SITC 2017 Abstract Titles – Clinical Trials (In Progress)

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Authors

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Keywords

P218

KEYNOTE-585: randomized, phase 3 study of chemotherapy + pembrolizumab vs chemotherapy + placebo as neoadjuvant/adjuvant treatment for patients with gastric or gastroesophageal junction (G/GEJ) cancer

Yung-Jue Bang1, Eric Van Cutsem2, Charles Fuchs3, Atsushi Ohtsu4, Josep Tabernero5, David Ilson6, Woo Jin Hyung7, Vivian Strong6, Thorsten Goetze8, Takaki Yoshikawa9, Laura Tang6, Linda Sun10, Aisha Hasan10, Minori Koshiji11, Kohei Shitara4

1Seoul National University Hospital, Seoul, Republic of Korea 2University Hospitals Gasthuisberg Leuven and KU Leuven, Leuven, Belgium 3Yale Cancer Center, New Haven, CT, USA 4National Cancer Hospital East, Chiba, Japan 5Vall d'Hebron University Hospital and Institute of Oncology (VHIO), Barcelona, Spain 6Memorial Sloan Kettering Cancer Center, New York, NY, USA 7Yonsei Cancer Hospital, Yonsei University Health System, Seoul, Republic of Korea 8Institute of Clinical Cancer Research, UCT University Cancer Center, Frankfurt, Germany 9Kanagawa Cancer Center, Kanagawa, Japan 10Merck & Co., Inc., Kenilworth, NJ, USA 11Merck & Co., Inc., New York, NY, USA

Antibody | Checkpoint blockade | Clinical trial | Targeted therapy | Solid tumors

P219

Phase 1/1b, first-in-human study of the PI3K-gamma inhibitor IPI-549 as monotherapy and combined with nivolumab in patients with advanced solid tumors

Antoni Ribas1, David Hong2, Anthony Tolcher3, Ryan Sullivan4, Geoffrey Shapiro5, Bartosz Chmielowski1, Les Brail6, Lucy Lee6, Suresh Mahabhashyam6, Claudio Dansky Ullmann6, Michael Postow7, Jedd Wolchok7

1University of California, Los Angeles, Los Angeles, CA, USA 2MD Anderson Cancer Center, Houston, TX, USA 3South Texas Accelerated Research Therapeutics (START), San Antonio, TX, USA 4Massachusetts General Hospital, Boston, MA, USA 5Dana-Farber Cancer Institute, Boston, MA, USA 6Infinity Pharmaceuticals, Inc., Cambridge, MA, USA 7Memorial Sloan Kettering Cancer Center, New York, NY, USA

Checkpoint blockade | Clinical study | Solid tumors | Tumor microenvironment | Chemotherapy | Clinical trial | Monocyte/Macrophage

P220

A phase 2, multicenter study to evaluate the efficacy and safety using autologous tumor infiltrating lymphocytes (LN-145) in patients with recurrent, metastatic, or persistent cervical carcinoma

Amir Jazaeri1, Robert Edwards2, Emese Zsiros3, Robert Brown4, Gorbatchevsky Igor4, Sam Suzuki4, Fardis Maria4, Robert Wenham5

1University of Texas MD Anderson Cancer Center, Houston, TX, USA 2Magee-Women's Hospital of University of Pittsburgh Medical Center, Pittsburgh, PA, USA 3Roswell Park Cancer Institute, Buffalo, NY, USA 4Iovance Biotherapeutics, San Carlos, CA, USA 5Moffitt Cancer Center, Tampa, FL, USA

Adoptive immunotherapy | Chemotherapy | Clinical study | Neoantigens | Targeted therapy | Tumor antigens | Clinical trial | Solid tumors | T cell | Tumor infiltrating lymphocytes (TILs)

P221

A phase 2 study to evaluate the safety and efficacy using autologous tumor infiltrating lymphocytes (LN-145) in patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck

Rom Leidner1, James Ohr2, Robert Brown3, Sam Suzuki3, Igor Gorbatchevsky3, Maris Fardis3, Robert Ferris2

1Earle A. Chiles Research Institute – Providence Cancer Center,, Portland, OR, USA 2Hillman Cancer Center at UPMC, Pittsburgh, PA, USA 3Iovance Biotherapeutics, San Carlos, CA, USA

Adoptive immunotherapy | Clinical study | Clinical trial | Tumor infiltrating lymphocytes (TILs) | T cell | Solid tumors | Tumor antigens

