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Monitoring Adverse Gastrointestintal Events In Cow’s Milk Immunotherapy Using the Esophageal STRING Test (MAGIC-STRING)
Scottsdale/Phoenix, AZ
The primary objective of this study is to evaluate markers of eosinophilic inflammation in the esophagus longitudinally in subjects on milk oral immunotherapy (OIT) or placebo.
This is a companion study to a parent clinical trial which is a phase 2, multicenter, randomized, double-blind, parallel group, 2 arm study in subjects aged 4 to 50 years inclusive who are allergic to milk. The parent study consists of a screening period, a 24-week treatment period, which includes 4 weeks of pre-treatment with dupilumab or placebo followed by 12 weeks of treatment with dupilumab or placebo in combination with a gradual up-dosing of milk protein ...
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Immunotherapeutic Strategy to Treat Recurrent Respiratory Papillomatosis
Scottsdale/Phoenix, AZ
The purpose of this study is to develop a novel immunotherapeutic strategy to treat Recurrent Respiratory Papillomatosis (RRP) patients and cure the disease.
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A Study to Evaluate Interferon-gamma in Antifungal Immunity
Rochester, MN
The purpose of this study is to evaluate the role of interferon-gamma (IFN-γ) in antifungal defense and its potential use in adjunctive immunotherapy. Solid organ transplant (SOT) and hematopoietic stem cell transplant (HSCT) recipients are at increased risk for invasive fungal infections. Mortality rates remain unacceptably high despite antifungal treatment. Novel therapeutic modalities are urgently needed. In this project, we propose to study the role of interferon-gamma (IFN-gamma) in antifungal defense and its potential use in adjunctive immunotherapy.
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Reporting Of Side Effects Among Stage III And IV Melanoma Patients Treated With Immune Checkpoint Inhibitors
Rochester, MN
This study seeks to understand the treatment experiences and side effect reporting behavior of Stage III and IV melanoma patients who have undergone immunotherapy.
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Impact Of Immunotherapy On Vestibular Function, The Mayo Clinic Arizona Experience
Scottsdale/Phoenix, AZ
This study evaluates the impact of immunotherapy on balance in patients receiving immunotherapy as part of their standard of care.
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Immune Monitoring And Immunotherapy In Myeloma
Rochester, MN
Characterize and identify the immune phenotype of patients with multiple myeloma by flow cytometry of peripheral blood circulating and bone marrow immune cells and by testing the immunogenticity of these cells in vitro. Samples will be collected from patients longitudinally at baseline and post treatments to examine the effect of treatments on host immunity. The treatments include IMiDs, proteosome inhibitors, chemotherapy, monoclonal antibodies and stem cell transplantation.To c
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A Study to Evaluate the Efficacy and Safety of CLBS16 in Subjects with Coronary Microvascular Dysfunction and Without Obstructive Coronary Artery Disease
Rochester, MN
The purpose of this study is to evaluate the effectiveness and safety of intracoronary delivery of autologous CD34+ cells (CLBS16) in subjects with coronary microvascular dysfunction (CMD) and without obstructive coronary artery disease
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A Study to Evaluate the Safety and Effectiveness of Dupilumab and Milk Oral Immunotherapy to Treat Patients with Cow's Milk Allergy
Scottsdale/Phoenix, AZ
The purpose of this study is to assess whether dupilumab as an adjunct to milk oral immunotherapy (OIT) compared to placebo improves desensitization and safety, defined as an increase in the proportion of subjects who pass a double-blind placebocontrolled food challenge (DBPCFC) to at least 2040 mg cumulative milk protein at week 18.
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A Study To Investigate The Safety And Preliminary Efficacy Of ALLO-329, An Allogeneic CAR T-cell Therapy, In Adults With Autoimmune Disease
Scottsdale/Phoenix, AZ; Jacksonville, FL
This is a first-in-human, single-arm, open-label study evaluating the safety, tolerability, and preliminary efficacy of ALLO-329 in adults with autoimmune diseases: systemic lupus erythematosus (SLE) with and without renal involvement, idiopathic inflammatory myopathy (IIM), and systemic sclerosis (SSc).The purpose of this trial is to evaluate the safety and tolerability of ALLO-329, an allogeneic anti-CD19, anti-CD70 dual chimeric antigen receptor (CAR) T cell therapy, in adults with autoimmune disorders, provide initial evidence of biological activity and clinical response to the treatment and determine the recommended Phase 2 regimen (RP2R).
