Search Clinical Trials
Sponsor Condition of Interest |
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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 |
Mechanistic Study of the Effect of Itepekimab on Airway Inflammation in Patients With COPD
Sanofi
Chronic Obstructive Pulmonary Disease
This study is an exploratory, two-part, 12-week, Phase 2a study to evaluate the mechanism
of action of Itepekimab (anti-IL-33-mAb) and its impact on airway inflammation in former
and current smokers with COPD, aged 40 to 70 years.
This study consists of participants who have been on a standard-of-care... expand
This study is an exploratory, two-part, 12-week, Phase 2a study to evaluate the mechanism of action of Itepekimab (anti-IL-33-mAb) and its impact on airway inflammation in former and current smokers with COPD, aged 40 to 70 years. This study consists of participants who have been on a standard-of-care (SoC) mono (long-acting β2-agonist [LABA]) or long-acting muscarinic antagonist [LAMA]), double (inhaled corticosteroid [ICS] + LABA, LABA + LAMA or ICS + LAMA), or triple (ICS + LABA + LAMA) controller therapy for COPD for at least 3 months prior to Screening (Visit 1) with stable dose and regimen for controller therapy for ≥1 month prior to Screening (Visit 1) and during the screening period. Participants will stay on their established controller medications for COPD throughout the duration of the study, with the exception of systemic corticosteroids and/or antibiotics used for acute exacerbation of COPD (AECOPD). The total study duration for each part (Part A and Part B) is approximately 36 weeks: - 4-week screening period - 12-week treatment period - 20-week followup period Type: Interventional Start Date: May 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 |
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 |
ATEMPT 2.0: Adjuvant T-DM1 Vs TH
Dana-Farber Cancer Institute
Breast Cancer
HER2-positive Breast Cancer
This research study is studying how well newly diagnosed breast cancer that has tested
positive for a protein called HER2 responds using one of two different combination of
HER2-directed therapies as a treatment after surgery.
The name of the study drugs involved are:
- Trastuzumab-emtansine... expand
This research study is studying how well newly diagnosed breast cancer that has tested positive for a protein called HER2 responds using one of two different combination of HER2-directed therapies as a treatment after surgery. The name of the study drugs involved are: - Trastuzumab-emtansine (T-DM1, Kadcyla) - Trastuzumab SC (Herceptin Hylecta) - Paclitaxel Type: Interventional Start Date: Jun 2021 |
A Phase I Study of IAG933 in Patients With Advanced Mesothelioma and Other Solid Tumors
Novartis Pharmaceuticals
Mesothelioma
The purpose of this study is to characterize the safety and tolerability of IAG933 in
patients with mesothelioma, NF2/LATS1/LATS2 mutated tumors and tumors with functional
YAP/TAZ fusions and to identify the maximum tolerated dose and/or recommended dose. expand
The purpose of this study is to characterize the safety and tolerability of IAG933 in patients with mesothelioma, NF2/LATS1/LATS2 mutated tumors and tumors with functional YAP/TAZ fusions and to identify the maximum tolerated dose and/or recommended dose. Type: Interventional Start Date: Oct 2021 |
Niraparib + Dostarlimab in BRCA Mutated Breast Cancer
Dana-Farber Cancer Institute
Stage I Breast Cancer
Stage II Breast Cancer
Stage III Breast Cancer
Breast Cancer
HER2-negative Breast Cancer
This research study involves pre-operative therapy that is specifically targeted for
breast cancer in individuals with BRCA and PALB2 mutations.
The names of the study drugs involved in this study are:
- Niraparib (Zejula)
- Dostarlimab expand
This research study involves pre-operative therapy that is specifically targeted for breast cancer in individuals with BRCA and PALB2 mutations. The names of the study drugs involved in this study are: - Niraparib (Zejula) - Dostarlimab Type: Interventional Start Date: Dec 2020 |
Study of Nivolumab and Ipilimumab in Children and Young Adults With INI1-Negative Cancers
Dana-Farber Cancer Institute
Malignant Rhabdoid Tumor
Rhabdoid Tumor of the Kidney
Epithelioid Sarcoma
Chordoma (Poorly Differentiated or De-differentiated)
Atypical Teratoid/Rhabdoid Tumor
This clinical trial is studying two immunotherapy drugs (nivolumab and ipilimumab) given
together as a possible treatment for INI1-negative tumors. expand
This clinical trial is studying two immunotherapy drugs (nivolumab and ipilimumab) given together as a possible treatment for INI1-negative tumors. Type: Interventional Start Date: Aug 2020 |
YES Study - Newly Diagnosed/Metastatic Intervention
Dana-Farber Cancer Institute
Breast Cancer
Symptom, Behavioral
This research study is being done to monitor common symptoms and behavior, and to provide
supportive care information and peer support, as well as research opportunities for young
women ages of 18-39 years old who have been diagnosed with stage 0-IV stage breast cancer
using a web-based portal (YES),... expand
This research study is being done to monitor common symptoms and behavior, and to provide supportive care information and peer support, as well as research opportunities for young women ages of 18-39 years old who have been diagnosed with stage 0-IV stage breast cancer using a web-based portal (YES), built for smartphones, tablets, and computers. Type: Interventional Start Date: Sep 2020 |
Medtronic Terminate AF Study
Medtronic Cardiac Surgery
Persistent Atrial Fibrillation
Longstanding Persistent Atrial Fibrillation
The purpose of this study is to demonstrate the safety and effectiveness of the
Cardioblate iRF and CryoFlex hand held devices for the treatment of non-paroxysmal AF. expand
The purpose of this study is to demonstrate the safety and effectiveness of the Cardioblate iRF and CryoFlex hand held devices for the treatment of non-paroxysmal AF. Type: Interventional Start Date: Nov 2018 |
Long-term Safety and Efficacy Extension Study for Participants With Advanced Tumors Who Are Currently...