P222

Clinical trial in progress: A phase 1b trial of talimogene laherparepvec (T-VEC) in combination with dabrafenib and trametinib in advanced melanoma with an activating BRAF mutation

Kenneth Byrd1, Nibedita Chakraborty2, Mehmet Kocak1, Alisa Harber2, Ari Vanderwalde2

1University of Tennessee Health Science Center, Memphis, TN, USA, Memphis, TN, USA 2West Cancer Center, Germantown, TN, USA, Germantown, TN, USA

Antigen presenting cells | Clinical trial | Vaccine

P223

KEYNOTE-199: Phase 2 nonrandomized study of pembrolizumab in patients with PD-L1+ and PD-L1– metastatic castration-resistant prostate cancer

Johann de Bono1, Josep Piulats2, Marine Gross-Goupil3, Jeffrey Goh4, Kristiina Ojamaa5, Christopher Hoimes6, Ulka Vaishampayan7, Raanan Berger8, Ahmet Sezer9, Ronald De Wit10, Charles Drake11, Haiyan Wu12, Christian Poehlein12, Emmanuel S. Antonarakis13

1Royal Marsden Hospital and the Institute of Cancer Research, London, United Kingdom 2Instituto Catalan de Oncologia, Hospital Duran i Reynals, Hospitalet de Llobregat, Barcelona, Spain 3Institut Bergonie, Bordeaux, France 4Royal Brisbane & Women’s Hospital, Brisbane, Australia 5East Tallinn Central Hospital, Tallinn, Estonia 6University Hospitals Seidman Cancer Center, Cleveland, OH, USA 7Karmanos Cancer Institute, Detroit, MI, USA 8Chaim Sheba Medical Center, Ramat-Gan, Israel 9Baskent Üniversitesi Adana Uyg. ve Arast, Adana, Turkey 10Erasmus MC Cancer Institute, Rotterdam, Netherlands 11Columbia University, New York, NY, USA 12Merck & Co., Inc., Kenilworth, NJ, USA 13Johns Hopkins Kimmel Cancer Center, Baltimore, MD, USA

Checkpoint blockade | Antibody | Clinical trial | Solid tumors | Targeted therapy

P224

Immunological correlates observed in an Interim analysis of the Phase 3 ADAPT Trial evaluating Rocapuldencel-T (AGS-003), for the treatment of patients with metastatic renal cell carcinoma (mRCC)

Mark DeBenedette1, Alicia Gamble1, Ana Plachco1, Marcus Norris1, Charles Nicolette1

1Argos Therapeutics Inc, Durham, NC, USA

Dendritic cell | Biomarkers | Immune monitoring | Clinical trial | T cell

P225

Functional reversal of Foxp3+ T regulatory activity in patients enrolled in the Phase 3 ADAPT Trial evaluating Rocapuldencel-T for the treatment of patients with metastatic renal cell carcinoma (mRCC)

Mark DeBenedette1, Joe Horvatinovich1, Elizabeth Grogan1, Larissa Benavente1, Irina Tcherepanova1, Charles Nicolette1

1Argos Therapeutics Inc, Durham, NC, USA

Dendritic cell | Regulatory T cell (Treg) | Immune monitoring | Biomarkers | Clinical trial | T cell

P226

FRACTION-RCC: a randomized, open-label, adaptive, phase 2 study of nivolumab in combination with other immuno-oncology agents in patients with advanced RCC

Corina Candiani Taitt1, Robert J. Motzer2, Toni K. Choueiri3, Bernard J. Escudier4, Timothy Kuzel5, Michael A. Carducci6, Suresh Nair7, Scott S. Tykodi8, Sarah Tannenbaum-Dvir1, Megan Wind-Rotolo1, Katy L. Simonsen1, Paula M. Fracasso1

1Bristol-Myers Squibb, Princeton, NJ, USA 2Memorial Sloan Kettering Cancer Center, New York, NY, USA 3Dana-Farber Cancer Institute, Boston, MA, USA 4Gustave Roussy Cancer Centre, Villejuif Cedex, France 5Rush University Medical Center, Chicago, IL, USA 6Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University, Baltimore, MD, USA 7Lehigh Valley Health Network, Allentown, PA, USA 8University of Washington and Fred Hutchinson Cancer Research Center, Seattle, WA, USA

