Thompson Cancer Survival Center – Clinical Trials

Female doctor reviews treatment plan with middle-aged male patient.

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 Susan Owenby, RN, 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

Name	Title	Contact Info
David Chism, MD	Medical Director of Clinical Research	[email protected] \| 865-331-1812
Kristi Simcox, BS, CCRP	Systems Director of Clinical Research	[email protected] \| 865-331-4985
Jessica Severt, RN, BSN	Study Coordinator	[email protected] \| 865-331-4966
Ashley Lyons, RN	Study Coordinator	[email protected] \| 865-331-2586
Sarah France, RN	Study Coordinator	[email protected] \| 865-331-2587
Casey Mastio-Partridge	Study Coordinator	[email protected] \| 865-331-1812
Christina Haller	Regulatory Specialist	[email protected] \| 865-331-1902
Catherine Duke-Taylor	Regulatory Specialist	[email protected] \| 865-331-1291

Active Clinical Trials

Bladder

Protocol Number	NCT Number	Title	Principal Investigator
IMMU 132-06	NCT03547973	A Phase II Open-Label, Study of IMMU-132 in Metastatic Urothelial Cancer	David Chism, MD

Breast

Protocol Number	NCT Number	Title	Principal Investigator
WO42633 (Astefania)	NCT04873362	A 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 therapy	David Chism, MD
D8534C00001 (Serena-6)	NCT04964934	A 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
ML43171	NCT0536340	A 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 cancer	David Chism, MD
D9673R00025 (Destiny) DB-Respond	NCT05592483	“A 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 cancer”	David Chism, MD

Esophageal

Protocol Number	NCT Number	Title	Principal Investigator
MK3475-975	NCT04210115	A 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-GI006	NCT03801876	PHASE III RANDOMIZED TRIAL OF PROTON BEAM THERAPY (PBT) VERSUS INTENSITY MODULATED PHOTON RADIOTHERAPY (IMRT) FOR THE TREATMENT OF ESOPHAGEAL CANCER	David Chism, MD

Gastrointestinal

Protocol Number	NCT Number	Title	Principal Investigator
EA2176	NCT04444921	A Randomized Phase III Study of Immune Checkpoint Inhibition with Chemotherapy in Treatment-Naïve Metastatic Anal Cancer Patients	David Chism, MD

Genitourinary

Protocol Number	NCT Number	Title	Principal Investigator
H-300-001	NCT05553639	A Phase 1/2 Study of Replicating Arenavirus-based Vector(s) Encoding Prostate Cancer-Associated Antigens in Participants with Metastatic Castration-Resistant Prostate Cancer	David Chism, MD
SGNDV-001	NCT05911295	An 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)	NCT04960709	A 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

Head and Neck

Protocol Number	NCT Number	Title	Principal Investigator
EA3202	NCT05063552	A Phase II/III Trial of Chemotherapy + Cetuximab vs Chemotherapy + Bevacizumab vs Atezolizumab + Bevacizumab Following Progression on Immune Checkpoint Inhibition in Recurrent/Metastatic Head and Neck Cancers	David Chism, MD

Kidney

Protocol Number	NCT Number	Title	Principal Investigator
BO43936 (Triplet RCC)	NCT05805501	A 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 Carcinoma	David Chism, MD
XL092-304 (STELLAR)	NCT05678673	A Randomized Open-Label Phase 3 Study of XL092 + Nivolumab vs Sunitinib in Subjects with Advanced or Metastatic Non-Clear Cell Renal Cell Carcinoma	David Chism, MD

Leukemia/Lymphoma

Protocol Number	NCT Number	Title	Principal Investigator
AZA-MDS-006 (CONNECT)	NCT01688011	The Myelodysplastic Syndromes (MDS) and Acute Myeloid Leukemia (AML) Disease Registry	David Chism, MD
M22-132	NCT05283720	Phase 1b/2, Open-Label Study to Evaluate Safety and Tolerability of Epcoritamab in Combination with Anti-Neoplastic Agents in Subjects with Non-Hodgkin Lymphoma	David Chism, MD
C4971003	NCT05626322	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 TRANSPLANTATION	David Chism, MD

Lung: Non-Small Cell

Protocol Number	NCT Number	Title	Principal Investigator
BX43361	NCT054191375	Master screening study to determine biomarker status and potential trial eligibility for patients with malignant tumors	David Chism, MD
BO42777	NCT05170204	A 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 cancer	David Chism, MD
NIT-119	NCT04984811	Phase II study to evaluate anti-tumor efficacy and safety of NT-I7 (efineptakin alfa) in combination with atezolizumab in subjects with previously untreated, PD-L1-expressing, locally advanced or metastatic Non-Small Cell LunA multicenter, open-label, single-arg Cancer	David Chism, MD
EFC15858	NCT04154956	Randomized, open-label, Phase 3 study of SAR408701 versus docetaxel in previously treated, metastatic, nonsquamous, non-small-cell lung cancer patients with CEACAM5-positive tumors	David Chism, MD

Melanoma

Protocol Number	NCT Number	Title	Principal Investigator
EA6141	NCT02339571	Randomized Phase II/III Study of Nivolumab plus Ipilimumab plus Sargramostim versus Nivolumab plus Ipilimumab in Patients with Unresectable Stage III or Stage IV Melanoma	David Chism, MD

COMING SOON

Genitourinary

Protocol Number	NCT Number	Title	Principal Investigator

D910PC00001 (VOLGA)	NCT04960709	A 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
MVT-601-056		Relugolix Versus Leuprolide in Patients with Prostate Cancer: A Randomized, Open-Label Study to Assess Major Adverse Cardiovascular Events (REPLACE-CV)	David Chism, MD

Non-Small Cell Lung Cancer

Protocol Number	NCT Number	Title	Principal Investigator
R3767-ONC-2235		A 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
R3467-ONC-2236		A 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 LEVELS	David Chism, MD

Breast

Protocol Number	NCT Number	Title	Principal Investigator
D926XC00001 (Tropion Breast-03)		A 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

Thompson Cancer Survival Center – Clinical Trials

Clinical Trials

Our Team

Active Clinical Trials

Genitourinary

Non-Small Cell Lung Cancer

Breast

Contact Us