Clinical Trials Directory

Are you interested in taking part in a clinical trial? Our Clinical Trials Directory includes all active clinical trials at The University of Tennessee Medical Center.

Moving Medical Knowledge Forward, Every Day

Doctors and researchers at The University of Tennessee Medical Center work together diligently. Our goal is to discover new and better ways to find and treat disease. We do this through various research projects and clinical trials.

Research projects at the medical center help move forward medical knowledge. The National Institutes of Health and related agencies fund researchers on our campus to bring the best of medical care to East Tennessee. Plus, our physicians provide clinical trial opportunities for our patients. We make them readily available to those who seek new medications and treatment.

Our research teams work closely with researchers throughout the University of Tennessee system as well as others throughout the nation.

The University of Tennessee Medical Center brings together outstanding patient care, challenging clinical training and stimulating research – all on one campus.

Find a Clinical Trial

Breast Cancer

Hormone Receptor Positive

A011801 — The COMPASSHER2 Residual Disease (RD)- A double-blinded phase 3 randomized trial of Adjuvant T-DM1 and placebo compared to T-DM1 and Tucatinib following neoadjuvant chemo and HER2 directed therapy.

AstraZeneca Cambria 2 — A phase 3, open-label randomized study of Camizestrant vs. Standard Endocrine as adjuvant treatment for patients with ER+/HER2- early breast cancer and an intermediate-high or high risk of recurrence who have completed definitive locoregional treatment and have no evidence of disease. 

Lilly EMBER-4 — Randomized, open-label phase 3 study of adjuvant Imlunestrant vs Standard Endocrine therapy in patients who have previously received 2-5 years of endocrine therapy in early breast cancer with increased risk of recurrence.

NRG-BR007 - A Phase III Clinical Trial Evaluating De-Escalation of Breast Radiation for Conservative Treatment of Stage I, Hormone Sensitive, HER-2 Negative, Oncotype Recurrence Score Less Than or Equal to 18 Breast Cancer. 

NRG-BR009 A Phase III Adjuvant Trial Evaluating the Addition of Adjuvant Chemotherapy to Ovarian Function Suppression Plus Endocrine Therapy in Premenopausal Patients With pN0-1, ER-Positive/HER2-Negative Breast Cancer and an Oncotype Recurrence Score Less Than or Equal to 25 (OFSET). 

Triple Negative Breast Cancer

Gilead ASCENT-05 — An open-label study of Sacituzumab Govitecan and Pembrolizumab vs treatment of physician’s choice in patients with Triple negative breast cancer who have residual invasive disease in the breast or lymph nodes after neoadjuvant therapy and surgery.

A012103A randomized study of Adjuvant Pembrolizumab vs observation in patients with triple negative breast cancer who had a pathological complete response after chemotherapy plus Pembrolizumab.

BioNTech BNT327-02 - A Phase II, Multi-site, Randomized, Open-label Clinical Trial to Evaluate the Safety, Efficacy, and Pharmacokinetics of BNT327 at Two Dose Levels in Combination With Chemotherapeutic Agents as First- and Second-line Treatment in Triple-negative Breast Cancer.

Gastrointestinal Cancer

None at this time

Genitourinary Cancer 

Urothelial Cancer

SeaGen RC48G001 — Phase 2 open-label study evaluating Disitamab Vedotin in patients with HER-2 expressing locally advanced unresectable or metastatic urothelial carcinoma who are platinum eligible.

Janssen Moonrise 42756493BLC3004 - A Phase 3, Randomized Study Evaluating the Efficacy and Safety of TAR-210 Erdafitinib Intravesical Delivery System Versus Single Agent Intravesical Chemotherapy in Participants With Intermediate-risk Non-muscle Invasive Bladder Cancer (IR-NMIBC) and Susceptible FGFR Alterations. 

Gynecological Cancer

Karyopharm XPORT-EC-042 — a randomized, placebo controlled, double-blind trial of Selinexor with maintenance treatment of patients with p53 wild type advance or recurrent endometrial carcinoma after systemic therapy.

Hematologic Malignancies and Conditions

Luekemia

Janssen Menin 75276617ALE1001 - A Phase 1/2, First-in-Human Study of the Menin-KMT2A (MLL1) Inhibitor Bleximenib in Participants With Acute Leukemia.

Myeloma

Janssen Car-T EAP  68284528MMY4006 - Intermediate-Size Population Expanded Access Program (EAP) for Ciltacabtagene Autoleucel (Cilta-cel) Out-of-Specification (OOS) in Patients With Multiple Myeloma.

Janssen HALO- A post-authorization safety study to evaluate the incidence of and risk factors for severe and fatal infusion related reactions in participants treated with Daratumumab (intravenous or subcutaneous).

Kite KT-US-679-0788 - A Phase 3, Randomized, Open-Label Study to Compare the Efficacy and Safety of Anitocabtagene Autoleucel Versus Standard of Care Therapy in Participants With Relapsed/Refractory Multiple Myeloma. 

