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A Study of ASP3082 in Adults With Advanced Solid Tumors
Solid Tumor
This is an open-label study. This means that people in this study and clinic staff will
know that they will receive ASP3082. The study aims to check how safe and well-tolerated
ASP3082 is for people with advanced solid tumors that have a specific mutation called
KRAS G12D.
This study will be in 21 expand
This is an open-label study. This means that people in this study and clinic staff will know that they will receive ASP3082. The study aims to check how safe and well-tolerated ASP3082 is for people with advanced solid tumors that have a specific mutation called KRAS G12D. This study will be in 2 parts. In Part 1, different small groups of people will receive lower to higher doses of ASP3082 by itself, or together with cetuximab. Any medical problems will be recorded at each dose. This is done to find suitable doses of ASP3082, by itself or together with cetuximab, to use in Part 2 of the study. The first group will receive the lowest dose of ASP3082. A medical expert panel will check the results from this group and decide if the next group can receive a higher dose of ASP3082. The panel will do this for each group until all groups have received ASP3082 (by itself or together with cetuximab) or until suitable doses have been selected for Part 2. In Part 2, ASP3082 will be given in by itself, or in combination with other chemotherapy agents. Study treatments will be given through a vein. This is called an infusion. Each treatment cycle is 21 or 28 days long. They will continue treatment until: they have medical problems from the treatment they can't tolerate; their cancer gets worse; they start other cancer treatment; or they ask to stop treatment. Type: Interventional Start Date: Jun 2022 |
A Study of Amivantamab Monotherapy and in Addition to Standard-of-Care Chemotherapy in Participants1
Advanced or Metastatic Colorectal Cancer
The purpose of this study is to assess the anti-tumor activity of amivantamab as a
monotherapy (Cohorts A, B, and C), to characterize the safety of amivantamab when added
to standard-of care (SoC) chemotherapy in participants with metastatic colorectal cancer
(mCRC) (Ph2 cohorts), and to assess the1 expand
The purpose of this study is to assess the anti-tumor activity of amivantamab as a monotherapy (Cohorts A, B, and C), to characterize the safety of amivantamab when added to standard-of care (SoC) chemotherapy in participants with metastatic colorectal cancer (mCRC) (Ph2 cohorts), and to assess the recommended phase 2 combination dose (RP2CD) of amivantamab when added to SoC chemotherapy (Ph1b cohorts). Type: Interventional Start Date: Jul 2022 |
Thoracotomy Versus Thoracoscopic Management of Pulmonary Metastases in Patients With Osteosarcoma
Metastatic Malignant Neoplasm in the Lung
Metastatic Osteosarcoma
Osteosarcoma
This phase III trial compares the effect of open thoracic surgery (thoracotomy) to
thoracoscopic surgery (video-assisted thoracoscopic surgery or VATS) in treating patients
with osteosarcoma that has spread to the lung (pulmonary metastases). Open thoracic
surgery is a type of surgery done through1 expand
This phase III trial compares the effect of open thoracic surgery (thoracotomy) to thoracoscopic surgery (video-assisted thoracoscopic surgery or VATS) in treating patients with osteosarcoma that has spread to the lung (pulmonary metastases). Open thoracic surgery is a type of surgery done through a single larger incision (like a large cut) that goes between the ribs, opens up the chest, and removes the cancer. Thoracoscopy is a type of chest surgery where the doctor makes several small incisions and uses a small camera to help with removing the cancer. This trial is being done evaluate the two different surgery methods for patients with osteosarcoma that has spread to the lung to find out which is better. Type: Interventional Start Date: Apr 2022 |
SPYRAL AFFIRM Global Study of RDN with the Symplicity Spyral RDN System in Subjects with Uncontroll1
Hypertension
Vascular Diseases
Cardiovascular Diseases
Chronic Kidney Diseases
Diabetes Mellitus
The purpose of this single-arm interventional study is to evaluate the long-term safety,
efficacy, and durability of the Symplicity Spyral system in subjects treated with renal
denervation.
