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

Center for Cancer Research
National Cancer Institute

Building 10, Room 13N240
Bethesda, MD 20892-1750
301-480-7164
301-480-8867
gulleyj@mail.nih.gov

Co-Director

Center for Immuno-Oncology

Senior Investigator

NCI Clinical Director

CCR Deputy Director

RESEARCH SUMMARY

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

Cancer Immunology and Immunotherapy

Prostate Cancer

Therapeutic Cancer Vaccines

Immune Checkpoint Inhibitors

Clinical Trials

Combining Immunotherapy With Other Therapies

Clinical Trials
Research
Publications
Biography
Job Vacancies
Team
News

Open - Recruiting
Summary Not Yet Available. Call Referral Contact.
Single- patient IND Expanded Access Study with STAR0602

Protocol ID
IRB001758

Investigator

James L. Gulley, M.D., Ph.D.
Open - Recruiting

CP-START-001

Protocol ID
001099

Investigator

James L. Gulley, M.D., Ph.D.
Open - Not yet Recruiting
Summary Not Yet Available. Call Referral Contact.
A Phase II Study of N803 Alone or in Combination with BN-Brachyury Vaccine or Bintrafusp alfa (M7824) for Participants with Castration Resistant Prostate Cancer

Protocol ID
000309

Investigator

James L. Gulley, M.D., Ph.D.
Open - Not yet Recruiting

An Open-label, Multicenter Follow-up Study to Collect Long-term Data on Participants from Multiple Bintrafusp alfa (M7824) Clinical Studies

Protocol ID
000647

Investigator

James L. Gulley, M.D., Ph.D.
Open - Recruiting

Hyperspectral Analysis of Sweat Metabolite Biometrics for Real-Time Detection of COVID-19

Protocol ID
000178

Investigator

James L. Gulley, M.D., Ph.D.
Open - Recruiting

The Effect of Diet and Exercise on ImmuNotherapy and the Microbiome (EDEN)

Hear more from the doctor

Protocol ID
000251

Investigator

James L. Gulley, M.D., Ph.D.
Open - Recruiting

A Phase I/II Study of Immunotherapy Combination BN-Brachyury vaccine, M7824, N-803 and Epacadostat (QuEST1)

Protocol ID
18-C-0078

Investigator

James L. Gulley, M.D., Ph.D.
Open - Not yet Recruiting

A Phase 1 Study of JNJ-80038114, a T-Cell Redirecting Agent Targeting Prostate Specific Membrane Antigen (PSMA), for Advanced Stage Prostate Cancer

Protocol ID
IRB001529

Investigator

James L. Gulley, M.D., Ph.D.
Open - Not yet Recruiting
Summary Not Yet Available. Call Referral Contact.
A Feasibility Multicenter Phase I Study of Therapeutic Drug Monitoring-Based Atezolizumab Dosing.

Protocol ID
IRB001559

Investigator

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

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

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 ]

Biography

Co-Director

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.