Biomarkers | Checkpoint blockade | Clinical trial | Coinhibition | Solid tumors | Targeted therapy | T cell

P227

A trial to evaluate the safety, immunogenicity and clinical activity of a helper peptide vaccine plus PD-1 blockade

Craig Slingluff, Jr1, Elizabeth Gaughan1, William Grosh1, Gina Petroni1, Kimberly Bullock1

1University of Virginia, Charlottesville, VA, USA

Vaccine | Checkpoint blockade

P228

Pembrolizumab and decitabine for relapsed and refractory acute myeloid leukemia (PD-AML)

Catherine Lai1, Oetjen Karolyn1, Katherine Lindblad1, Christin Destefano1, Meghali Goswami1, Hong Yuen Wong1, Therese Intrater1, Debbie Draper1, Laura Dillon1, Christopher Hourigan1

1National Heart, Lung and Blood Institute, National Institutes of Health, Bethesda, MD, USA

Leukemia/Lymphoma | Checkpoint blockade | Clinical trial | Clinical study | Immune adjuvant

P229

WITHDRAWN




P230

Phase I/II Safety and Efficacy Study of Image Guided Intratumoral CD40 Agonistic Monoclonal Antibody APX005M in Combination with Systemic Pembrolizumab in Metastatic Melanoma Patients

Daniel Johnson H Johnson1, Srisuda Lecagoonporn1, Chantale Bernatchez1, Cara Haymaker1, Salah Bentebibel1, Marc Uemura1, Cassian Yee1, Rodabe Amaria1, Sapna Patel1, Hussein Tawbi1, Isabella Glitza1, Michael A. Davies1, Michael K. Wong1, Wen-Jen Hwu1, Patrick Hwu1, Willem Overwijk1, Adi Diab1

1UT-MD Anderson Cancer Center, Houston, TX, USA

Antigen presenting cells | Dendritic cell | Checkpoint blockade | Clinical study

P231

KEYNOTE-590: randomized, phase 3 study of chemotherapy + pembrolizumab vs chemotherapy + placebo as first-line therapy for patients with advanced esophageal or esophagogastric junction (E/EGJ) cancer

Ken Kato1, Manish Shah2, Peter Enzinger3, Jaafar Bennouna4, Lin Shen5, Antoine Adenis6, Ying Zhu7, Pooja Bhagia7, Minori Koshiji7, Toshihiko Doi8

1National Cancer Center Hospital, Tokyo, Japan 2Weill Cornell Medical College, New York Presbyterian Hospital, New York, NY, USA 3Dana Farber Cancer Institute, Boston, MA, USA 4CHU de Nantes, Nantes, France 5Beijing Cancer Hospital, Beijing, China 6Institut du Cancer de Montpellier, Montpellier, France 7Merck & Co., Inc., Kenilworth, NJ, USA 8National Cancer Center East, Chiba, Japan

Antibody | Checkpoint blockade | Clinical trial | Targeted therapy

P232

A pilot study to evaluate the clinical and immunological effects of incorporating a CD40-agonistic antibody into the multimodality treatment of resectable esophageal and GE junction cancers

Andrew H. Ko1, Lawrence Fong1

1University of California San Francisco, San Francisco, CA, USA

Antigen presenting cells | T cell | Chemotherapy | Clinical trial | Radiotherapy | Antibody

P233

A phase I study to evaluate the safety of multi-antigen stimulated tumor specific cellular therapy (MASCT-I) in patients with advanced solid tumors

Ruihua Xu1, Xiaoshuang Li2, Yanjun Kong2, Jianchuan Xia1, Desheng Weng1, Xiaoshi Zhang1, Xing Zhang1

1Sun Yat-sen university affiliated oncology hospital, Guangzhou, China 2HRYZ Biotech Company, Shenzhen, China

Adoptive immunotherapy | Clinical trial | Dendritic cell | Solid tumors | T cell | Vaccine | Tumor antigens

P234

AST-VAC2: An allogeneic dendritic cell cancer immunotherapy entering clinical trials in patients with lung cancer in the advanced and adjuvant setting

Christian Ottensmeier1, Hayley Farmer-Hall2, Gary Acton2, Heike Lentfer3, Kevin Nishimoto4, Uzma Shoukat-Mumtaz4, Erik Whiteley4, Rob Allen4, Jane Lebkowski4

