CLINICAL TRIALS DIRECTORY
Browse this directory to find the active clinical trials at The University of Tennessee Medical Center. If you are interested in any of these trials, contact us at 865-305-9773.
BBI-DSP7888-201G— A Phase 2 randomized trial of DSP-7888 dosing emulsion in combination with Bevacizumab versus Bevacizumab alone in patients with recurrent or progressive glioblastoma following initial therapy.
Alliance A071102— A Phase 2/3 randomized trial of Veliparib or Placebo in combination with adjuvant Temozolomide in newly diagnosed Glioblastoma with MGMT promoter Hypermethylation.
NRG-BR003 - A randomized, phase 3 trial for node-positive, high-risk node-negative triple-negative invasive breast cancer.
Merck Keynote 355-00 - A randomized, phase 3 trial Pembrolizumab plus chemotherapy vs. placebo plus chemotherapy for metastatic triple negative breast cancer.
Lilly 13Y-MC-JPCF (MonarchE)-A randomized, open-label Phase 3 trial of Abemaciclib combined with standard adjuvant Endocrine therapy versus standard adjuvant Endocrine therapy alone in patients with high risk, node positive, early stage, hormone receptor positive, human epidermal receptor 2 negative, breast cancer.
SWOG S0820 - A randomized, placebo controlled trial of Eflornithine and Sulindac to prevent recurrence of high risk adenomas and primary colorectal cancers in patients with Stage 0-Stage III colon or rectal cancer.
Boston Biomedical CanStem 303 C - 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).
Merck MK3475-590 - A randomized, double-blind, placebo-controlled Phase III clinical trial of Pembrolizumab (MK-3475) 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)
GENITAL AND URINARY CANCERS
Astra Zeneca D4191C00068 Strong - An open-label, multi-centre, safety study of fixed-dose Durvalumab + Tremelimumab combination therapy or Durvalumab monotherapy in advanced solid malignancies. Current module open is for Bladder Cancer.
Merck MK-3475-361 KEYNOTE-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.
Eisai E7080-G000-218 - A Randomized, double-blind, Phase 2 trial to assess safety and efficacy of Lenvatinib at two different starting doses (18 mg vs. 14 mg QD) in combination with Everolimus (5 mg QD) in Renal Cell Carcinoma following one prior VEGF-targeted treatment.
Merck MK3475-672—A phase 3 randomized, double-blind trial of Pembrolizumab (MK-3475) in combination with Epacadostat or placebo in participants with cisplatin-ineligible urothelial carcinoma.
GOG-0225 - A study to examine if diet and physical activity can modulate progression-free survival in ovarian, fallopian tube, and primary peritoneal cancers.
GOG-0238 - A randomized, phase 2 trial of pelvic irradiation with or without concurrent weekly Cisplatin in patients with recurrent endometrial cancer.
Morphotek MoRAb-003 - A randomized, placebo controlled, phase 2 study to assess the efficacy and safety of Farletuzumab (MoRAb-003) in combination with Carboplatin plus Paclitaxel or Carboplatin plus PLD in patients with Low CA125, platinum-sensitive, recurrent ovarian cancer.
Astra Zeneca D8488C00001 Concerto - A single arm, open-label, Phase IIb study to assess the efficacy and safety of the combination of Cediranib and Olaparib tablets in women with Recurrent Platinum Resistant Epithelial Ovarian Cancer, including Fallopian Tube and/or Primary Peritoneal Cancer who do not carry a deleterious or suspected deleterious germline BRCA mutation.
HEAD AND NECK CANCER
RTOG 1008—A randomized, Phase 2/ Phase 3 study of adjuvant, concurrent radiation and chemotherapy versus radiation alone in resected high-risk malignant salivary gland tumors.
Sillajen Jx594-HEP024 - A randomized, phase 3 open-label study comparing Pexa-Vec followed by Sorafenib vs. Sorafenib alone in patients with advanced hepatocellular carcinoma without prior systemic therapy.
Connect MDS/AML - The myelodysplastic syndromes and acute myeloid leukemia disease registry.
Helsinn Pran-16-52-AML - A Phase III, double-blind, placebo-controlled, multicenter, randomized study of Pracinostat in combination with Azacitidine in patients ≥18 years with newly diagnosed Acute Myeloid Leukemia unfit for standard Induction Chemotherapy.
Non-Small Cell Lung Cancer: No clinical trials at this time.
Small Cell Lung Cancer: G1 Therapeutics G1T28-03—A phase 1b/2a safety and pharmacokinetic study of G1T28 in patients with previously treated extensive-stage small cell lung cancer (SCLS) receiving Topotecan Chemotherapy.
BMS CA209-812 Hodgkin’s Lymphoma - A 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)
Pharmacyclics PCYC-1123-CA--An open label Phase1b/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.
Amgen Masterkey 265 - A Phase 3, multicenter trial of Talimogene Laherparepvec in combination with Pembrolizumab (MK-3475) for treatment of unresectable Stage IIIB to IVM1c Melanoma (MASTERKEY-265/KEYNOTE-034).
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.
Novartis CPDR001F2301—A randomized, double-blind, placebo-controlled, Phase 3 trial comparing the combination of PDR001, Dabrafenib, and Trametinib versus Placebo, Dabrafenib, and Trametinib in previously untreated patients with unresectable or metastatic BRAF V600 mutant melanoma.
BMS Preamble-CA204008 ST - An observational evaluation in Multiple Myeloma.
Boston Biomedical CanStem 111P - A Phase III study of BBI-608 plus Nab-Paclitaxel with Gemcitabine in adult patients with Metastatic Pancreatic Adenocarcinoma.
Brain and Spine institute
Acadia ACP-103-045—A double-blind, placebo controlled, relapse prevention study of Pimavanserin for the treatment of hallucinations and delusions associated with Dementia-related psychosis.
Biogen 221AD301 ENGAGE - A Phase 3 multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of Aducanumab (BIIB037) in subjects with Early Alzheimer's Disease.
Biogen 109MS401 ESTEEM - 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 (ESTEEM).
Center for Women and Infants
Bayer 1454032/18894 POET Essure - An open-label, non-randomized, prospective observational cohort study to assess post procedural outcomes in two cohorts of women who Chose to undergo either Hysteroscopic Sterilization (Essure®) or Laparoscopic Tubal Sterilization.
Heart Lung Vascular Institute
GE-265-303 A Phase 3, Open-label, study of Flupiridaz (18F) 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.
Vertex VX16-661-114—A Phase 3b, randomized, double-blind, placebo-controlled, parallel group study to assess the safety, efficacy, and tolerability of Tezacaftor/Ivacaftor (TEZ/IVA) in an Orkambi experienced population who are homozygous for the F508del-CFTR mutation.
Sanofi EFC14868 A Randomized, Double-blind, Placebo-controlled, Parallel-group, 52-week Study to Evaluate the Efficacy and Safety of Sotagliflozin in Patients with Type 2 Diabetes Who Have Inadequate Glycemic Control on Basal Insulin Alone or in Addition to Oral Antidiabetes Drugs (OADs)
Sanofi EFC14867 A 26-week Randomized, Double-blind, Controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Sotagliflozin compared to Empagliflozin, and Placebo in Patients with Type 2 Diabetes Who Have Inadequate Glycemic Control on Dipeptidyl Peptidase 4 Inhibitor (DPP4(i)) With or Without Metformin