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

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

  • Center for Cancer Research
  • National Cancer Institute

RESEARCH SUMMARY

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 MD/PhD 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 (NCI) as Co-Director of the Center for Immuno-Oncology, and also serves as the Clinical Director of the NCI. He has been instrumental in the clinical development multiple immunotherapeutic agents and has led multiple first-in-human immunotherapy studies through phase 3 clinical trials. He was the coordinating PI of an international trial of avelumab that led to regulatory approval. He was the PI of the first-in-human international study of a first in class agent, bintrafusp alfa, which targets PDL1 and TGF-beta. He also leads a number of rationally designed, cutting edge combination immunotherapy studies.

Dr. Gulley serves on many national and NIH boards and committees and is actively involved with the Society for Immunotherapy of Cancer. He has been an investigator on over 200 clinical trials, and has authored over 350 scientific papers or chapters which have been cited over 28,000 times. He has made hundreds of scientific presentations at universities or national / international meetings. He has had multiple awards including the 2010 Presidential Early Career Award for Scientists and Engineers, the highest award bestowed by the US President on investigators early in their careers. He also was awarded the 2018 Hubert H. Humphrey Award for Service to America for contributing to the health, safety, and well-being of the nation by helping to get FDA approval for avelumab for Merkel cell carcinoma and urothelial carcinoma and has received 10 CCR, NCI or NIH Director’s Awards.

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. 

Publications

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

Position Degree Required Contact Name Contact Email
Investigator - Lasker Clinical Research Scholar M.D. or equivalent Dr. Charles Dearoff LaskerScholar@nih.gov

Team

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
Staff Scientist
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

News

Groundbreaking Pivotal Study Conducted at the National Cancer Institute for PRGN-2012 in Patients with Recurrent Respiratory Papillomatosis (RRP), in Which More Than Half of Patients Achieved Complete Response. 

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PRGN-2012, a novel gorilla adenovirus-based immunotherapy

RRP is a rare, devastating HPV-mediated chronic disease that causes wart-like (benign) growths in the airways. These growths can be removed by surgery but typically grow back. In 2023, the FDA granted the first-in-class investigational PRGN-2012 (a gorilla adenovirus–vectored HPV immunotherapy developed via a Cooperative Research and Development Agreement between the NCI and Precigen Inc.) Breakthrough Therapy Designation and Orphan Drug Designation for the treatment of RRP.  The first-in-human, phase 1 study (NCT04724980) of adjuvant PRGN-2012 treatment in adult patients with severe, aggressive RRP, conducted at the NCI and led by Scott M. Norberg, D.O., Associate Research Physician in the Center for Immuno-Oncology, Center for Cancer Research, NCI,  demonstrated the overall safety and clinically meaningful benefit observed with PRGN-2012, with a 50% complete response rate in patients treated at the highest dose. Study results were published in "The tumor microenvironment state associates with response to HPV therapeutic vaccination in patients with respiratory papillomatosis," Science Translational Medicine, 2023 Oct 25;15(719):eadj0740, by Norberg...Schlom, Gulley...Sabzevari...Allen. https://www.science.org/doi/10.1126/scitranslmed.adj0740. Study results were also presented by Dr. Norberg, on June 3, 2024, during ASCO's Annual Meeting, in a presentation titled "PRGN-2012, a novel gorilla adenovirus-based immunotherapy, provides the first treatment that leads to complete and durable responses in recurrent respiratory papillomatosis patients."