JamesLGulleyMDPh.D.

Oncology • Bethesda, MD

Genitourinary Oncology, Hematologic Oncology

Clinical Trials Group Center for Cancer Research National Cancer Institute

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Office
10 Center Dr.
Bethesda, MD 20892
Phone(301) 435-2956
Fax(301) 480-5094
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Education & Training

National Institutes of Health Clinical CenterFellowship, Medical Oncology, 1998 - 2001
Emory UniversityResidency, Internal Medicine, 1995 - 1998
Loma Linda University School of MedicineClass of 1995

Certifications & Licensure

MD State Medical License 2001 - 2022
GA State Medical License 1996 - 2007
American Board of Internal Medicine Medical Oncology

Awards, Honors, & Recognition

America's Top Doctors Castle Connolly, 2009-2014
America's Top Doctors for Cancer Castle Connolly, 2008-2013
Top Doctors:Baltimore Area Castle Connolly, 2012
Top Doctors:Washington DC Area Castle Connolly, 2012
Top Doctors:Washington-Baltimore Castle Connolly, 2012
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Clinical Trials

A Phase Ib Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Avelumab in Combination With M9241(NHS-IL12) Start of enrollment: 2017 Jan 01Medical Responsible
PROSTVAC in Combination With Nivolumab and/or Ipilimumab in Men With Prostate Cancer Start of enrollment: 2016 Oct 01James L Gulley, M.D.
Oral VT-464 in Patients With Castration-Resistant Prostate Cancer Previously Treated With Enzalutamide Start of enrollment: 2014 Apr 01Ravi Madan, MD
Enzalutamide With or Without Vaccine Therapy for Advanced Prostate Cancer Start of enrollment: 2013 May 01Gulley, J.L.
Enzalutamide in Combination With PSA-TRICOM in Patients With Non-Metastatic Castration Sensitive Prostate Cancer Start of enrollment: 2013 May 01Gulley, J.L.
A Phase 2 Study of GI-6207 in Patients With Recurrent Medullary Thyroid Cancer Start of enrollment: 2013 Feb 01Ravi A Madan, MD
MSB0010718C in Solid Tumors Start of enrollment: 2013 Jan 01Gulley, J.L.
Cabozantinib Plus Docetaxel and Prednisone for Advanced Prostate Cancer Start of enrollment: 2012 Sep 01Dahut, W.L.,Gulley, J.L.
Open Label Study to Evaluate the Safety and Tolerability of GI-6301 (Whole Heat-Killed Recombinant Yeast Modified to Express Brachyury Protein) in Adults With Solid Tumors Start of enrollment: 2012 Jan 01Gulley, J.L.
A Randomized, Double-blind, Phase 3 Efficacy Trial of PROSTVAC-V/F +/- GM-CSF in Men With Asymptomatic or Minimally Symptomatic Metastatic Castrate-Resistant Prostate Cancer Start of enrollment: 2011 Nov 01Gulley, J.L.,Kantoff, P.,Lombardo, J.,Mann, A.
First In-Human Phase I Trial of NHS-IL12 in Subjects With Metastatic Solid Tumors Start of enrollment: 2011 Jul 01Gulley, J.L.,McMahon, S.A.
Effect of Talactoferrin in Adults With Non-Small Cell Lung Cancer Start of enrollment: 2008 Jun 01Gulley, J.L.
A Double-Blind Randomized Phase 2.5 Trial of ONY-P1 Vaccine Versus Placebo in Men With D0 Prostate Cancer Following Limited Androgen Ablation Start of enrollment: 2007 Mar 01Gulley, J.L.
Vaccine Therapy With PROSTVAC/TRICOM and Flutamide Versus Flutamide Alone to Treat Prostate Cancer Start of enrollment: 2007 Feb 01Gulley, J.L.
A Randomized Phase 2.5 Study of (153)Sm-EDTMP (Quadramet) With or Without a PSA/TRICOM Vaccine in Men With Androgen-Insensitive Metastatic Prostate Cancer Start of enrollment: 2007 Feb 01Gulley, J.L.,Pazdur, M.P.
A Randomized Pilot Phase II Study of Docetaxel Alone or in Combination With PANVAC(Trademark)-V (Vaccinia) and PANVAC(Trademark)-F (Fowlpox) in Adults With Metastatic Breast Cancer Start of enrollment: 2005 Sep 01Gulley, J.L.
Phase I Trial of a PSA Based Vaccine and an Anti-CTLA-4 Antibody in Adults With Metastatic Androgen Independent Prostrate Cancer Start of enrollment: 2005 Jun 01Gulley, J.L.
Follow-Up of Study Subjects Previously Enrolled in Immunotherapy Studies Utilizing Gene Transfer Start of enrollment: 2004 Sep 01Gulley, J.L.
An Open Label Pilot Study to Evaluate the Safety and Tolerability of PANVAC-V (Vaccinia) and PANVAC-F (Fowlpox) in Combination With Sargramostim in Adults With Metastatic Carcinoma Start of enrollment: 2004 Jul 01Gulley, J.L.
A Phase I/II Pilot Study of Sequential Vaccinations With rFowlpox-PSA (L155)-TRICOM (PROSTVAC-F/TRICOM) Alone, or in Combination With rVaccinia-PSA (L155)-TRICOM (PROSTVAC-V/TRICOM), and the Role of GM-CSF, in Men With Prostate Cancer Start of enrollment: 2003 May 01Gulley, J.L.
Collection of Blood and Urine From Patients With Cancer Start of enrollment: 2002 Apr 01Gulley, J.L.,Pazdur, M.P.
Eligibility Screening for the NIH Intramural Research Program Clinical Protocols James L Gulley, M.D.
A Feasibility Study Investigating the Use of Machine Learning to Analyze Facial Imaging, Voice and Spoken Language for the Capture and Classification of Cancer Pain James L Gulley, M.D.
Phase I/II Study of Immunotherapy Combination BN-Brachyury Vaccine, M7824, ALT-803 and Epacadostat (QuEST1). James L Gulley, M.D.
Neoantigen DNA Vaccine in Combination With Nivolumab/Ipilimumab and PROSTVAC in Metastatic Hormone-Sensitive Prostate Cancer Russell Pachynski, M.D.
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Publications & Presentations

