Search Clinical Trials
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Study of Subcutaneous Epcoritamab in Combination With Intravenous Rituximab and Oral Lenalidomide (R2)...
Genmab
Follicular Lymphoma (FL)
Follicular Lymphoma (FL) is the second most common B-cell cancer and the most common type
of cancer of lymphocytes. Unfortunately, this disease is incurable with conventional
treatment and the disease recurs in almost all patients. This study will assess how safe
and effective epcoritamab is in combination... expand
Follicular Lymphoma (FL) is the second most common B-cell cancer and the most common type of cancer of lymphocytes. Unfortunately, this disease is incurable with conventional treatment and the disease recurs in almost all patients. This study will assess how safe and effective epcoritamab is in combination with lenalidomide and rituximab (R2) in treating adult participants with relapsed or refractory (R/R) FL. Adverse events and change in disease condition will be assessed. Epcoritamab is an investigational drug being developed for the treatment of FL. Study doctors put the participants in 1 of 3 groups, called treatment arms. Each group receives a different treatment. Enrollment to one of the groups is closed. Around 500 adult participants with R/R FL will be enrolled in approximately 300 sites across the world. Participants will receive R2 (375 mg/m^2 intravenous infusion of rituximab up to 5 cycles and oral capsules of 20 mg lenalidomide for up to 12 cycles) alone or in combination with subcutaneous injections of epcoritamab for up to 12 cycles (each cycle is 28 days). There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires. Type: Interventional Start Date: Sep 2022 |
Safety and Efficacy Study of Epcoritamab in Subjects With Relapsed/Refractory Chronic Lymphocytic Leukemia...
Genmab
Relapsed/Refractory Chronic Lymphocytic Leukemia
Small Lymphocytic Lymphoma
Richter's Syndrome
The study is a global, multi-center safety and efficacy trial of epcoritamab, an antibody
also known as EPKINLY™ and GEN3013 (DuoBody®-CD3xCD20). Epcoritamab will either be
studied as:
- Monotherapy, or
- Combination therapy:
- epcoritamab + venetoclax
- epcoritamab... expand
The study is a global, multi-center safety and efficacy trial of epcoritamab, an antibody also known as EPKINLY™ and GEN3013 (DuoBody®-CD3xCD20). Epcoritamab will either be studied as: - Monotherapy, or - Combination therapy: - epcoritamab + venetoclax - epcoritamab + lenalidomide - epcoritamab + R-CHOP (i.e., rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine (Oncovin®) and prednisone). The study includes patients with relapsed/refractory chronic lymphocytic leukemia (R/R CLL)/small lymphocytic lymphoma (SLL) and patients with Richter's Syndrome (RS). Study participants with R/R CLL/SLL are treated either with epcoritamab as monotherapy or epcoritamab + venetoclax. Study participants with RS are treated either with epcoritamab as monotherapy or epcoritamab + lenalidomide or epcoritamab + R-CHOP. The trial consists of two parts, a dose-escalation phase (phase Ib) and an expansion phase (phase II). Patients with RS are only included in the expansion phase. Epcoritamab will be injected subcutaneously (under the skin). Standard-of-care and combination treatments (venetoclax, lenalidomide, and R-CHOP) will be given either orally (by mouth) or intravenously (in a vein). Study details include: - Study duration will be up to 5 years. - The treatment duration for each participant will be between 18 months (1.5 years) and 24 months (2 years), depending upon the treatment arm assigned. - The visit frequency will be either weekly, every other week, or monthly, depending upon the part of the study. All participants will receive active drug; no one will be given placebo. Type: Interventional Start Date: Nov 2020 |
Pan Tumor Rollover Study
Bristol-Myers Squibb
Cancer
Main Objective of this study is to examine long-term safety of nivolumab monotherapy
including combinations and other cancer therapies in various tumor types. expand
Main Objective of this study is to examine long-term safety of nivolumab monotherapy including combinations and other cancer therapies in various tumor types. Type: Interventional Start Date: Aug 2019 |
R-P NH of Genetic Vasculopathies
Massachusetts General Hospital
Multisystemic Smooth Muscle Dysfunction Syndrome
This study will combine retrospective review of medical records from patients with ACTA2
and ongoing collection of clinical data using standardized instruments and intervals on
an observational basis from patients with ACTA2.
