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Comparing the Outcome of Immunotherapy-Based Drug Combination Therapy With or Without Surgery to Remove...
SWOG Cancer Research Network
Metastatic Clear Cell Renal Cell Carcinoma
Metastatic Renal Cell Carcinoma
Stage IV Renal Cell Cancer AJCC v8
This phase III trial compares the effect of adding surgery to a standard of care
immunotherapy-based drug combination versus a standard of care immunotherapy-based drug
combination alone in treating patients with kidney cancer that has spread to other places
in the body (metastatic). Immunotherapy... expand
This phase III trial compares the effect of adding surgery to a standard of care immunotherapy-based drug combination versus a standard of care immunotherapy-based drug combination alone in treating patients with kidney cancer that has spread to other places in the body (metastatic). Immunotherapy with monoclonal antibodies, such as nivolumab, ipilimumab, pembrolizumab, and avelumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Axitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Surgery to remove the kidney, called a nephrectomy, is also considered standard of care; however, doctors who treat kidney cancer do not agree on its benefits. It is not yet known if the addition of surgery to an immunotherapy-based drug combination works better than an immunotherapy-based drug combination alone in treating patients with kidney cancer. Type: Interventional Start Date: Mar 2021 |
T-DM1 and Tucatinib Compared With T-DM1 Alone in Preventing Relapses in People With High Risk HER2-Positive...
Alliance for Clinical Trials in Oncology
Anatomic Stage IA Breast Cancer AJCC v8
Anatomic Stage II Breast Cancer AJCC v8
Anatomic Stage IIA Breast Cancer AJCC v8
Anatomic Stage IIB Breast Cancer AJCC v8
Anatomic Stage III Breast Cancer AJCC v8
This phase III trial studies how well trastuzumab emtansine (T-DM1) and tucatinib work in
preventing breast cancer from coming back (relapsing) in patients with high risk, HER2
positive breast cancer. T-DM1 is a monoclonal antibody, called trastuzumab, linked to a
chemotherapy drug, called DM1. Trastuzumab... expand
This phase III trial studies how well trastuzumab emtansine (T-DM1) and tucatinib work in preventing breast cancer from coming back (relapsing) in patients with high risk, HER2 positive breast cancer. T-DM1 is a monoclonal antibody, called trastuzumab, linked to a chemotherapy drug, called DM1. Trastuzumab is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, known as HER2 receptors, and delivers DM1 to kill them. Tucatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving T-DM1 and tucatinib may work better in preventing breast cancer from relapsing in patients with HER2 positive breast cancer compared to T-DM1 alone. Type: Interventional Start Date: Jan 2021 |
A Phase 1/2 Study in Patients With HPV16+ Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma...
Hookipa Biotech GmbH
HPV-Related Squamous Cell Carcinoma
This is a First in Human (FIH) Phase I/II, multinational, multicenter, open-label study
of HB-201 single vector therapy and HB-201 & HB-202 two-vector therapy in patients with
HPV 16+ confirmed cancers comprising two parts: Phase I Dose Escalation and Phase II Dose
Expansion. expand
This is a First in Human (FIH) Phase I/II, multinational, multicenter, open-label study of HB-201 single vector therapy and HB-201 & HB-202 two-vector therapy in patients with HPV 16+ confirmed cancers comprising two parts: Phase I Dose Escalation and Phase II Dose Expansion. Type: Interventional Start Date: Dec 2019 |
Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Tuspetinib...
Aptose Biosciences Inc.
Leukemia, Myeloid, Acute
Refractory AML
Relapsed Adult AML
Myelodysplastic Syndrome With Excess Blasts-2
Chronic Myelomonocytic Leukemia
The main purpose of this study is to identify a safe and potentially effective dose of
tuspetinib to be used in future studies in study participants diagnosed with acute
myeloid leukemia (AML), myelodysplastic syndromes with increased blasts grade 2
(MDS-IB2), or chronic myelomonocytic leukemia (CMML)... expand
The main purpose of this study is to identify a safe and potentially effective dose of tuspetinib to be used in future studies in study participants diagnosed with acute myeloid leukemia (AML), myelodysplastic syndromes with increased blasts grade 2 (MDS-IB2), or chronic myelomonocytic leukemia (CMML) that is relapsed or refractory after at least one line of prior therapy, or in study participants with newly diagnosed AML. Tuspetinib will be administered as a single agent or in combination with other drugs (venetoclax or venetoclax plus azacitidine), as specified for each part of the study. Type: Interventional Start Date: Mar 2019 |
Long-term Safety, Tolerability and Effectiveness Study of Ofatumumab in Patients With Relapsing MS
Novartis Pharmaceuticals
Relapsing Multiple Sclerosis
The purpose of this study is to collect long-term safety, tolerability, effectiveness and
health outcomes data in eligible subjects who have participated in a Novartis ofatumumab
clinical MS study.
