, Christine K. Gause, Jonathan D. Cheng, Rodolfo F. Perini, Shilpa Gupta. Pembrolizumab (Pembro; MK-3475) for advanced urothelial cancer: Results of a phase IB study.J Clin Oncol 33, 2015 (suppl 7; abstr 296).
  49. Elizabeth R. Plimack, Joaquim Bellmunt, Shilpa Gupta, Raanan Berger, Robert B. Montgomery, Karl Heath, Jonathan Juco, Kenneth Emancipator, Kumudu Pathiraja, Jared K. Lunceford, Rodolfo F. Perini, Peter H. O'Donnell. Pembrolizumab (MK-3475) for advanced urothelial cancer: Updated results and biomarker analysis from KEYNOTE-012.J Clin Oncol 33, 2015 (suppl; abstr 4502).
  50. Bendell JC, Kim TW, Goh BC, Wallin J, Oh DY, Han SW, Lee CB, Hellmann MD, Desai J, Lewin JH, Solomon BJ, Chow LQM, Miller WH, Gainor JF, Flaherty K, Infante JR, Das-Thakur M, Foster P, Cha E, Bang YJ, Clinical activity and safety of cobimetinib (cobi) and atezolizumab in colorectal cancer (CRC), 2016, J Clin Oncol 34, abstr 3502.
  51. Werner TL, Sachdev JC, Swisher EM, Gutierrez M, Kittaneh M, Stein MN, Xiong H, Dunbar M, Sullivan DM, Ansell PJ, Hetman R, Komarnitsky P, McKee MD, Tan AR, Veliparib (ABT-888) extended-release formulations: A phase 1 study on safety, pharmacokinetics (PK), and bioavailability in patients with advanced solid tumors, 2016, J Clin Oncol 34, abstr 2579.
  52. Infante JR, Hansen AR, Pishvaian MJ, Chow LCM, McArthur GA, Bauer TM, Liu SV, Sandhu SK, Tsai FYC, Kim J, Stefanich E, Li CC, Gilbert H, McCall B, Anderson MS, Huseni M, Rhee IP, Siu LL, Gordon MS, A phase 1b dose escalation study of the OX40 agonist MOXR0916 and the PD-L1 inhibitor atezolizumab in patients with advanced solid tumors, 2016, J Clin Oncol 34, abstr 101.
  53. Bullock AJ, Hingorani SR, Wu XW, Jiang P, Chondros D, Khelifa S, Aldrich C, Pu J, Hendifar AE, Final analysis of stage 1 data from a randomized phase II study of PEGPH20 plus nab-Paclitaxel/gemcitabine in stage IV previously untreated pancreatic cancer patients (pts), utilizing Ventana companion diagnostic assay, 2016, J Clin Oncol 34, abstr 4104.
  54. Somaiah N, Block MS, Kim JW, Shapiro G, Do KT, Hwu P, Eder JP, Jones RL, Gnjatic S, Lu H, Meulen JT, Hsu FJ, Pollack S, Single-agent LV305 to induce anti-tumor immune and clinical responses in patients with advanced or metastatic sarcoma and other cancers expressing NY-ESO-1, 2016, J Clin Oncol 34, abstr 3093.
  55. Herbst RS, Bendell JC, Isambert N, Calvo E, Santana-Davila R, Cassier P, Perez-Gracia JL, Yang J, Rege J, Ferry D, Mi G, Chau I, A phase 1 study of ramucirumab (R) plus pembrolizumab (P) in patients (pts) with advanced gastric or gastroesophageal junction (G/GEJ) adenocarcinoma, non-small cell lung cancer (NSCLC), or urothelial carcinoma (UC): Phase 1a results, 2016, J Clin Oncol 34, abstr 3056.
  56. Chow LQM, Mehra R, Haddad RI, Mahipal A, Weiss J, Berger R, Eder JP, Burtness B, Tahara M, Keam B, Le DT, Muro K, Geva R, Chung HC, Lin CC, Ayers M, Aurora-Garg D, Lunceford JK, Cheng JD, Seiwert TY, Biomarkers and response to pembrolizumab (pembro) in recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC), 2016, J Clin ONcol 34, abstr 6010.
  57. Mehra R, Seiwert TY, Mahipal A, Weiss J, Berger R, Eder JP, Burtness B, Tahara M, Keam B, Le DT, Muro K, Geva R, Chung HC, Lin CC, Meister A, Hille D, Cheng JD, Chow LQM, Haddad RI, Efficacy and safety of pembrolizumab in recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC): Pooled analyses after long-term follow-up in KEYNOTE-012, 2016, J Clin Oncol 34, abstr 6012.