Patients in cohorts 1-3 will be asked to attend clinic visits in person... expand
This study will combine retrospective review of medical records from patients with ACTA2 and ongoing collection of clinical data using standardized instruments and intervals on an observational basis from patients with ACTA2. Patients in cohorts 1-3 will be asked to attend clinic visits in person per the schedule of events. At minimum, the medical records of patients with ACTA2 will be reviewed to record data on aspects of the disease, including disease characteristics and developmental milestones. The study is planned to enroll a total of 100 patients: 7 in cohort 1, 7 in cohort 2, and the remaining in cohorts 3 and 4. This study is planned to study patients for at least 3 years with the option to continue as long as possible for assessment of disease progression. During their continued study participation, as patients age, they may move into the next cohort. Beyond 3 years the duration of the study with be determined by availability of funding from sponsors. Type: Observational Start Date: May 2024 |
Transcranial Magnetic Stimulation Treatment for Alzheimer's Disease
Massachusetts General Hospital
Alzheimer Disease
Mild Cognitive Impairment
Logopenic Progressive Aphasia
Amnestic Symptoms
In this research study we want to learn more about the effects of non-invasive brain
stimulation on memory and brain-network function in cognitively unimpaired older adults
and in patients with amnestic mild cognitive impairment (aMCI).
This study will use a form of non-invasive brain stimulation... expand
In this research study we want to learn more about the effects of non-invasive brain stimulation on memory and brain-network function in cognitively unimpaired older adults and in patients with amnestic mild cognitive impairment (aMCI). This study will use a form of non-invasive brain stimulation called repetitive Transcranial Magnetic Stimulation (rTMS). rTMS will slightly alter activity in an area of your brain that controls memory. Changes resulting from this stimulation will be measured with behavioral tests of memory and general cognition, as well as by taking images of your brain with Magnetic Resonance Imaging (MRI). Participants will come in for one baseline visit followed by 10 days of daily rTMS study visits (Monday through Friday) and an evaluation visit. Then, there will be a 2-week break. After this break, they will return for another baseline visit, an additional 10 days of rTMS, and a final evaluation visit. Type: Interventional Start Date: May 2023 |
First-in-Human Study of OKI-219 in Advanced Solid Tumors and Advanced Breast Cancer
OnKure, Inc.
Advanced Cancer
Breast Cancer
OKI-219-101 is a Phase 1a/1b, open-label, multicenter, dose-escalation study designed to
evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PDx), and
efficacy of OKI-219 as monotherapy and in combination with fulvestrant or trastuzumab.
Phase 1a (Part A) will investigate escalating... expand
OKI-219-101 is a Phase 1a/1b, open-label, multicenter, dose-escalation study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PDx), and efficacy of OKI-219 as monotherapy and in combination with fulvestrant or trastuzumab. Phase 1a (Part A) will investigate escalating doses of OKI-219 monotherapy, and Phase 1b will investigate OKI-219 (at a tolerated dose determined in Part A) in combination with standard dose fulvestrant (Part B) or standard dose trastuzumab (Part C). Participants will continue to receive study treatment until disease progression, intolerable toxicity, or other study treatment withdrawal criteria are met. Type: Interventional Start Date: Mar 2024 |
Obsidio™ Conformable Embolic Registry
Boston Scientific Corporation
Hypervascular Tumors
Bleeding
Hemorrhage
OCCLUDE is a prospective, post-approval, open-label, single arm, multi-center US registry
of patients who undergo embolization with Obsidio™ Conformable Embolic. The purpose of
this Registry is to assess effectiveness and safety outcomes of subjects who undergo
embolization with Obsidio. expand
OCCLUDE is a prospective, post-approval, open-label, single arm, multi-center US registry of patients who undergo embolization with Obsidio™ Conformable Embolic. The purpose of this Registry is to assess effectiveness and safety outcomes of subjects who undergo embolization with Obsidio. Type: Observational [Patient Registry] Start Date: Jun 2024 |
PrProfile: A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ION717.