Additionally, long-term follow-up data will also be collected from eligible subjects
previously treated in t1 expand
The purpose of this single-arm interventional study is to evaluate the long-term safety, efficacy, and durability of the Symplicity Spyral system in subjects treated with renal denervation. Additionally, long-term follow-up data will also be collected from eligible subjects previously treated in the SPYRAL PIVOTAL-SPYRAL HTN-OFF MED and SPYRAL HTN-ON MED studies. Type: Interventional Start Date: Oct 2021 |
Impact of Bromocriptine on Clinical Outcomes for Peripartum Cardiomyopathy
Peripartum Cardiomyopathy, Postpartum
The study will enroll 200 women newly diagnosed with peripartum cardiomyopathy within 5
months postpartum in a randomized placebo controlled trial of bromocriptine therapy to
evaluate its impact on myocardial recovery and clinical outcomes. Given that
bromocriptine prevents breastfeeding, an additi1 expand
The study will enroll 200 women newly diagnosed with peripartum cardiomyopathy within 5 months postpartum in a randomized placebo controlled trial of bromocriptine therapy to evaluate its impact on myocardial recovery and clinical outcomes. Given that bromocriptine prevents breastfeeding, an additional 50 women with peripartum cardiomyopathy excluded from the trial due to a desire to continue breastfeeding but meeting all other entry criteria will be followed in an observational cohort. Type: Interventional Start Date: Jul 2022 |
A Research Study on How Well Concizumab Works for You if You Have Haemophilia A or B With or Withou1
Haemophilia A and B With and Without Inhibitors
This study will test how well a new medicine called concizumab works for participants who
have haemophilia A or B with or without inhibitors. The purpose is to show that
concizumab can prevent bleeds and is safe to use.
Participants will have to inject the study medicine every day under the skin w1 expand
This study will test how well a new medicine called concizumab works for participants who have haemophilia A or B with or without inhibitors. The purpose is to show that concizumab can prevent bleeds and is safe to use. Participants will have to inject the study medicine every day under the skin with a pen-injector. The study will last for at least 2 years and up to about 4 years. The length of time the participant will be in the study depends on if the study medicine will be available for purchase in their country. Type: Interventional Start Date: Mar 2022 |
Impact of Deutetrabenazine on Functional Speech and Gait Dynamics in Huntington Disease
Huntington Disease
Examine the effects of deutetrabenazine on functional speech and gait impairment expand
Examine the effects of deutetrabenazine on functional speech and gait impairment Type: Interventional Start Date: Nov 2021 |
Abatacept for the Treatment of Giant Cell Arteritis
Giant Cell Arteritis
This randomized, double-blind, placebo-controlled trial will seek to determine the
efficacy of abatacept in GCA. To examine this objective, 62 eligible patients who have
newly diagnosed or relapsing GCA within 8 weeks prior to screening will be randomized at
a 1:1 ratio to receive subcutaneous abat1 expand
This randomized, double-blind, placebo-controlled trial will seek to determine the efficacy of abatacept in GCA. To examine this objective, 62 eligible patients who have newly diagnosed or relapsing GCA within 8 weeks prior to screening will be randomized at a 1:1 ratio to receive subcutaneous abatacept 125mg/week or placebo. Patients who achieve remission will remain on their blinded assignment for 12 months at which time abatacept/placebo will be stopped. Patients who do not achieve remission by Month 3, who experience a relapse within the first 12 months will have the option of receiving open-label abatacept for a maximum of 12 months. Type: Interventional Start Date: Mar 2021 |
A Study of the Drugs Selumetinib vs. Carboplatin and Vincristine in Patients With Low-Grade Glioma
Low Grade Astrocytoma
Low Grade Glioma
Metastatic Low Grade Astrocytoma
Metastatic Low Grade Glioma
This phase III trial compares the effect of selumetinib versus the standard of care
treatment with carboplatin and vincristine (CV) in treating patients with newly diagnosed
or previously untreated low-grade glioma (LGG) that does not have a genetic abnormality
called BRAFV600E mutation and is not1 expand
