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Thompson Cancer Survival Center – Clinical Trials

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Clinical Trials

Clinical trials are research studies designed to discover new ways to treat different cancers and directly impact the number of new therapies and treatments available to fight cancer. Today’s trials are tomorrow’s standard of cancer care.

Thompson was the first to bring cancer clinical trials to East Tennessee over 25 years ago. Today, Thompson’s clinical trials department is under the leadership of David Chism, MD, and Kristi Simcox, BS, CCRP, System Director of Clinical Research. Our oncologists are certified to participate in clinical trials and work with multiple cancer research groups to bring innovative treatments to East Tennessee. In addition, we partner with pharmaceutical companies to give our patients access to new treatments not otherwise available. We offer clinical trials because they often lead to better ways to diagnose, treat, and prevent cancer, allowing people to live healthier and longer lives. Ask your doctor if a clinical trial might be right for you.

Thompson Cancer Survival Center offers clinical trials at the following Thompson Oncology Group locations:

  • Blount 
  • Downtown Knoxville
  • Lenoir City 
  • Oak Ridge 
  • West Knoxville

Our Team

NameTitleContact Info
David Chism, MDMedical Director of Clinical Research[email protected] | 865-331-1812
Kristi Simcox, BS, CCRPSystems Director of Clinical Research[email protected] | 865-331-4985
Jessica Severt, RN, BSNStudy Coordinator[email protected] | 865-331-4966
Ashley Lyons, RNStudy Coordinator[email protected] | 865-331-2586
Sarah France, RNStudy Coordinator[email protected] | 865-331-2587
Casey Mastio-PartridgeStudy Coordinator [email protected] | 865-331-1812
Christina HallerRegulatory Specialist[email protected] | 865-331-1902
Catherine Duke-TaylorRegulatory Specialist[email protected] | 865-331-1291

Active Clinical Trials

Breast

Protocol NumberNCT NumberTitlePrincipal Investgator
WO42633  (Astefania)NCT04873362A Phase III, Randomized, Double-Blind, Placebo-Controlled clinical trial to evaluate the efficacy and safety of Adjuvant Atezolizumab or Placebo and Trastuzumab Emtansine for HER2-Positive Breast Cancer at high risk of recurrence following preoperative therapyDavid Chism, MD
D8534C00001 (Serena-6)NCT04964934A Phase III, Double-blind, Randomised Study to
Assess Switching to AZD9833 (a Next Generation, Oral SERD) + CDK4/6 Inhibitor (Palbociclib or Abemaciclib) vs Continuing Aromatase Inhibitor (Letrozole or Anastrozole) + CDK4/6
Inhibitor in HR+/HER2- MBC Patients with Detectable ESR1 Mutation Without Disease Progression During 1L Treatment with
Aromatase Inhibitor + CDK4/6 Inhibitor
David Chism, MD
ML43171NCT0536340A Phase III, randomized, open-label, multicenter study evaluating the efficacy and safety of Giredestrant plus Everolimus compared with Exemestane plus Everolimus in patients with estrogen receptor-positive, her2- negative, locally advanced or metastatic breast cancerDavid Chism, MD
D9673R00025 (Destiny) DB-RespondNCT05592483A multi-center, multi-country prospective observational study of patients initiating T-DXd in the first or second treatment line for HER2+ and HER2-low unresectable and/or metastatic breast cancerDavid Chism, MD
D926XC00001 (Tropion Breast-03)NCT05629585A Phase 3 Open-label, Randomised Study of Datopotamab Deruxtecan (Dato-DXd) With or Without Durvalumab Versus Investigator’s Choice of Therapy in Patients With Stage I-III Triple-negative Breast Cancer Who Have Residual Invasive Disease in the Breast and/or Axillary Lymph Nodes at Surgical Resection Following Neoadjuvant Systemic Therapy (TROPION-Breast03)David Chism, MD

Esophageal

Protocol NumberNCT NumberTitlePrincipal Investigator
MK3475-975NCT04210115A Randomized, Double-blind, Placebo-controlled Phase 3 Trial of Pembrolizumab (MK-3475) Versus Placebo in Participants with Esophageal Carcinoma Receiving Concurrent Definitive Chemoradiotherapy (KEYNOTE 975)David Chism, MD
NRG-GI006NCT03801876Phase iii randomized trial of proton beam therapy (pbt) versus intensity modulated photon radiotherapy (imrt) for the treatment of esophageal cancerDavid Chism, MD

Gastrointestinal

Protocol NumberNCT NumberTitlePrincipal Investigator
EA2176NCT04444921A Randomized Phase III Study of Immune Checkpoint Inhibition with Chemotherapy in Treatment-Naïve Metastatic Anal Cancer PatientsDavid Chism, MD

