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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 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.

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

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

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

Grant Clark, MD

Gastrointestinal

Protocol Number NCT Number Title Principal Investigator
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
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
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
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
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

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
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
213410

NCT04655976

A RANDOMIZED, OPEN-LABEL PHASE 2/3 STUDY COMPARING COBOLIMAB + DOSTARLIMAB + DOCETAXEL TO DOSTARLIMAB + DOCETAXEL TO DOCETAXEL ALONE IN PARTICIPANTS WITH ADVANCED NON-SMALL CELL LUNG CANCER WHO HAVE PROGRESSED ON PRIOR ANTI-PD-(L)1 THERAPY AND CHEMOTHERAPY (COSTAR LUNG)

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
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Genitourinary

Protocol Number NCT Number Title Principal Investigator
SGNDV-001   

 

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 Cancer 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

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

 


Patient Stories

  • Clinical Trial: HER2+ Breast Cancer  ROCHE WO42633

    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 […]

  • Clinical Trials – Understanding the Process

    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 […]

  • Testing National Recommendations – Improving Quality of Life

    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 […]

  • First Annual TCSC Clinical Trials Symposium A Success

    “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 […]

  • Understanding the Phases and Types of Clinical Trials

    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 […]

  • Taking the Hospital Home – New Lung Cancer Research

    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 […]