Vaccination sub-study The purpose of this research sub-study is to find out the effects
of ofatumumab... expand
The purpose of this study is to collect long-term safety, tolerability, effectiveness and health outcomes data in eligible subjects who have participated in a Novartis ofatumumab clinical MS study. Vaccination sub-study The purpose of this research sub-study is to find out the effects of ofatumumab on the development of antibody responses to selected vaccines and keyhole limpet hemocyanin (KLH) neo-antigen in subjects with relapsing multiple sclerosis (RMS). Type: Interventional Start Date: Dec 2018 |
TAPUR: Testing the Use of Food and Drug Administration (FDA) Approved Drugs That Target a Specific Abnormality...
American Society of Clinical Oncology
Lymphoma, Non-Hodgkin
Multiple Myeloma
Advanced Solid Tumors
The purpose of the study is to learn from the real world practice of prescribing targeted
therapies to patients with advanced cancer whose tumor harbors a genomic variant known to
be a drug target or to predict sensitivity to a drug.
NOTE: Due to character limits, the arms section does NOT include... expand
The purpose of the study is to learn from the real world practice of prescribing targeted therapies to patients with advanced cancer whose tumor harbors a genomic variant known to be a drug target or to predict sensitivity to a drug. NOTE: Due to character limits, the arms section does NOT include all TAPUR Study relevant biomarkers. For additional information, contact TAPUR@asco.org, or if a patient, your nearest participating TAPUR site (see participating centers). ******************************************************************** Results in publication or poster presentation format are posted as they become available for individual cohorts at www.tapur.org/news. The results may be accessed at any time. All results will be made available on clinicaltrials.gov at the end of the study. Indexing of available results on PubMed is in progress. ******************************************************************** Type: Interventional Start Date: Mar 2016 |
Childhood Cancer Survivor Study
St. Jude Children's Research Hospital
Cancer
The Childhood Cancer Survivor Study (CCSS) will investigate the long-term effects of
cancer and its associated therapies. A retrospective cohort study will be conducted
through a multi-institutional collaboration, which will involve the identification and
active follow-up of a cohort of approximately... expand
The Childhood Cancer Survivor Study (CCSS) will investigate the long-term effects of cancer and its associated therapies. A retrospective cohort study will be conducted through a multi-institutional collaboration, which will involve the identification and active follow-up of a cohort of approximately 50,000 survivors of cancer, diagnosed before 21 years of age, between 1970 and 1999 and 10,000 sibling controls. This project will study children and young adults exposed to specific therapeutic modalities, including radiation, chemotherapy, and/or surgery, who are at increased risk of late-occurring adverse health outcomes. A group of sibling controls will be identified and data collected for comparison purposes. Type: Observational Start Date: Jan 1995 |
Improving Gout Care After an ED Visit
University of Alabama at Birmingham
Gout
The prevalence of gout has been steadily increasing over several decades and is
correlated with the rising burden of obesity, chronic cardiac and renal disease; all
conditions overrepresented in the Southeastern U.S. - particularly in African Americans.