  58. Atkins MB, Hodi FS, Thompson JA, McDermott DF, Hwu WJ, Lawrence DP, Dawson NA, Wong DJL, Bhatia S, James M, Shu X, Perini RF, Ibrahim N, Ribas A, Choueiri TK, Pembrolizumab (pembro) plus ipilimumab (ipi) or pegylated interferon alfa-2b (PEG-IFN) for advanced melanoma or renal cell carcinoma (RCC), 2016, J Clin Oncol 34, abstr 3013.
  59. Long GV, Atkinson V, Cebon JS, Jameson MB, Fitzharris BM, McNeil CM, Hill AG, Ribas A, Atkins MB, Thompson JA, Hwu WJ, Hodi FS, Menzies AM, Guminski AD, Kefford R, Shu Z, Ebbinghaus S, Ibrahim N, Carlino MS, Pembrolizumab (pembro) plus ipilimumab (ipi) for advanced melanoma: Results of the KEYNOTE-029 expansion cohort, 2016, J Clin Oncol 34, abstr 9506.
  60. Tolcher AW, Sznol M, Hu-Lieskovan S, Papadopoulos KP, Patnaik A, Rasco DW, Gravio DD, Huang B, Gambhire D, Chen Y, Pathan N, Wang K, Schmidt EV, Chow LQM, Phase 1b study of PF-05082566 in combination with pembrolizumab in patients with advanced solid tumors, 2016, J Clin Oncol 34, abstr 3002.
  61. Ribas A, Chow LQ, Boyd JK, Long GV, Gorczyca M, Davis C, Pavlov D, Thall AD, Avelumab (MSB0010718C; anti-PD-L1) in combination with other cancer immunotherapies in patients with advanced malignancies: The phase 1b/2 JAVELIN Medley study, 2016, J Clin Oncol 34, abstr TPS3106.
  62. Hamid O, Thompson JA, Diab A, Ros W, Eskens F, Bermingham C, Konto C, Long H, Liao K, Ganguly BJ, Fleener C, Pleasic-Williams S, Garzone PD, Patel PH, Joh T, Nuyten DSA, El-Khoueiry AB, First in human (FIH) study of an OX40 agonist monoclonal antibody (mAb) PF-04518600 (PF-8600) in adult patients (pts) with select advanced solid tumors: Preliminary safety and pharmacokinetic (PK)/pharmacodynamic results, 2016, J Clin Oncol 34, abstr 3079.
  63. Nanda R, Specht J, Dees C, Berger R, Gupta S, Geva R, Pusztai L, Pathiraja K, Ray A, Karantza V and Buisseret L. KEYNOTE-012: Long-lasting responses in a phase Ib study of pembrolizumab for metastatic triple-negative breast cancer (mTNBC).2016 San Antonio Breast Cancer Symposium.Publication Number: P6-10-03.
  64. Forero-Torres A, Modi S, Specht J, Miller K, Weise A, Burris III H, Liu M, Krop I, Pusztai L, Kostic A, Li M and Mita M.Phase 1 study of the antibody-drug conjugate (ADC) SGN-LIV1A in patients with heavily pretreated metastatic breast cancer. 2016 San Antonio Breast Cancer Symposium.Publication Number: P6-12-04.
  65. Evan Lipson, Ajay Gopal, Sattva S Neelapu, Philippe Armand, Stephen Spurgeon, John P Leonard, F Stephen Hodi, Rachel E Sanborn, Ignacio Melero, Thomas F Gajewski, Matthew Maurer, Serena Perna, Andres A Gutierrez, Raphael Clynes, Priyam Mitra, Satyendra Suryawanshi, Douglas Gladstone, Margaret K Callahan. Initial experience administering BMS-986016, a monoclonal antibody that targets lymphocyte activation gene (LAG)-3, alone and in combination with nivolumab to patients with hematologic and solid malignancies.Journal for ImmunoTherapy of Cancer 2016, 4(Suppl 1):P232
  66. Andrew L Coveler, David C Smith, Juneko E Grilley-Olson, Thomas F Gajewski, Sanjay Goel, Shyra J Gardai, Che-Leung Law, Gary Means, Thomas Manley, Brendan Curti. SEA-CD40 is a CD40 agonist with early evidence of pharmacodynamic and antitumor activity: preliminary results from a phase I study in advanced solid malignancies.Journal for ImmunoTherapy of Cancer 2016, 4(Suppl 1):P145.
  67. Mark Ayers, Jared Lunceford, Michael Nebozhyn, Erin Murphy, Andrey Loboda, David R Kaufman, Andrew Albright, Jonathan Cheng, S Peter Kang, Veena Shankaran, Sarina A Piha-Paul, Jennifer Yearley, Tanguy Seiwert, Antoni Ribas, Terrill K McClanahan. An immune-related gene expression profile delineates features of the tumor microenvironment required for clinical response to PD-1 blockade.Journal for ImmunoTherapy of Cancer 2016, 4(Suppl 1):P71.
