UVA Investigator-initiated Trials (single- and multi-site)

• Jones DR, Moskaluk CA, Gillenwater HH, Petroni GR, et al. A phase I trial of induction histone deacetylase and proteasome inhibition followed by surgery in non-small-call lung cancer. J Thorac Oncol 2012; 7:1683-1690.

• Melssen MM, Petroni GR, Chianese-Bullock KA, Wages NA, et al. A multipeptide vaccine plus toll-like receptor agonists LPS or polyICLC in combination with IFA in melanoma patients. J Immunother Cancer 2019; 7: 163. 

• Muller DA, Wages NA, Wilson DD, et al. STAT RAD: A prospective dose escalation clinical trial of single fraction scan-plan-QA-treat SBRT for painful osseous metastases. Pract Radiat Oncol 2020; 10: e444-e451.
• Wages NA, Sanders JC, Smith A, et al. Hypofractionated post-prostatectomy radiotherapy for prostate cancer to reduce toxicity and improve patient convenience: A Phase I/II trial. Int J Radiat Oncol Biol Phys 2020; [epub ahead of print] Nov 21.
• Slingluff CL, Petroni GR, Chianese-Bullock KA, Wages NA, et al. A trial to evaluate the immunogenicity and safety of a melanoma helper peptide vaccine plus incomplete Freund’s adjuvant, cyclophosphamide, and polyICLC (Mel 63). J Immunother Cancer 2021 (in press).
• Lau CL, Beller JP, Boys JA, Zhao Y, Phillips J, Cosner M, Conaway MR, Petroni GR, et al. Adenosine A2A receptor agonist (regadenoson) in human lung transplantation. J Heart Lung Transplant 2020; 39: 563-570.
• Kaufman DA, Berenz A, Itell HL, Conaway MR, et al. Dose escalation study of bovine lactoferrin in preterm infants: getting the dose right. Biochem Cell Biol 2020; [epub ahead of print] Aug 26. 

• A phase I/II trial of long peptide vaccine plus TLR agonists (Mel 60) (NCT02126579).

• Optimal dose finding study of ABT-199 and ibrutinib in MCL (ABT-199) (NCT02419560).
• Focused ultrasound therapy to augment antigen presentation and immune-specificity of checkpoint inhibitor therapy with pembrolizumab in metastatic breast cancer (Breast 48) (NCT03237572)
• A pilot study of the combination of entinostat with capecitabine in high risk breast cancer after neo-adjuvant therapy (Breast 49) (NCT03473639).
• Phase I study of inotuzumab with augmented BFM re-Induction for younger adults with relapsed/refractory B-cell ALL (NCT03962465)
• Melanoma vaccine against neoantigen and shared antigens by CD40 activation and TLR agonists in patients with melanoma (Mel66) (NCT04364230)
• Prospective trial of combination external beam radiation therapy and MRI-guided, dose-differentiated high dose-rate prostate brachytherapy boost for unfavorable-intermediate and high-risk prostate cancer (Prostate-005) (NCT04465500)
• Pilot evaluation of focused ultrasound ablation and focused ultrasound ablation plus PD-1 antibody blockade in advanced solid tumors (AM-003) (NCT04116320)

External Collaborations

• Adjuvant hypofractionated whole pelvis radiation therapy in endometrial cancer (NCT04458402) [University of Cincinnati].

External Consultations

• University of Kentucky
• Mayo Clinic
• University of Miami
• Duke University
• University of Pennsylvania
• Columbia University
• Johns Hopkins University
• Memorial Sloan Kettering Cancer Center
• Medical University of South Carolina
• St. Jude Children's Hospital
• Nagoya University (Japan)
• Pfizer Inc.
• Boehringer Ingelheim Pharmaceuticals
• Eli Lilly & Company
• Onyx Pharmaceuticals

Protocol Statistical Section Templates

• Continual reassessment method (CRM) for escalation of one agent

• Partial order continual reassessment method (PO-CRM) for escalation of two agents