This phase III trial compares the effect of selumetinib versus the standard of care treatment with carboplatin and vincristine (CV) in treating patients with newly diagnosed or previously untreated low-grade glioma (LGG) that does not have a genetic abnormality called BRAFV600E mutation and is not associated with systemic neurofibromatosis type 1. Selumetinib works by blocking some of the enzymes needed for cell growth and may kill tumor cells. Carboplatin and vincristine are chemotherapy drugs that work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. The overall goal of this study is to see if selumetinib works just as well as the standard treatment of CV for patients with LGG. Another goal of this study is to compare the effects of selumetinib versus CV in subjects with LGG to find out which is better. Additionally, this trial will also examine if treatment with selumetinib improves the quality of life for subjects who take it. Type: Interventional Start Date: Jan 2020 |
A Study of the Drugs Selumetinib Versus Carboplatin/Vincristine in Patients With Neurofibromatosis1
Low Grade Glioma
Neurofibromatosis Type 1
Visual Pathway Glioma
This phase III trial studies if selumetinib works just as well as the standard treatment
with carboplatin/vincristine (CV) for subjects with NF1-associated low grade glioma
(LGG), and to see if selumetinib is better than CV in improving vision in subjects with
LGG of the optic pathway (vision nerve1 expand
This phase III trial studies if selumetinib works just as well as the standard treatment with carboplatin/vincristine (CV) for subjects with NF1-associated low grade glioma (LGG), and to see if selumetinib is better than CV in improving vision in subjects with LGG of the optic pathway (vision nerves). Selumetinib is a drug that works by blocking some enzymes that low-grade glioma tumor cells need for their growth. This results in killing tumor cells. Drugs used as chemotherapy, such as carboplatin and vincristine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether selumetinib works better in treating patients with NF1-associated low-grade glioma compared to standard therapy with carboplatin and vincristine. Type: Interventional Start Date: Jan 2020 |
Testing the Effectiveness of Two Immunotherapy Drugs (Nivolumab and Ipilimumab) With One Anti-cance1
Bladder Adenocarcinoma
Bladder Clear Cell Adenocarcinoma
Bladder Mixed Adenocarcinoma
Bladder Neuroendocrine Carcinoma
Bladder Small Cell Neuroendocrine Carcinoma
This phase II trial studies how well cabozantinib works in combination with nivolumab and
ipilimumab in treating patients with rare genitourinary (GU) tumors that has spread from
where it first started (primary site) to other places in the body. Cabozantinib may stop
the growth of tumor cells by bl1 expand
This phase II trial studies how well cabozantinib works in combination with nivolumab and ipilimumab in treating patients with rare genitourinary (GU) tumors that has spread from where it first started (primary site) to other places in the body. Cabozantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving cabozantinib, nivolumab, and ipilimumab may work better in treating patients with genitourinary tumors that have no treatment options compared to giving cabozantinib, nivolumab, or ipilimumab alone. Type: Interventional Start Date: May 2019 |
Active Surveillance, Bleomycin, Etoposide, Carboplatin or Cisplatin in Treating Pediatric and Adult1
Childhood Extracranial Germ Cell Tumor
Extragonadal Embryonal Carcinoma
Germ Cell Tumor
Malignant Germ Cell Tumor
Malignant Ovarian Teratoma
This phase III trial studies how well active surveillance help doctors to monitor
subjects with low risk germ cell tumors for recurrence after their tumor is removed. When
the germ cell tumor has spread outside of the organ in which it developed, it is
considered metastatic. Drugs used in chemother1 expand
This phase III trial studies how well active surveillance help doctors to monitor subjects with low risk germ cell tumors for recurrence after their tumor is removed. When the germ cell tumor has spread outside of the organ in which it developed, it is considered metastatic. Drugs used in chemotherapy, such as bleomycin, carboplatin, etoposide, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. The trial studies whether carboplatin or cisplatin is the preferred chemotherapy to use in treating metastatic standard risk germ cell tumors. Type: Interventional Start Date: May 2017 |
Phase 3 Trial to Evaluate the Efficacy and Safety of Aficamten Compared to Placebo in Adults With S1
Symptomatic Non-Obstructive Hypertrophic Cardiomyopathy
This clinical trial will study the effects of aficamten (versus placebo) on the quality
of life, exercise capacity, and clinical outcomes of patients with non-obstructive
hypertrophic cardiomyopathy. expand
This clinical trial will study the effects of aficamten (versus placebo) on the quality of life, exercise capacity, and clinical outcomes of patients with non-obstructive hypertrophic cardiomyopathy. Type: Interventional Start Date: Aug 2023 |
A Study of NST-6179 in Subjects With Intestinal Failure-Associated Liver Disease (IFALD).
