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+1 301-435-2956

Fax+1 301-480-5094
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Education & Training

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

Certifications & Licensure

MD State Medical License 2001 - 2024
GA State Medical License 1996 - 2007

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

Eligibility Screening for the NIH Intramural Research Program Clinical Protocols Start of enrollment: 2004 Jan 14
Enrolling by invitation
Collection of Blood From Patients With Cancer Start of enrollment: 2002 Jul 16
Recruiting
Sequential Vaccinations in Prostate Cancer Patients Start of enrollment: 2003 May 22
Completed
Phase 1, Phase 2
PANVAC-V and PANVAC-F Vaccines Plus Sargramostim to Treat Advanced Cancer Start of enrollment: 2004 Jul 21
Completed
Phase 1, Phase 2
Vaccine and Antibody Treatment of Prostate Cancer Start of enrollment: 2005 Jun 08
Completed
Phase 1
Docetaxel Alone or in Combination With Vaccine to Treat Breast Cancer Start of enrollment: 2005 Sep 01
Completed
Phase 2
Vaccine Therapy With PROSTVAC/TRICOM and Flutamide Versus Flutamide Alone to Treat Prostate Cancer Start of enrollment: 2007 Feb 23
Completed
Phase 2
153Sm-EDTMP With or Without a PSA/TRICOM Vaccine To Treat Men With Androgen-Insensitive Prostate Cancer Start of enrollment: 2007 Feb 01
Completed
Phase 2
Follow-Up Study of Subjects Previously Enrolled in Poxviral Vector Gene Transfer Studies Start of enrollment: 2004 Sep 13
Recruiting
Vaccine Therapy in Treating Patients With Stage D0 Prostate Cancer Start of enrollment: 2007 Mar 01
Unknown status
Phase 2
Effect of Talactoferrin in Adults With Non-Small Cell Lung Cancer Start of enrollment: 2008 Jun 19
Completed
Phase 1
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 28
Completed
Phase 3
NHS-IL12 for Solid Tumors Start of enrollment: 2011 Dec 12
Completed
Phase 1
Cancer Vaccine Targeting Brachyury Protein in Tumors Start of enrollment: 2012 Jan 05
Completed
Phase 1
Cabozantinib Plus Docetaxel and Prednisone for Advanced Prostate Cancer Start of enrollment: 2012 Sep 07
Completed
Phase 1, Phase 2
Avelumab in Metastatic or Locally Advanced Solid Tumors (JAVELIN Solid Tumor) Start of enrollment: 2013 Jan 31
Completed
Phase 1
QUILT-3.006 for Recurrent Medullary Thyroid Cancer Start of enrollment: 2013 Mar 07
Active, not recruiting
Phase 2
Enzalutamide With or Without Vaccine Therapy for Advanced Prostate Cancer Start of enrollment: 2013 Aug 12
Completed
Phase 2
Enzalutamide in Combination With PSA-TRICOM in Patients With Non-Metastatic Castration Sensitive Prostate Cancer Start of enrollment: 2013 Jul 22
Completed
Phase 2
Oral VT-464 in Patients With Castration-Resistant Prostate Cancer Previously Treated With Enzalutamide, Androgen Receptor Positive Triple-Negative Breast Cancer Patients, and Men With ER Positive Breast Cancer Start of enrollment: 2014 Apr 01
Completed
Phase 2
PROSTVAC in Combination With Nivolumab in Men With Prostate Cancer Start of enrollment: 2017 Apr 18
Active, not recruiting
Phase 1, Phase 2
A Phase Ib Study to Evaluate the Safety, Tolerability, and Pharmacokinetics (PK) of Avelumab in Combination With M9241(NHS-IL12) (JAVELIN IL-12) Start of enrollment: 2017 Jan 31
Terminated
Phase 1
Phase I/II Study of Immunotherapy Combination BN-Brachyury Vaccine, M7824, N-803 and Epacadostat (QuEST1) Start of enrollment: 2018 May 01
Active, not recruiting
Phase 1, Phase 2
Neoantigen DNA Vaccine in Combination With Nivolumab/Ipilimumab and PROSTVAC in Metastatic Hormone-Sensitive Prostate Cancer Start of enrollment: 2018 Sep 14
Completed
Phase 1
Machine Learning to Analyze Facial Imaging, Voice and Spoken Language for the Capture and Classification of Cancer/Tumor Pain Start of enrollment: 2020 Oct 27
Active, not recruiting
The Effect of Diet and Exercise on ImmuNotherapy and the Microbiome (EDEN) Start of enrollment: 2023 Jul 25
Recruiting
Not Applicable
Roles: Contact, Principal Investigator
Hyperspectral Analysis of Sweat Metabolite Biometrics for Real-Time Detection of COVID-19 Start of enrollment: 2022 Aug 30
Recruiting
Roles: Principal Investigator, Contact
N-803 Alone or in Combination With BN-Brachyury Vaccine or Bintrafusp Alfa (M7824) for Participants With Castration Resistant Prostate Cancer Start of enrollment: 2024 Apr 01
Withdrawn
Phase 2
Roles: Contact, Principal Investigator
A Study of Therapeutic Drug Monitoring-Based Atezolizumab Dosing Start of enrollment: 2024 Apr 23
Not yet recruiting
Phase 1
Roles: Contact, Principal Investigator
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Publications & Presentations