  68. J. Desai; Y.S. Hong; J.E. Kim; T.W. Kim; S.W. Han; Y-J. Bang; C.E. Chee; V.Y.M. Heong; A. McRee; L.Q. Chow; E.L. Kwak; J.R. Infante; J. Wallin; M. Das Thakur; G. Mwawasi; P. Foster; E. Cha; J.C. Bendell .Efficacy and safety of cobimetinib (cobi) and atezolizumab (atezo) in an expanded phase 1b study of microsatellite-stable (MSS) metastatic colorectal cancer (mCRC).Ann Oncol (2016) 27 (suppl_6): 470P.
  69. O. Hamid; L.Q. Chow; R.E. Sanborn; S. Marshall; C. Black; M. Gribbin; J. McDevitt; J.J. Karakunnel; J.E. Gray Combination of MEDI0680, an anti-PD-1 antibody, with durvalumab, an anti-PD-L1 antibody: A phase 1, open-label study in advanced malignancies.Ann Oncol (2016) 27 (suppl_6): 1050PD.
  70. P.M. Fracasso; D.J. Freeman; K. Simonsen; Y. Shen; M. Gupta; A. Comprelli; J.F. Gainor; M. Hellmann; L.Q. Chow; P.M. Forde; R. Govindan; T.P. Reilly; J. Cassidy.A phase 2, fast real-time assessment of combination therapies in immuno-oncology trial in patients with advanced non-small cell lung cancer (FRACTION-lung).Ann Oncol (2016) 27 (suppl_6): 1295TiP.
  71. S. Hingorani; A. Bullock; W. Harris; W. Wu; P. Jiang; D. Chondros; S. Khelifa; C. Aldrich; J. Pu; A. Hendifar. Final analysis of stage 1 data from a randomized phase 2 study of PEGPH20 plus nab-paclitaxel/gemcitabine in stage IV previously untreated pancreatic cancer patients, utilizing Ventana companion diagnostic assay. Ann Oncol (2016) 27 (suppl_2): ii103.
  72. Infante J, Kim TM, Friedmann J, Miller Jr WH, Lee C, Jamal R, Chow LQ, Reddy S, Liu B,  Cha E, Rooney I, Flaherty K. Safety and clinical activity of atezolizumab combined with cobimetinib in metastatic melanoma.  Oral presentation at Society for Melanoma Research Congress. November 2016, Boston, MA.
  73. Seth Pollack, Hailing Lu, Neeta Somaiah, Sant Chawla, John Morris,, Khanh T Do, Joseph W Kim, Matthew S Block, Marissa Vignali, Julie Rytlewski, Erik Yusko,Frank Hsu, Chet Bohac, Patrick Hwu, Sacha Gnjatic, Jan ter Meulen. CMB305 or LV305-induced and Baseline Anti-NY-ESO-1 Immunity is Associated With Survival in Recurrent Cancer Patients.J Clin Oncol 35, 2017 (suppl, Abstract 3090).
  74. Neeta Somaiah, Sant P. Chawla, Ma3hew Stephen Block, John Morris,  Khanh Do, Joseph W. Kim, Mihaela Druta, Kamalesh Kumar Sankhala,  Patrick Hwu, Robin Jones, Sacha GnjaDc, Hailing Lu, Richard T. Kenney,  Chet Bohac, Seth Pollack. Immune response, safety, and survival impact  from CMB305 in NY-ESO-1+ recurrent  soft tissue sarcomas (C131 Study).J Clin Oncol 35, 2017 (suppl, Abstract 3090).
  75. Sunil R. Hingorani, Andrea J. Bullock, Tara Elisabeth Seery, Lei Zheng, Darren Sigal, Paul S. Ritch, Fadi S. Braiteh, Mark Zalupski, Nathan Bahary, William Proctor Harris, Jie Pu, Carrie Aldrich, Sihem Khelifa, Xionghua W. Wu, Joaquina Baranda, Ping Jiang, Andrew Eugene Hendifar; Randomized phase II study of PEGPH20 plus nab-paclitaxel/gemcitabine (PAG) vs AG in patients (Pts) with untreated, metastatic pancreatic ductal adenocarcinoma (mPDA).  J Clin Oncol 35, 2017 (suppl; abstr 4008).
  76. Amy E. Chang, Safi Shahda, William Proctor Harris, Stacey Cohen, Andrew L. Coveler, Bert H. O'Neil, Vijayakrishna K. Gadi, Reina Hibbert, Hannah H Lee, Anne Younger, Kinsey Ann McCormick, Colin Pritchard, Mary Weber Redman, E. Gabriela Chiorean;  Phase I/IB multicenter study of afatinib in combination with capecitabine in patients (pts) with refractory solid tumors and pancreatico-biliary cancers.  J Clin Oncol 35, 2017 (suppl 4S; abstract TPS515).
