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Lower-Dose Chemoradiation in Treating Patients With Early-Stage Anal Cancer, the DECREASE Study
Anal Basaloid Carcinoma
Anal Canal Cloacogenic Carcinoma
Anal Canal Squamous Cell Carcinoma
Anal Margin Squamous Cell Carcinoma
Stage I Anal Cancer AJCC v8
This phase II trial studies how well lower-dose chemotherapy plus radiation
(chemoradiation) therapy works in comparison to standard-dose chemoradiation in treating
patients with early-stage anal cancer. Drugs used in chemotherapy, such as mitomycin,
fluorouracil, and capecitabine, work in different... expand
This phase II trial studies how well lower-dose chemotherapy plus radiation (chemoradiation) therapy works in comparison to standard-dose chemoradiation in treating patients with early-stage anal cancer. Drugs used in chemotherapy, such as mitomycin, fluorouracil, and capecitabine, 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. Radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors. Giving chemotherapy with radiation therapy may kill more tumor cells. This study may help doctors find out if lower-dose chemoradiation is as effective and has fewer side effects than standard-dose chemoradiation, which is the usual approach for treatment of this cancer type. Type: Interventional Start Date: Jan 2020 |
Standard Systemic Therapy With or Without Definitive Treatment in Treating Participants With Metastatic...
Castration Levels of Testosterone
Metastatic Prostatic Adenocarcinoma
Stage IV Prostate Cancer AJCC v8
Stage IVA Prostate Cancer AJCC v8
Stage IVB Prostate Cancer AJCC v8
This phase III trial studies how well standard systemic therapy with or without
definitive treatment (prostate removal surgery or radiation therapy) works in treating
participants with prostate cancer that has spread to other places in the body. Addition
of prostate removal surgery or radiation therapy... expand
This phase III trial studies how well standard systemic therapy with or without definitive treatment (prostate removal surgery or radiation therapy) works in treating participants with prostate cancer that has spread to other places in the body. Addition of prostate removal surgery or radiation therapy to standard systemic therapy for prostate cancer may lower the chance of the cancer growing or spreading. Type: Interventional Start Date: Sep 2018 |
OMEGA: Outcome Measures in Eosinophilic Gastrointestinal Disorders Across the Ages
Eosinophilic Gastrointestinal Disorders (EGIDs)
Eosinophilic Esophagitis
Eosinophilic Gastritis
Eosinophilic Gastroenteritis
Eosinophilic Colitis
The purpose of this observational study is to find the best measures to define how well a
person with eosinophilic disorder is doing. People with EoE, EoG, EoN and EoC normally
undergo endoscopy and/or colonoscopy where cells are collected for microscopic analysis.
Treatments are then decided based... expand
The purpose of this observational study is to find the best measures to define how well a person with eosinophilic disorder is doing. People with EoE, EoG, EoN and EoC normally undergo endoscopy and/or colonoscopy where cells are collected for microscopic analysis. Treatments are then decided based on how the cells look. We are aiming to compare different tissue components such as inflammatory cell types with clinical symptoms. We want to see if scores on standard questionnaires can give us an idea how well the person is doing. Type: Observational Start Date: Jul 2015 |
Trial of Efficacy and Safety of NS-229 Versus Placebo in Patients With Eosinophilic Granulomatosis With...
Eosinophilic Granulomatosis With Polyangiitis
Churg-Strauss Syndrome
This study will enroll male and female subjects who are 18 years of age or older with
Eosinophilic Granulomatosis With Polyangiitis. expand
This study will enroll male and female subjects who are 18 years of age or older with Eosinophilic Granulomatosis With Polyangiitis. Type: Interventional Start Date: Dec 2023 |
Surgical Debulking Prior to Peptide Receptor Radionuclide Therapy in Well Differentiated Gastroenteropancreatic...
