James L. Gulley, M.D., Ph.D.
- Center for Cancer Research
- National Cancer Institute
- Building 10, Room 3-2551
- Bethesda, MD 20892-1750
- 301-480-7164
- 301-480-8867
- gulleyj@mail.nih.gov
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 31,000 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
Information for Patients
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James L. Gulley, M.D., Ph.D.
Clinical Trials
Research
Dr. Gulley is especially interested in immunotherapy for prostate cancer. He works collaboratively with CIO translational researchers 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 bintrafusp alfa, a first in class bifunctional antibody targeting PDL1 and TGF-beta.
Publications
Phase I Trial of M7824 (MSB0011359C), a Bifunctional Fusion Protein Targeting PD-L1 and TGFβ, in Advanced Solid Tumors
Avelumab, an Anti-Programmed Death-Ligand 1 Antibody, In Patients With Refractory Metastatic Urothelial Carcinoma: Results From a Multicenter, Phase Ib Study
Ipilimumab and a poxviral vaccine targeting prostate-specific antigen in metastatic castration-resistant prostate cancer: a phase 1 dose-escalation trial
Neoadjuvant PROSTVAC prior to radical prostatectomy enhances T-cell infiltration into the tumor immune microenvironment in men with prostate cancer
Phase III trial of PROSTVAC in asymptomatic or minimally symptomatic metastatic castration-resistant prostate cancer
Biography
James L. Gulley, M.D., Ph.D.
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 as Co-Director of the Center for Immuno-Oncology, the Director of the Medical Oncology Service (CCR), and Deputy Director of the CCR. 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 is a founding editor of the Clinical / Translational Section of JITC. He serves on many national and NIH boards and committees. He has been an investigator on over 200 clinical trials, and has authored over 350 scientific papers or chapters which have been cited over 20,000 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 NCI or NIH Director’s Awards.
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Seminars
The CIO Distinguished Lecture Series is a premier virtual seminar series aimed at showcasing groundbreaking advancements in immunotherapy for cancer research. Recent highlights include clinical successes in CAR-T cell therapies targeting solid tumors, translational breakthroughs in bispecific T-cell engagers (BiTEs) for enhanced tumor specificity, and bench research on novel immune checkpoint inhibitor combinations that overcome key resistance mechanisms. The series also explores the development of personalized neoantigen vaccines and strategies for modulating the tumor microenvironment to boost immune response. By fostering a collaborative environment, the series disseminates cutting-edge research findings across clinical, translational, and bench research, bridging the translation of novel immunotherapeutic strategies into clinical practice and ultimately advancing our understanding and treatment of various cancers. The audience are scientists and clinical researchers within Center for Immuno-Oncology at the National Cancer Institute (NCI); however, we often accrue upwards of 200 attendees from across the NCI keen on gaining valuable insights into the latest scientific discoveries and technological innovations helping to shape the future of cancer immunotherapy.
CIO Distinguished Lecture Series Speakers include:
2022: Drs. Lisa Butterfield, Robert Ferris, Marcella Maus, Greg Delgoffe, Sandra Demaria, Jeffrey Miller, and William Murphy
2023: Drs. Robert Herman Vonderheid, Michael Caligiuri, Christopher Klebanoff, Elisabeth de Vries, Tak Mak, Saman MalekiVreki, Jeffrey Miller, and Cassian Yee
2024: Drs. Bernard Fox, Thomas Marron, Lawrence Fong, Saul Priceman, Jennifer Guerriero, Catherine Wu, and Franco Marincola