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

Amyloidosis

Prothena — A Phase 3, Multicenter, Open-Label, Single-Arm, Efficacy and Safety Study of Birtamimab Plus Standard of Care in Mayo Stage IV Subjects with Light Chain (AL) Amyloidosis.

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 1- A phase 3, Randomized, open-label study of adjuvant Camizestrant vs Standard Endocrine therapy in patients with intermediate to high-risk ER+, HER2- cancer that have previously received locoregional therapy and 2-5 years of endocrine 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.

HER 2 Negative

S2007 — A Phase II Trial of Sacituzumab Govitecan for Patients with HER2-Negative invasive Breast Cancer that has metastasized to the brain.

Inflammatory Breast Cancer

S1706 — A Phase II Randomized Trial of Olaparib (NSC-747856) Administered Concurrently with Radiotherapy versus Radiotherapy Alone for Inflammatory Breast Cancer.

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.

Gastrointestinal Cancer

Biliary Tract/Gallbladder Cancer

EA2197 — A phase 2 trial to compare chemotherapy before and after surgery vs after surgery alone for the treatment of Gallbladder cancer.

Compass Companion-002 — A Study of CTX-009 in Combination With Paclitaxel in Adult Patients With Unresectable Advanced, Metastatic or Recurrent Biliary Tract Cancers (COMPANION-002).

Gastrointestinal Stromal Tumors

Cogent CGT9486-21-301 — (PEAK) A phase 3, randomized, open-label study of CGT9486+ Sunitinib vs Sunitinib in patients with locally advanced, unresectable, or metastatic GIST.

Genitourinary Cancer

Penile Cancer

Ascendis TCTLR-101 — Phase 1/2, Open-label study of TransCon TLR7/8 Agonist Alone or in Combination with Pembrolizumab in Participants with Locally Advanced, unresectable recurrent or Metastatic Penile cancer.

Renal Cell Carcinoma

A031704 PDIGREE — PD Inhibitor (Nivolumab) and Ipilimumab followed by Nivolumab vs. VEGF TKI Cabozantinib with Nivolumab: A Phase 3 trial in metastatic untreated Renal Cell Cancer.

Urothelial Cancer

A031702 ICONIC — Phase 2 study of Ipilimumab, Cabozantinib, and Nivolumab in rare genitourinary cancers.

A032001 MAIN-CAV —Phase 3 study of maintenance Cabozantinib and Avelumab vs Avelumab after first-line platinum-based chemotherapy in patients with metastatic urothelial cancer.

Janssen Sunrise 2 — A Phase 3, Multi-Center, randomized study evaluating efficacy of TAR-200 in combination with Cetrelimab vs concurrent Chemoradiotherapy in patients with muscle-invasive bladder cancer who are not receiving radical cystectomy.

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.

SGN DV-001 — Open-label, Randomized, Controlled Phase 3 Study of Disitamab Vedotin in Combination with Pembrolizumab Versus Chemotherapy in Patients with Previously Untreated Locally Advanced or Metastatic Urothelial Carcinoma that Expresses HER2.

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.

HPV associated tumor types (Cervical, Vulvar, Vaginal)

Ascendis TCTLR-101 — Phase 1/2, Open-label study of TransCon TLR7/8 Agonist Alone or in Combination with Pembrolizumab in Participants with Locally Advanced, unresectable recurrent or Metastatic HPV related cancer.

Head and Neck Cancer

Ascendis TCTLR-101 — Phase 1/2, Open-label, Dose Escalation and Dose Expansion Study of TransCon TLR7/8 Agonist Alone or in Combination with Pembrolizumab in Participants with Locally Advanced or Metastatic Solid Tumor Malignancies.

Ascendis – ASND 0038 – BelieveIT-201 — Phase 2 open label TransCon TLR 7/8 Agonist + Pembrolizumab OR TransCon TLR 7/8 Agonist + TransCon 1L-2b/y OR Pembrolizumab monotherapy as neoadjuvant therapy in participants with Stage III-IVA resectable advanced Head and Neck squamous cell carcinoma. 

Hematologic Malignancies and Conditions

B-Cell Lymphomas

Curis CA-4948-101 — An open-label trial evaluating oral CA-4948 plus Ibrutinib in patients with relapsed refractory NHL subtype Primary Central Nervous System Lymphoma.

Epizyme EZH-302 — A phase 3 study evaluating Tazemetostat/Placebo plus Lenalidomide and Rituximab in patients with relapsed/refractory Grade 1-3A Follicular Lymphoma. Patients must have had at least one prior line of therapy.

Onopharm ONO-4059-09 — A phase 2 open-label study to evaluate Tirabrutinib in patients with relapsed/refractory Primary Central Nervous System Lymphoma.

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).