PubMed

Cooperative Armoring of CAR and TCR T Cells by T Cell-Restricted IL15 and IL21 Universally Enhances Solid Tumor Efficacy.
Rosa Nguyen, Ekaterina Doubrovina, Charlotte M Mousset, Benjamin Y Jin, Reona Okada, Xiyuan Zhang, Arina Clavel, Jeyshka M Reyes-Gonzalez, Vadim Dyomin, Louis Diaz, Li...> ;Clinical Cancer Research. 2024 Apr 15
Efficacy, safety, and biomarker analyses of bintrafusp alfa, a bifunctional fusion protein targeting TGF-β and PD-L1, in patients with advanced non-small cell lung can...
Arun Rajan, Houssein Abdul Sater, Osama Rahma, Richy Agajanian, Wiem Lassoued, Jennifer L Marté, Yo-Ting Tsai, Renee N Donahue, Elizabeth Lamping, Shania Bailey, Andre...> ;Journal for Immunotherapy of Cancer. 2024 Mar 13
Increasing diversity in clinical trials: Demographic trends at the national cancer institute, 2005-2020.
Nipp, R., Choradia, N., Karzai, F., Naqash, A., Gulley, J., Floudas, C.> ;Journal of the National Cancer Institute. 2024 Feb 19
Comparison of Large Language Models in Answering Immuno-Oncology Questions: A Cross-Sectional Study.
Iannantuono, G., Bracken-Clarke, D., Choo-Wosoba, H., Karzai, F., Gulley, J., Floudas, C.> ;The Oncologist. 2024 Feb 3
Deep Learning-Based Detection and Classification of Bone Lesions on Staging Computed Tomography in Prostate Cancer: A Development Study.
Belue, M., Harmon, S., Yang, D., An, J., Gaur, S., Law, Y., Turkbey, E., Xu, Z., Tetreault, J., Lay, N., Yilmaz, E., Phelps, T., Simon, B., Lindenberg, L., Mena, E., P...> ;Academic Radiology. 2024 Jan 22
Health diplomacy in action: The cancer legacy of the Good Friday Agreement.
Lawler, M., Sullivan, R., Abou-Alfa, G., McCloskey, K., Keatley, D., Feighan, J., Dahut, W., Mulroe, E., Ladner, R., Genead, M., Lowery, M., Gulley, J., Scott, C., Lon...> ;Journal of Cancer Policy. 2023 Dec 1
A T cell receptor β chain-directed antibody fusion molecule activates and expands subsets of T cells to promote antitumor activity.
Jonathan Hsu, Renee N Donahue, Madan Katragadda, Jessica Lowry, Wei Huang, Karunya Srinivasan, Gurkan Guntas, Jian Tang, Roya Servattalab, Jacques Moisan, Yo-Ting Tsai...> ;Science Translational Medicine. 2023 Nov 29
1 citations
Comparison of Large Language Models in Answering Immuno-Oncology Questions: A Cross-Sectional Study.
Iannantuono, G., Bracken-Clarke, D., Karzai, F., Choo-Wosoba, H., Gulley, J., Floudas, C.> ;Medrxiv. 2023 Oct 31
1 citations
The tumor microenvironment state associates with response to HPV therapeutic vaccination in patients with respiratory papillomatosis.
Scott M Norberg, Ke Bai, Cem Sievers, Yvette Robbins, Jay Friedman, Xinping Yang, Meg Kenyon, Elizabeth Ward, Jeffrey Schlom, James Gulley, Amy Lankford, Roshanak Semn...> ;Science Translational Medicine. 2023 Oct 25
1 citations
Quantitative Analysis of Serial Positron Emission Tomography Imaging in Men with Metastatic Castration-resistant Prostate Cancer Treated with Enzalutamide.