  77. Toni K. Choueiri, F. Stephen Hodi, John A. Thompson, David F. McDermott, Wen-Jen Hwu, Donald P. Lawrence, Nancy Ann Dawson, Deborah Jean Lee Wong, Shailender Bhatia, Marihella James, Xinxin Shu, Blanca Homet Moreno, Nageatte Ibrahim, Rodolfo F. Perini, Antoni Ribas, Michael B. Atkins; Pembrolizumab (pembro) plus low-dose ipilimumab (ipi) for patients (pts) with advanced renal cell carcinoma (RCC): Phase 1 KEYNOTE-029 study. J Clin Oncol 35, 2017 (suppl 6S; abstract 510).
  78. Wilson H. Miller, Tae Min Kim, Carrie B. Lee, Keith T. Flaherty, Sunil Reddy, Rahima Jamal, Laura Q. Chow, Isabelle Anne Rooney, Bethany Pitcher, Edward Cha, Jeffrey R. Infante; Atezolizumab (A) + cobimetinib (C) in metastatic melanoma (mel): Updated safety and clinical activity.  J Clin Oncol 35, 2017 (suppl; abstr 3057).
  79. Robert I. Haddad, Tanguy Y. Seiwert, Laura Quan Man Chow, Shilpa Gupta, Jared Weiss, Iris Gluck, Joseph Paul Eder, Barbara Burtness, Makoto Tahara, Bhumsuk Keam, Hyunseok Kang, Kei Muro, Andrew Albright, Lingkang Huang, Mark Ayers, Robin Mogg, Razvan Cristescu, Jonathan D. Cheng, Ranee Mehra; Genomic Determinants of Response to Pembrolizumab in Head and Neck Squamous Cell Carcinoma.  J Clin Oncol 35, 2017 (suppl; abstr 6009).
  80. Howard A. Burris, Margaret K. Callahan, Anthony W. Tolcher, Shivaani Kummar, Gerald Steven Falchook, Russell Kent Pachynski, Scott S. Tykodi, Geoffrey Thomas Gibney, Tanguy Y. Seiwert, Justin F. Gainor, Patricia LoRusso, James Hilbert, Josh F Apgar, Fei Hua, John M Burke, Manny Lazaro, Myles Clancy, Baoyu Ding, Elizabeth G. Trehu, Timothy Anthony Yap;  Phase 1 safety of ICOS agonist antibody JTX-2011 alone and with nivolumab (nivo) in advanced solid tumors; predicted vs observed pharmacokinetics (PK) in ICONIC.  J Clin Oncol 35, 2017 (suppl; abstr 3033).
  81. Adi Diab, Nizar M. Tannir, Chantale Bernatchez, Cara L. Haymaker, Salah E Bentebibel, Brendan D. Curti, Michael K.K. Wong, Ivan Gergel, Mary Ann Tagliaferri, Jonathan Zalevsky, Ute Hoch, Sandra Aung, Michael Imperiale, Daniel C. Cho, Scott S. Tykodi, Igor Puzanov, Harriet M. Kluger, Michael E. Hurwitz, Patrick Hwu, Mario Sznol;   A phase 1/2 study of a novel IL-2 cytokine, NKTR-214, and nivolumab in patients with select locally advanced or metastatic solid tumors.  J Clin Oncol 35, 2017 (suppl; abstr e14040).
  82. John A. Thompson, Oleg Akilov, Christiane Querfeld, Matthew H. Taylor, Lisa Johnson, Tina Catalano, Penka S. Petrova, Robert A. Uger, Meghan Irwin, Eric L. Sievers;  A phase 1 dose-escalation trial of intratumoral TTI-621, a novel immune checkpoint inhibitor targeting CD47, in subjects with relapsed or refractory percutaneously-accessible solid tumors and mycosis fungoides.J Clin Oncol 35, 2017 (suppl; abstr TPS3101).
  83. Anthony B. El-Khoueiry, Omid Hamid, John A. Thompson, Willeke Ros, Ferry Eskens, Toshihiko Doi, Siwen Hu-Lieskovan, Jeffrey Chou, Ken Liao, Bishu J Ganguly, Catherine Fleener, Tenshang Joh, Adi Diab;  The relationship of pharmacodynamics (PD) and pharmacokinetics (PK) to clinical outcomes in a phase I study of OX40 agonistic monoclonal antibody (mAb) PF-04518600 (PF-8600).  J Clin Oncol 35, 2017 (suppl; abstr 3027)
  84. Matteo S. Carlino, Victoria Atkinson, Jonathan S. Cebon, Michael B. Jameson, Bernie M. Fitzharris, Catriona M. McNeil, Andrew G Hill, Antoni Ribas, Michael B. Atkins, John A. Thompson, Wen-Jen Hwu, F. Stephen Hodi, Alexander M. Menzies, Alexander David Guminski, Richard Kefford, Xinxin Shu, Nageatte Ibrahim, Blanca Homet Moreno, Georgina V. Long;  KEYNOTE-029: Efficacy and safety of pembrolizumab (pembro) plus ipilimumab (ipi) for advanced melanoma.  J Clin Oncol 35, 2017 (suppl; abstr 9545)
  85. Toni K. Choueiri, F. Stephen Hodi, John A. Thompson, David F. McDermott, Wen-Jen Hwu, Donald P. Lawrence, Nancy Ann Dawson, Deborah Jean Lee Wong, Shailender Bhatia, Marihella James, Xinxin Shu, Blanca Homet Moreno, Nageatte Ibrahim, Rodolfo F. Perini, Antoni Ribas, Michael B. Atkins;  Pembrolizumab (pembro) plus low-dose ipilimumab (ipi) for patients (pts) with advanced renal cell carcinoma (RCC): Phase 1 KEYNOTE-029 study.  J Clin Oncol 35, 2017 (suppl 6S; abstract 510).