Genitourinary

Protocol NumberNCT NumberTitlePrincipal Investigator
H-300-001NCT05553639A Phase 1/2 Study of Replicating Arenavirus-based Vector(s) Encoding Prostate Cancer-Associated Antigens in Participants with Metastatic Castration-Resistant Prostate CancerDavid Chism, MD
SGNDV-001NCT05911295An Open-label, Randomized, Controlled Phase 3 Study of Disitamab Vedotin in Combination with Pembrolizumab Versus Chemotherapy in Subjects with Previously Untreated Locally Advanced or Metastatic Urothelial Carcinoma that Expresses HER2 (IHC 1+ and Greater)David Chism, MD
D910PC00001 (VOLGA)NCT04960709A Phase III Randomized, Open-Label, Multicenter Study to Determine the Efficacy and Safety of Durvalumab in Combination With Tremelimumab and Enfortumab Vedotin or Durvalumab in Combination With Enfortumab Vedotin for Perioperative Treatment in Patients Ineligible for Cisplatin or Who Refuse Cisplatin Undergoing Radical Cystectomy for Muscle Invasive Bladder Cancer (VOLGA)David Chism, MD
IMMU-132-06NCT03547973A Phase II Open-Label, Study of IMMU-132 in Metastatic Urothelial Cancer After Failure of Platinum-Based Regimen or Anti-PD-1/PD-L1 Based ImmunotherapyDavid Chism, MD

Kidney

Protocol NumberNCT NumberTitlePrincipal Investigator
BO43936 (Triplet RCC) NCT05805501A Randomized Open Label Phase II Study of Immune Checkpoint Inhibitor Combinations with Axitinib in patients with Previously Untreated Locally Advanced Unresectable or Metastatic Renal Cell CarcinomaDavid Chism, MD
XL092-304  (STELLAR)NCT05678673A Randomized Open-Label Phase 3 Study of XL092 + Nivolumab vs Sunitinib in Subjects with Advanced or Metastatic Non-Clear Cell Renal Cell CarcinomaDavid Chism, MD

Leukemia/Lymphoma

Protocol NumberNCT NumberTitlePrincipal Investigator
AZA-MDS-006 (CONNECT)NCT01688011The Myelodysplastic Syndromes (MDS) and Acute Myeloid Leukemia (AML) Disease RegistryDavid Chism, MD
M22-132NCT05283720Phase 1b/2, Open-Label Study to Evaluate Safety and Tolerability of Epcoritamab in Combination with Anti-Neoplastic Agents in Subjects with Non-Hodgkin LymphomaDavid Chism, MD
C4971003NCT05626322 A phase 1b/2 study of pf-07901801, a cd47 blocking agent, with Tafasitamab and Lenalidomide for participants with relapsed/refractory diffuse large b cell lymphoma not eligible for stem cell transplantationDavid Chism, MD

Melanoma

Protocol NumberNCT NumberTitlePrincipal Investigator
EA6141NCT02339571Randomized Phase II/III Study of Nivolumab plus Ipilimumab plus Sargramostim versus Nivolumab plus Ipilimumab in Patients with Unresectable Stage III or Stage IV MelanomaDavid Chism, MD

Non-Small Cell Lung Cancer

Protocol NumberNCT NumberTitlePrincipal Investigator
R3767-ONC-2235NCT05785767A randomized, double-blind phase 2/3 study of fianlimab (anti-lag-3 antibody) in combination with Cemiplimab (anti-pd-1 antibody) versus Cemiplimab monotherapy in first-line treatment of patients with advanced nonsmall cell lung cancer (nsclc) with tumors expressing pd-l1 ≥50%David Chism, MD
R3767-ONC-2236NCT05800015A randomized, double-blind phase 2/3 study of Fianlimab (anti-lag-3 antibody), Cemiplimab (anti-pd-1 antibody), and chemotherapy versus Cemiplimab and chemotherapy in first-line treatment of patients with advanced non-small cell lung cancer (nsclc) irrespective of pd-l1 expression levelsDavid Chism, MD
BX43361NCT05419375MASTER SCREENING STUDY TO DETERMINE BIOMARKER STATUS AND POTENTIAL TRIAL ELIGIBILITY FOR PATIENTS WITH MALIGNANT TUMORSDavid Chism, MD
BO42777NCT05170204A PHASE I-III, MULTICENTER STUDY EVALUATING THE EFFICACY AND SAFETY OF MULTIPLE THERAPIES IN COHORTS OF PATIENTS SELECTED ACCORDING TO BIOMARKER STATUS, WITH LOCALLY ADVANCED, UNRESECTABLE, STAGE III NON-SMALL CELL LUNG CANCERDavid Chism, MD
D926NC00001 (AVANZAR)NCT05687266A Phase III, Randomised, Open-label, Multicentre, Global Study of Datopotamab Deruxtecan (Dato-DXd) in Combination With Durvalumab and Carboplatin Versus Pembrolizumab in Combination With Platinum-based Chemotherapy for the First-line Treatment of Patients With Locally Advanced or Metastatic NSCLC Without Actionable Genomic AlterationsDavid Chism, MD
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