Search Clinical Trials
Sponsor Condition of Interest |
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Biomarker Profiling in Individuals at Risk for Prion Disease
Massachusetts General Hospital
CJD (Creutzfeldt Jakob Disease)
Prion Diseases
GSS
FFI
Familial Fatal Insomnia
We are doing this research to identify biomarkers in individuals who are at-risk for
familial prion disease. We hope to use these biomarkers to predict timing of disease
onset in pre-symptomatic individuals and to guide the direction of future clinical
trials. expand
We are doing this research to identify biomarkers in individuals who are at-risk for familial prion disease. We hope to use these biomarkers to predict timing of disease onset in pre-symptomatic individuals and to guide the direction of future clinical trials. Type: Observational [Patient Registry] Start Date: Dec 2017 |
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 |
Effects of Auditory Stimulation on Sleep and Memory in Schizophrenia
Massachusetts General Hospital
Schizophrenia
The investigators will test the hypothesis that auditory stimulation (playing quiet
sounds during sleep) can normalize brain activity during sleep and improve memory in
patients with schizophrenia. The investigators will do this by measuring sleep and memory
performance under two conditions separated... expand
The investigators will test the hypothesis that auditory stimulation (playing quiet sounds during sleep) can normalize brain activity during sleep and improve memory in patients with schizophrenia. The investigators will do this by measuring sleep and memory performance under two conditions separated by one week: receiving auditory stimulation during sleep and not receiving auditory stimulation during sleep. The investigators will study healthy subjects and outpatients with schizophrenia. Type: Interventional Start Date: Apr 2020 |
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 |
A Study of Lazertinib as Monotherapy or in Combination With Amivantamab in Participants With Advanced...
Janssen Research & Development, LLC
Carcinoma, Non-Small-Cell Lung
The purpose of this study is to confirm the tolerability of recommended Phase 2 dose
(RP2D) of Lazertinib (Phase 1), to determine the tolerability and identify the
recommended Phase 2 combination dose of Lazertinib when combined with Amivantamab
(JNJ-61186372) (Phase 1b), to characterize the safety... expand
The purpose of this study is to confirm the tolerability of recommended Phase 2 dose (RP2D) of Lazertinib (Phase 1), to determine the tolerability and identify the recommended Phase 2 combination dose of Lazertinib when combined with Amivantamab (JNJ-61186372) (Phase 1b), to characterize the safety and tolerability of Lazertinib and Amivantamab combinations at the RP2CD in participants with advanced non-small cell lung cancer (NSCLC) with documented advanced or metastatic epidermal growth factor receptor (EGFR) mutation (Phase 1b expansion cohorts A, B, C, D and E), to estimate the antitumor activity of Lazertinib and Amivantamab combinations at the RP2CD in participants with advanced NSCLC with documented advanced or metastatic EGFR mutation (Phase 1b expansion cohorts A, B, C, and D), to validate the biomarker identified in Phase 1b expansion Cohort D as a predictor of antitumor activity of Lazertinib and Amivantamab combination (Cohort E) or Amivantamab monotherapy (Cohort F) in participants with osimertinib-relapsed, chemotherapy-naïve, EGFR Exon19del or L858R mutated NSCLC, to identify the recommended Phase 2 dose (RP2ChD) of Lazertinib when combined with Amivantamab and standard of care chemotherapy and to determine the tolerability of the Lazertinib, Amivantamab, and platinum-doublet chemotherapy (LACP) combination (Phase 1b LACP combination cohort) and to characterize the safety and tolerability of Lazertinib at the RP2ChD and Amivantamab and standard of care chemotherapy in participants with advanced or metastatic EGFR-mutated NSCLC (Phase 1b LACP combination cohort), to assess 2 potential biomarker strategies to identify participants at increased, or decreased, probability of tumor response with JNJ-61186372 and lazertinib combination in participants with EGFR Exon19del or L858R mutated NSCLC progressed on or after osimertinib (Phase 1b expansion Cohort D). Type: Interventional Start Date: Sep 2019 |
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 |
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 |
Biliary Atresia Research Network Northeast
Yale University
Biliary Atresia
This is a multi-center retrospective chart review to compile a data repository of the
management and outcomes of children with biliary atresia. Overall, investigators aim to
evaluate which specific factors contribute to improved patient outcomes, to help guide
potential improvements in patient care... expand
This is a multi-center retrospective chart review to compile a data repository of the management and outcomes of children with biliary atresia. Overall, investigators aim to evaluate which specific factors contribute to improved patient outcomes, to help guide potential improvements in patient care and resource utilization. Type: Observational Start Date: May 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 |
RAPA-501 Therapy for ALS Expanded Access Protocol
Rapa Therapeutics LLC
Amyotrophic Lateral Sclerosis
RAPA-501-ALS is an Intermediate-Size Expanded Access Trial of RAPA-501 autologous hybrid
TREG/Th2 cells in patients living with amyotrophic lateral sclerosis (pwALS). expand
RAPA-501-ALS is an Intermediate-Size Expanded Access Trial of RAPA-501 autologous hybrid TREG/Th2 cells in patients living with amyotrophic lateral sclerosis (pwALS). Type: Interventional Start Date: Mar 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 |
First-in-Human Study of STX-478 as Monotherapy and in Combination With Other Antineoplastic Agents in...