Through a novel post-emergency department visit... expand
The prevalence of gout has been steadily increasing over several decades and is correlated with the rising burden of obesity, chronic cardiac and renal disease; all conditions overrepresented in the Southeastern U.S. - particularly in African Americans. Through a novel post-emergency department visit intervention, we aim to improve the care patients with gout receive, both during acute exacerbations and long-term. A secondary goal of the project is to concurrently enhance participation of minorities in biomedical research in the Deep South. Type: Interventional Start Date: Jun 2024 |
Efficacy and Safety Studies of Frexalimab (SAR441344) in Adults With Relapsing Forms of Multiple Sclerosis
Sanofi
Multiple Sclerosis
The purpose of each study is to independently measure the annualized relapse rate (ARR)
with administration of frexalimab compared to a daily oral dose of teriflunomide in male
and female participants with relapsing forms of multiple sclerosis (aged 18 to 55 years
at the time of enrollment). People... expand
The purpose of each study is to independently measure the annualized relapse rate (ARR) with administration of frexalimab compared to a daily oral dose of teriflunomide in male and female participants with relapsing forms of multiple sclerosis (aged 18 to 55 years at the time of enrollment). People diagnosed with relapsing forms of multiple sclerosis are eligible for enrollment as long as they meet all the inclusion criteria and none of the exclusion criteria. Study details include: - This event-driven study will have variable duration of approximately 40 months for the first participant being randomized and approximately 20 months for the last participant randomized. - The study intervention duration will vary ranging from approximately 12 to 40 months. - The assessment of scheduled visits will include 1 common end of study [EOS] visit and 3 follow-up visits) with a visit frequency of every 4 weeks for the first 6 months and then every 3 months. Type: Interventional Start Date: Dec 2023 |
Phase 2 Study of AFM13 in Combination With AB-101 in Subjects With R/R HL and CD30+ PTCL
Affimed GmbH
Relapsed or Refractory Hodgkin Lymphoma
Peripheral T Cell Lymphoma
AFM13-203 is a phase 2, open-label, multi-center, multi-cohort study with a safety run-in
followed by expansion cohorts. The study is evaluating the safety and efficacy of AFM13
in combination with AB-101 in subjects with R/R classical HL and CD30-positive PTCL. expand
AFM13-203 is a phase 2, open-label, multi-center, multi-cohort study with a safety run-in followed by expansion cohorts. The study is evaluating the safety and efficacy of AFM13 in combination with AB-101 in subjects with R/R classical HL and CD30-positive PTCL. Type: Interventional Start Date: Oct 2023 |
Study With Immunotherapy Combinations in Participants With Metastatic Non-Small Cell Lung Cancer
Gilead Sciences
Advanced Non-Small Cell Lung Cancer
The purpose of this study is to assess the objective response rate (ORR) of
immunotherapy-based combination therapy and to assess the safety and tolerability of
immunotherapy-based combination therapy. expand
The purpose of this study is to assess the objective response rate (ORR) of immunotherapy-based combination therapy and to assess the safety and tolerability of immunotherapy-based combination therapy. Type: Interventional Start Date: Feb 2023 |
Integrated e-Health (Electronic Health) for HIV and Substance Use Disorders in Justice Involved Women
Yale University
HIV
Opioid Use Disorder
eHealth
The purpose of this 2-site (CT, AL) study is to test innovative interventions to reduce
stigma and improve the pre-exposure prophylaxis (PrEP) and opioid use disorder (OUD) care
continua in women involved in the criminal justice system (WICJ).
This study evaluates a newly validated PrEP decision... expand
The purpose of this 2-site (CT, AL) study is to test innovative interventions to reduce stigma and improve the pre-exposure prophylaxis (PrEP) and opioid use disorder (OUD) care continua in women involved in the criminal justice system (WICJ). This study evaluates a newly validated PrEP decision aid and eHealth for integrated PrEP and MOUD compared to a decision aid-only for WICJ with OUD. Type: Interventional Start Date: Jul 2023 |
5-HT2A Agonist Psilocybin in the Treatment of Tobacco Use Disorder
Johns Hopkins University
Tobacco Use Disorder
This is a multi-site, double-blind, randomized clinical trial of the 5-HT2A receptor
agonist psilocybin for smoking cessation. Four sites with experience in conducting
psilocybin research will be involved in this trial: Johns Hopkins University (JHU), the
University of Alabama at Birmingham (UAB),... expand
This is a multi-site, double-blind, randomized clinical trial of the 5-HT2A receptor agonist psilocybin for smoking cessation. Four sites with experience in conducting psilocybin research will be involved in this trial: Johns Hopkins University (JHU), the University of Alabama at Birmingham (UAB), New York University (NYU), and Sheppard Pratt (SP). The proposed study will treat 66 participants (22 at each site), randomized to receive either: 1) oral psilocybin (30 mg in session 1 and either 30 mg or 40 mg in session 2); or 2) oral niacin (150 mg in session 1 and either 150 mg or 200 mg in session 2), with sessions 1 week apart. Type: Interventional Start Date: Nov 2023 |
Neural-Derived Plasma Exosomal MicroRNAs As Promising Novel Biomarkers for Suicidality and Treatment...
University of Alabama at Birmingham
Major Depressive Disorder
Suicidal Ideas
Suicide, Attempted
MDD
Depression
This study is dedicated to help identify biomarkers for depression and suicide. The
purpose of the study is to better understand these links to improve medical and
psychiatric care in the future. This research is also to test the effects of standard
treatment of depression on improvement in depressive... expand
This study is dedicated to help identify biomarkers for depression and suicide. The purpose of the study is to better understand these links to improve medical and psychiatric care in the future. This research is also to test the effects of standard treatment of depression on improvement in depressive and suicidal behavior and on biomarkers (e.g. miRNA) for these disorders. Type: Interventional Start Date: Oct 2022 |
Implementation Trial to Evaluate a Population Health Combination Intervention to Meet HIV Testing, Linkage,...
