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

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

  • Center for Cancer Research
  • National Cancer Institute


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.

In addition to his role as the CIO Co-Director, Dr. James L. Gulley is also the NCI Clinical Director.

Areas of Expertise

Therapeutic Cancer Vaccines
Immune Checkpoint Inhibitors
Clinical Trials
Combining Immunotherapy With Other Therapies

Information for Patients

Learn more about our clinical trials and the highly specialized care teams that lead them. 

Clinical Trials


Selected Key Publications

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. 24(6): 1287-1295, 2018. [ Journal Article ]

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. 35(19): 2117-2124, 2017. [ Journal Article ]

Ipilimumab and a poxviral vaccine targeting prostate-specific antigen in metastatic castration-resistant prostate cancer: a phase 1 dose-escalation trial

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 ]

Neoadjuvant PROSTVAC prior to radical prostatectomy enhances T-cell infiltration into the tumor immune microenvironment in men with prostate cancer

Abdul Sater H, Marté JL, Donahue RN, Walter B, Heery CR, Steinberg SM, Cordes LM, Chun G, Karzai F, Bilusic M, Harmon S, Turkbey IB, Choyke P, Schlom J, Dahut WL, Madan RA, Pinto PA, Gulley JL*
J ImmunoTher Cancer. 8: e000655, 2020. [ Journal Article ]

Phase III trial of PROSTVAC in asymptomatic or minimally symptomatic metastatic castration-resistant prostate cancer

Gulley JL, Borre M, Vogelzang NJ, Ng S, Agarwal N, Parker CC, Pook DW, Rathenborg P, Flaig TW, Galceran JC, Saad F, Shore ND, Chen L, Heery CR, Gerritsen WR, Priou F, Langkilde NC, Novikov A, Kantoff PW
J Clin Oncol. 37: 1051-1061, 2019. [ Journal Article ]

Job Vacancies

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Adjunct Investigator
Isaac Brownell, M.D., Ph.D.
Clinical Collaborator
Marc Theoret, M.D.
Clinical Research Coordinator
Jennifer Marte, M.D.
No photo
Physician Assistant
Amy Hankin, PA-C, MMSc
Nurse Practitioner
Monique Williams, N.P.
Research Nurse
Erin Ferraro, R.N.
Research Nurse
Michell Manu, R.N.
Clinical Research Associate II
Manuk Manukyan
Ling Zhang, Ph.D.
Postdoctoral Fellow
Andrew Sinkoe, Ph.D.
Research Assistant
Zulmarie Franco
Research Assistant
Alex Kuznetsov
Research Assistant
Terri Larus
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Medical Officer
Dimana Dimitrova, MD
Research Nurse Practitioner
Elizabeth Krauss, MS, FNP-C, AOCNP