Shruti U Gandhy, Fatima H Karzai, Marijo Bilusic, Sheri McMahon, Lisa M Cordes, Jennifer Marte, Amy J Weisman, Timothy G Perk, Liza Lindenberg, Esther Mena, Baris Turk...> ;European Urology Oncology. 2023 Oct 17
1 citations
Prediction of cancer treatment response from histopathology images through imputed transcriptomics.
Danh-Tai Hoang, Gal Dinstag, Leandro C Hermida, Doreen S Ben-Zvi, Efrat Elis, Katherine Caley, Stephen-John Sammut, Sanju Sinha, Neelam Sinha, Christopher H Dampier, C...> ;Research Square. 2023 Sep 15
5 citations
Efficacy and safety of PARP inhibitors in metastatic castration-resistant prostate cancer: A systematic review and meta-analysis of clinical trials.
Giovanni Maria Iannantuono, Elias Chandran, Charalampos S Floudas, Hyoyoung Choo-Wosoba, Gisela Butera, Mario Roselli, James L Gulley, Fatima Karzai> ;Cancer Treatment Reviews. 2023 Nov 1
1 citations
The NIH pediatric/young adult chordoma clinic and natural history study: Making advances in a very rare tumor.
Liny John, Hannah Smith, Maran Ilanchezhian, Robin Lockridge, Karlyne M Reilly, Margarita Raygada, Eva Dombi, Abby Sandler, Barbara J Thomas, John Glod, Markku Miettin...> ;Pediatric Blood & Cancer. 2023 Jun 22
Avelumab in Patients With Metastatic Colorectal Cancer.
Jason M Redman, Geraldine O'Sullivan Coyne, Clay T Reed, Ravi A Madan, Julius Strauss, Seth J Steinberg, Jennifer Marté, Lisa Cordes, Christopher Heery, James L Gulley> ;The Oncologist. 2023 Sep 7
1 citations
Flutamide With or Without PROSTVAC in Non-metastatic Castration Resistant (M0) Prostate Cancer.
Ravi A Madan, Marijo Bilusic, Mark N Stein, Renee N Donahue, Philip M Arlen, Fatima Karzai, Elizabeth Plimack, Yu-Ning Wong, Daniel M Geynisman, Matthew Zibelman, Tina...> ;The Oncologist. 2023 Jul 5
3 citations
First-in-human phase Ib trial of M9241 (NHS-IL12) plus avelumab in patients with advanced solid tumors, including dose expansion in patients with advanced urothelial c...
Julius Strauss, Jean-Laurent Deville, Mario Sznol, Alain Ravaud, Marco Maruzzo, Russell K Pachynski, Theodore S Gourdin, Michele Maio, Luc Dirix, Jeffrey Schlom, Renee...> ;Journal for Immunotherapy of Cancer. 2023 May 1
1 citations
Adaptive Immunity in Genitourinary Cancers.
Madhuri Koti, Trinity Bivalacqua, Peter C Black, Toni Cathomen, Matthew D Galsky, James L Gulley, Molly A Ingersoll, Ashish M Kamat, Wassim Kassouf, D Robert Siemens, ...> ;European Urology Oncology. 2023 Jun 1
11 citations
Phenotypic plasticity and reduced tissue retention of exhausted tumor-infiltrating T cells following neoadjuvant immunotherapy in head and neck cancer.
Cem Sievers, Marco Craveiro, Jay Friedman, Yvette Robbins, Xinping Yang, Ke Bai, Andy Nguyen, Jason M Redman, Raj Chari, Patrick Soon-Shiong, Jeffrey Schlom, James Gul...> ;Cancer Cell. 2023 May 8
1 citations