Digestive System Neuroendocrine Tumor G1
Digestive System Neuroendocrine Tumor G2
Metastatic Digestive System Neuroendocrine Neoplasm
Metastatic Malignant Neoplasm in the Liver
Pancreatic Neuroendocrine Tumor G1
This phase IV trial evaluates how well giving standard of care (SOC) peptide receptor
radionuclide therapy (PRRT) after SOC surgical removal of as much tumor as possible
(debulking surgery) works in treating patients with grade 1 or 2, somatostatin receptor
(SSTR) positive, gastroenteropancreatic... expand
This phase IV trial evaluates how well giving standard of care (SOC) peptide receptor radionuclide therapy (PRRT) after SOC surgical removal of as much tumor as possible (debulking surgery) works in treating patients with grade 1 or 2, somatostatin receptor (SSTR) positive, gastroenteropancreatic neuroendocrine tumors (GEP-NETs) that have spread from where they first started (primary site) to the liver (hepatic metastasis). Lutetium Lu 177 dotatate is a radioactive drug that uses targeted radiation to kill tumor cells. Lutetium Lu 177 dotatate includes a radioactive form (an isotope) of the element called lutetium. This radioactive isotope (Lu-177) is attached to a molecule called dotatate. On the surface of GEP-NET tumor cells, a receptor called a somatostatin receptor binds to dotatate. When this binding occurs, the lutetium Lu 177 dotatate drug then enters somatostatin receptor-positive tumor cells, and radiation emitted by Lu-177 helps kill the cells. Giving lutetium Lu 177 dotatate after surgical debulking may better treat patients with grade 1/2 GEP-NETs Type: Interventional Start Date: May 2024 |
Observational Study to Characterize Biomarkers and Disease Progression in Participants With Methyl CpG...
Methyl CpG Binding Protein 2 (MECP2) Duplication Syndrome
The purpose of the study is to prospectively assess longitudinal changes in biomarkers
(MECP2, potential biomarkers of target engagement and disease activity) in cerebrospinal
fluid (CSF) and blood; characterize longitudinal changes in performance on clinical
scales (clinician-reported measures of... expand
The purpose of the study is to prospectively assess longitudinal changes in biomarkers (MECP2, potential biomarkers of target engagement and disease activity) in cerebrospinal fluid (CSF) and blood; characterize longitudinal changes in performance on clinical scales (clinician-reported measures of neurodevelopment and functioning) and caregiver-reported outcome assessments (communication, gastrointestinal, social-emotional-adaptive behavioral measures); evaluate longitudinal changes in caregiver-reported health-related quality-of-life measures; and assess the frequency, type, and severity of seizures over time. Type: Observational Start Date: Oct 2023 |
Pounce™ Thrombectomy System Retrospective Registry
Peripheral Arterial Disease
Acute Limb Ischemia
The PROWL registry is an open-label retrospective, multi-center, US study of the
Surmodics™ Pounce™ Thrombectomy System for the non-surgical removal of emboli and thrombi
in the peripheral arterial vasculature. expand
The PROWL registry is an open-label retrospective, multi-center, US study of the Surmodics™ Pounce™ Thrombectomy System for the non-surgical removal of emboli and thrombi in the peripheral arterial vasculature. Type: Observational Start Date: Apr 2023 |
Tennessee Alzheimer's Project
Aging
Alzheimer Disease
Biomarker
Cognitive Dysfunction
Mild Cognitive Impairment
The primary objective of the Vanderbilt Alzheimer's Disease Research Center (VADRC) is to
provide local and national researchers with access to a well-characterized and diverse
clinical cohort, including participant referrals, biosamples, clinical data, and
neuroimaging data. The VADRC Clinical Core... expand
The primary objective of the Vanderbilt Alzheimer's Disease Research Center (VADRC) is to provide local and national researchers with access to a well-characterized and diverse clinical cohort, including participant referrals, biosamples, clinical data, and neuroimaging data. The VADRC Clinical Core will create an infrastructure to support research efforts of both local and national investigator studies to develop early detection, prevention, and treatment strategies for Alzheimer's disease. The Clinical Core intends to enroll up to 1000 participants, including individuals who are cognitively unimpaired, have mild cognitive impairment, or have Alzheimer's disease. This cohort of about 1000 participants will be called the Tennessee Alzheimer's Project. Participants will be seen annually for comprehensive clinical characterization and then referred to other studies to enhance Alzheimer's disease research activities. Type: Observational Start Date: Oct 2021 |
A Safety and Efficacy Study of Treatment Combinations With and Without Chemotherapy in Adult Participants...