Ionis Pharmaceuticals, Inc.
Prion Disease
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and
pharmacodynamics of intrathecal (IT) delivery of ION717. expand
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of intrathecal (IT) delivery of ION717. Type: Interventional Start Date: Jan 2024 |
INcreased Sun Exposure Without Pain In Research Participants With EPP or XLP
Mitsubishi Tanabe Pharma America Inc.
Erythropoietic Protoporphyria (EPP)
X-Linked Protoporphyria (XLP)
To investigate the efficacy of MT-7117 on time to onset and severity of first prodromal
symptoms (burning, tingling, itching, or stinging) associated with sunlight exposure in
adults and adolescents with EPP or XLP. expand
To investigate the efficacy of MT-7117 on time to onset and severity of first prodromal symptoms (burning, tingling, itching, or stinging) associated with sunlight exposure in adults and adolescents with EPP or XLP. Type: Interventional Start Date: Dec 2023 |
Enlighten Study: The EV-ICD Post Approval Registry
Medtronic
Ventricular Arrhythmia
Tachycardia
Medtronic is sponsoring Enlighten: The EV-ICD Post Approval Registry, to further confirm
safety and effectiveness of EV-ICD in routine clinical practice, following commercial
release of EV-ICD devices. expand
Medtronic is sponsoring Enlighten: The EV-ICD Post Approval Registry, to further confirm safety and effectiveness of EV-ICD in routine clinical practice, following commercial release of EV-ICD devices. Type: Observational Start Date: Sep 2023 |
CTSN Embolic Protection Trial
Icahn School of Medicine at Mount Sinai
Delirium
Ischemic Stroke
Acute Kidney Injury
Heart Valve Disease
Coronary Artery Disease
This is a prospective, multi-center, randomized effectiveness trial of the CardioGard
Embolic Protection Cannula in high-risk valve surgery patients. expand
This is a prospective, multi-center, randomized effectiveness trial of the CardioGard Embolic Protection Cannula in high-risk valve surgery patients. Type: Interventional Start Date: Sep 2023 |
A Study of NPX267 for Subjects With Solid Tumors Known to Express HHLA2/B7-H7
NextPoint Therapeutics, Inc.
Metastatic Malignant Neoplasm
NPX267 is an antibody drug targeting the inhibitory receptor for B7-H7 (HHLA2) which may
control evasion of the immune response in tumors. The goal of this clinical trial is to
learn whether NPX267 is safe and tolerable in patients whose cancers are known to express
HHLA2 including epidermal growth... expand
NPX267 is an antibody drug targeting the inhibitory receptor for B7-H7 (HHLA2) which may control evasion of the immune response in tumors. The goal of this clinical trial is to learn whether NPX267 is safe and tolerable in patients whose cancers are known to express HHLA2 including epidermal growth factor receptor (EGFR) mutant non-small cell lung cancer. The main questions it aims to answer are: - what is an appropriate dose to be given to patients? - are the side effects of treatment manageable? Participants will be evaluated for participation in the study. Patients who are treated will receive an intravenous infusion of NPX267 every three weeks if their disease has not progressed. Patients will be closely monitored by the treating physician. Type: Interventional Start Date: Jul 2023 |
Study to Assess Adverse Events, Change in Disease Activity, and How Oral Upadacitinib Moves Through the...
AbbVie
Ulcerative Colitis
Ulcerative colitis (UC) is a type of inflammatory bowel disease that causes inflammation
and bleeding from the lining of the rectum and colon (large intestine). This study will
assess how safe and effective Upadacitinib is in treating pediatric participants with UC.