Immune correlates with response in patients with metastatic solid tumors treated with a tumor targeting immunocytokine NHS-IL12.
Nicole J Toney, Margaret E Gatti-Mays, Nicholas P Tschernia, Julius Strauss, James L Gulley, Jeffrey Schlom, Renee N Donahue> ;International Immunopharmacology. 2023 Mar 1
2 citations
Society for Immunotherapy of Cancer (SITC) consensus definitions for resistance to combinations of immune checkpoint inhibitors with targeted therapies.
Michael B Atkins, Paolo A Ascierto, David Feltquate, James L Gulley, Douglas B Johnson, Nikhil I Khushalani, Jeffrey Sosman, Timonthy A Yap, Harriet Kluger, Ryan J Sul...> ;Journal for Immunotherapy of Cancer. 2023 Mar 1
7 citations
Phase 1 Study of Safety and Preliminary Clinical Activity of JNJ-63898081, a PSMA and CD3 Bispecific Antibody, for Metastatic Castration-Resistant Prostate Cancer.
Emerson A Lim, Michael T Schweizer, Kim N Chi, Rahul Aggarwal, Neeraj Agarwal, James Gulley, Edward Attiyeh, James Greger, Shujian Wu, Pharavee Jaiprasart, John Loffre...> ;Clinical Genitourinary Cancer. 2023 Jun 1
1 citations
Avelumab in Men With Metastatic Castration-Resistant Prostate Cancer, Enriched for Patients Treated Previously With a Therapeutic Cancer Vaccine.
Ravi A Madan, Jason M Redman, Fatima Karzai, William L Dahut, Lisa Cordes, Farhad Fakhrejahani, Tuyen Vu, Nadeem Sheikh, Jeffrey Schlom, James L Gulley> ;Journal of Immunotherapy. 2023 May 1
Tumor cell HLA class I expression and pathologic response following neoadjuvant immunotherapy for newly diagnosed head and neck cancer.
Yvette Robbins, Jay Friedman, Jason Redman, Cem Sievers, Wiem Lassoued, James L Gulley, Clint T Allen> ;Oral Oncology. 2023 Mar 1
2 citations
A Phase I Single-Arm Study of Biweekly NHS-IL12 in Patients With Metastatic Solid Tumors.
Margaret E Gatti-Mays, Nicholas P Tschernia, Julius Strauss, Ravi A Madan, Fatima H Karzai, Marijo Bilusic, Jason Redman, Houssein Abdul Sater, Charalampos S Floudas, ...> ;The Oncologist. 2023 Apr 6
4 citations
In Silico Re-Optimization of Atezolizumab Dosing Using Population Pharmacokinetic Simulation and Exposure-Response Simulation.
Cody J Peer, Keith T Schmidt, Oluwatobi Arisa, William J Richardson, Koosha Paydary, Daniel A Goldstein, James L Gulley, William D Figg, Mark J Ratain> ;Journal of Clinical Pharmacology. 2023 Jun 1
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Journal Articles

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

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

Marengo Therapeutics Appoints Kevin Chin, MD, MS as Chief Medical OfficerMarch 1st, 2023
Immunotherapy and… Nothing Else? Studies Test Potential Paradigm Shift in Cancer TreatmentFebruary 23rd, 2023
'We Don't Know' What the Limits Are for RNA TherapiesJanuary 9th, 2023
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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