Gastrointestinal Tract Malignancies
The purpose of this study is to evaluate the safety and preliminary clinical activity of
treatment combinations with and without chemotherapy in participants with locally
advanced unresectable or metastatic gastric, GEJ, and esophageal adenocarcinoma.
Chemotherapy will consist of FOLFOX (oxaliplatin,... expand
The purpose of this study is to evaluate the safety and preliminary clinical activity of treatment combinations with and without chemotherapy in participants with locally advanced unresectable or metastatic gastric, GEJ, and esophageal adenocarcinoma. Chemotherapy will consist of FOLFOX (oxaliplatin, leucovorin, fluorouracil). Type: Interventional Start Date: Jun 2022 |
Randomized Trial of Sedative Choice for Intubation
Acute Respiratory Failure
Among critically ill adults undergoing emergency tracheal intubation, one in five
experience hypotension, cardiac arrest, or death. The sedatives used to rapidly induce
anesthesia for emergency tracheal intubation have been hypothesized to effect
cardiovascular complications and patient outcomes,... expand
Among critically ill adults undergoing emergency tracheal intubation, one in five experience hypotension, cardiac arrest, or death. The sedatives used to rapidly induce anesthesia for emergency tracheal intubation have been hypothesized to effect cardiovascular complications and patient outcomes, but the optimal sedative medication for intubation of critically ill adults remains unknown. Ketamine and etomidate are the two most commonly used sedatives during intubation of critically ill adults. Data from a randomized clinical trial are urgently needed to determine the effect of ketamine versus etomidate on cardiovascular complications and clinical outcomes of emergency tracheal intubation. Type: Interventional Start Date: Apr 2022 |
Neural Correlates of Psychiatric Disorders
Psychiatric Disorder
Memory Disorders
This ClincialTrials.gov record originally corresponded to the protocol approved under IRB
# 202370. The study was expanded to include stimulation and recordings approved under new
IRB #211037. The participant data originally acquired from IRB# 202370 will be included
in this new record:
This study... expand
This ClincialTrials.gov record originally corresponded to the protocol approved under IRB # 202370. The study was expanded to include stimulation and recordings approved under new IRB #211037. The participant data originally acquired from IRB# 202370 will be included in this new record: This study seeks to better understand the neural activity underlying neuro cognitive disorders. Resting state local field potential recordings will be collected from medically refractory epilepsy patients implanted with depth electrodes for seizure localization, and metrics of neural activity will be correlated with psychiatric symptoms as measured from questionnaires. Subjects will also participate in neuro cognitive tasks while neural recordings are performed, and/or receive neural stimulation through implanted depth electrodes. A better understanding of disordered neural activity underlying neuropsychiatric disorders may additionally contribute to novel methods for diagnosing, treating, and preventing these diseases. Type: Observational Start Date: Mar 2021 |
PROACTIVE-HF-2 Trial Heart Failure NYHA Class II and III
Heart Failure NYHA Class II
Heart Failure NYHA Class III
This is a prospective, multi-center, open label, randomized control clinical trial
evaluating the safety and efficacy of the Cordella™ Pulmonary Artery Sensor System in
NYHA Class II-III Heart Failure Patients (PROACTIVE-HF-2 Trial).