PubMed

Circulating Tumor Cell Subtypes and T-cell Populations as Prognostic Biomarkers to Combination Immunotherapy in Metastatic Genitourinary Cancer Patients.
Heather Chalfin, Tiziano Pramparo, Amir Mortazavi, Scot Anthony Niglio, Joseph D. Schonhoft, Adam Jendrisak, Yen-Lin Chu, Robin Richardson, Rachel Krupa, Amanda K. L. ...> ;Clinical Cancer Research. 2020 Dec 1
Cabozantinib plus docetaxel and prednisone in metastatic castration-resistant prostate cancer.
Ravi A. Madan, Fatima Karzai, Munjid Al Harthy, Daniel P. Petrylak, Joseph Kim, Philip M. Arlen, Inger L. Rosner, Marc R. Theoret, Lisa M. Cordes, Marijo Bilusic, Cody...> ;BJUI. 2020 Oct 23
Phase I neoadjuvant study of intravesical recombinant fowlpox-GM-CSF (rF-GM-CSF) or fowlpox-TRICOM (rF-TRICOM) in patients with bladder carcinoma.
Daniella E. Portal, Robert E. Weiss, Malgorzata Wojtowicz, Amal Mansour, Claude Monken, Janice M. Mehnert, Joseph Aisner, Michael P. Kane, Jennifer Nishioka, Seena Ais...> ;Cancer Gene Therapy. 2020 Jun 1
Phase 2 Study of Seviteronel (INO-464) in Patients With Metastatic Castration-Resistant Prostate Cancer After Enzalutamide Treatment.
Madan, R. A., Schmidt, K. T., Karzai, F., Peer, C. J., Cordes, L. M., Chau, C. H., Steinberg, S. M., Owens, H., Eisner, J., Moore, W. R., Dahut, W. L., Gulley, J. L., ...> ;Clinical genitourinary cancer. 2020 Apr 25
Neoadjuvant PROSTVAC prior to radical prostatectomy enhances T-cell infiltration into the tumor immune microenvironment in men with prostate cancer.
Sater, H. A., Marté, J. L., Donahue, R. N., Walter-Rodriguez, B., Heery, C. R., Steinberg, S. M., Cordes, L. M., Chun, G., Karzai, F., Bilusic, M., Harmon, S. A., Turk...> ;Journal for immunotherapy of cancer. 2020 Apr 10
Defining tumor resistance to PD-1 pathway blockade: recommendations from the first meeting of the SITC Immunotherapy Resistance Taskforce.
Kluger, H. M., Tawbi, H. A., Ascierto, M. L., Bowden, M., Callahan, M. K., Cha, E., Chen, H. X., Drake, C. G., Feltquate, D. M., Ferris, R. L., Gulley, J. L., Gupta, S...> ;Journal for immunotherapy of cancer. 2020 Apr 3
Endocrine-Related Adverse Events Related to Immune Checkpoint Inhibitors: Proposed Algorithms for Management.
Jaydira Del Rivero, Lisa M Cordes, Joanna Klubo-Gwiezdzinska, Ravi A Madan, Lynnette K Nieman, James L Gulley> ;2020 Apr 1
Insights from immuno-oncology: the Society for Immunotherapy of Cancer Statement on access to IL-6-targeting therapies for COVID-19.
Paolo A. Ascierto, Bernard A. Fox, Walter J. Urba, Ana C. Anderson, Michael B. Atkins, Ernest C. Borden, Julie R. Brahmer, Lisa H. Butterfield, Alessandra Cesano, Dani...> ;Journal for ImmunoTherapy of Cancer. 2020 Apr 1