University of Alabama at Birmingham
HIV
HIV Linkage to Care
HIV Testing
HIV Treatment
The purpose of this study is to adapt and evaluate a combination intervention that
includes: (1) a data-driven approach to directed community-based HIV testing to areas
with high need, (2) Project Connect to expedite linkage to care at time of diagnosis, (3)
and a Rapid ART (antiretroviral therapy)Start... expand
The purpose of this study is to adapt and evaluate a combination intervention that includes: (1) a data-driven approach to directed community-based HIV testing to areas with high need, (2) Project Connect to expedite linkage to care at time of diagnosis, (3) and a Rapid ART (antiretroviral therapy)Start program, all in Mobile County Health Department (MCHD) jurisdictions in Alabama. Type: Interventional Start Date: Mar 2024 |
Phase 2 Safety and Efficacy Evaluation of AL8326 in ≥2nd Line SCLC
Advenchen Pharmaceuticals, LLC.
Small Cell Lung Cancer
This trial is a Phase II trial designed to evaluate the safety and efficacy of using oral
AL8326 , a multi-targeted receptor Tyrosine Kinase Inhibitor( TKI) , to recurrent,
advanced, or metastatic small cell lung cancer (SCLC) patients who need ≥2nd line
treatment . expand
This trial is a Phase II trial designed to evaluate the safety and efficacy of using oral AL8326 , a multi-targeted receptor Tyrosine Kinase Inhibitor( TKI) , to recurrent, advanced, or metastatic small cell lung cancer (SCLC) patients who need ≥2nd line treatment . Type: Interventional Start Date: Nov 2022 |
Exploratory Study of Low Dose Psilocybin
University of Alabama at Birmingham
Demoralization
The purpose of the present study is to evaluate the feasibility, initial signals of
efficacy, and potential mechanisms of action of "microdoses" of psilocybin (i.e., low
doses of psilocybin that are not believed to produce mystical-type, transcendent,
hallucinogenic, or other overtly salient subjective... expand
The purpose of the present study is to evaluate the feasibility, initial signals of efficacy, and potential mechanisms of action of "microdoses" of psilocybin (i.e., low doses of psilocybin that are not believed to produce mystical-type, transcendent, hallucinogenic, or other overtly salient subjective effects that limit functionality) in the treatment of moderate to severe demoralization (feelings of hopelessness and meaningless that frequently accompany medical illness and other life hardship). Type: Interventional Start Date: Aug 2023 |
Cognitive Behavioral Therapy Following Esketamine for Major Depression and Suicidal Ideation for Relapse...
Yale University
Depression and Suicide
This is a rater-blinded, randomized controlled trial. All patients will receive
esketamine for treatment of Major Depression with Suicidal Ideation (MDSI). Subjects will
be randomized (1:1) to receive CBT (computer-assisted) or TAU alone following esketamine. expand
This is a rater-blinded, randomized controlled trial. All patients will receive esketamine for treatment of Major Depression with Suicidal Ideation (MDSI). Subjects will be randomized (1:1) to receive CBT (computer-assisted) or TAU alone following esketamine. Type: Interventional Start Date: Mar 2021 |
Study of Selinexor in Combination With Ruxolitinib in Myelofibrosis
Karyopharm Therapeutics Inc
Myelofibrosis
This is a global, multicenter Phase 1/3 study to evaluate the efficacy and safety of
selinexor plus ruxolitinib in JAK inhibitor (JAKi) treatment-naïve myelofibrosis (MF)
participants. The study will be conducted in two phases: Phase 1 (open-label) and Phase 3
(double-blind). Phase 1 (enrollment completed)... expand
This is a global, multicenter Phase 1/3 study to evaluate the efficacy and safety of selinexor plus ruxolitinib in JAK inhibitor (JAKi) treatment-naïve myelofibrosis (MF) participants. The study will be conducted in two phases: Phase 1 (open-label) and Phase 3 (double-blind). Phase 1 (enrollment completed) was an open-label evaluation of the safety and recommended dose (RD) of selinexor in combination with ruxolitinib and included a dose escalation using a standard 3+3 design (Phase 1a) and a dose expansion part (Phase 1b). In Phase 3, JAKi treatment-naïve MF participants are enrolled in 2:1 ratio to receive the combination therapy of selinexor + ruxolitinib or the combination of placebo + ruxolitinib. Type: Interventional Start Date: Mar 2021 |
ARrest RESpiraTory Failure From PNEUMONIA
Stanford University
Pneumonia
Hypoxemia
Acute Respiratory Failure
COVID-19 Pneumonia
This research study seeks to establish the effectiveness of a combination of an inhaled