The study contains of 5 arms:
Randomized Arm - To demonstrate... expand
This is a prospective, multi-center, open label, randomized control clinical trial evaluating the safety and efficacy of the Cordella™ Pulmonary Artery Sensor System in NYHA Class II-III Heart Failure Patients (PROACTIVE-HF-2 Trial). The study contains of 5 arms: Randomized Arm - To demonstrate safety and efficacy of the Cordella PA Sensor System in NYHA Class II HF patients. - Treatment Arm (Cohort 1) - Active Control Arm (Cohort 2) - Crossover Arm (Cohort 3) Single Arm - To demonstrate safety and efficacy of the Cordella PA Sensor System linked with a clinician-directed patient self-management strategy in NYHA Class III HF patients. - Clinician-Directed Patient Self-Management Arm (Cohort 4) - Clinician Management Arm (Cohort 5) Type: Interventional Start Date: Nov 2023 |
XVIVO Heart Perfusion System (XHPS) With Supplemented XVIVO Heart Solution (SXHS)
Heart Failure
Transplant; Failure, Heart
The purpose of this study is to evaluate if Non-Ischemic Heart Preservation (NIHP) of
extended criteria donor hearts using the XVIVO Heart Preservation System (XHPS) is a safe
and effective way to preserve and transport hearts for transplantation. expand
The purpose of this study is to evaluate if Non-Ischemic Heart Preservation (NIHP) of extended criteria donor hearts using the XVIVO Heart Preservation System (XHPS) is a safe and effective way to preserve and transport hearts for transplantation. Type: Interventional Start Date: Oct 2023 |
A Study of CDX-0159 in Patients With Eosinophilic Esophagitis
Eosinophilic Esophagitis
The purpose of this study is to assess the efficacy and safety of barzolvolimab in adult
Eosinophilic Esophagitis patients. expand
The purpose of this study is to assess the efficacy and safety of barzolvolimab in adult Eosinophilic Esophagitis patients. Type: Interventional Start Date: Jun 2023 |
Vanderbilt Memory and Aging Project
Alzheimer Disease
Aging
Aged, 80 and Over
Biomarkers
Brain
This study will use an observational cohort to cross-sectionally and longitudinally
relate vascular health to clinical, imaging, and biological markers of early Alzheimer's
disease and cerebrovascular disease among aging adults. Adjusting for relevant clinical
covariates, we will test the hypothesis... expand
This study will use an observational cohort to cross-sectionally and longitudinally relate vascular health to clinical, imaging, and biological markers of early Alzheimer's disease and cerebrovascular disease among aging adults. Adjusting for relevant clinical covariates, we will test the hypothesis that vascular health is associated with clinical, brain magnetic resonance imaging (MRI), neuropsychological, and cerebrospinal fluid markers of early cerebrovascular and Alzheimer's disease changes (i.e., prior to the onset of significant cognitive decline or dementia). Secondarily, we will examine medical and genetic factors that might mediate associations between vascular health and brain aging, such as inflammatory processes, insulin resistance, and genetic factors (e.g., APOE, a susceptibility risk factor for dementia). Findings will advance knowledge regarding the role that vascular health plays in brain aging. Type: Observational Start Date: Sep 2012 |
Microbiome Metabolites and Alcohol in HIV to Reduce CVD RCT
Microtia
Dysbiosis
Alcohol Drinking
HIV Infections
Cardiovascular Diseases
Among people living with HIV, heavy drinking increases the risk of heart disease and
death. Studies suggest that alcohol changes the number and kind of bacteria in your gut
and these changes increase the risk of heart disease and death. This randomized
controlled trial will determine whether a pill... expand
Among people living with HIV, heavy drinking increases the risk of heart disease and death. Studies suggest that alcohol changes the number and kind of bacteria in your gut and these changes increase the risk of heart disease and death. This randomized controlled trial will determine whether a pill containing healthy gut bacteria can increase the number good bacteria in the gut, lower levels of inflammation, and lower the risk of heart disease and death. Type: Interventional Start Date: Sep 2023 |
nCCR for Chemotherapy Related Cognitive Impairment Randomized Study
Chemo-brain
Chemotherapy-Related Cognitive Impairment
The investigators propose to apply neuroplasticity-based computerized cognitive
remediation (nCCR) to treat chemotherapy-related cognitive impairment (CRCI). expand
The investigators propose to apply neuroplasticity-based computerized cognitive remediation (nCCR) to treat chemotherapy-related cognitive impairment (CRCI). Type: Interventional Start Date: Aug 2022 |
RA-PRO PRAGMATIC TRIAL
Rheumatoid Arthritis
The 2021 ACR RA treatment guideline, based on widely acknowledged low to moderate quality
evidence, recommends switching to a non-tumor necrosis factor (TNFi) biologic (choose
among existing medications, currently, rituximab, abatacept, tocilizumab, or sarilumab)
or a targeted synthetic DMARD arm... expand
The 2021 ACR RA treatment guideline, based on widely acknowledged low to moderate quality evidence, recommends switching to a non-tumor necrosis factor (TNFi) biologic (choose among existing medications, currently, rituximab, abatacept, tocilizumab, or sarilumab) or a targeted synthetic DMARD arm (tsDMARD; choose among existing medications, currently, tofacitinib, baricitinib, upadacitinib) in patients with active RA despite the use of a TNFi-biologic. In practice, most patients receive another TNFi-biologic, i.e., a second TNFi-biologic first. This is not based on solid evidence, but on arbitrary algorithms often proposed by health insurance plans, and/or physician experience and habit (TNFis launched 22 yrs ago vs. the first tsDMARD 8 years ago vs. first non-TNF-biologic launched 17 years ago). This study will fill a critical knowledge gap by generating CER data for important PROs between these treatment options, switching to a non-TNFi biologic or a tsDMARD in patients with active RA despite the use of a TNFi-biologic. Type: Interventional Start Date: Sep 2021 |
Safety and Efficacy of ALLO-501A Anti-CD19 Allogeneic CAR T Cells in Adults With Relapsed/Refractory...