  86. Ian Chau, Johanna C. Bendell, Emiliano Calvo, Rafael Santana-Davila, Hendrik-Tobias Arkenau, Gu Mi, Jin Jin, Jessicca Rege, David Ferry, Roy S. Herbst, Charles S. Fuchs; Ramucirumab (R) plus pembrolizumab (P) in treatment naive and previously treated advanced gastric or gastroesophageal junction (G/GEJ) adenocarcinoma: A multi-disease phase I study.J Clin Oncol 35, 2017 (suppl; abstr 4046).
  87. Daniel Peter Petrylak, Hendrik-Tobias Arkenau, Jose Luis Perez-Gracia, Matthew Krebs, Rafael Santana-Davila, Jing Yang, Jessicca Rege, Gu Mi, David Ferry, Roy S. Herbst; A multicohort phase I study of ramucirumab (R) plus pembrolizumab (P): Interim safety and clinical activity in patients with urothelial carcinoma.J Clin Oncol 35, 2017 (suppl 6S; abstract 349).
  88. Ian Chau, Johanna C. Bendell, Emiliano Calvo, Rafael Santana-Davila, Jordi Rodon Ahnert, Nicolas Penel, Hendrik-Tobias Arkenau, Jing Yang, Jessicca Rege, Gu Mi, David Ferry, Roy S. Herbst, Charles S. Fuchs; Interim safety and clinical activity in patients (pts) with advanced gastric or gastroesophageal junction (G/GEJ) adenocarcinoma from a multicohort phase 1 study of ramucirumab (R) plus pembrolizumab (P).J Clin Oncol 35, 2017 (suppl 4S; abstract 102).
  89. Olivia Sears, Howard Burris, Anthony Tolcher, Margaret Callahan, Timothy Yap, Shivanni Kummar, Gerald Falchook7, Russell Pachynski, Scott Tykodi, Tanguy Siewert, Geoffrey Gibney, Justin Gainor, Patricia LoRusso, Emmanuel Lazaro, Myles Clancy, Ella Li, Baoyu Ding, Elizabeth Trehu. ICONIC: Phase 1/2 trial of ICOS agonist JTX-2011 alone and in combination with nivolumab (nivo).Cancer Res 2017;77(13 Suppl):Abstract nr CT035.
  90. Suzanne L. Topalian, Shailender Bhatia, Antoine Hollebecque, Ahmad Awada, Jan Paul De Boer, Ragini R. Kudchadkar, Anthony Goncalves, Jean-Pierre Delord, Uwe M. Martens, Jose Maria Lopez Picazo, Ana Oaknin, William C. Spanos, Raid Aljumaily, William H. Sharfman, Shangbang Rao, Ibrahima Soumaoro, Alexander Cao, Paul Nghiem, Dirk Schadendorf. Non-comparative, open-label, multiple cohort, phase 1/2 study to evaluate nivolumab (NIVO) in patients with virus-associated tumors (CheckMate 358): Efficacy and safety in Merkel cell carcinoma (MCC). Cancer Res 2017;77(13 Suppl):Abstract nr CT074.
  91. Sunil Hingorani; Andrea Bullock; Tara Seery; Lei Zheng; Darren Sigal; Paul Ritch; Fadi Braiteh; Mark Zalupski; Nathan Bahary; William Harris; Jie Pu; Carrie Aldrich; Sihem Khelifa; Wilson Wu; Joaquina Baranda; Ping Jiang; Andrew Hendifar. PEGPH20 improves pfs in patients with metastatic pancreatic ductal adenocarcinoma: A randomized phase 2 study in combination with nab-paclitaxel/gemcitabine. Ann Oncol (2017) 28 (suppl_3): mdx262.002.18.