Intestinal Failure Associated Liver Disease
This is a phase 2a, multicenter, randomized, double-blind, placebo-controlled study to
evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of
NST-6179 in subjects with intestinal failure-associated liver disease (IFALD) receiving
parenteral nutrition (PN).
The study1 expand
This is a phase 2a, multicenter, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of NST-6179 in subjects with intestinal failure-associated liver disease (IFALD) receiving parenteral nutrition (PN). The study will be conducted in 2 sequential parts. Up to 36 subjects diagnosed with IFALD will be enrolled in the study, of which up to 18 subjects will be enrolled in each of the 2 parts and randomized (2:1) to receive NST-6179 (N=12/part) or matched placebo (N=6/part). Subjects in Part A will receive once daily (QD) oral administration of 800 mg (32 mL solution) NST-6179 or placebo for 4 weeks. The NST-6179 dose for Part B is planned to be 1200 mg QD for 12 weeks. Actual dose, however, will be determined during the safety review meeting. Type: Interventional Start Date: Jan 2024 |
Testing the Addition of Total Ablative Therapy to Usual Systemic Therapy Treatment for Limited Meta1
Metastatic Colorectal Adenocarcinoma
Stage IV Colorectal Cancer AJCC V8
This phase III trial compares total ablative therapy and usual systemic therapy to usual
systemic therapy alone in treating patients with colorectal cancer that has spread to up
to 4 body sites (limited metastatic). The usual approach for patients who are not
participating in a study is treatment w1 expand
This phase III trial compares total ablative therapy and usual systemic therapy to usual systemic therapy alone in treating patients with colorectal cancer that has spread to up to 4 body sites (limited metastatic). The usual approach for patients who are not participating in a study is treatment with intravenous (IV) (through a vein) and/or oral medications (systemic therapy) to help stop the cancer sites from getting larger and the spread of the cancer to additional body sites. Ablative means that the intention of the local treatment is to eliminate the cancer at that metastatic site. The ablative local therapy will consist of very focused, intensive radiotherapy called stereotactic ablative radiotherapy (SABR) with or without surgical resection and/or microwave ablation, which is a procedure where a needle is temporarily inserted in the tumor and heat is used to destroy the cancer cells. SABR, surgical resection, and microwave ablation have been tested for safety, but it is not scientifically proven that the addition of these treatments are beneficial for your stage of cancer. The addition of ablative local therapy to all known metastatic sites to the usual approach of systemic therapy could shrink or remove the tumor(s) or prevent the tumor(s) from returning. Type: Interventional Start Date: Oct 2023 |
A Trial Comparing Unrelated Donor BMT with IST for Pediatric and Young Adult Patients with Severe A1
Severe Aplastic Anemia
Severe Aplastic Anemia (SAA) is a rare condition in which the body stops producing enough
new blood cells. SAA can be cured with immune suppressive therapy or a bone marrow
transplant. Regular treatment for patients with aplastic anemia who have a matched
sibling (brother or sister), or family dono1 expand