Myelodysplastic Syndrome

BMS ELEMENT MDS — A study to compare the efficacy and safety of Luspatercept in patients with Myelodysplastic Syndrome (MDS) and Anemia, not receiving blood transfusions.

Cold Agglutinin Diesease

Sanofi CADENCE- patients with cold agglutinin disease (CAD) or cold agglutinin syndrome (CAS, previously known as secondary CAD) to prospectively collect longitudinal data and better understand patient and clinical characteristics.

Lung Cancer

Non-Small Cell Lung Cancer

Amgen CODEBREAK 202 — A study evaluating Sotorasib platinum doublet combination versus Pembrolizumab platinum doublet combination as a front-line therapy in patients with Stage 4 or Advanced stage (3b/c) Nonsquamous Non-Small Cell Lung Cancer.

Amgen 20230167 - Limited availability - A Phase 1b Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of AMG 193 Alone or in Combination With Other Therapies in Subjects With Advanced Thoracic Tumors With Homozygous MTAP-deletion (Master Protocol).

Alliance A151216 — Adjuvant lung cancer enrichment marker identification and sequencing trial.

Alliance A081801 — Integration of immunotherapy into adjuvant therapy for resected non-small cell lung cancer.

BioNTech BNT327-06 - A Phase II/III, Multisite, Randomized Master Protocol for a Global Trial of BNT327 in Combination With Chemotherapy and Other Investigational Agents in First-line Non-small Cell Lung Cancer

Iovance-IOV-LUN-202 — A Phase 2 Multicenter Study of Autologous Tumor Infiltrating Lymphocytes (LN-145) in Patients with Metastatic Non-Small-Cell Lung Cancer.

OncoC4 Preserve-003 — Phase 3, Two-stage, Randomized Study of ONC-392 Versus Docetaxel in Metastatic Non-Small Cell Lung Cancers that Progressed on PD-1/PD-L1 Inhibitors.

Regeneron R3767-ONC-2235 — A study to learn if a combination of Fianlimab and Cemiplimab versus Cemiplimab alone is more effective for adult patients with Advanced Non-Small Cell Lung Cancer.

Regeneron R3767-ONC-2236 — A trial to learn how the combination of Fianlimab with Cemiplimab and Chemotherapy works compared with Cemiplimab and Chemotherapy for treating adults with Advanced Non-Small Cell Lung Cancer.

Regeneron R2810-ONC-2268 - A Randomized Phase 2 Platform Study to Evaluate Cemiplimab Plus Chemotherapy Versus Cemiplimab Plus Chemotherapy Plus Other Cancer Treatments for the Perioperative Treatment of Patients With Resectable Non-Small Cell Lung Cancer.

Genmab GCT1046-06 - A Prospective, Open-Label, Randomized, Phase 3 Trial of Acasunlimab (GEN1046) in Combination With Pembrolizumab Versus Docetaxel in Subjects With PD-L1 Positive Metastatic Non-Small Cell Lung Cancer After Treatment With a PD-1/PD-L1 Inhibitor and Platinum-Containing Chemotherapy.

Small Cell Lung Cancer

BioNTech BNT327-01 - A Phase II, Multi-site, Open-label, Parallel Group Trial of BNT327 in Combination With Chemotherapy for Participants With Untreated Extensive-stage Small-cell Lung Cancer and Participants With Previously Treated Small-cell Lung Cancer.

BioNTech BNT327-03 - A Phase III, Multisite, Double-blinded Randomized Trial of BNT327 in Combination With Chemotherapy (Etoposide/Carboplatin) Compared to Atezolizumab in Combination With Chemotherapy (Etoposide/Carboplatin) in Participants With First-line Extensive-stage Small-cell Lung Cancer

Pancreatic Cancer

Alliance A021806 — A Phase 3 trial of perioperative versus adjuvant chemotherapy for resectable pancreatic cancer.

S2104 — Phase II Trial of Postoperative Adjuvant Capecitabine and Temozolomide Versus Observation in High-Risk Pancreatic Neuroendocrine Tumors.

Skin Cancer

Melanoma

Amgen Herpetic Infection 20130193 — A post-marketing prospective cohort study of Melanoma patients treated with Imlygic (Talimogene Laherparepvec) in clinical practice to characterize the risk of herpetic infection among patients, close contacts, and health care providers, and long-term safety in treated patients.

Castle Decide — Study of patients with Melanoma who care being considered for a SLNB and Decision DX as part of clinical care.

Immunocore IMCgp100-203 — A Phase 2/3 randomized study of Tebentafusp as monotherapy and in combination with Pembrolizumab versus Investigator's choice in patients with previously treated advanced melanoma (TEBE-AM).