1University of Southampton, Southampton, United Kingdom 2Cancer Research UK, London, United Kingdom 3Cancer Research UK, Potters Bar, United Kingdom 4Asterias Biotherapeutics, Fremont, CA, USA

Antigen presenting cells | Clinical trial | Solid tumors | Dendritic cell | T cell | Clinical study | Immune contexture | Targeted therapy | Adoptive immunotherapy

P235

Nivolumab in Patients with Advanced or Metastatic Non-Small Cell Lung Cancer (Stage IIIb/IV) who Have Received at Least One Prior Systemic chemotherapeutic Regimens

Sung Yong Lee1, Sang Mi Chung1, Ju Whan Choi1, Young Seok Lee1, Jong Hyun Choi1, Jee Youn Oh1, Kyung Hoon Min1, Gyu Young Hur1, Jae Jeong Shim1, Kyung Ho Kang1

1Korea University Medical Center, Seoul, Republic of Korea

Checkpoint blockade | Clinical study

P236

Innate immunotherapy of neuroblastoma and PD-1 checkpoint blockade

Holger Lode1, Maxi Zumpe1, Madlen Juettner1, Sascha Troschke-Meurer1, Evelyne Janzek2, Romana Schaefer2, Hans Loibner2, Nikolai Siebert1

1University Medicine Greifswald, Greifswald, Germany 2Apeiron Biologics, Vienna, Austria

Clinical study | Checkpoint blockade | Biomarkers | Antibody | Cytokine | Solid tumors

P237

Phase I study of adoptive transfer of iNKT cells for treating patients with relapsed/advanced hepatocellular carcinoma

Jun Lu1, Xuli Bao1, Jia Guo1, Wenfeng Sun2, Hui Chen2, Yanpin Ma1, Xiongwei Cui1

1Beijing YouAn Hospital, Capital Medical University, Beijing, China 2Beijing Gene Key Life Technology Co.Ltd., Beijing, China

Adoptive immunotherapy | Clinical trial | Immune monitoring | Immune toxicity | Clinical study | Solid tumors | NK/NK T cell | Targeted therapy | Cytokine | T cell

P238

Phase I study of adoptive transfer of specific hepatocellular carcinoma antigens CD8+ T cells for treating patients with relapsed/advanced HCC

Jun Lu1, Xuli Bao1, Yanpin Ma1, Hui Chen2, Wenfeng Sun2, Jia Guo1, Xiongwei Cui1

1Beijing YouAn Hospital, Capital Medical University, Beijing, China 2Beijing Gene Key Life Technology Co.Ltd., Beijing, China

Adoptive immunotherapy | Antigen presenting cells | Dendritic cell | Tumor antigens | Tumor infiltrating lymphocytes (TILs) | T cell | Solid tumors | Clinical trial | Cytokine

P239

Phase 3 Study of Pembrolizumab Plus Chemoradiation (CRT) vs CRT Alone for Locally Advanced Head and Neck Squamous Cell Carcinoma (LA-HNSCC): KEYNOTE-412

Jean-Pascal Machiels1, Chia-Jui Yen2, Lisa Licitra3, Danny Rischin4, John Waldron5, Barbara Burtness6, Vincent Gregoire1, Sanjiv Agarwala7, Yun Gan Tao8, Jeffrey Yorio9, Sercan Aksoy10, Sadakatsu Ikeda11, Ruey-Long Hong12, Joy Yang Ge13, Holly Brown13, Behzad Bidadi13, Lillian Siu5

1Cliniques Universitaires Saint-Luc, Brussels, Belgium 2National Cheng Kung University Hospital, Tainan City, Taiwan 3Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy 4Peter MacCallum Cancer Centre, East Melbourne, Australia 5Princess Margaret Cancer Centre, Toronto, ON, Canada 6Yale University School of Medicine, New Haven, CT, USA 7St. Luke's Cancer Center–Anderson, Easton, PA, USA 8Institut Gustave Roussy, Villejuif, France 9Texas Oncology–Austin Central, Austin, TX, USA 10Hacettepe Universitesi Tip Fakultesi, Ankara, Turkey 11Medical Hospital, Tokyo Medical and Dental University, Tokyo, Japan 12National Taiwan University Hospital, Taipei City, Taiwan 13Merck & Co., Inc., Kenilworth, NJ, USA

Antibody | Checkpoint blockade | Clinical trial | Targeted therapy

P240

Phase 1b trial of cabozantinib in combination with atezolizumab in patients with locally advanced or metastatic urothelial carcinoma or renal cell carcinoma