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Testing The Addition Of An Immunotherapy Drug, Cemiplimab (REGN2810), Plus Surgery To The Usual Surgery Alone For Treating Advanced Skin Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This phase III trial compares the effect of adding cemiplimab to standard therapy (surgery with or without radiation) versus standard therapy alone in treating patients with stage III/IV squamous cell skin cancer that is able to be removed by surgery (resectable) and that may have come back after a period of improvement (recurrent). The usual treatment for patients with resectable squamous cell skin cancer is the removal of the cancerous tissue (surgery) with or without radiation, which uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. Immunotherapy with monoclonal antibodies, such as cemiplimab, may ...
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A Study to Assess Epicardial Delivery of XC001 Gene Therapy for Refractory Angina Coronary Treatment (The EXACT Trial)
Scottsdale/Phoenix, AZ
The primary purpose of this trial is to determine the safety of XC001 (AdVEGFXC1) in patients who suffer from angina caused by coronary artery disease and have no other treatment options. Subjects in this study will receive one of four intramyocardial doses of XC001 that expresses human vascular endothelial growth factor (VEGF) which induces therapeutic angiogenesis (revascularization).
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hTERT Immunotherapy Alone or in Combination With IL-12 DNA Followed by Electroporation in Adults With Solid Tumors at High Risk of Relapse
Rochester, MN; Scottsdale/Phoenix, AZ
This is a Phase I, open label study to evaluate the safety, tolerability, and immunogenicity of INO-1400 alone or in combination with INO-9012, delivered by electroporation in subjects with high-risk solid tumor cancer with no evidence of disease after surgery and standard therapy. Subjects will be enrolled into one of six treatment arms. Subjects will be assessed according to standard of care. Restaging and imaging studies will be performed to assess disease relapse per NCCN guidelines. RECIST will be used to validate the findings in cases of relapse.
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A Study Of STX-0712 In Patients With Advanced Hematologic Malignancies
Rochester, MN
The purpose of this study is to evaluate the safety and preliminary efficacy of STX-0712 in patients with advanced hematologic malignancies CMML and AML for whom there are no further treatment options known to confer clinical benefit.
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A Study Of V940 Plus Pembrolizumab (MK-3475) Versus Placebo Plus Pembrolizumab In Participants With Non-small Cell Lung Cancer (V940-002)
Jacksonville, FL
The goal of this study is to evaluate V940 plus pembrolizumab versus placebo plus pembrolizumab for the adjuvant treatment of margin negative, completely resected Stage II, IIIA, IIIB (with nodal involvement \[N2\]) non-small cell lung cancer (NSCLC). The primary hypothesis is that V940 plus pembrolizumab is superior to placebo plus pembrolizumab with respect to disease-free survival (DFS) as assessed by the investigator.
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A Study of Donor-Alloantigen-Reactive Regulatory T Cell Therapy with an Immunosuppression Regimen in Adult Liver Transplantation
Rochester, MN
The purpose of this study is to assess the safety, tolerability, and dose limiting toxicities of taking a specific combination of immunosuppressant drugs on infused donor-alloantigen-reactive regulatory T cells after liver transplantation, to improve immune function without liver rejection.
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Therapeutic Plasma Exchange With Enfortumab Vedotin And Pembrolizumab For Treatment Of Bladder Cancers
Rochester, MN
This phase II trial compares therapeutic plasma exchange followed by enfortumab vedotin and pembrolizumab to standard of care next-line therapy for the treatment of patients with bladder or upper urinary tract cancers that have spread from where they first started (primary site) to other places in the body (metastatic) and that have not responded to previous treatment (refractory). TPE is a process that slowly removes a patient's blood through an intravenous or central line. The blood is sent through a machine that separates the plasma (the liquid part of blood) from other blood components (red cells, white cells, platelets). The ...