Regeneron R3767-ONC-2208 - A Phase 2 and Phase 3 Peri-operative Trial of Fianlimab and Cemiplimab Compared With Anti-PD1 Alone in Patients With Resectable Stage III and IV Melanoma.

Regeneron R3767-ONC-22122 - A Phase 3 Study of Fixed Dose Combinations of Fianlimab and Cemiplimab Versus Relatlimab and Nivolumab in Participants With Unresectable or Metastatic Melanoma.

Replimune RP1-104 - Randomized, Ph3 Clinical Study Comparing Vusolimogene Oderparepvec in Combination With Nivolumab Vs Treatment of Physician's Choice in Patients With Advanced Melanoma That Progressed on Anti-PD-1 and Anti-CTLA-4 Containing Treatment.

Myasthenia Gravis

Alexion MG-501 — Long-term observational registry of patients with generalized myasthenia gravis who have received treatment with complement C5 inhibition therapies.

Multiple Sclerosis

TG Therapeutics ENABLE TG1101-RMS406 - Real World Experience With BRIUMVI® (UblituximAB-xiiy) Treated Patients: A Longitudinal Registry Study (ENABLE)

 

 

None at this time.

Cardiology

Heart Failure

Cleerly Medical CONFIRM2 (Quantitative COroNary CT Angiography Evaluation For Evaluation of Clinical Outcomes: An InteRnational, Multicenter Registry).

Cleerly Transform 202302CPC - A Randomized Comparison of Cleerly Coronary Artery Disease Stage-Based Care Versus Risk Factor-Based Care for Primary Prevention of Cardiovascular Events.

HeartFlow CP-910-001 DECIDE Registry - AI Derived Plaque Quantification: CCTA and AI-QCPA for Determining Effective CAD Management.

Pulmonary

Inari Peerless II - PEERLESS II: RCT of FlowTriever Vs. Anticoagulation Alone in Pulmonary Embolism.

Cystic Fibrosis

Vertex VX20-121-104 — A Phase 3, open-label study Evaluating the long-term safety and efficacy of VX-121 combination therapy in patients with Cystic Fibrosis.

Aortic Aneurysms

Gore_Tambe AAA 17-01 - Evaluation of the GORE® EXCLUDER® Thoracoabdominal Branch Treatment of the Thoracoabdominal and Pararenal Aortic Aneurysms (TAM). 

Dialysis/Vascular Surgery

Humacyte HAV-012 — A Phase 3 open-label, sponsor blinded study to compare the efficacy and safety of the Humacyte Human Acellular Vessel (HAV) with that of an Autogenous Arteriovenous Fistula (AVF) in female patients with end stage renal disease requiring hemodialysis.

Wake Forest AV Access - A Randomized Trial of Fistula vs. Graft Arteriovenous Vascular Access in Older Adults With End-Stage Kidney Disease on Hemodialysis.

Due to the nature of emergency medicine, pre-consent is not always feasible. Community members are invited to participate in a survey here to give feedback and learn about the study.

Aorta - Trauma Patients receive aortic Occlusions

Direct Biologics DB-EF-PHASEIII-0001 - Bone Marrow Mesenchymal Stem Cell Derived Extracellular Vesicles for Hospitalized Patients With Moderate-to-Severe ARDS: A Phase III Clinical Trial.

TOWAR — Open label, multi-center, pre-hospital randomized trial utilizing 10 level-1 trauma centers designed to determine the efficacy and safety of low titer whole blood resuscitation as compared to standard of care resuscitation in patients at risk of hemorrhagic shock and to appropriately characterize the hemostatic competency of whole blood relative to its age.

Due to the nature of emergency medicine, pre-consent is not always feasible. Community members are invited to participate in a survey here to give feedback and learn about the study.

Pain Control following Nephrolithotomy.

ANES-07-072021 — Erector Spinae Block vs Standard of care for pain control following Percutaneous Nephrolithotomy.

Prostate Cancer

Cirium CURCu64PSM0003 - Phase 3, Multi-Center, Open-label Study to Test the Diagnostic Performance of Copper Cu 64 PSMA I&T PET/CT in Staging Men With Newly Diagnosed Unfavorable Intermediate-risk, High-risk or Very High-risk Prostate Cancer Electing to Undergo Radical Prostatectomy With Pelvic Lymph Node Dissection.

Urothelial Cancer

Janssen Moonrise 42756493BLC3004 - A Phase 3, Randomized Study Evaluating the Efficacy and Safety of TAR-210 Erdafitinib Intravesical Delivery System Versus Single Agent Intravesical Chemotherapy in Participants With Intermediate-risk Non-muscle Invasive Bladder Cancer (IR-NMIBC) and Susceptible FGFR Alterations.

Gastroparesis

Enterra – Expedite CLN-001-PR-01218 - Examination of Programming with the Enterra® Therapy System in a Double-Blinded, Randomized, Prospective Study in the Treatment of Nausea and Vomiting Symptoms Using Gastric Electrical Stimulation

 

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