Manuel Caitano Maia1, Neeraj Agarwal2, Bradley McGregor3, Ulka Vaishampayan4, Toni K. Choueiri3, Marjorie Green5, Colin Hessel6, Christian Scheffold6, Gisela Schwab6, Thomas Powles7, Sumanta Pal1

1City of Hope, Duarte, CA, USA 2Huntsman Cancer Hospital, Salt Lake City, UT, USA 3Dana-Farber Cancer Institute, Boston, MA, USA 4Karmanos Cancer Center, Detroit, MI, USA 5Genentech, South San Francisco, CA, USA 6Exelixis Inc., South San Francisco, CA, USA 7Barts Cancer Institute, London, United Kingdom

Clinical trial | Targeted therapy | Checkpoint blockade | Solid tumors

P241

A First-in-Human Study of ALX148: CD47 Blockade to Enhance Innate and Adaptive Immunity for Advanced Solid Tumor Malignancy and Non Hodgkin Lymphoma

Nehal Lakhani1, Patricia LoRusso2, Anuradha Krishnamurthy3, Timothy O'Rourke1, Philip Fanning4, Yonggang Zhao5, Hong Wan4, Jaume Pons4, Sophia Randolph4, Wells Messersmith3

1START Midwest, Grand Rapids, MI, USA 2Yale Cancer Center, New Haven, CT, USA 3University of Colorado Cancer Center, Aurora, CO, USA 4Alexo Therapeutics Inc., South San Francisco, CA, USA 5Skyview Research, Norristown, PA, USA

Checkpoint blockade | Clinical trial | Monocyte/Macrophage | Solid tumors | Antigen presenting cells | Dendritic cell | Myeloid cells | Tumor microenvironment | Tumor evasion | Targeted therapy

P242

A phase 1 multicenter, dose escalation study of CBT-501, a novel anti-PD-1 inhibitor in subjects with select advanced or relapsed/recurrent solid tumors

Purvi Patel1, Mamatha Reddy1, Melissa Lopez1, Neil Sankar1, Sarath Kanekal1, Mike Li1, Sanjeev Redkar1, Gavin Choy1

1CBT Pharmaceuticals, Inc., Pleasanton, CA, USA

Checkpoint blockade | Clinical study

P243

An Open-Label Perioperative Pilot Study Evaluating Nivolumab Alone Versus Nivolumab Plus Ipilimumab in Patients with Resectable and Potentially Resectable HCC

Ahmed Kaseb1, Shiraj Sen1, Jean-Nicolas Vauthey1, Kanwal Raghav1, Lauren Girard1, Thomas Aloia1, Yun Chun1, Claudius Conrad1, Jeffrey Morris1, Adi Diab1, James Yao1

1UT MD Anderson Cancer Center, Houston, TX, USA

Surgery | Checkpoint blockade | Clinical study | Solid tumors | Immune adjuvant | Clinical trial

P244

A phase 1, first-in-human, open-label, dose escalation study of MGD013, a bispecific DART® protein binding PD‑1 and LAG‑3 in patients with unresectable or metastatic neoplasms

Sadhna Shankar1, Manish Patel2, George Blumenschein3, Erika Hamilton4, Jason Luke5, Ross La-Motte Mohs1, Kalpana Shah1, Lisa Adali-Piston1, Syd Johnson1, Ezio Bonivini1, Paul Moore1, Jon Wigginton1, Jim Vasselli1

1MacroGenics Inc., Rockville, MD, USA 2Florida Cancer Specialists, Sarah Canon Research Institute, Sarasota, FL, USA 3MD Anderson Cancer Center, Houston, TX, USA 4Sarah Cannon Research Institute, Nashville, TN, USA 5University of Chicago, Chicago, IL, USA

Checkpoint blockade | Clinical study | Clinical trial | Antibody | Solid tumors | T cell

P245

CAPRA: A Phase 1b study of intratumoral Coxsackievirus A21 (CVA21) and systemic pembrolizumab in advanced melanoma patients.