Relapsed or Refractory Large B Cell Lymphoma, Relapsed or Refractory Chronic Lymphocytic Leukemia, Relapsed or Refractory Small Lymphocytic Lymphoma
This is a single-arm, open label, multicenter Phase 1/2 study evaluating ALLO-501A in
adult subjects with R/R LBCL and CLL/SLL. The purpose of the ALPHA2 study is to assess
the safety, efficacy, and cell kinetics of ALLO-501A in adults with relapsed or
refractory large B-cell lymphoma and assess the... expand
This is a single-arm, open label, multicenter Phase 1/2 study evaluating ALLO-501A in adult subjects with R/R LBCL and CLL/SLL. The purpose of the ALPHA2 study is to assess the safety, efficacy, and cell kinetics of ALLO-501A in adults with relapsed or refractory large B-cell lymphoma and assess the safety of ALLO-501A in adults with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) after a lymphodepletion regimen comprising fludarabine, cyclophosphamide, and ALLO-647. Type: Interventional Start Date: May 2020 |
The Gut, Liver And Metabolome in Human Immunodeficiency Virus and Non Alcoholic Fatty Liver Disease
HIV
Non-Alcoholic Fatty Liver Disease
Metabolic-Associated Steatotic Liver Disease
Persons with human immunodeficiency virus (HIV) have higher risk of developing fatty
liver disease (NAFLD) than HIV-negative persons but the reasons for this discrepancy are
not known. Changes in the intestinal microbiome may contribute to the development of
NAFLD in persons with HIV (PWH) through... expand
Persons with human immunodeficiency virus (HIV) have higher risk of developing fatty liver disease (NAFLD) than HIV-negative persons but the reasons for this discrepancy are not known. Changes in the intestinal microbiome may contribute to the development of NAFLD in persons with HIV (PWH) through impairment of barrier function of the intestinal wall and by producing metabolites that are harmful to the liver. This project will test the hypothesis that HIV-related NAFLD is associated with differences in the intestinal microbiome and that supplementation with probiotic and prebiotic fiber will lead to improvements in markers of NAFLD in PWH. Type: Interventional Start Date: Apr 2024 |
Prophylactic Antibiotic Coated Nail to Prevent Infection: A Clinical Trial
Osteomyelitis Tibia
Tibial Fractures
Open Tibia Fracture
This prospective randomized clinical trial will compare outcomes between patients treated
primarily with a prophylactic antibiotic coated nail and those treated with traditional
standard of care intramedullary (IM) nailing. expand
This prospective randomized clinical trial will compare outcomes between patients treated primarily with a prophylactic antibiotic coated nail and those treated with traditional standard of care intramedullary (IM) nailing. Type: Interventional Start Date: May 2023 |
Trial of Indication-Based Transfusion of Red Blood Cells in ECMO
Extracorporeal Membrane Oxygenation
Red Blood Cell Transfusion
Organ Failure, Multiple
TITRE - Trial of Indication-based Transfusion of Red Blood Cells in ECMO, is a
multicenter, prospective, randomized clinical trial. The overarching goal of TITRE is to
determine whether restricting red blood cell (RBC) transfusion according to an
indication-based strategy for those with bleeding and/or... expand
TITRE - Trial of Indication-based Transfusion of Red Blood Cells in ECMO, is a multicenter, prospective, randomized clinical trial. The overarching goal of TITRE is to determine whether restricting red blood cell (RBC) transfusion according to an indication-based strategy for those with bleeding and/or deficit of tissue oxygen delivery, compared with transfusion based on center-specific hemoglobin or hematocrit thresholds, can reduce organ dysfunction and improve later neurodevelopment in critically ill children receiving Extracorporeal Membrane Oxygenation (ECMO) support. Type: Interventional Start Date: Apr 2023 |