Merck Sharp & Dohme LLC
Solid Tumors
Hematologic Malignancies
The purpose of this study is to evaluate the long-term safety and efficacy of
pembrolizumab (MK-3475) in participants from previous Merck pembrolizumab-based parent
studies who transition into this extension study.
This study will consist of three phases: 1) First Course Phase, 2) Survival Follow-up
Phase... expand
The purpose of this study is to evaluate the long-term safety and efficacy of pembrolizumab (MK-3475) in participants from previous Merck pembrolizumab-based parent studies who transition into this extension study. This study will consist of three phases: 1) First Course Phase, 2) Survival Follow-up Phase or 3) Second Course Phase. Each participant will transition to this extension study in one of the following three phases, depending on the study phase they were in at the completion of the parent study. Participants who were in the First Course Phase of study treatment with pembrolizumab or lenvatinib in their parent study will enter the First Course Phase of this study and complete up to 35 doses or more every 3 weeks (Q3W) or 17 doses or more every 6 weeks (Q6W) of study treatment with pembrolizumab or a pembrolizumab-based combination or lenvatinib according to arm assignment. Participants who were in the Follow-up Phase in the parent study (post-treatment or Survival Follow-up Phase) will enter the Survival Follow-up Phase of this study. Participants who were in the Second Course Phase in their parent study will enter Second Course Phase of this study and complete up to 17 doses Q3W or 8 doses Q6W of study treatment with pembrolizumab or a pembrolizumab-based combination according to arm assignment. Any participant originating from a parent trial where crossover to pembrolizumab was permitted upon disease progression may be eligible for 35 doses as Q3W or 17 doses Q6W of pembrolizumab (approximately 2 years), if they progress while on the control arm and pembrolizumab is approved for the indication in the country where the potential eligible crossover participant is being evaluated. Type: Interventional Start Date: Aug 2018 |
Safety, Tolerability, and Immunogenicity of mRNA-4157 Alone and in Combination in Participants With Solid...
ModernaTX, Inc.
Solid Tumors
The purpose of this study is to assess the safety, tolerability, and immunogenicity of
mRNA-4157 alone and in combination in participants with solid tumors. expand
The purpose of this study is to assess the safety, tolerability, and immunogenicity of mRNA-4157 alone and in combination in participants with solid tumors. Type: Interventional Start Date: Aug 2017 |
Selinexor and Backbone Treatments of Multiple Myeloma Patients
Karyopharm Therapeutics Inc
Multiple Myeloma
This study will independently assess the efficacy and safety of 11 combination therapies
in 12 arms, in dose-escalation/-evaluation and expansion phases, for the treatment of
patients with relapsed/refractory multiple myeloma (RRMM) and newly diagnosed multiple
myeloma (NDMM). The combinations to... expand
This study will independently assess the efficacy and safety of 11 combination therapies in 12 arms, in dose-escalation/-evaluation and expansion phases, for the treatment of patients with relapsed/refractory multiple myeloma (RRMM) and newly diagnosed multiple myeloma (NDMM). The combinations to be evaluated are: - Arm 1: Selinexor + dexamethasone + pomalidomide (SPd); enrollment complete - Arm 2: Selinexor + dexamethasone + bortezomib (SVd); enrollment complete - Arm 3: Selinexor + dexamethasone + lenalidomide (SRd) in RRMM; enrollment complete - Arm 4: Selinexor + dexamethasone + pomalidomide + bortezomib (SPVd); enrollment complete - Arm 5: Selinexor + dexamethasone + daratumumab (SDd); enrollment complete - Arm 6: Selinexor + dexamethasone + carfilzomib (SKd); enrollment complete - Arm 7: Selinexor + dexamethasone + lenalidomide (SRd) in NDMM; enrollment complete - Arm 8: Selinexor + dexamethasone + ixazomib (SNd); enrollment complete - Arm 9: Selinexor + dexamethasone + pomalidomide + elotuzumab (SPEd); enrollment complete - Arm 10: Selinexor + dexamethasone + belantamab mafodotin (SBd); enrollment complete - Arm 11: Selinexor + dexamethasone + pomalidomide + daratumumab (SDPd); enrollment complete - Arm 12: Selinexor + dexamethasone + mezigdomide (SMd); actively recruiting Selinexor pharmacokinetics: - PK Run-in (Days 1-14): Starting in protocol version 8.0, patients enrolled to any arm in the Dose Escalation Phase (i.e., Arm 4 [SPVd], Arm 6 [SKd], Arm 8 [SNd], Arm 9 [SPEd], Arm 10 [SBd], and Arm 11 [SDPd]) will also first be enrolled to a pharmacokinetics (PK) Run-in period until 9 patients have been enrolled to this period to evaluate the PK of selinexor before and after co-administration with a strong CYP3A4 inhibitor. This run-in period does not apply to Arm 12 (SMd). Type: Interventional Start Date: Oct 2015 |