Ann Silk1, Howard Kaufman1, Nashat Gabrail2, Janice Mehnert1, Jennifer Bryan1, Jacqueline Norrell1, Azra Haider1, Daniel Medina1, Praveen Bommareddy3, Darren Shafren4, Mark Grose4, Andrew Zloza1

1Rutgers Cancer Institute of New Jersey, New Brunswick, NJ, USA 2Gabrail Cancer Center, Canton, OH, USA 3Rutgers University, Piccataway, NJ, USA 4Viralytics Limited, Sydney, Australia

Checkpoint blockade | Clinical study | Clinical trial | Targeted therapy | Immune monitoring | Immune toxicity | Solid tumors

P246

Phase 1/2 study of in situ vaccination with tremelimumab + intravenous (IV) durvalumab + poly‑ICLC in patients with select relapsed, advanced cancers with measurable, biopsy-accessible tumors.

Craig Slingluff, Jr.1, Sunita Hack2, Paul Schwarzenberger3, Toni Ricciardi3, Mary Macri3, Aileen Ryan3, Ralph Venhaus3, Nina Bhardwaj4

1University of Virginia, Charlottesville, VA, USA 2Ludwig Institute for Cancer Research, New York, NY, USA 3Ludwig Cancer Research, New York, NY, USA 4Icahn School of Medicine at Mt Sinai, New York, NY, USA

Antibody | Solid tumors | Checkpoint blockade | TLR | Tumor microenvironment | Tumor infiltrating lymphocytes (TILs) | Clinical trial

P247

Study Design: Phase 1 dose escalation, multi-tumor study to assess safety, tolerability and antitumor activity of genetically engineered MAGE-A4 SPEAR T-cells in HLA-A2+ subjects with MAGE-A4+ tumors

David S Hong1, Melissa Johnson2, Anthony J Olszanski3, Marcus Butler4, Connie Erickson-Miller5, Malini Iyengar5, Trupti Trivedi5, Karen Chagin5, Rafael Amado5

1The University of Texas MD Anderson Cancer Center, Houston, TX, USA 2Sarah Cannon, Nashville, TN, USA 3Anthony.Olszanski@FCCC.edu, Philadelphia, PA, USA 4Princess Margaret Cancer Centre, Toronto, ON, Canada 5Adaptimmune, Philadelphia, PA, USA

Adoptive immunotherapy | Clinical study | T cell

P248

Study Design: An Open-label Randomized Pilot Study of NY-ESO-1 SPEAR T-cells Alone or in Combination with Pembrolizumab in HLA-A2+ Subjects with Relapsed and Refractory Multiple Myeloma (NCT03168438)

Aaron P Rapoport1, James E Hoffman2, Myo Htut3, Taiga Nishihori4, Karen Chagin5, Thomas Faitg5, Elliot Norry5, Trupti Trivedi5, Rafael Amado5

1University of Maryland School of Medicine, Baltimore, MD, USA 2Sylvester Cancer Center at the University of Miami, Miami, FL, USA 3City of Hope, Duarte, CA, USA 4Moffit Cancer Center, Tampa, FL, USA 5Adaptimmune, Philadelphia, PA, USA

Adoptive immunotherapy | Targeted therapy | T cell

P249

A Phase 1 Study of the Safety, Tolerability, and Pharmacokinetics (PK) of MGA012 (anti-PD-1 antibody) in Patients with Advanced Solid Tumors

Nehal Lakhani1, Janice M. Mehnert2, Drew Rasco3, Michael Gordon4, Joanna Lohr5, Pepi Pencheva5, Sharad Sharma5, Hua Li5, Ross LaMotte-Mohs5, Paul Moore5, Jichao Sun5, Bradley Sumrow5, Jon Wigginton5, John Powderly6

1START Midwest - South Texas Accelerated Research Therapeutics, LLC, Grand Rapids, MI, USA 2Rutgers Cancer Institute of New Jersey, New Brunswick, NJ, USA 3START - South Texas Accelerated Research Therapeutics, LLC, San Antonio, TX, USA 4Honor Health Research Institute, Scottsdale, AZ, USA 5MacroGenics, Inc., Rockville, MD, USA 6Carolina BioOncology Institute, Huntersville, NC, USA

Solid tumors | Clinical trial | Checkpoint blockade | Antibody | Clinical study

P250

LTX-315, an oncolytic peptide converts "cold" tumors to "hot" in a majority of patients with advanced cancer: results from an ongoing phase I study.