Adverse events and change in disease... expand
Ulcerative colitis (UC) is a type of inflammatory bowel disease that causes inflammation and bleeding from the lining of the rectum and colon (large intestine). This study will assess how safe and effective Upadacitinib is in treating pediatric participants with UC. Adverse events and change in disease activity will be assessed. Upadacitinib (RINVOQ) is a drug approved in adults for moderate- to severely active UC and is being developed for moderate- to severely active UC in pediatric participants. This study is conducted in 2 periods: Period 1 is comprised of two phases: an 8-week open-label induction phase which means that the study doctor and patients know that participants will receive UPA Dose-A (or the adult equivalent based on body weight) followed by a 44-week double-blind maintenance phase meaning that neither the participants nor the study doctors will know which dose of upadacitinib will be given(UPA Dose B or Dose C). Period 2 is a 260 week open-label extension (OLE) of Period 1. Approximately 110 pediatric participants with moderate to severely active UC will be enrolled at up to 100 sites worldwide. Participants will receive upadacitinib oral tablets once daily or oral solution twice daily at approximately the same time each day, with or without food. Participants will be followed up for 30 days after each phase (i.e. after induction, maintenance, OLE) and only if a participant doesn't continue into the next phase. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires. Type: Interventional Start Date: Nov 2023 |
Study of Efficacy and Safety of Iptacopan in Participants With IC-MPGN
Novartis Pharmaceuticals
IC-MPGN
This study is designed as a multicenter, randomized, double-blind, parallel group,
placebo-controlled study to evaluate the efficacy and safety of iptacopan (LNP023) in
idiopathic immune complex mediated membranoproliferative glomerulonephritis. expand
This study is designed as a multicenter, randomized, double-blind, parallel group, placebo-controlled study to evaluate the efficacy and safety of iptacopan (LNP023) in idiopathic immune complex mediated membranoproliferative glomerulonephritis. Type: Interventional Start Date: Oct 2023 |
Efficacy and Safety of Encaleret Compared to Standard of Care in Participants With ADH1
Calcilytix Therapeutics, Inc., a BridgeBio company
Autosomal Dominant Hypocalcemia (ADH)
The primary purpose of the study is to understand the effectiveness, safety, and
tolerability of encaleret when compared to standard of care (SoC) treatment in
participants with Autosomal Dominant Hypocalcemia Type 1 (ADH1). expand
The primary purpose of the study is to understand the effectiveness, safety, and tolerability of encaleret when compared to standard of care (SoC) treatment in participants with Autosomal Dominant Hypocalcemia Type 1 (ADH1). Type: Interventional Start Date: Jan 2023 |
A Study of Tislelizumab in Combination With Investigational Agents in Participants With Non-Small Cell...
BeiGene
Non-small Cell Lung Cancer
Metastatic Non-small Cell Lung Cancer
The purpose of this study is to assess the antitumor activity, safety, and tolerability
of tislelizumab plus investigational agent(s) with or without chemotherapy. This study is
structured as a master protocol with separate sub- studies. Sub-study 1 includes
participants with non-small cell lung cancer... expand
The purpose of this study is to assess the antitumor activity, safety, and tolerability of tislelizumab plus investigational agent(s) with or without chemotherapy. This study is structured as a master protocol with separate sub- studies. Sub-study 1 includes participants with non-small cell lung cancer (NSCLC) with high programmed cell death protein ligand-1 (PD-L1) expression (≥ 50%), and Sub-study 2 includes participants with NSCLC with low or negative (PD-L1) expression (< 50%). Type: Interventional Start Date: Mar 2023 |
Ecopipam Tablets to Study Tourette's Disorder in Children, Adolescents and Adults
Emalex Biosciences Inc.
