The University of Tennessee Graduate School of Medicine, Knoxville



The Department of Medicine

Clinical Trials

A clinical trial is a research study which tests an intervention for future use in the treatment of people, usually individuals with a specified medical problem. A clinical trial can test a potential medication, procedure, behavioral treatment, medical device or preventive care. Participants in clinical trials are divided into various groups to evaluate the effect of the intervention on health outcomes. Participants in clinical trials make invaluable contributions to the advancement of medical knowledge and treatment and prevention of disease. Participants often benefit immensely by receiving lifesaving interventions that would not otherwise be available. For more information about our clinical trials please contact JFerris@utmck.edu or phone 865-305-7975.

The following National Clinical Trials are currently ongoing by faculty in the Department of Medicine:

Pulmonary Division

Principal Investigator: Callison, J.
Sub-Investigator: McCormack, M.
Vertex VX17-659-102: A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-659 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF)
Dates: 2017-Present

Principal Investigator: Callison, J.
Sub-Investigator: McCormack, M.
Vertex 103: A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-659 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous or the F508del Mutation (F/F)
Dates: 2017-Present

Principal Investigator: Callison, J.
Sub-Investigator: McCormack, M.
Vertex VX17-659-105: A Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy of VX-659 Combination Therapy in Subjects with Cystic Fibrosis Who are Homozygous or Heterozygous for the F508del Mutation
Dates: 2017-Present

Hematology/Oncology Division

Principal Investigator: Hanna, W.
Apellis APL-2-CP-AIHA-208 An Open Label, Prospective Study to Assess the Safety, Tolerability, Efficacy and Pharmacokinetics of APL-2 in Patients with Warm Antibody Autoimmune Hemolytic Anemia (wAIHA) or Cold Agglutinin Disease (CAD)
Dates: September 2018-Present

Principal Investigator: Hanna, W.
Apellis APL-302: A Phase III, Randomized, Multi-Center, Open Label, Active-Comparator Controlled Study to Evaluate the Efficacy and Safety of APL-2 in Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH)
Dates: September 2018-Present

Principal Investigator: Hanna, W.
Sub-Investigators: Mosley, J.
BrightPath GRN-1201: A Pilot, Open-Label, Multi-Center, Multi-Dose Study of GRN-1201 Added to Pembrolizumab in Subjects with PD-L1 + Non-Small Cell Lung Cancer
Dates: May 2018-Present

Principal Investigator: Hanna, W.
Sub-Investigators: Charles, A.
Astra Zeneca Strong: An Open-Label, Multi-Centre, Safety Study of Fixed-Dose Durvalumab + Tremelimumab Combination Therapy or Durvalumab Monotherapy in Advanced Solid Malignancies (STRONG) - Core Protocol Module A - Post-Chemotherapy Urothelial and Non-Urothelial Carcinoma of the Urinary Tract
Dates: 2017-Present

Principal Investigator: Hanna, W.
Sub-Investigators: Charles, A.
BMS CA209-812: Randomized, Open-label, Phase 3 Trial of Nivolumab plus Brentuximab vedotin versus Brentuximab vedotin alone in Participants with Relapsed Refractory or Ineligible for Autologous Stem Cell Transplant (ASCT) Advanced Stage Classical Hodgkin Lymphoma (CheckMate 812: CHECKpoint pathway and nivoluMAb clinical Trial evaluation 812)
Dates: 2017-Present

Principal Investigator: Hanna, W.
Sub-Investigators: Charles, A.
Boston Biomedical CanStem303C: A Phase III Study of BBI-608 in combination with 5-Fluorouracil, Leucovorin, Irinotecan (FOLFIRI) in Adult Patients with Previously Treated Metastatic Colorectal Cancer (CRC)
Dates: 2017-Present

Principal Investigator: Hanna, W.
Sub-Investigators: Charles, A., Newman, S.
Boston Biomedical CanStem 111P: A Phase III Study of BBI-608 plus nab-Paclitaxel with Gemcitabine in Adult Patients with Metastatic Pancreatic Adenocarcinoma
Dates: 2017-Present

Principal Investigator: Hanna, W.
Sub-Investigators: Charles, A.
Boston Biomedical BBI-DSP7888-201G: A Randomized, Multicenter, Phase 2 Study of DSP-7888 Dosing Emulsion in Combination with Bevacizumab versus Bevacizumab Alone in Patients with Recurrent or Progressive Glioblastoma following Initial Therapy
Dates: 2017-Present

Principal Investigator: Hanna, W.
Sub-Investigators: Charles, A.
Eisai E7080G000218: A randomized, Double-blind, Phase 2 Trial to Assess Safety and Efficacy of Lenvatinib at Two Different Starting Doses (18mg vs 14 mg AD) in Combination with Everolimus (5mg QD) in Renal Cell Carcinoma Following One Prior VEGF-Targeted Treatment
Dates: 2017-Present

Principal Investigator: Hanna, W.
Sub-Investigators: Charles, A., Newman, S.
G1 Therapeutics G1T28-02: Phase 1b/2a Safety and Pharmacokinetic Study of G1T28 in Patients with Extensive-Stage Small Cell Lung Cancer (SCLC) Receiving Etoposide and Carboplatin Chemotherapy
Dates: 2017-Present

Principal Investigator: Hanna, W.
Sub-Investigators: Charles, A., Newman, S.
G1 Therapeutics G1T28-03: Phase 1b/2a Safety and Pharmacokinetic Study of G1T28 in Patients with Previously Treated Extensive-Stage Small Cell Lung Cancer (SCLC) Receiving Topotecan Chemotherapy
Dates: 2017-Present

