James L Gulley MD Ph.D.

Clinical Trials

• Eligibility Screening for the NIH Intramural Research Program Clinical Protocols Start of enrollment: 2004 Jan 14

  COMPLETED

• 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 26

  COMPLETED

  PHASE2

• 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

  Completed

  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

  PHASE1

• Phase I/II Study of Immunotherapy Combination BN-Brachyury Vaccine, M7824, N-803 and Epacadostat (QuEST1) Start of enrollment: 2018 May 01

  COMPLETED

  PHASE1, PHASE2

• 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

  COMPLETED

• The Effect of Diet and Exercise on ImmuNotherapy and the Microbiome (EDEN) Start of enrollment: 2023 Jul 25

  RECRUITING

  NA

  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: 2025 Apr 08

  RECRUITING

  PHASE1

  Roles: Contact, Principal Investigator

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