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 vaccines and other immunostimulatory agents, and the combination of immunotherapy with other treatment strategies. In particular, he has played a central role in the clinical development of a prostate cancer vaccine, created in the NCI, and serves as the principal investigator on an international Phase III randomized clinical trial of this vaccine. He is also the coordinating principal investigator of an international trial of an anti-PDL1 antibody.
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 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 vaccine-mediated killing. In particular, he played a pivotal role in the clinical development of a prostate cancer vaccine, created at the NCI, and he now serves as the Principal Investigator on a global Phase III randomized clinical trial (Prospect) of this vaccine.
View Dr. Gulley's Complete Bibliography at Google Scholar.
Selected Key Publications
- J. Urol. 178: 1515-20, 2007. [ Journal Article ]
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 ]
Immunologic and prognostic factors associated with overall survival employing a poxviral-based PSA vaccine in metastatic castrate-resistant prostate cancer.Cancer Immunol. Immunother. 59: 663-74, 2010. [ 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 Ph.D. in microbiology in 1994 and an M.D. in 1995. As part of this eight-year M.D./Ph.D. Medical Scientist Training Program he completed a dissertation on tumor immunology. Dr. Gulley completed his residency in internal medicine at Emory University in 1998, followed by a medical oncology fellowship at the NCI. Since 1999 he has authored and run a variety of clinical trials at the NCI, serving as Principal Investigator or Associate Investigator on more than 60 trials. Dr. Gulley has received numerous awards, including the 2010 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. He serves on many national and NIH boards and committees. Dr. Gulley has authored more than 180 scientific papers and book chapters, edited 4 books and has made numerous invited presentations at national and 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.)|