Tourette Disorder
This Phase 3 multicenter study evaluates the maintenance of efficacy, safety and
tolerability of ecopipam tablets in children, adolescents and adults in the treatment of
Tourette's Disorder (TD). The study includes an open-label period followed by
double-blind, placebo-controlled, randomized withdrawal... expand
This Phase 3 multicenter study evaluates the maintenance of efficacy, safety and tolerability of ecopipam tablets in children, adolescents and adults in the treatment of Tourette's Disorder (TD). The study includes an open-label period followed by double-blind, placebo-controlled, randomized withdrawal period. Type: Interventional Start Date: Jan 2023 |
A Study of LOXO-435 in Participants With Cancer With a Change in a Gene Called FGFR3
Eli Lilly and Company
Urinary Bladder Neoplasms
Neoplasm Metastasis
Ureteral Neoplasms
The main purpose of this study is to learn more about the safety, side effects, and
effectiveness of LOXO-435. LOXO-435 may be used to treat cancer of the cells that line
the urinary system and other solid tumor cancers that have a change in a particular gene
(known as the FGFR3 gene). Participation... expand
The main purpose of this study is to learn more about the safety, side effects, and effectiveness of LOXO-435. LOXO-435 may be used to treat cancer of the cells that line the urinary system and other solid tumor cancers that have a change in a particular gene (known as the FGFR3 gene). Participation could last up to 30 months (2.5 years) and possibly longer if the disease does not get worse. Type: Interventional Start Date: Jan 2023 |
Strategies and Treatments for Respiratory Infections & Viral Emergencies (STRIVE): Shionogi Protease...
University of Minnesota
COVID-19
Treatments are needed to improve outcomes among patients hospitalized for COVID-19,
including direct-acting antiviral (DAA) agents to mitigate the pathology driven by
ongoing viral replication. This trial will evaluate S-217622 (ensitrelvir), an
anti-SARS-CoV2 3C-like protease inhibitor (PI) developed... expand
Treatments are needed to improve outcomes among patients hospitalized for COVID-19, including direct-acting antiviral (DAA) agents to mitigate the pathology driven by ongoing viral replication. This trial will evaluate S-217622 (ensitrelvir), an anti-SARS-CoV2 3C-like protease inhibitor (PI) developed by Shionogi &; Co. Ltd. The study design is a randomized, placebo-controlled, multi-center international clinical trial that will evaluate the clinical efficacy of ensitrelvir when given in addition to standard of care (SOC) for inpatients with COVID-19. The SOC will be determined by local established guidelines and may include additional DAA (e.g., remdesivir) and immunomodulatory treatment strategies. Certain SOC treatments will be pre-specified prior to randomization. Type: Interventional Start Date: Dec 2022 |
A Diagnostic Test for Dementia With Lewy Bodies
CND Life Sciences
MCI-AD, Early Stage Alzheimer's Disease
MCI-DLB, Early Stage Dementia With Lewy Bodies
The Syn-D Study will be evaluating α-synuclein in patients with suspected MCI-AD and
MCI-DLB. Using a simple diagnostic test will improve clinical accuracy in diagnosing,
earlier diagnosis, and distinguish between neurodegenerative diseases. expand
The Syn-D Study will be evaluating α-synuclein in patients with suspected MCI-AD and MCI-DLB. Using a simple diagnostic test will improve clinical accuracy in diagnosing, earlier diagnosis, and distinguish between neurodegenerative diseases. Type: Observational Start Date: Aug 2022 |
A Study of Bleximenib in Combination With Acute Myeloid Leukemia (AML) Directed Therapies
Janssen Research & Development, LLC
Leukemia, Myeloid, Acute
The purpose of this study is to determine the recommended Phase 2 dose (RP2D)
candidate(s) of bleximenib in combination with AML directed therapies (dose selection)
and further to evaluate safety and tolerability of bleximenib in combination with AML
directed therapies at the RP2D(s) (dose expansion). expand
The purpose of this study is to determine the recommended Phase 2 dose (RP2D) candidate(s) of bleximenib in combination with AML directed therapies (dose selection) and further to evaluate safety and tolerability of bleximenib in combination with AML directed therapies at the RP2D(s) (dose expansion). Type: Interventional Start Date: Oct 2022 |
Chemotherapy for the Treatment of Patients With Newly Diagnosed Very Low-Risk and Low Risk Fusion Negative...