Bintrafusp Alfa, a Bifunctional Fusion Protein Targeting TGF-β and PD-L1, in Second-Line Treatment of Patients With NSCLC: Results From an Expansion Cohort of a Phase ...
Paz-Ares, L., Kim, T. M., Vicente, D., Felip, E., Lee, D. H., Lee, K. H., Lin, C., Flor, M. J., Di Nicola, M., Alvarez, R. M., Dussault, I., Helwig, C., Ojalvo, L. S.,...> ;Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer. 2020 Mar 17
Putting the Pieces Together: Completing the Mechanism of Action Jigsaw for Sipuleucel-T.
Madan, R. A., Antonarakis, E. S., Drake, C. G., Fong, L., Yu, E. Y., McNeel, D. G., Lin, D. W., Chang, N. N., Sheikh, N. A., Gulley, J. L.> ;Journal of the National Cancer Institute. 2020 Mar 8
Use of Magnetic Resonance Imaging to Identify Immune Checkpoint Inhibitor-Induced Inflammatory Arthritis.
Subedi, A., Williams, S. G., Yao, L., Maharjan, S., Strauss, J., Sharon, E., Thomas, A., Apolo, A. B., Gourh, P., Hasni, S. A., Gulley, J. L., Kaplan, M. J., Katz, J. ...> ;JAMA network open. 2020 Feb 27
Dual targeting of TGF-β and PD-L1 via a bifunctional anti-PD-L1/TGF-βRII agent: status of preclinical and clinical advances.
Lind, H., Gameiro, S. R., Jochems, C., Donahue, R. N., Strauss, J., Gulley, J. L., Palena, C., Schlom, J.> ;Journal for immunotherapy of cancer. 2020 Feb 23
A case report of multiple primary prostate tumors with differential drug sensitivity.
Wilkinson, S., Harmon, S. A., Terrigino, N. T., Karzai, F., Pinto, P. A., Madan, R. A., VanderWeele, D. J., Lake, R., Atway, R., Bright, J. R., Carrabba, N. V., Troste...> ;Nature communications. 2020 Feb 15
Phase I Trial of a Modified Vaccinia Ankara Priming Vaccine Followed by a Fowlpox Virus Boosting Vaccine Modified to Express Brachyury and Costimulatory Molecules in A...
Collins, J. M., Donahue, R. N., Tsai, Y., Manu, M., Palena, C., Gatti-Mays, M. E., Marté, J. L., Madan, R. A., Karzai, F., Heery, C. R., Strauss, J., Abdul-Sater, H., ...> ;The oncologist. 2019 Dec 27
Augmented Radiologist Workflow Improves Report Value and Saves Time: A Potential Model for Implementation of Artificial Intelligence.
M, H., Spear, L. G., Nikpanah, M., Mirmomen, S. M., Machado, L. B., Toscano, A. P., Turkbey, B., Bagheri, M. H., Gulley, J. L., Folio, L. R.> ;Academic radiology. 2019 Dec 11
Radium-223 mechanism of action: implications for use in treatment combinations.
Morris, M. J., Corey, E., Guise, T. A., Gulley, J. L., Kelly, W. K., Quinn, D. I., Scholz, A., Sgouros, G.> ;Nature reviews. Urology. 2019 Nov 13
If we build it they will come: targeting the immune response to breast cancer
Margaret E. Gatti-Mays, Justin M. Balko, Sofia R. Gameiro, Harry D. Bear, Sangeetha Prabhakaran, Jami Aya Fukui, Mary L. Disis, Rita Nanda, James L. Gulley, Kevin Kali...> ;2019 Oct 29
