Department of Medicine

Department of Medicine

  Division of Hematology/Oncology

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photo James J. Lee, MD, PhD

Associate Professor of Medicine

Director of Early Phase Clinical Research, UPMC Hillman Cancer Center

Medical Director of Phase I Clinic, UPMC Hillman Cancer Center


Phone: 412-648-6586

Office: UPMC Cancer Pavilion,
5150 Centre Avenue, Fifth Floor, Room 568
Pittsburgh, PA 15232
Phone: 412-648-6586
Fax: 412-648-6579
Administrative Assistant:
Janice Kizior
Address: 5150 Centre Avenue
5th floor
Pittsburgh, PA 15232
Phone: 412-864-7764
Fax: 412-648-6579
Education and Training
M.D., Seoul National University, 1988
Ph.D. in Immunology, Johns Hopkins University School of Medicine, 2000
Residency in Internal Medicine, Albert Einstein College of Medicine, 2003
Medical Oncology Fellowship, National Cancer Institute, 2005
Research Interest
The primary focus of my research has been on early-phase clinical development of novel agents for solid tumors and clinical development of immunotherapy for colorectal cancer.


HCC 14-118: A phase 2 study of MK-3475 in combination with azacitidine in subjects with chemo-refractory metastatic colorectal cancer (Role: Study Sponsor/PI)

HCC 16-123: A phase IB/II study of epacadostat (INCB024360) in combination with pembrolizumab (MK-3475) and azacitidine in subjects with chemo-refractory metastatic colorectal cancer (Role: Study Sponsor/PI)

HCC 17-191: A Phase I/II study of pembrolizumab in combination with metformin in patients with metastatic microsatellite (MSS) colorectal cancer (Role: Study Sponsor/PI)

NRG-GI004/SWOG-S1610: Colorectal cancer metastatic dMMR immuno-therapy (COMMIT) study: A randomized phase III study of mFOLFOX6/bevacizumab combination chemotherapy with or without atezolizumab or atezolizumab monotherapy in the first-line treatment of patients with deficient DNA mismatch repair (dMMR) metastatic colorectal cancer (Role: Principal Investigator, NRG Oncology)

NSABP FC-9: A phase II study of the dual immune checkpoint blockade with durvalumab plus tremelimumab following palliative hypofractionated radiation in patients with microsatellite stable metastatic colorectal cancer progressing on chemotherapy (Role: Protocol Chair)

NSABP FC-10: A phase IB study of pembrolizumab in combination with pemetrexed and oxaliplatin in patients with chemo-refractory metastatic colorectal cancer (Role: Protocol Chair)
Clinical Interest
James J. Lee, MD, PhD, is a medical oncologist who specializes in early phase drug development (phase I clinical trials) of new cancer drugs and the treatment of colon cancer. His research has been focused on the development of new cancer drugs including cytotoxic chemotherapeutic agents and immunotherapy. He also has a strong interest in the translational research of colorectal cancer
For my complete bibliography, Click Here.
Selected Publications:
Le DT, Durham JN, Smith KN, Wang H, Bartlett BR, Aulakh LK, Lu S, Kemberling H, Wilt C, Luber BS, Wong F, Azad ND, Rucki AA, Laheru D, Donehower R, Zaheer A, Fisher GA, Crocenzi TS, Lee JJ, Greten TF. Mismatch-repair deficiency predicts response of solid tumors to PD-1 blockade. Science. 2017.
Lee JJ, Chu E. Adjuvant Chemotherapy for Stage II Colon Cancer: The Debate Goes On. J Oncol Pract. 2017; 13(4): 245-246.
Lee JJ, Chu E. Adherence, Dosing, and Managing Toxicities With Trifluridine/Tipiracil (TAS-102). Clin Colorectal Cancer. 2017; 16(2): 85-92.
Lee JJ, Seraj J, Yoshida K, Mizuguchi H, Strychor S, Fiejdasz J, Faulker T, Pollice L, Mason S, Sun W, Chu E, Croft M, Nugteren J, Tedder T, Beumer JH. Human mass balance study of TAS-102 using 14C analyzed by accelerator mass spectrometry. Cancer Chemotherapy and Pharmacology. 2016; 77(3): 515-26.
Lee JJ, Beumer JH, Chu E. Therapeutic drug monitoring of 5-fluorouracil. Cancer Chemother Pharmacol. 2016; 78(3): 447-64.
Lee JJ, Sun W. Options for second-line treatment in metastatic colorectal cancer. Clin Adv Hematol Oncol. 2016; 14(1): 46-54.
Le DT, Uram JN, Wang H, Bartlett BR, Kemberling H, Eyring AD, Skora AD, Luber BS, Azad NS, Laheru D, Biedrzycki B, Donehower RC, Zaheer A, Fisher GA, Crocenzi TS, Lee JJ, Duffy SM, Goldberg RM, de la Chapelle A, Koshiji M, Bhaijee F, Huebner T, Wood LD, Cuka N, Pardoll DM,Papadopoulos N, Kinzler KW, Zhou S, Cornish TC, Taube JM Anders RA, Eshleman JR, Vogelstein B, Diaz LA, Jr. PD-1 Blockade in Tumors with Mismatch-Repair Deficiency. New England Journal of Medicine. 2015; 372(26): 2509-20.
Lee JJ, Chu E. Sequencing of antiangiogenic agents in the treatment of metastatic colorectal cancer. Clinical Colorectal Cancer. 2014; 13(3): 135-55.
Lee JJ, Chu E. The role of predictive molecular biomarkers for the treatment of metastatic colorectal cancer. Curr Colorectal Cancer Rep. 2014; 10: 395-402.
Lee JJ, Chu E. Personalized medicine in the adjuvant chemotherapy of stage II colon cancer - are we there yet?. Oncology. 2013; 27(8): 754.
Notable Achievements
Member, NCI Gastrointestinal Cancer Steering Committee (GISC), 2017-present
Member, NCI Colon Cancer Task Force, 2016-2017
Member, NCI Radiation Research Program (RRP) Colorectal Cancer Working Group, 2017-present
Member, NRG Oncology Colorectal Cancer Core Committee, 2016-present
Member, NRG Oncology Immunotherapy and Immune Modulation Committee, 2017-present
Editorial Board, Journal of the National Cancer Institute, 2017-present
Editorial Board, Clinical Colorectal Cancer, 2006-present
Editorial Board, Oncology Research, 2015-present
The 2014 UPCI Junior Scholar Award in Clinical Cancer Research