A Phase II/III Trial of Nivolumab, Ipilimumab, and GM-CSF in Patients With Advanced Melanoma
National Cancer Institute (NCI)
Stage III Cutaneous Melanoma AJCC v7
Stage IV Cutaneous Melanoma AJCC v6 and v7
This phase II/III trial studies the side effects of nivolumab and ipilimumab when given
together with or without sargramostim and to see how well they work in treating patients
with stage III-IV melanoma that cannot be removed by surgery (unresectable) and that may
have spread from where it first... expand
This phase II/III trial studies the side effects of nivolumab and ipilimumab when given together with or without sargramostim and to see how well they work in treating patients with stage III-IV melanoma that cannot be removed by surgery (unresectable) and that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). Immunotherapy with monoclonal antibodies, such as ipilimumab and nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Colony-stimulating factors, such as sargramostim, may increase the production of white blood cells. It is not yet known whether nivolumab and ipilimumab are more effective with or without sargramostim in treating patients with melanoma. Type: Interventional Start Date: Nov 2015 |
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 |
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 |
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 |
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 |
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 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 |
Study to Evaluate Safety and Tolerability of CC-91633 (BMS-986397) in Participants With Relapsed or Refractory...
Celgene
Leukemia, Myeloid, Acute
Myelodysplastic Syndromes
Study CC-91633-AML-001 is a Phase 1, open-label, dose escalation and expansion,
first-in-human (FIH) clinical study of CC-91633 (BMS-986397) in participants with
relapsed or refractory acute myeloid leukemia (R/R AML) or in participants with relapsed
or refractory higher-risk myelodysplastic syndromes... expand
Study CC-91633-AML-001 is a Phase 1, open-label, dose escalation and expansion, first-in-human (FIH) clinical study of CC-91633 (BMS-986397) in participants with relapsed or refractory acute myeloid leukemia (R/R AML) or in participants with relapsed or refractory higher-risk myelodysplastic syndromes (R/R HR-MDS). The Dose Escalation part (Part A) of the study will enroll participants with R/R AML and R/R HR-MDS and will evaluate the safety and tolerability of escalating doses of CC-91633 (BMS-986397), administered orally, and determine the maximum tolerated dose (MTD) or preliminary recommended Phase 2 doses (RP2D) and schedule. Throughout the study, final decisions on dose escalation/de-escalation will be made by the safety review committee (SRC). Approximately 60 participants may be enrolled in Part A of the study. The expansion part (Part B) will confirm tolerability of the selected doses and schedules and evaluate whether efficacy is in a range that warrants further clinical development. Approximately 60 response-evaluable subjects per indication (R/R AML or R/R HR-MDS) may be enrolled. Parts A and B will consist of 3 periods: Screening, Treatment, and Follow-up. Type: Interventional Start Date: Dec 2021 |
Impella®-Supported PCI in High-Risk Patients with Complex Coronary Artery Disease and Reduced Left Ventricular...
Abiomed Inc.
Left Ventricular Dysfunction
Coronary Artery Disease
The purpose of this study is to assess if using the Impella® CP (or Impella® 2.5) device
during high-risk PCI in patients with reduced left-sided heart function will result in an
improvement in symptoms, heart function and health after a heart procedure compared to
the current standard of care. expand
The purpose of this study is to assess if using the Impella® CP (or Impella® 2.5) device during high-risk PCI in patients with reduced left-sided heart function will result in an improvement in symptoms, heart function and health after a heart procedure compared to the current standard of care. Type: Interventional Start Date: Apr 2021 |
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