  92. Michael B. Atkins, Matteo S. Carlino, Andrew G. Hill, Catriona M. McNeil, Georgina V. Long, Victoria Atkinson, Jonathan S. Cebon, Michael B. Jameson, Wen-Jen Hwu, John A. Thompson, James Anderson, Blanca Homet Moreno, Nageatte Ibrahim, and Antoni Ribas. KEYNOTE 029: A phase I/II randomized trial of pembrolizumab (pembro) plus 2 dose regimens of ipilimumab (ipi) for advanced melanoma.Cancer Res 2017;77(13 Suppl):Abstract nr CT065.
Abstracts

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Publications
  1. Fishman MN, Thompson JA, Pennock GK, Gonzalez R, Diez LM, Daud AI, Weber JS, Huang BY, Tang S, Rhode PR, Wong HC, Phase 1 trial of ALT-801, an interleukin-2/T cell receptor fusion protein targeting p53 (aa264-272)/HLA-A*0201 complex, in patients with advanced malignancies, 2011, Clin Cancer Res, 17(24):7765-75.
  2. Jonathan R. Fromm, Julie A. McEarchern, Dana Kennedy, Anju Thomas, Andrei R. Shustov, Ajay K. Gopal. Clinical Binding Properties, Internalization Kinetics, and Clinicopathologic Activity of Brentuximab Vedotin: An Antibody-Drug Conjugate for CD30-Positive Lymphoid Neoplasms 2012. Clinical Lymphoma, Myeloma & Leukemia, Vol. 12, No. 4, 280-3.
  3. Julie R. Brahmer, M.D., Scott S. Tykodi, M.D., Ph.D., Laura Q.M. Chow, M.D., Wen-Jen Hwu, M.D., Ph.D., Suzanne L. Topalian, M.D., Patrick Hwu, M.D., Charles G. Drake, M.D., Ph.D., Luis H. Camacho, M.D., M.P.H., John Kauh, M.D., Kunle Odunsi, M.D., Ph.D., Henry C. Pitot, M.D., Omid Hamid, M.D., Shailender Bhatia, M.D., Renato Martins, M.D., M.P.H., Keith Eaton, M.D., Ph.D., Shuming Chen, Ph.D., Theresa M. Salay, M.S., Suresh Alaparthy, Ph.D., Joseph F. Grosso, Ph.D., Alan J. Korman, Ph.D., Susan M. Parker, Ph.D., Shruti Agrawal, Ph.D., Stacie M. Goldberg, M.D., Drew M. Pardoll, M.D., Ph.D., Ashok Gupta, M.D., Ph.D., and Jon M. Wigginton, M.D. Safety and Activity of Anti–PD-L1 Antibody in Patients with Advanced Cancer.N Engl J Med. 2012 Jun 28;366(26):2455-65.
  4. Nademanee, Stephen J. Forman and Ajay K. Gopal, Robert Chen, Joycelynne M. Palmer, Sandra H. Thomas, Ni-Chun Tsai, Len Farol, Auayporn.Brentuximab vedotin enables successful reduced-intensity allogeneic hematopoietic cell transplantation in patients with relapsed or refractory Hodgkin lymphoma.Blood. 2012 Jun 28;119(26):6379-81.
  5. Gopal AK, Tarantolo SR, Bellam N, Green DJ, Griffin M, Feldman T, Kato AR, Eisenfeld AJ, Stromatt SC, Goy A. Phase 1b study of otlertuzumab (TRU-016), an anti-CD37 monospecific ADAPTIRTM therapeutic protein, in combination with rituximab and bendamustine in relapsed indolent lymphoma patients, 2014, Invest New Drugs, Dec; 32(6):1213-258
  6. Alice T. Shaw, M.D., Ph.D., Dong-Wan Kim, M.D., Ph.D., Ranee Mehra, M.D., Daniel S.W. Tan, M.B., B.S., Enriqueta Felip, M.D., Ph.D., Laura Q.M. Chow, M.D., D. Ross Camidge, M.D., Ph.D., Johan Vansteenkiste, M.D., Ph.D., Sunil Sharma, M.D., Tommaso De Pas, M.D., Gregory J. Riely, M.D., Ph.D., Benjamin J. Solomon, M.B., B.S., Ph.D., Juergen Wolf, M.D., Ph.D., Michael Thomas, M.D., Martin Schuler, M.D., Geoffrey Liu, M.D., Armando Santoro, M.D.,Yvonne Y. Lau, Ph.D., Meredith Goldwasser, Sc.D., Anthony L. Boral, M.D., Ph.D., and Jeffrey A. Engelman, M.D., Ph.D.Ceritinib in ALK-Rearranged Non–Small-Cell Lung Cancer.N Engl J Med 2014;370:1189-97.