Myelofibrosis

Celgene INDEPENDENCE — A Phase double blind, randomized study to compare the efficacy and safety of luspatercept versus placebo in patients with myeloproliferative neoplasm-associated myelofibrosis on concomitant jak2 inhibitor therapy and who require red blood cell transfusions.

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 Disease

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.

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.

ECOG EA5163/S1709 — A randomized Phase III study of first line immunotherapy alone or in combination with chemotherapy in induction/maintenance or post progression in advanced non-squamous non-small cell lung cancer with Immunobiomarker signature-driven analysis.

ECOG E4512 — A component of the Alchemist trial-a randomized Phase III trial for surgically resected early-stage non- small cell lung cancer: Crizotinib versus observation for patients with tumors harboring the anaplastic lymphoma kinase (ALK) Fusion protein.

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.

Small Cell Lung Cancer

Merck MK7339-013 — A phase 3 study of Pembrolizumab in combination with concurrent chemoradiation therapy followed by Pembrolizumab with or without Olaparib, compared to concurrent chemoradiation therapy followed by placebo in participants with newly diagnosed treatment naïve limited-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.

ECOG EA2185 — A study comparing the clinical impact of pancreatic cyst surveillance programs.

Skin Cancer

Cutaneous Squamous Cell Carcinoma

Ascendis TCTLR-101 — Phase 1/2, Open-label, Dose Escalation and Dose Expansion Study of TransCon TLR7/8 Agonist Alone or in Combination with Pembrolizumab in Participants with Locally Advanced or Metastatic Solid Tumor Malignancies (Also for Melanoma)

Castle CBI-2019_cSCC_PVS_001 Prospective Validation of a Gene Expression Assay to Predict the Risk of Recurrence Disease in high-risk invasive Cutaneous Squamous Cell Carcinoma.

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.

Ascendis TCTLR-101 — Phase 1/2, Open-label, Dose Escalation and Dose Expansion Study of TransCon TLR7/8 Agonist Alone or in Combination with Pembrolizumab in Participants with Locally Advanced or Metastatic Solid Tumor Malignancies

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-2011 — A Phase 3 trial of Fianlimab (REGN-3767, Anti-LAG 3) + Cemiplimab vs. Pembrolizumab in patients with previously untreated unresectable locally advanced or metastatic melanoma.

Regeneron R3767-ONC-2055 — A trial to see if the combination of Fianlimab with Cemiplimab works better than Pembrolizumab for preventing or delaying melanoma from coming back after it has been removed with surgery.

Alzheimer’s Disease

Cognito Hope — A randomized, double-blind, sham-controlled, adaptive-design pivotal study of sensory stimulation in subjects with mild to moderate Alzheimer's disease.

Myasthenia Gravis

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

Stroke

Bayer OCEANIC — A study to test Asundexian to prevent a clot-related stroke in participants after an Acute Ischemic Stroke or High-risk TIA/Mini-stroke (Transient Ischemic Attack)

Genentech TIMEKEEPER — Tenecteplase in patients with Acute Ischemic Stroke: A Pharmacokinetic Study.

Seizures/Status Epilepticus

Marinus RAISE — Phase 2b international, multi-center, placebo-controlled study of Ganaxolone as an adjunctive treatment in adults suffering from partial onset seizures.

None at this time.

Cardiology

Myocardial Infarction

Abiomed STEMI-DTU — The Door to Unload (DTU) STEMI pivotal trial: A prospective, multicenter, two-arm, randomized controlled trial that plans to enroll 668 patients undergoing treatment for a STEMI.

Heart Failure

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

Pulmonary

Acute Respiratory Distress Syndrome

Dompe RESPARITO — Phase 2, Randomized, Double-blinded, Placebo-controlled, Multicenter Study to Assess Efficacy and Safety of Reparixin as add-on Therapy to SoC in Acute Respiratory Distress Syndrome (RESPIRATIO)

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.

Pneumonia

Dompe Revapid-22 REP0321 — A study to evaluate Reparixin as add-on therapy to standard of care to limit disease progression in adult patients with Community Acquired Pneumonia.

Sinovent Pharmaceuticals — A Phase 3 study to evaluate the efficacy and safety of intravenous Imipenim/Cilastatin in comparison with Imipenim/Cilastatin/Relebactam in adults with hospital acquired bacterial pneumonia or ventilator associated bacterial pneumonia.

Pulmonary Embolus

Inari FLARE-FT2 — A study to evaluate the use of FlowTriever2 in Pulmonary Embolectomy.

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.

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 surveyhere to give feedback and learn about the study.

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 surveyhere 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.

Urothelial Cancer

Janssen Sunrise 2 — A Phase 3, Multi-Center, randomized study evaluating efficacy of TAR-200 in combination with Cetrelimab vs concurrent Chemoradiotherapy in patients with muscle-invasive bladder cancer who are not receiving radical cystectomy.

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