Avelumab monotherapy as first-line or second-line treatment in patients with metastatic renal cell carcinoma: phase Ib results from the JAVELIN Solid Tumor trial.
Vaishampayan, U., Schöffski, P., Ravaud, A., Borel, C., Peguero, J., Chaves, J., Morris, J. C., Kotecki, N., Smakal, M., Zhou, D., Guenther, S., Bajars, M., Gulley, J. L.> ;Journal for immunotherapy of cancer. 2019 Oct 28
Efficacy and tolerability of anti-programmed death-ligand 1 (PD-L1) antibody (Avelumab) treatment in advanced thymoma.
Rajan, A., Heery, C. R., Thomas, A., Mammen, A. L., Perry, S., Coyne, G. O., Guha, U., Berman, A., Szabo, E., Madan, R. A., Ballester, L. Y., Pittaluga, S., Donahue, R...> ;Journal for immunotherapy of cancer. 2019 Oct 23
Ferumoxytol-Enhanced MR Lymphography for Detection of Metastatic Lymph Nodes in Genitourinary Malignancies: A Prospective Study.
Turkbey, B., Czarniecki, M., Shih, J. H., Harmon, S. A., Agarwal, P. K., Apolo, A. B., Citrin, D. E., Gulley, J. L., Harisinghani, M., Madan, R. A., Metwalli, A. R., P...> ;AJR. American journal of roentgenology. 2019 Oct 16
Successful 5-fluorouracil (5-FU) infusion re-challenge in a metastatic colorectal cancer patient with coronary artery disease who experienced symptoms consistent with ...
Redman, J. M., Rhea, L. P., Brofferio, A., Whelpley, M., Gulley, J. L., Gatti-Mays, M. E., McMahon, S., Cordes, L. M., Strauss, J.> ;Journal of gastrointestinal oncology. 2019 Oct 12
Endocrine-Related Adverse Events Related to Immune Checkpoint Inhibitors: Proposed Algorithms for Management.
Del Rivero, J., Cordes, L. M., Klubo-Gwiezdzinska, J., Madan, R. A., Nieman, L. K., Gulley, J. L.> ;The oncologist. 2019 Oct 12
A Phase I Trial Using a Multitargeted Recombinant Adenovirus 5 (CEA/MUC1/Brachyury)-Based Immunotherapy Vaccine Regimen in Patients with Advanced Cancer.
Gatti-Mays, M. E., Redman, J. M., Donahue, R. N., Palena, C., Madan, R. A., Karzai, F., Bilusic, M., Sater, H. A., Marté, J. L., Cordes, L. M., McMahon, S., Steinberg,...> ;The oncologist. 2019 Oct 9
Two may be better than one: PD-1/PD-L1 blockade combination approaches in metastatic breast cancer.
David B. Page, Harry D. Bear, Sangeetha Prabhakaran, Margaret E. Gatti-Mays, Alexandra Thomas, Erin F. Cobain, Heather L. McArthur, Justin M. Balko, Sofia R. Gameiro, ...> ;2019 Oct 8
Low Abundance of Circulating Tumor DNA in Localized Prostate Cancer.
S. Thomas Hennigan, Shana Y. Trostel, Nicholas T. Terrigino, Olga Voznesensky, Rachel J. Schaefer, Nichelle C. Whitlock, Scott Wilkinson, Nicole V. Carrabba, Rayann At...> ;JCO precision oncology. 2019 Sep 9
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Journal Articles

