James Gulley


Affiliation: National Institutes of Health
Country: USA


  1. Strauss J, Heery C, Kim J, Jochems C, Donahue R, Montgomery A, et al. First-in-Human Phase I Trial of a Tumor-Targeted Cytokine (NHS-IL12) in Subjects with Metastatic Solid Tumors. Clin Cancer Res. 2019;25:99-109 pubmed publisher
    ..8 μg/kg, which is the recommended phase II dose. Early clinical immune-related activity warrants further studies, including combination with immune checkpoint inhibitors.See related commentary by Lyerly et al., p. 9. ..
  2. Boyiadzis M, Kirkwood J, Marshall J, Pritchard C, Azad N, Gulley J. Significance and implications of FDA approval of pembrolizumab for biomarker-defined disease. J Immunother Cancer. 2018;6:35 pubmed publisher
    ..Here we discuss key issues and implications arising from the biomarker-based disease classification implied by this historic approval. ..
  3. request reprint
    Gulley J, Dahut W. Novel clinical trials in androgen-independent prostate cancer. Clin Prostate Cancer. 2002;1:51-7 pubmed
    ..This review focuses on the novel agents being tested with chemotherapy in metastatic prostate cancer. ..
  4. Gulley J. Therapeutic vaccines: the ultimate personalized therapy?. Hum Vaccin Immunother. 2013;9:219-21 pubmed publisher
    ..The ongoing active sculpting of the immune response, along with the lack of significant side effects, uniquely positions therapeutic vaccines as perhaps the ultimate in personalized therapy. ..
  5. Gulley J, Madan R, Tsang K, Arlen P, Camphausen K, Mohebtash M, et al. A pilot safety trial investigating a vector-based vaccine targeting carcinoembryonic antigen in combination with radiotherapy in patients with gastrointestinal malignancies metastatic to the liver. Expert Opin Biol Ther. 2011;11:1409-18 pubmed publisher
    ..CEA/TRICOM vaccination in combination with low-dose radiation therapy is safe. There was limited evidence of activity in this patient population. ..
  6. Gulley J, Heery C, Madan R, Walter B, Merino M, Dahut W, et al. Phase I study of intraprostatic vaccine administration in men with locally recurrent or progressive prostate cancer. Cancer Immunol Immunother. 2013;62:1521-31 pubmed publisher
    ..Improved serum PSA kinetics and intense post-vaccination inflammatory infiltrates were seen in the majority of patients. Clinical trials examining clinical end points are warranted. ..
  7. Gulley J, Marté J, Heery C, Madan R, Steinberg S, Leitman S, et al. The impact of leukapheresis on immune-cell number and function in patients with advanced cancer. Cancer Immunol Immunother. 2015;64:1429-35 pubmed publisher
    ..Limitations include a restriction to 2-L leukapheresis procedure and small sample size. ..
  8. Gulley J, Madan R, Tsang K, Jochems C, Marté J, Farsaci B, et al. Immune impact induced by PROSTVAC (PSA-TRICOM), a therapeutic vaccine for prostate cancer. Cancer Immunol Res. 2014;2:133-41 pubmed publisher
    ..This suggests that post-vaccine PSA kinetics were not affected by PSA antibodies. An ongoing phase III study will evaluate the systemic immune responses and correlation with clinical outcomes. ..
  9. Gulley J, Rajan A, Spigel D, Iannotti N, Chandler J, Wong D, et al. Avelumab for patients with previously treated metastatic or recurrent non-small-cell lung cancer (JAVELIN Solid Tumor): dose-expansion cohort of a multicentre, open-label, phase 1b trial. Lancet Oncol. 2017;18:599-610 pubmed publisher
    ..Avelumab showed an acceptable safety profile and antitumour activity in patients with progressive or treatment-resistant NSCLC, providing a rationale for further studies of avelumab in this disease setting. Merck KGaA and Pfizer. ..

More Information


  1. Heery C, O Sullivan Coyne G, Madan R, Cordes L, Rajan A, Rauckhorst M, et al. Avelumab for metastatic or locally advanced previously treated solid tumours (JAVELIN Solid Tumor): a phase 1a, multicohort, dose-escalation trial. Lancet Oncol. 2017;18:587-598 pubmed publisher
    ..Based on pharmacokinetics, target occupancy, and immunological analysis, we chose 10 mg/kg every 2 weeks as the dose for further development and phase 3 trials are ongoing. National Cancer Institute and Merck KGaA. ..
  2. Strauss J, Heery C, Schlom J, Madan R, Cao L, Kang Z, et al. Phase I Trial of M7824 (MSB0011359C), a Bifunctional Fusion Protein Targeting PD-L1 and TGFβ, in Advanced Solid Tumors. Clin Cancer Res. 2018;24:1287-1295 pubmed publisher
    ..Early signs of efficacy are encouraging, and multiple expansion cohorts are ongoing in a range of tumors. Clin Cancer Res; 24(6); 1287-95. ©2018 AACR. ..
  3. Bilusic M, Madan R, Gulley J. Immunotherapy of Prostate Cancer: Facts and Hopes. Clin Cancer Res. 2017;23:6764-6770 pubmed publisher
    ..With such concerted efforts, the future of immunotherapy in prostate cancer looks brighter than ever. Clin Cancer Res; 23(22); 6764-70. ©2017 AACR. ..
  4. Cordes L, Gulley J. Avelumab for the treatment of metastatic Merkel cell carcinoma. Drugs Today (Barc). 2017;53:377-383 pubmed publisher
    ..Serious treatment-related adverse events were reported in 5 patients (6%), but no grade 4 adverse events or treatment-related deaths were reported. Preliminary data evaluating avelumab in chemotherapy-naive patients is also encouraging. ..
  5. Heery C, Palena C, McMahon S, Donahue R, Lepone L, Grenga I, et al. Phase I Study of a Poxviral TRICOM-Based Vaccine Directed Against the Transcription Factor Brachyury. Clin Cancer Res. 2017;23:6833-6845 pubmed publisher
    ..Further studies of this vaccine in combination therapies are warranted and planned. Clin Cancer Res; 23(22); 6833-45. ©2017 AACR. ..