  7. Shailender Bhatia, Brendan Curti, Marc S Ernstoff, Michael Gordon, Elisabeth I Heath, Wilson H Miller Jr, Igor Puzanov, David I Quinn, Thomas W Flaig, Peter VanVeldhuizen, Kelly Byrnes-Blake1, Jeremy A Freeman, Rachel Bittner, Naomi Hunder, Sonia Souza and John A Thompson. Recombinant interleukin-21 plus sorafenib for metastatic renal cell carcinoma: a phase 1/2 study. J Immunother Cancer. 2014 Jan 27;2:2.
  8. Tannir NM, Forero-Torres A, Ramchandren R, Pal SK, Ansell SM, Infante JR, de Vos S, Hamlin PA, Kim SK, Whiting NC, Gartner EM, Zhao B, Thompson JA.Phase I dose-escalation study of SGN-75 in patients with CD70-positive relapsed/refractory non-Hodgkin lymphoma or metastatic renal cell carcinoma.Invest New Drugs. 2014 Dec;32(6):1246-57.
  9. Konopleva M, Thall PF, Yi CA, Borthakur G, Coveler A, Bueso-Ramos C, Benito J, Konoplev S, Gu Y, Ravandi F, Jabbour E, Faderl S, Thomas D, Cortes J, Kadia T, Kornblau S, Daver N, Pemmaraju N, Nguyen HQ, Feliu J, Lu H, Wei C, Wilson WR, Melink TJ, Gutheil JC, Andreeff M, Estey EH, Kantarjian H.Phase I/II study of the hypoxia-activated prodrug PR104 in refractory/relapsed acute myeloid leukemia and acute lymphoblastic leukemia.Haematologica. 2015 Jul;100(7):927-34.
  10. Martinelli G, Oehler VG, Papayannidis C, Courtney R, Shaik MN, Zhang X, O'Connell A, McLachlan KR, Zheng X, Radich J, Baccarani M, Kantarjian HM, Levin WJ, Cortes JE, Jamieson C. Treatment with PF-04449913, an oral smoothened antagonist, in patients with myeloid malignancies: a phase 1 safety and pharmacokinetics study.Lancet Haematol. 2015 Aug;2(8):e339-46.
  11. Munster P, Aggarwal R, Hong D, Schellens JHM, van der Noll R, Specht J, Witteveen PO, Werner TL, Dees EC, Bergsland E, Agarwal N, Kleha JF, Durante M, Adams L, Smith DA, Lampkin TA, Morris SR, Kurzrock R, First-in-human phase 1 study of GSK2126458, an oral pan-class I phosphatidylinositol-3-kinase inhibitor, in patients with advanced solid tumor malignancies, 2015, Clin Cancer Res, 22(8):1932-9, PMID 26603258
  12. Jones RL, Bendell JC, Smith DC, Diefenbach K, Lettieri J, Boix O, Lockhart AC, O'Bryant C, Moore KN.A phase I open-label trial evaluating the cardiovascular safety of regorafenib in patients with advanced cancer.Cancer Chemother Pharmacol. 2015 Oct;76(4):777-84.
  13. Smith DC, Kalebic T, Infante JR, Siu LL, Sullivan D, Vlahovic G, Kauh JS, Gao F, Berger AJ, Tirrell S, Gupta N, Di Bacco A, Berg D, Liu G, Lin J, Hui AM, Thompson JA.Phase 1 study of ixazomib, an investigational proteasome inhibitor, in advanced non-hematologic malignancies.Invest New Drugs. 2015 Jun;33(3):652-63.
  14. Zhao B, Chen R, O'Connor OA, Gopal AK, Ramchandren R, Goy A, Matous JV, Fasanmade AA, Manley TJ, Han TH. Brentuximab vedotin, an antibody-drug conjugate, in patients with CD30-positive haematologic malignancies and hepatic or renal impairment.Br J Clin Pharmacol. 2016 Sep;82(3):696-705.
  15. Hingorani SR, Harris WP, Beck JT, Berdov BA, Wagner SA, Pshevlotsky EM, Tjulandin SA, Gladkov OA, Holcombe RF, Korn R, Raghunand N, Dychter S, Jiang P, Shepard HM, Devoe CE. Phase 1b study of PEGylated recombinant human hylauronidase and gemcitabine in patients with advanced pancreatic cancer. 2016, Clin Cancer Res; 22(12): 2848-54, PMID 26813359
  16. Rodler ET, Kurland BF, Griffin M, Gralow JR, Porter P, Yeh RF, Gadi VK, Guenthoer J, Beumer JH, Korde L, Strychor S, Kiesel BF, Linden HM, Thompson JA, Swisher E, Chai X, Shepherd S, Giranda V, Specht JM. Phase 1 study of veliparib (ABT-888) combined with cisplatin and vinorelbine in advanced triple-negative breast cancer and/or BRCA mutation-associated breast cancer. 2016, Clin Cancer Res, 22(12):2855-64.
