James L. Gulley, M.D., Ph.D.

James L. Gulley, M.D., Ph.D.
Senior Investigator
Head, Immunotherapy Section
Director, Medical Oncology Service, CCR Office of the Clinical Director

In addition to his role as Branch Chief, Dr. James L. Gulley is also Director of the Medical Oncology Service, Office of the Clinical Director.

Dr. Gulley is an internationally recognized expert in cancer immunotherapy with a strong interest in prostate cancer. Since 1998 he has authored and run a variety of clinical trials at the NCI. These innovative, investigator-initiated studies involve the use of cancer immunotherapy to (a) initiate immune responses, (b) expand immune responses and/or (c) allow the immune responses to be effective within the tumor microenvironment.

Areas of Expertise

1) immunotherapy, 2) therapeutic cancer vaccines, 3) immune checkpoint inhibitors,
4) prostate cancer, 5) clinical trials, 6) combining immunotherapy with other therapies

Contact Info

James L. Gulley, M.D., Ph.D.
Center for Cancer Research
National Cancer Institute
Building 10, Room 13N240
Bethesda, MD 20892-1750
Ph: 301-480-7164
Fax: 301-480-8867

Dr. Gulley is especially interested in immunotherapy for prostate cancer. He works collaboratively with the Laboratory of Tumor Immunology and Biology, CCR and others, and takes promising laboratory findings and uses these to design and conduct clinical trials. These innovative, investigator-initiated studies involve the use of cancer vaccines and other immunostimulatory agents to modulate the immune response in cancer patients, and the addition of other strategies to enhance immune-mediated killing. He has been instrumental in the clinical development from first-in-human studies through large efficacy seeking studies for multiple immunotherapy agents including Prostvac, avelumab and M7824, a first in class bifunctional antibody targeting PDL1 and TGF-beta.

NIH Scientific Focus Areas:
Clinical Research, Immunology
  1. Kantoff PW, Schuetz TJ, Blumenstein BA, Glode LM, Bilhartz DL, Wyand M, Manson K, Panicali DL, Laus R, Schlom J, Dahut WL, Arlen PM, Gulley JL, Godfrey WR.
    J. Clin. Oncol. 28: 1099-105, 2010. [ Journal Article ]
  2. 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. 24(6): 1287-1295, 2018. [ Journal Article ]
  3. 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. 35(19): 2117-2124, 2017. [ Journal Article ]
  4. Madan RA, Mohebtash M, Arlen PM, Vergati M, Rauckhorst M, Steinberg SM, Tsang KY, Poole DJ, Parnes HL, Wright JJ, Dahut WL, Schlom J, Gulley JL.
    Lancet Oncol. 13: 501-8, 2012. [ Journal Article ]
  5. Gulley JL, Heery CR, Madan RA, Walter BA, Merino MJ, Dahut WL, Tsang KY, Schlom J, Pinto PA.
    Cancer Immunol. Immunother. 62: 1521-31, 2013. [ Journal Article ]

Dr. James Gulley is an internationally recognized expert in immunotherapy for cancer. He graduated from Loma Linda University in California with a PhD in microbiology in 1994 and an MD in 1995. As part of this eight-year M.D./P.hD. Medical Scientist Training Program, he completed a dissertation on tumor immunology. He completed his residency in internal medicine at Emory University in 1998, followed by a medical oncology fellowship at the National Cancer Institute (NCI). 

Dr. Gulley serves within the Center for Cancer Research (CCR) of the National Cancer Institute as Chief of the Genitourinary Malignancies Branch (GMB), the Director of the Medical Oncology Service (CCR), and also Head of the Immunotherapy Section within the GMB. He has been instrumental in the clinical development of a number of therapeutic cancer vaccines. In addition, he serves as the coordinating Principal Investigator (PI) of several international trials of immunotherapies, one of which led to FDA approval of an immunotherapy called avelumab. 

Dr. Gulley has received numerous awards including the Presidential Early Career Award for Scientists and Engineers (PECASE), the highest award bestowed by the U.S. government on outstanding scientists early in their careers. Dr. Gulley serves on many national and NIH boards and committees. He has been an investigator on more than 120 clinical trials, authored more than 250 scientific papers or chapters, serves on a number of editorial boards of scientific journals and has made hundreds of presentations at national/international meetings.

Name Position
Houssein Abdul Sater, M.D. Assistant Research Physician
Marijo Bilusic, M.D., Ph.D. Associate Research Physician
Isaac Brownell M.D., Ph.D. Adjunct Investigator
William Figg Predoctoral Fellow (Graduate Student)
Amy Hankin PA-C, MMSc Physician Assistant
Christopher Heery M.D. Special Volunteer
Fatima Karzai, M.D. Assistant Research Physician
Michell Manu R.N. Research Nurse (Contr.)
Ariel Marciscano M.D. Clinical Fellow
Jennifer Marte M.D. Clinical Research Coordinator
Lee Pai-Scherf M.D. Clinical Collaborator
Lilian Spear Special Volunteer
Marc Theoret M.D. Clinical Collaborator
Armine Tumasyan M.D., M.P.H., CCRP Clinical Research Associate II (Contr.)
Beatriz Walter Rodriguez Ph.D. Scientist (Contr.)
Monique Williams N.P. Nurse Practitioner (Contr.)