Children's Oncology Group
Embryonal Rhabdomyosarcoma
Fusion-Negative Alveolar Rhabdomyosarcoma
Spindle Cell/Sclerosing Rhabdomyosarcoma
Rhabdomyosarcoma is a type of cancer that occurs in the soft tissues in the body. This
phase III trial aims to maintain excellent outcomes in patients with very low risk
rhabdomyosarcoma (VLR-RMS) while decreasing the burden of therapy using treatment with 24
weeks of vincristine and dactinomycin... expand
Rhabdomyosarcoma is a type of cancer that occurs in the soft tissues in the body. This phase III trial aims to maintain excellent outcomes in patients with very low risk rhabdomyosarcoma (VLR-RMS) while decreasing the burden of therapy using treatment with 24 weeks of vincristine and dactinomycin (VA) and examines the use of centralized molecular risk stratification in the treatment of rhabdomyosarcoma. Another aim of the study it to find out how well patients with low risk rhabdomyosarcoma (LR-RMS) respond to standard chemotherapy when patients with VLR-RMS and patients who have rhabdomyosarcoma with DNA mutations get separate treatment. Finally, this study examines the effect of therapy intensification in patients who have RMS cancer with DNA mutations to see if their outcomes can be improved. Type: Interventional Start Date: Aug 2022 |
The FLOTILLA Study: Providing Continued Access to The Study Medicines Encorafenib and Binimetinib for...
Pfizer
Solid Tumors
The purpose of this clinical trial (called the FLOTILLA study) is to give continued
access to the study medicines, as well as safety follow-up, for participants in prior
clinical trials of encorafenib and/or binimetinib.
All participants who took part in earlier encorafenib and/or binimetinib studies... expand
The purpose of this clinical trial (called the FLOTILLA study) is to give continued access to the study medicines, as well as safety follow-up, for participants in prior clinical trials of encorafenib and/or binimetinib. All participants who took part in earlier encorafenib and/or binimetinib studies may participate the FLOTILLA study if they are still benefiting from the use of the study medicines. This will be determined by the study doctor. People may not participate in the FLOTILLA study if they have not enrolled in a prior study of encorafenib or binimetinib. Participants that had enrolled but had stopped receiving the study treatment in a prior study cannot enrolled in this study. Participants in the FLOTILLA study will receive encorafenib and/or binimetinib at the same dose and frequency as in their prior study, for up to about 5 years. Type: Interventional Start Date: Jul 2022 |
Olorofim Aspergillus Infection Study
F2G Biotech GmbH
Invasive Aspergillosis
The purpose of this study is to compare treatment with olorofim versus treatment with
AmBisome® followed by standard of care (SOC) in patients with IFD caused by proven IA or
probable lower respiratory tract disease Aspergillus species (invasive aspergillosis,
IA). expand
The purpose of this study is to compare treatment with olorofim versus treatment with AmBisome® followed by standard of care (SOC) in patients with IFD caused by proven IA or probable lower respiratory tract disease Aspergillus species (invasive aspergillosis, IA). Type: Interventional Start Date: Mar 2022 |
Comparison of Anti-coagulation and Anti-Platelet Therapies for Intracranial Vascular Atherostenosis
University of Florida
Intracranial Arteriosclerosis
Stroke
The primary goal of the trial is to determine if the experimental arms (rivaroxaban or
ticagrelor or both) are superior to the clopidogrel arm for lowering the 1-year rate of
ischemic stroke, intracerebral hemorrhage, or vascular death. expand
The primary goal of the trial is to determine if the experimental arms (rivaroxaban or ticagrelor or both) are superior to the clopidogrel arm for lowering the 1-year rate of ischemic stroke, intracerebral hemorrhage, or vascular death. Type: Interventional Start Date: Aug 2022 |
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