corticosteroid and a beta agonist compared to placebo for the prevention of acute
respiratory failure (ARF) in hospitalized patients with pneumonia and hypoxemia. expand
This research study seeks to establish the effectiveness of a combination of an inhaled corticosteroid and a beta agonist compared to placebo for the prevention of acute respiratory failure (ARF) in hospitalized patients with pneumonia and hypoxemia. Type: Interventional Start Date: Jun 2020 |
Nitrous Oxide For Endoscopic Ablation of Refractory Barrett's Esophagus (NO FEAR-BE)
University of North Carolina, Chapel Hill
Barrett Esophagus
Intestinal Metaplasia
Esophageal Dysplasia
A multicenter, prospective, single arm, non randomized clinical trial to evaluate the
safety and efficacy of the C2 CryoBalloon Focal Ablation System (CbFAS) for the treatment
of persistent dysplasia or intestinal metaplasia (IM) in the tubular esophagus after 3 or
more radiofrequency ablations (RFA)... expand
A multicenter, prospective, single arm, non randomized clinical trial to evaluate the safety and efficacy of the C2 CryoBalloon Focal Ablation System (CbFAS) for the treatment of persistent dysplasia or intestinal metaplasia (IM) in the tubular esophagus after 3 or more radiofrequency ablations (RFA) for dysplastic BE, or <50% eradication of Barrett's Esophagus (BE) after 2 RFA treatments. Type: Interventional Start Date: Sep 2018 |
RESTORE: An RCT to Evaluate the Efficacy of the Revi System
BlueWind Medical
Urinary Urge Incontinence
The Revi System is indicated for the treatment of patients with symptoms of urgency
incontinence alone or in combination with urinary urgency. expand
The Revi System is indicated for the treatment of patients with symptoms of urgency incontinence alone or in combination with urinary urgency. Type: Interventional Start Date: Feb 2024 |
Study of INBRX-101 Compared to Plasma-derived A1PI Therapy in Adults With AATD Emphysema
Sanofi
Alpha 1-Antitrypsin Deficiency
Emphysema
Phase 2 study to compare INBRX-101 to plasma derived A1PI therapy in adults with AATD
emphysema expand
Phase 2 study to compare INBRX-101 to plasma derived A1PI therapy in adults with AATD emphysema Type: Interventional Start Date: Oct 2023 |
Multiparametic Metabolic and Hypoxic PET/MRI for Disease Assessment in High Grade Glioma
University of Alabama at Birmingham
High Grade Glioma
This feasibility study will assess the clinical potential of a new imaging approach to
detect viable high grade glioma (HGG) in pediatric and adult patients after standard of
care radiation therapy (RT) with or without concurrent temozolomide (TMZ). Study
participants will undergo simultaneous positron... expand
This feasibility study will assess the clinical potential of a new imaging approach to detect viable high grade glioma (HGG) in pediatric and adult patients after standard of care radiation therapy (RT) with or without concurrent temozolomide (TMZ). Study participants will undergo simultaneous positron emission tomography/magnetic resonance imaging (PET/MRI) with O-([2-[F-18]fluoroethyl)-L-tyrosine (FET, amino acid transport) and 1H-1-(3-[F-18]fluoro-2-hydroxypropyl)-2-nitroimidazole (FMISO, hypoxia) at the time of standard of care imaging after completion of RT. The presence of viable tumor at this time point will be assessed on a per patient basis. Study participants will be followed clinically and with standard of care (SOC) imaging for up to 2 years after completion of PET/MRI to determine the nature of lesions seen on investigational imaging and to obtain patient outcome data. The imaging data will also be used to develop a semi-automated workflow suitable for implementation in clinical trials and standard of care PET/MRI studies. Type: Interventional Start Date: Mar 2024 |
Add-on Reparixin in Adult Patients With ARDS
Dompé Farmaceutici S.p.A
Acute Respiratory Distress Syndrome, Adult
Study objectives
1. To characterize the efficacy of reparixin in ameliorating lung injury and systemic
inflammation and expediting clinical recovery and liberation from mechanical
ventilation in adult patients with moderate to severe ARDS (PaO2/FIO2 ratio ≤ 200).
2. To evaluate... expand
Study objectives 1. To characterize the efficacy of reparixin in ameliorating lung injury and systemic inflammation and expediting clinical recovery and liberation from mechanical ventilation in adult patients with moderate to severe ARDS (PaO2/FIO2 ratio ≤ 200). 2. To evaluate the safety of reparixin vs. placebo in patients enrolled in the study. Type: Interventional Start Date: Feb 2023 |
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