James L. Gulley, M.D., Ph.D.
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.
A Phase I/II study of immunotherapy combination BN-Brachyury vaccine, M7824, ALT-803 and Epacadostat (QuEST1)Open - RecruitingNCI Protocol ID NCI-18-C-0078Investigator James L. Gulley, M.D., Ph.D.Share this trial: Referral Contacts
Contact Name Phone Number Michell J. B. Manu 240-760-7117
A Feasibility Study of Mobile Sensor Technologies to Assess General Symptomology of Cancer PatientsOpen - Not yet Recruiting Protocol Summary Not Yet Available. Call Referral Contact.NCI Protocol ID NCI-17-C-0158Investigator James L. Gulley, M.D., Ph.D.Share this trial: Referral Contacts
Contact Name Phone Number Alanvin Orpia, BSN, R.N. 301-594- 0490
A Phase Ib Open Label, Dose Finding Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of Avelumab in Combination with M9241 (NHS-IL12) in Subjects with Locally Advanced, Unresectable, or Metastatic Solid TumorsOpen - RecruitingNCI Protocol ID NCI-17-C-0038Investigator James L. Gulley, M.D., Ph.D.Share this trial: Referral Contacts
Contact Name Phone Number Elizabeth Lamping 240.760.7966
Phase I/II Study of PROSTVAC in Combination with Nivolumab and / or Ipilimumab in Men with Prostate CancerOpen - RecruitingNCI Protocol ID NCI-17-C-0007Investigator James L. Gulley, M.D., Ph.D.Share this trial: Referral Contacts
Contact Name Phone Number Myrna Rauckhorst 240.760.7971
A Phase I, open-label, multiple-ascending dose trial to investigate the safety, tolerability, pharmacokinetics, biological and clinical activity of MSB0011359C in subjects with metastatic or locally advanced solid tumors with expansion to selectedOpen - RecruitingNCI Protocol ID NCI-15-C-0179Investigator James L. Gulley, M.D., Ph.D.Share this trial: Referral Contacts
Contact Name Phone Number Cynthia Boyle 240.760.6006
Open - RecruitingNCI Protocol ID NCI-11-C-0225Investigator James L. Gulley, M.D., Ph.D.Share this trial: Referral Contacts
Contact Name Phone Number Elizabeth Lamping 240.760.7966
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.
View Dr. Gulley's Complete Bibliography at Google Scholar.
Selected Key Publications
Overall survival analysis of a phase II randomized controlled trial of a poxviral-based PSA-targeted immunotherapy in metastatic castration-resistant prostate cancer.J. Clin. Oncol. 28: 1099-105, 2010. [ Journal Article ]
Phase I Trial of M7824 (MSB0011359C), a Bifunctional Fusion Protein Targeting PD-L1 and TGFβ, in Advanced Solid Tumors.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.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.Lancet Oncol. 13: 501-8, 2012. [ Journal Article ]
Phase I study of intraprostatic vaccine administration in men with locally recurrent or progressive prostate cancer.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.
|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|
|Sunnie Kim M.D.||Special Volunteer|
|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.)|