Severe Aplastic Anemia (SAA) is a rare condition in which the body stops producing enough new blood cells. SAA can be cured with immune suppressive therapy or a bone marrow transplant. Regular treatment for patients with aplastic anemia who have a matched sibling (brother or sister), or family donor is a bone marrow transplant. Patients without a matched family donor normally are treated with immune suppressive therapy (IST). Match unrelated donor (URD) bone marrow transplant (BMT) is used as a secondary treatment in patients who did not get better with IST, had their disease come back, or a new worse disease replaced it (like leukemia). This trial will compare time from randomization to failure of treatment or death from any cause of IST versus URD BMT when used as initial therapy to treat SAA. The trial will also assess whether health-related quality of life and early markers of fertility differ between those randomized to URD BMT or IST, as well as assess the presence of marrow failure-related genes and presence of gene mutations associated with MDS or leukemia and the change in gene signatures after treatment in both study arms. This study treatment does not include any investigational drugs. The medicines and procedures in this study are standard for treatment of SAA. Type: Interventional Start Date: Jan 2023 |
Savolitinib Plus Osimertinib Versus Platinum-based Doublet Chemotherapy in Participants With Non-Sm1
Carcinoma
Non-Small-Cell Lung
Clinical study to investigate the efficacy and safety of savolitinib in combination with
osimertinib versus platinum-based doublet chemotherapy in participants with EGFR mutated,
MET-overexpressed and/or amplified, locally advanced or metastatic NSCLC who have
progressed on treatment with Osimertin1 expand
Clinical study to investigate the efficacy and safety of savolitinib in combination with osimertinib versus platinum-based doublet chemotherapy in participants with EGFR mutated, MET-overexpressed and/or amplified, locally advanced or metastatic NSCLC who have progressed on treatment with Osimertinib. Type: Interventional Start Date: Aug 2022 |
SELUTION4BTK Trial
Peripheral Arterial Disease
Chronic Limb-Threatening Ischemia Nos of Native Arteries of Extremities
This study aims to demonstrate superior efficacy and equivalent safety of the SELUTION
SLR™ DEB 014 compared to plain (uncoated) balloon angioplasty in the treatment of
peripheral arterial disease (PAD) in the BTK arteries in CLTI patients. expand
This study aims to demonstrate superior efficacy and equivalent safety of the SELUTION SLR™ DEB 014 compared to plain (uncoated) balloon angioplasty in the treatment of peripheral arterial disease (PAD) in the BTK arteries in CLTI patients. Type: Interventional Start Date: May 2022 |
Study of TJ033721 (givastomig) in Subjects with Advanced or Metastatic Solid Tumors
Solid Tumor
Advanced Cancer
Metastatic Cancer
Gastric Cancer
Gastroesophageal Junction Carcinoma
This is an open label, multi-center, multiple dose Phase 1 study to evaluate the safety,
tolerability, MTD PK, and PD of TJ033721 (givastomig) in subjects with advanced or
metastatic solid tumors. expand
This is an open label, multi-center, multiple dose Phase 1 study to evaluate the safety, tolerability, MTD PK, and PD of TJ033721 (givastomig) in subjects with advanced or metastatic solid tumors. Type: Interventional Start Date: Jun 2021 |
Post-Surgical Stereotactic Radiotherapy (SRT) Versus GammaTile-ROADS (Radiation One and Done Study)
Brain Metastases
This trial will be a randomized controlled study comparing the efficacy and safety of
intraoperative radiation therapy using GammaTilesTM (GT) versus SRT 3-4 weeks following
metastatic tumor resection which is the current standard of care. expand
This trial will be a randomized controlled study comparing the efficacy and safety of intraoperative radiation therapy using GammaTilesTM (GT) versus SRT 3-4 weeks following metastatic tumor resection which is the current standard of care. Type: Interventional Start Date: Apr 2021 |
A Study of Oral Nuvisertib (TP-3654) in Patients with Myelofibrosis
Myelofibrosis
This study is a Phase 1/2, multicenter, dose-escalation, open-label trial to assess
safety, tolerability, pharmacokinetics and pharmacodynamics of nuvisertib (TP-3654) in
patients with intermediate or high-risk primary or secondary MF. expand