PREvention of CardIovascular and DiabEtic kidNey Disease in Type 2 Diabetes
Type2Diabetes
ASCVD
PRECIDENTD is a randomized, open label, pragmatic clinical trial designed to compare
rates of the total number of cardiovascular, kidney, and death events among two
alternative treatments for patients with type 2 diabetes (T2D) and either established
atherosclerotic cardiovascular disease (ASCVD)... expand
PRECIDENTD is a randomized, open label, pragmatic clinical trial designed to compare rates of the total number of cardiovascular, kidney, and death events among two alternative treatments for patients with type 2 diabetes (T2D) and either established atherosclerotic cardiovascular disease (ASCVD) or at high risk for ASCVD. To accomplish this objective, we will randomly assign 6,000 patients with established T2D and ASCVD or high-risk for ASCVD in a 1:1 allocation to sodium-glucose cotransporter-2 inhibitor (SGLT2i) or glucagon-like peptide-1 receptor agonists (GLP-1RA). Participants will be followed for the occurrence of the trial primary endpoint of the total (first and recurrent) number of episodes of myocardial infarction (MI), stroke, arterial revascularization, hospitalization for heart failure, development of end-stage kidney disease, kidney transplantation, and mortality, counting all events from randomization until end of study. Type: Interventional Start Date: Sep 2022 |
PROMISE III: Percutaneous Deep Vein Arterialization for the Treatment of Late-Stage Chronic Limb-Threatening...
Critical Limb Ischemia
Chronic Limb-Threatening Ischemia
Peripheral Arterial Disease
A prospective, single-arm, multi-center study designed to gather additional information
on the LimFlow System. expand
A prospective, single-arm, multi-center study designed to gather additional information on the LimFlow System. Type: Interventional Start Date: Dec 2022 |
Testing the Addition of Nivolumab to Standard Treatment for Patients With Metastatic or Unresectable...
Metastatic Colon Adenocarcinoma
Metastatic Rectal Adenocarcinoma
Stage III Colon Cancer AJCC v8
Stage III Rectal Cancer AJCC v8
Stage IV Colon Cancer AJCC v8
This phase II trial tests whether adding nivolumab to the usual treatment (encorafenib
and cetuximab) works better than the usual treatment alone to shrink tumors in patients
with colorectal cancer that has spread to other places in the body (metastatic) or that
cannot be removed by surgery (unresectable)... expand
This phase II trial tests whether adding nivolumab to the usual treatment (encorafenib and cetuximab) works better than the usual treatment alone to shrink tumors in patients with colorectal cancer that has spread to other places in the body (metastatic) or that cannot be removed by surgery (unresectable) and whose tumor has a mutation in a gene called BRAF. Encorafenib is in a class of medications called kinase inhibitors. It is used in patients whose cancer has a certain mutation (change) in the BRAF gene. It works by blocking the action of mutated BRAF that signals cancer cells to multiply. This helps to stop or slow the spread of cancer cells. Cetuximab is in a class of medications called monoclonal antibodies. It binds to a protein called EGFR, which is found on some types of cancer cells. This may help keep cancer cells from growing. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving nivolumab in combination with encorafenib and cetuximab may be more effective than encorafenib and cetuximab alone at stopping tumor growth and spreading in patients with metastatic or unresectable BRAF-mutant colorectal cancer. Type: Interventional Start Date: Jul 2022 |
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