Vaccines as an Integral Component of Cancer Immunotherapy
James Gulley, MD, JAMA Psychiatry

Abstracts/Posters

Interleukin-15 (IL-5) in Combination with Avelumab in Relapsed/Refractory Mature T-Cell Malignancies
James Gulley, 61st Annual American Society of Hematology Meeting, Orlando, FL, 12/7/2019

Lectures

Results of PROSPECT: A randomized phase 3 trial of PROSTVAC-V/F (PRO) in men with asymptomatic or minimally symptomatic metastatic, castration-resistant prostate cancer.
2018 ASCO Annual Meeting - Chicago, Illinois - 06/4/2018
Effect of rilimogene galvacirepvec/rilimogene glafolivec on intra/peritumoral immune infiltrate in patients with localized prostate cancer undergoing radical prostatec...
2018 ASCO Annual Meeting - Chicago, Illinois - 06/2/2018
New Agents in Clinical Trials: Significant Phase I-III Clinical Trials. The Future of Immunotherapy: Novel Agents in Clinical Trials
2018 ASCO Annual Meeting - Chicago, Illinois - 06/1/2018

Press Mentions

JAVELIN Solid Tumor Clinical Trials Evaluating Use of AvelumabOctober 24, 2020 18:56
Precigen Announces First Patient Dosed in Phase I/II Study of First-in-Class PRGN-2009 AdenoVerse™ Immunotherapy to Treat HPV-Associated CancersAugust 18, 2020 10:50
AUA 2020: Why Precision Matters: Implications of Genomic Analysis for mCRPCJune 28, 2020 10:33
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Grant Support

Clinical Trials Employing Cancer Vaccine Combination TherapiesNational Cancer Institute2010–2011
Cancer Therapy Clinical Trials Using Novel Recombinant VaccinesNational Cancer Institute2010–2011
Clinical Trials Employing Cancer Vaccine Combination TherapiesDivision Of Basic Sciences - Nci2009
Cancer Therapy Clinical Trials Using Novel Recombinant VaccinesDivision Of Basic Sciences - Nci2009
Clinical Trials Employing Cancer Vaccine Combination TherapiesNational Cancer Institute2008
Cancer Therapy Clinical Trials Using Novel Recombinant VaccinesNational Cancer Institute2008
Vaccine Clinical TrialsNational Cancer Institute2007
Vaccine Clinical TrialsDivision Of Basic Sciences - Nci2005–2006

Professional Memberships

American Society of Clinical Oncology - ASCO
Member

Hospital Affiliations

National Institutes of Health Clinical CenterBethesda, Maryland

JamesLGulleyMDPh.D.

Dr. Gulley is on Doximity

Education & Training

Certifications & Licensure

Awards, Honors, & Recognition

Clinical Trials

Publications & Presentations

Press Mentions

Grant Support

Professional Memberships

Hospital Affiliations

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JamesLGulleyMDPh.D.

Dr. Gulley is on Doximity

Education & Training

Certifications & Licensure

Awards, Honors, & Recognition

Clinical Trials

Publications & Presentations

Press Mentions

Grant Support

Professional Memberships

Hospital Affiliations

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