Scorpion Therapeutics, Inc.
Breast Cancer
Gynecologic Cancer
HNSCC
Solid Tumors, Adult
Study STX-478-101 is a multipart, open-label, phase 1/2 study evaluating the safety,
tolerability, pharmacokinetics (PK), and preliminary antitumor activity of STX-478 in
participants with advanced solid tumors with P13Ka mutations.
Part 1 will evaluate STX-478 as monotherapy in participants with... expand
Study STX-478-101 is a multipart, open-label, phase 1/2 study evaluating the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of STX-478 in participants with advanced solid tumors with P13Ka mutations. Part 1 will evaluate STX-478 as monotherapy in participants with advanced solid tumors. Part 2 will evaluate STX-478 therapy as combination therapy with fulvestrant in participants with hormone receptor positive (HR+) breast cancer. Part 3 will evaluate STX-478 as combination therapy with fulvestrant and a CDK4/6 Inhibitor (either Ribociclib or Palbociclib) in participants with HR+ breast cancer. Each study part will include a 28-day screening period, followed by treatment with STX-478 monotherapy or combination therapy. Type: Interventional Start Date: Apr 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 |
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 |
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 |
TACTIVE-U: A Study to Learn About the Study Medicine (Vepdegestrant) When Given With Other Medicines...
Pfizer
Breast Cancer
The purpose of this clinical trial is to learn about the safety and effects of the study
medicine (called ARV-471) when given together with other medicines for the potential
treatment of advanced or metastatic breast cancer.
This study is seeking participants who have breast cancer that:
-... expand
The purpose of this clinical trial is to learn about the safety and effects of the study medicine (called ARV-471) when given together with other medicines for the potential treatment of advanced or metastatic breast cancer. This study is seeking participants who have breast cancer that: - is advanced, may have spread to other organs (metastatic) and cannot be fully treated by surgery or radiation therapy - is sensitive to hormonal therapy (it is called estrogen receptor positive); and - is no longer responding to previous treatments This study is divided into separate sub-studies. For Sub-Study A: All participants will receive ARV-471 and a medicine called abemaciclib. ARV-471 will be given by mouth, at home, 1 time a day. Abemaciclib will be given by mouth, at home, 2 times a day. We will examine the experiences of people receiving the study medicines. This will help us determine if the study medicines are safe and effective. Participants will continue to take ARV-471 and abemaciclib until their cancer is no longer responding, or side effects become too severe. They will have visits at the study clinic about every 4 weeks. Type: Interventional Start Date: Feb 2023 |
Study of Efficacy, Safety and Tolerability of Remibrutinib in Adult Participants With an Allergy to Peanuts
Novartis Pharmaceuticals
Allergy, Peanut
A study to evaluate the safety, efficacy and tolerability of remibrutinib at three doses
versus placebo in adult participants who have a confirmed allergy to peanuts. The
efficacy will be measured by the ability of participants to tolerate increasing doses of
peanut protein during an oral food challenge... expand
A study to evaluate the safety, efficacy and tolerability of remibrutinib at three doses versus placebo in adult participants who have a confirmed allergy to peanuts. The efficacy will be measured by the ability of participants to tolerate increasing doses of peanut protein during an oral food challenge after 1 month of study treatment. Type: Interventional Start Date: Oct 2022 |
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 |
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