| Thompson Cancer Survival Center

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.

Click here to learn more about our new and upcoming clinical trials.

Thompson was the first to bring cancer clinical trials to East Tennessee more than 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.

Bladder

Protocol Number	NCT Number	Title	Principal Investigator
IMMU 132-13	NCT04527991	A Randomized Open-Label Phase III Study of Sacituzumab Govitecan Versus Treatment of Physician’s Choice in Subjects With Metastatic or Locally Advanced Unresectable 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

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

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

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

Gastrointestinal

Protocol Number	NCT Number	Title	Principal Investigator
A021502	NCT02912559	Randomized Trial of Standard Chemotherapy alone or combined with Atezolizumab as adjuvant therapy for patients with Stage III Colon Cancer and Deficient DNA Mismatch Repair(ATOMIC: Adjuvant Trial of Deficient Mismatch Repair in Colon Cancer)	David Chism, MD
NRG-GI005	NCT04068103	Phase II/III Study of Circulating tumor DNA as a Predictive BiomaRker in Adjuvant Chemotherapy in Patients with Stage IIA Colon Cancer (COBRA)	David Chism, MD
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
NRG-GU009	NCT04513717	Parallel Phase III Randomized Trials for High Risk Prostate Cancer evaluating De-Intensification for Lower Genomic risk and intensification of concurrent therapy for Higher Genomic risk with radiation (PREDICT-RT) Prostate RNA Expression/Decipher to Individualize Concurrent Therapy with Radiation	David Chism, MD
IMMU-132-06	NCT03547973	A 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 Immunotherapy	David Chism, MD

Gynecologic

Protocol Number	NCT Number	Title	Principal Investigator
NRG-GY023	NCT04739800	A Randomized Phase II Trial of Triplet Therapy (a PD-L1 Inhibitor Durvalumab (MEDI4736) in Combination with Olaparib and Cediranib) Compared to Olaparib and Cediranib or Durvalumab (MEDI4736) and Cediranib or Standard of Care Chemotherapy in Women with Platinum-Resistant Recurrent Epithelial Ovarian Cancer, Primary Peritoneal or Fallopian Cancer Who Have Received Prior Bevacizumab	Brook Saunders, 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

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
NDS-DLBCL-003	NCT04982471	Connect® Lymphoma Disease Registry: A US-Based Prospective Observational Cohort Study	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

Lung: Small Cell

Protocol Number	NCT Number	Title	Principal Investigator
NRG-LU005	NCT03811002	Limited Stage Small Cell Lung Cancer (LS-SCLC): A Phase II/III Randomized Study of Chemoradiation Versus Chemoradiation Plus Atezolizumab	Grant Clark, MD

Lung: Non-Small Cell

Protocol Number	NCT Number	Title	Principal Investigator
M14-239	NCT03539536	Phase II, Open-Label Safety and Efficacy Study of Telisotuzuumab Vedotin (ABBV-399) in Subjects with previously Treated c-Met+ NSCLC Non-Squamous	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

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

Pancreatic

Protocol Number	NCT Number	Title	Principal Investigator
EA2186 (GIANT)	NCT04233866	A Randomized Phase II Study of Gemcitabine and Nab-Paclitaxel Compared with 5-Fluorouracil, Leucovorin, and Liposomal Irinotecan in Older Patients with Treatment Naïve Metastatic Pancreatic Cancer (GIANT)	David Chism, MD

Clinical Trial Studies – COMING SOON!

NSCLC

Protocol Number	NCT Number	Title	Principal Investigator
BX43361	NCT05419375	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
BO42592 (Skyscraper 06)	NCT04619797	A PHASE II/III, RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED STUDY OF TIRAGOLUMAB IN COMBINATION WITH ATEZOLIZUMAB PLUS PEMETREXED AND CARBOPLATIN/CISPLATIN VERSUS PEMBROLIZUMAB PLUS PEMETREXED AND CARBOPLATIN/CISPLATIN IN PATIENTS WITH PREVIOUSLY UNTREATED ADVANCED NON-SQUAMOUS NON-SMALL-CELL LUNG CANCER	David Chism, MD

Renal Cell Carcinoma

Protocol Number	NCT Number	Title	Principal Investigator
BO43936 (Skyscraper 10)		A Randomized Open Label Phase II Study of Immune Checkpoint Combinations with Axitinib in Patients with Previously Untreated Locally Advanced Unresectable or Metastatic Renal Cell Carcinoma	David Chism, MD

Breast

Protocol Number	NCT Number	Title	Principal Investigator
ML43171	NCT05306340	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

Patient Stories

This blog was written using content provided by Jessica Severt, RN, BSN, Clinical Research Nurse Coordinator, Thompson Cancer Survival Center Around 14% of new breast cancer diagnoses are categorized as HER2-positive which is generally associated with more aggressive cancer1. HER2-positive means an overexpression (too much) of the HER2 protein is found in the breast tumor […]
Created with content provided by Jessica Severt, RN, BSN, Clinical Research Nurse Coordinator at Thompson Cancer Survival Center Have you ever wondered how patients are selected to participate in a clinical trial or how they know where to start? Maybe your doctor has mentioned the possibility of you or a loved one being in […]
Thompson Cancer Survival Center has boasted a strong mission to participate in research and clinical trials since its inception. Thompson frequently participates as an approved site in national trials. Such participation ensures our patients and providers are offered access to the latest in novel therapeutics or treatments. The Thompson team also initiates trials or studies […]
“I consider the first annual Clinical Trials Symposium a huge success!” Susie Owenby, System Director of Research for Covenant Health System responded with excitement when asked about the recent event. She went on to explain, “It was well attended by medical providers, ancillary staff, and the community, both in-person and virtually. Getting the word out […]
Content authored by Jessica Severt RN, BSN, Clinical Research Nurse Coordinator at Thompson Cancer Survival Center Clinical Trials: Phases and Types Did you know that most drugs go through at least 3 different levels of clinical trial testing before they are approved? It may also surprise you to know, that even after a drug is […]
This content was written by Shelly Abrams, RN, BSN, Clinical Research Coordinator Can Mobile Devices Identify Post-Treatment Problems Early? ON TRAX – Evaluating a mobile technology monitoring device used in patients with inoperable Stage 3 Lung Cancer Lung cancer is one of the leading causes of cancer deaths in men and women worldwide. People […]