This study is a Phase 1/2, multicenter, dose-escalation, open-label trial to assess safety, tolerability, pharmacokinetics and pharmacodynamics of nuvisertib (TP-3654) in patients with intermediate or high-risk primary or secondary MF. Type: Interventional Start Date: Dec 2019 |
Edwards PASCAL Transcatheter Valve Repair System Pivotal Clinical Trial
Tricuspid Regurgitation
Tricuspid Valve Insufficiency
Tricuspid Valve Disease
To establish the safety and effectiveness of the Edwards PASCAL Transcatheter Repair
System in patients with symptomatic severe tricuspid regurgitation who have been
determined to be at an intermediate or greater estimated risk of mortality with tricuspid
valve surgery by the cardiac surgeon with c1 expand
To establish the safety and effectiveness of the Edwards PASCAL Transcatheter Repair System in patients with symptomatic severe tricuspid regurgitation who have been determined to be at an intermediate or greater estimated risk of mortality with tricuspid valve surgery by the cardiac surgeon with concurrence by the local Heart Team Type: Interventional Start Date: Dec 2019 |
Salt-Sensitivity and Immunity Cell Activation
High Blood Pressure
Salt; Excess
Inflammation
Salt-sensitive hypertension affects nearly 50% of the hypertensive and 25% of the
normotensive population, and strong evidence indicates that reducing salt intake
decreases blood pressure and cardiovascular events. The precise mechanisms of how dietary
salt contributes to blood pressure elevation,1 expand
Salt-sensitive hypertension affects nearly 50% of the hypertensive and 25% of the normotensive population, and strong evidence indicates that reducing salt intake decreases blood pressure and cardiovascular events. The precise mechanisms of how dietary salt contributes to blood pressure elevation, renal injury, and cardiovascular disease remains unclear. Our data indicated that monocytes exhibit salt sensitivity, and the investigators hypothesize that of salt sensitivity of these and similar immune cells correlate with the hypertensive response to salt intake. Currently, the research tools for diagnosing salt-sensitivity are costly, time consuming and laborious. In this study the investigators will identify monocyte salt-sensitivity as a marker of salt-sensitive hypertension. Type: Interventional Start Date: Sep 2021 |
Study of Sacituzumab Govitecan in Participants With Urothelial Cancer That Cannot Be Removed or Has1
Metastatic Urothelial Cancer
The objective of this study is to evaluate the efficacy and safety of sacituzumab
govitecan-hziy monotherapy and with novel combinations in participants with metastatic
urothelial cancer (mUC). expand
The objective of this study is to evaluate the efficacy and safety of sacituzumab govitecan-hziy monotherapy and with novel combinations in participants with metastatic urothelial cancer (mUC). Type: Interventional Start Date: Aug 2018 |
Gastrointestinal Biomarkers in Tissue and Biological Fluid Samples from Colorectal Cancer Patients
Colorectal Cancer
Esophageal Cancer
Gastric Cancer
Pancreatic Cancer
Precancerous Condition
RATIONALE: Studying samples of tissue, blood, urine, stool, and other biological fluids
from patients with cancer and from healthy volunteers undergoing colonoscopy or endoscopy
may help doctors identify and learn more about biomarkers related to cancer.
PURPOSE: This research study is looking at1 expand
RATIONALE: Studying samples of tissue, blood, urine, stool, and other biological fluids from patients with cancer and from healthy volunteers undergoing colonoscopy or endoscopy may help doctors identify and learn more about biomarkers related to cancer. PURPOSE: This research study is looking at gastrointestinal biomarkers in tissue and biological fluid samples from patients and participants undergoing colonoscopy, endoscopy, or surgery. Type: Observational Start Date: Jun 2002 |
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