Aurelien Marabelle1, Jean-Francois Baurain2, Ahmad Awada3, Rebecca Kristeleit4, Dag-Erik Jøssang5, Nina-louise Jebsen5, Delphine Loirat6, Andrew Saunders7, Wenche Olsen7, Berit Nicolaisen7, Baldur Sveinbjornsson7, Vibeke Sundvold Gjerstad7, Øystein Rekdal7, Pal Brunsvig8, Jerome Galon9, Fabienne Hermitte10, Bjorn-Tore Gjertsen5, Anna Armstrong11, James Spicer12

1Gustave Roussy, Villejuif, France 2Saint-Luc University Hospital, Brussel, Belgium 3Institut Jules Bordet, Brussel, Belgium 4Univerity College London Hospital, London, United Kingdom 5Haukeland Univeristy Hospital, Bergen, Norway 6Institut Curie, Paris, France 7Lytix Biopharma, Oslo, Norway 8Oslo University Hospital, Oslo, Norway 9Laboratory of Integrative Cancer Immunology, INSERM, Paris, France 10INSERM, Paris, France 11Christie Hospital, Manchester UK, Manchester, United Kingdom 12King´s College London, London, United Kingdom

Clinical study | Tumor microenvironment | Immune monitoring | Immunoscore | Tumor infiltrating lymphocytes (TILs)

P251

A Study to Evaluate the Safety and Efficacy of the CD40 Agonistic Antibody APX005M in Combination with Nivolumab in Subjects with Non-small Cell Lung Cancer and Subjects with Metastatic Melanoma

Linda Garland1, Ravi Salgia2, Melissa Johnson3, Amy Weise4, Gerald Linette5, Thomas Tremblay6, Ovid Trifan6, Martin Edelman7

1University of Arizona Cancer Center, Tucson, AZ, USA 2City of Hope, Duarte, CA, USA 3Sarah Cannon Research Institute, Tennessee Oncology, Nashville, TN, USA 4Karmanos Cancer Center, Detroit, MI, USA 5Abramson Cancer Center, University of Pennsylvania, Philadelphia, PA, USA 6Apexigen Inc., San Carlos, CA, USA 7Fox Chase Cancer Center, Philadelphia, PA, USA

Antigen presenting cells | Clinical trial | Antibody | Clinical study | Checkpoint blockade | Dendritic cell

P252

Phase 1 Study to Evaluate the Safety and Tolerability of the CD40 Agonistic Monoclonal Antibody APX005M in Subjects with Solid Tumors

Marwan Fakih1, David Bajor2, Ronac Mamtani3, Thomas Tremblay4, Ovid Trifan4, Robert Vonderheide3

1City of Hope, Duarte, CA, USA 2University Hospitals Cleveland Medical Center, Cleveland, OH, USA 3Abramson Cancer Center, University of Pennsylvania, Philadelphia, PA, USA 4Apexigen Inc., San Carlos, CA, USA

Antigen presenting cells | Clinical trial | Antibody | Solid tumors

P253

Prioritizing tumor types for treatment with a novel immunotherapy: LYC-55716 a small-molecule RORγ agonist

Xiao Hu1, Xikui Liu1, Hongxiu Li1, Madhumita Bogdan1, Yilin Gao1, Brian Fox2, H. Jeffrey Wilkins3, Laura Carter1

1Lycera Corp., Ann Arbor, MI, USA 2Celgene Corp., Seattle, WA, USA 3Lycera Corp., Plymouth Meeting, PA, USA

T cell | Gene expression | Bioinformatics | Tumor microenvironment | Clinical trial

P254

A Phase 1b/2 Study of CD40 Agonistic Monoclonal Antibody (APX005M) Together with Gemcitabine and nab-Paclitaxel with or without Nivolumab in Untreated Metastatic Pancreatic Adenocarcinoma Patients

Mark O’Hara1, Rosemarie Mick2, Jaclyn Lyman3, Jingying Xu3, Maryam Hosseini3, Theresa LaVallee3, Pier Federico Gherardini3, Barbara Vance1, Ovid Trifan4, Ute Dugan5, Aiman Shalabi6, Ramy Ibrahim3, Robert Vonderheide1

1University of Pennsylvania, Philadelphia, PA, USA 2University of Pennsylvania Perelman, Philadelphia, PA, USA 3Parker Institute for Cancer Immunotherapy, San Francisco, CA, USA 4Apexigen, San Carlos, CA, USA 5Bristol-Myers Squibb, New York City, NY, USA 6Cancer Research Institute, New York, NY, USA

Checkpoint blockade | Chemotherapy | Clinical study | Coinhibition | Solid tumors | Clinical trial