Principal Investigator: Hanna, W.
Sub-Investigator: Charles, A.
Pharmacyclics: A Multicenter Open-Label Phase 1b/2 Study of the Bruton's Tyrosine Kinase (BTK) Inhibitor, Ibrutinib, in Combination with Lenalidomide and Rituximab in Subjects with Relapsed or Refractory Diffuse Large B-Cell Lymphoma
Dates: 2017-Present

Principal Investigator: Hanna, W.
Sub-Investigators: Panella, T., Newman, S.
BMS Preamble: PREAMBLE Prospective Research Assessment in Multiple Myeloma: An
Observational Evaluation
Dates: 2015-Present

Principal Investigator: Hanna, W.
Sub-Investigators: Panella, T., Newman, S.
Celgene Connect: The Myelodysplastic Syndromes (MDS) and Acute Myeloid Leukemia (AML) Disease Registry
Dates: 2014-Present

Principal Investigator: Panella, T.
Sub-Investigators: Charles, A., Hanna, W., Newman, S.
Helsinn Nepa-17-05: Phase 3b, multicenter, randomized, double-blind, double-dummy, active-controlled, parallel group study to assess the efficacy and safety of IV fosnetupitant/palonosetron (260 mg/0.25 mg) combination (IV NEPA FDC) compared to oral netupitant/palonosetron (300 mg/0.5 mg) combination (Akynzeo) for the prevention of chemotherapy-induced nausea and vomiting in anthracycline-cyclophosphamide (AC) naive female breast cancer patients receiving AC chemotherapy
Dates: July 2018-Present

Principal Investigator: Panella, T.
Sub-Investigators: Faulkner, N., Mosley, J.
Merck Mk-716: KEYNOTE-716 Phase III randomized, double-blind study of adjuvant therapy with Pembolizumab versus placebo in resected stage II melanoma
Dates: 2018-Present

Principal Investigator: Panella, T.
Sub-Investigator: Faulkner, N.
Novartis CPDR001F2301: A randomized, double-blind placebo-controlled, Phase 3 study comparing PDR001, dabrafenib, and trametinib versus placebo, dabrafenib and trametinib in untreated patients with unresectable or metastatic BRAF V600 mutant melanoma
Dates: 2018-Present

Principal Investigator: Panella, T.
Sub-Investigators: Charles, A., Hanna, W., Newman, S.
Lilly I3Y-MC-JPCF: A Randomized, Open-Label, Phase 3 Study of Abemaciclib combined with Standard Adjuvant Endocrine Therapy versus Standard Endocrine Therapy Alone in Patients with High Risk, Node Positive, Early Stage, Hormone Receptor Positive, Human Epidermal Receptor 2 Negative, Breast Cancer.
Dates: 2017-Present

Principal Investigator: Panella, T.
Sub-Investigators: Hanna, W., Newman, S.
Merck MK-355: A Randomized, Double-Blind, Phase III Study of Pembrolizumab (MK-3475) plus Chemotherapy vs Placebo plus Chemotherapy for Previously Untreated Locally Recurrent Inoperable or Metastatic Triple Negative Breast Cancer - (KEYNOTE-355)
Dates: 2017-Present

Principal Investigator: Panella, T
Sub-Investigators: Faulkner, N
Array 818-103: A Sequential 2-arm, Open-label Phase 1 Study to Evaluate the Effects of Encorafenib in Combination with Binimetinib on the Pharmacokinetics of Losartan, Midazolam, Caffeine, Omeprazole, and Dextromethorphan Administered in a Cocktail Approach and on the Pharmacokinetics of Rosuvastatin in Patients with BRAF V600-mutant Unresectable or Metastatic Melanoma or Other Advanced Solid tumors
Dates: 2017-Present

Principal Investigator: Panella, T.
Sub-Investigators: Hanna, W., Newman, S.
Polynoma: A Multicenter, Double-Blind, Placebo-controlled, Adaptive Phase 3 Trial of POL-103A Polyvalent Melanoma Vaccine in Post-resection Melanoma Patients with a High Risk of Recurrence. MAVIS - Melanoma Antigen Vaccine Immunotherapy Study
Dates: 2015-Present

Principal Investigator: Charles, A.
Sub-Investigators: Hanna, W., Newman, S.
Merck MK-590: Phase 3 study of Pembrolizumab in Combination with Cisplatin and 5-Fluorouracil versus Placebo in Combination with Cisplatin and 5-Fluorouracil as First-Line Treatment in Subjects with Advanced/Metastatic Esophageal Carcinoma (KEYNOTE-590)
Dates: 2017-Present

Principal Investigator: Charles, A.
Sub-Investigators: Hanna, W.
Merck MK-361: A Phase III Randomized, Controlled Clinical Trial of Pembrolizumab with or without Platinum-Based Combination Chemotherapy versus Chemotherapy in Subjects with Advanced or Metastatic Urothelial Carcinoma
Dates: 2017-Present

Cardiology Division

Principal Investigator: Mehmood, M.
Sub-Investigators: Janoyan, J.
Duke Clinical Research Institute Connect: Care Optimization through patient and hospital engagement clinical trial for Heart Failure.
Dates: 2018-Present

Principal Investigator: Shepple, B.
GE Healthcare GE-265-303: A Phase 3, Open-Label, Multicenter Study of Flurpiridaz Injection for Positron Emission Tomography (PET) Imaging for Assessment of Myocardial Perfusion in Patients Referred for Invasive Coronary Angiography Because of Suspected Coronary Artery Disease
Dates: 2018-Present

Neurology Division

Principal Investigator: Trudell, R.
Biogen Esteem Registry: A Multicenter, Global, Observational Study to Collect Information on Safety and to Document the Drug Utilization of Tecfidera (Dimethyl Fumarate) When Used in Routine Medical Practice in the Treatment of Multiple Sclerosis
Dates: 2014-Present

 




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