  17. Chow LQ, Haddad R, Gupta S, Mahipal A, Mehra R, Tahara M, Berger R, Eder JP, Burtness B, Lee SH, Keam B, Kang H, Muro K, Weiss J, Geva R, Lin CC, Chung HC, Meister A, Dolled-Filhart M, Pathiraja K, Cheng JD, Seiwert TY.Antitumor Activity of Pembrolizumab in Biomarker-Unselected Patients With Recurrent and/or Metastatic Head and Neck Squamous Cell Carcinoma: Results From the Phase Ib KEYNOTE-012 Expansion Cohort. 2016, J Clin Oncol. 34 (32): 3838-3845.
  18. Chow LQ, Smith DC, Tan AR, Denlinger CS, Wang D, Shepard DR, Chaudhary A, Lin Y, Gao L.Lack of pharmacokinetic drug-drug interaction between ramucirumab and paclitaxel in a phase II study of patients with advanced malignant solid tumors.2016 Cancer Chemother Pharmacol. 78(2):433-41.
  19. Seiwert TY, Burtness B, Mehra R, Weiss J, Berger R, Eder JP, Heath K, McClanahan T, Lunceford J, Gause C, Cheng JD, Chow LQ.Safety and clinical activity of pembrolizumab for treatment of recurrent or metastatic squamous cell carcinoma of the head and neck (KEYNOTE-012): an open-label, multicentre, phase 1b trial. 2016, Lancet Oncol. 17(7):956-65.
  20. Nanda R, Chow LQ, Dees EC, Berger R, Gupta S, Geva R, Pusztai L, Pathiraja K, Aktan G, Cheng JD, Karantza V, Buisseret L.Pembrolizumab in Patients With Advanced Triple-Negative Breast Cancer: Phase Ib KEYNOTE-012 Study. 2016, J Clin Oncol. 34(21):2460-7.
  21. Bhatia S, Pavlick AC, Boasberg P, Thompson JA, Mulligan G, Pickard MD, Faessel H, Dezube BJ, Hamid O.A phase I study of the investigational NEDD8-activating enzyme inhibitor pevonedistat (TAK-924/MLN4924) in patients with metastatic melanoma. 2016, Invest New Drugs. 34(4):439-49.
  22. Coveler AL, Ko AH, Catenacci DV, Von Hoff D, Becerra C, Whiting NC, Yang J, Wolpin B.A phase 1 clinical trial of ASG-5ME, a novel drug-antibody conjugate targeting SLC44A4, in patients with advanced pancreatic and gastric cancers.Invest New Drugs. 2016 Jun;34(3):319-28.
  23. Muro K, Chung HC, Shankaran V, Geva R, Catenacci D, Gupta S, Eder JP, Golan T, Le DT, Burtness B, McRee AJ, Lin CC, Pathiraja K, Lunceford J, Emancipator K, Juco J, Koshiji M, Bang YJ.Pembrolizumab for patients with PD-L1-positive advanced gastric cancer (KEYNOTE-012): a multicentre, open-label, phase 1b trial.Lancet Oncol. 2016 Jun;17(6):717-26.
  24. Stein M, Chow LQM, Smith DC, Shepard D, Wang D, Powderly J, Chaudhary A, Lin Y, Gao L. Phase II Study Evaluating the Effect of Concomitant Ramucirumab on the Pharmacokinetics of Docetaxel in Patients with Advanced Solid Tumors. Clin Pharmacol Biopharm 5:161. doi: 10.4172/2167-065X.1000161
  25. Plimack ER, Bellmunt J, Gupta S, Berger R, Chow LQ, Juco J, Lunceford J, Saraf S, Perini RF, O'Donnell PH.Safety and activity of pembrolizumab in patients with locally advanced or metastatic urothelial cancer (KEYNOTE-012): a non-randomised, open-label, phase 1b study.Lancet Oncol. 2017 Feb;18(2):212-220.
  26. Frankel AE, Flaherty KT, Weiner GJ, Chen R, Azad NS, Pishvaian MJ, Thompson JA, Taylor MH, Mahadevan D, Lockhart AC, Vaishampayan UN, Berlin JD, Smith DC, Sarantopoulos J, Riese M, Saleh MN, Ahn C, Frenkel EP.Academic Cancer Center Phase I Program Development.Oncologist. 2017 Apr;22(4):369-374.
  27. Anthony W Tolcher, Mario Sznol, Siwen Hu-Lieskovan, Kyriakos P. Papadopoulos, Amita Patnaik, Drew Rasco, Donna Di Gravio, Bo Huang, Dhiraj Gambhire, Ying Chen, Aron Thall, Nuzhat Pathan, Emmett V. Schmidt and Laura Q.M. Chow. Phase Ib Study of Utomilumab (PF-05082566), a 4-1BB/CD137 Agonist, in Combination with Pembrolizumab (MK-3475) in Patients with Advanced Solid Tumors.Clin Cancer Res. 2017 Jun 20.  [Epub ahead of print].
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