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Study of Pembrolizumab (MK-3475) in Participants With Progressive Locally Advanced or Metastatic Carcinoma, Melanoma, or Non-small Cell Lung Carcinoma (P07990/MK-3475-001/KEYNOTE-001)
Scottsdale/Phoenix, AZ; Rochester, MN
This study will be done in 6 parts. In Part A the dose of intravenous (IV) pembrolizumab (MK-3475) will be escalated to find the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) for participants with a histologically or cytologically confirmed diagnosis of any type of carcinoma or melanoma (MEL). Part B of the study will explore the safety, tolerability, and efficacy of the drug in participants with advanced or metastatic MEL and compare every 2 week to every 3 week dosing. Part C of the study will explore the safety, tolerability, and efficacy of the drug in participants ...
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Phase 3 Trial of Autologous Dendritic Cell Immunotherapy (AGS-003) Plus Standard Treatment of Advanced Renal Cell Carcinoma (RCC)
Scottsdale/Phoenix, AZ
This is a trial of AGS-003, which is being studied as a possible treatment for Advanced Renal Cell Carcinoma. The purpose of this study is to determine whether there is an overall survival (OS) benefit between subjects treated with AGS-003 in combination with standard treatment versus subjects treated with standard treatment alone.
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A Two-part Phase IIb Trial of Vigil in Ewing's Sarcoma
Jacksonville, FL
The purpose of this study is to determine the overall survival of patients treated with Vigil versus gemcitabine/docetaxel.
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A Study Evaluating the Safety and Efficacy of KITE-585 in Subjects With Relapsed/Refractory Multiple Myeloma
Rochester, MN
To evaluate the safety and tolerability of KITE-585, an autologous engineered CAR T-cell product targeting a protein commonly found on myeloma cells called BCMA. Patients will be given a 3 day course of chemotherapy followed by a single infusion of KITE-585.
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Testing The Role Of DNA Released From Tumor Cells Into The Blood In Guiding The Use Of Immunotherapy After Surgical Removal Of The Bladder, Kidney, Ureter, And Urethra For Urothelial Cancer Treatment, MODERN Study
Scottsdale/Phoenix, AZ; Jacksonville, FL
This phase II/III trial examines whether patients who have undergone surgical removal of bladder, kidney, ureter or urethra, but require an additional treatment called immunotherapy to help prevent their urinary tract (urothelial) cancer from coming back, can be identified by a blood test. Many types of tumors tend to lose cells or release different types of cellular products including their DNA which is referred to as circulating tumor DNA (ctDNA) into the bloodstream before changes can be seen on scans. Health care providers can measure the level of ctDNA in blood or other bodily fluids to determine which patients are ...
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Study of BN Brachyury and Radiation in Advanced Chordoma Patients
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to determine if the combination of BN-Brachyury plus radiation therapy can induce objective radiographic response rate (ORR) in patients, using a Simon 2-stage optimal design. In stage 1, a minimum of threshold of activity will be needed to proceed to stage 2.
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EF-41/KEYNOTE D58: Phase 3 Study Of Optune Concomitant With Temozolomide Plus Pembrolizumab In Newly Diagnosed Glioblastoma
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This is a multicenter, two-arm, randomized, double-blind, placebo-controlled study of Optune® (Tumor Treating Fields at 200 kHz) together with maintenance Temozolomide (TMZ) chemotherapy agent and pembrolizumab compared to Optune® together with maintenance TMZ and placebo in newly diagnosed Glioblastoma (GBM) patients. The primary objective of the study is to evaluate the Overall Survival (OS).
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Cellular Immunotherapy in Recipients of HLA-matched, Living Donor Kidney Transplants
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The primary objective of this study is to demonstrate the safety and efficacy of cellular immunotherapy with MDR-101 for induction of functional immune tolerance in recipients of human leukocyte antigen (HLA)-matched, living donor kidney transplants.