Clinical trials in North Carolina

Minimal change disease (MCD), focal segmental glomerulosclerosis (FSGS), and Membranous nephropathy (MN), generate an enormous individual and societal financial burden, accounting for approximately 12% of prevalent end stage renal disease (ESRD) cases (2005) at an annual cost in the US of more than $3 billion. However, the clinical classification of these diseases is widely believed to be inadequate by the scientific community.

NCT01209000 · Official ClinicalTrials.gov record · University of Michigan

Continuation of the CARRA Registry as described in the protocol will support data collection on patients with pediatric-onset rheumatic diseases. The CARRA Registry will form the basis for future CARRA studies.

NCT02418442 · Official ClinicalTrials.gov record · Duke University

Background: Genes are the basic units of heredity. When genes are changed, certain cells don t work like they should.

NCT02771236 · Official ClinicalTrials.gov record · National Eye Institute (NEI)

This phase II trial studies how well osimertinib works in treating patients with non-small cell lung cancer with EGFR exon 20 insertion mutation that is stage IIIB-IV or has come back after a period of improvement (recurrent). Osimertinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

NCT03191149 · Official ClinicalTrials.gov record · National Cancer Institute (NCI)

This is an umbrella study evaluating the how well it works and safety of multiple treatment combinations in participants with metastatic or inoperable locally advanced breast cancer. The study will be performed in two stages.

NCT03424005 · Official ClinicalTrials.gov record · Hoffmann-La Roche

This is a prospective study for the long-term follow-up (LTFU) of safety and how well it works for all pediatric and adult participants exposed to Gene-modified (GM) T-cell therapy participating in a previous Celgene sponsored or Celgene alliance partner sponsored study. Participants who received at least one infusion of GM T cells will be asked to enroll in this LTFU protocol upon either premature discontinuation from, or completion of the prior parent treatment protocol.

NCT03435796 · Official ClinicalTrials.gov record · Celgene

This phase I study is designed to establish the safety, maximally tolerated dose (MTD) and recommended phase II dose (RP2D) of the ERK inhibitor ulixertinib (BVD-523) when combined with the CDK4/6 inhibitor palbociclib.

NCT03454035 · Official ClinicalTrials.gov record · UNC Lineberger Comprehensive Cancer Center

This study wants to measure the long-term safety and how well it works 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.

NCT03486873 · Official ClinicalTrials.gov record · Merck Sharp & Dohme LLC

This study will measure the long-term whether it is safe and how hard side effects are to live with of the Port Delivery System with ranibizumab (PDS) (100 mg/mL) in participants with neovascular age-related macular degeneration (nAMD) who have either completed Phase II Study GX28228 (Ladder), Phase III Study GR40548 (Archway), Phase IIIb Study WR42221 (Velodrome), or completed Week 24 visit in Study WR42221 but were not eligible to be randomly assigned in WR42221.

NCT03683251 · Official ClinicalTrials.gov record · Hoffmann-La Roche

This randomly assigned research trial studies how well serum tumor marker directed disease monitoring works in monitoring patients with hormone receptor positive Her2 negative breast cancer that has spread to other places in the body. Using markers to prompt when scans should be ordered may be as good as the usual approach to monitoring disease.

NCT03723928 · Official ClinicalTrials.gov record · SWOG Cancer Research Network

This phase II trial studies how well cabozantinib works in combination with nivolumab and ipilimumab in treating patients with rare genitourinary (GU) tumors that has spread from where it first started (primary site) to other places in the body. Cabozantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

NCT03866382 · Official ClinicalTrials.gov record · National Cancer Institute (NCI)

Main Objective of this study is to examine long-term safety of nivolumab this drug alone including combinations and other cancer therapies in various tumor types.

NCT03899155 · Official ClinicalTrials.gov record · Bristol-Myers Squibb

Glioblastoma (GBM) adaptive, global, innovative learning environment (GBM AGILE) is an international, seamless Phase II/III response adaptive randomization platform trial designed to evaluate multiple therapies in newly diagnosed (ND) and recurrent GBM. All institutions are enrolling Newly Diagnosed participants.

NCT03970447 · Official ClinicalTrials.gov record · Global Coalition for Adaptive Research

This study will examine the association between low muscle mass (myopenia) at diagnosis and chemotherapy toxicity in older adults with newly diagnosed advanced colorectal cancer.

NCT03998202 · Official ClinicalTrials.gov record · Wake Forest University Health Sciences

This is a multi-center prospective rater-masked (blinded) randomly assigned controlled trial of 156 participants, comparing the treatment strategy of Autologous Hematopoietic Stem Cell Transplantation (AHSCT) to the treatment strategy of Best Available Therapy (BAT) for treatment-resistant relapsing multiple sclerosis (MS). you would be randomly assigned at a 1 to 1 (1:1) ratio.

NCT04047628 · Official ClinicalTrials.gov record · National Institute of Allergy and Infectious Diseases (NIAID)

This phase III trial compares the effect of bevacizumab and osimertinib combination vs. osimertinib alone for the treatment of non-small cell lung cancer that has spread outside of the lungs (stage IIIB-IV) and has a change (mutation) in a gene called EGFR.

NCT04181060 · Official ClinicalTrials.gov record · National Cancer Institute (NCI)

This clinical trial evaluates how well two surgical procedures (bilateral salpingectomy and bilateral salpingo-oophorectomy) work in reducing the risk of ovarian cancer for individuals with BRCA1 mutations. Bilateral salpingectomy involves the surgical removal of fallopian tubes, and bilateral salpingo-oophorectomy involves the surgical removal of both the fallopian tubes and ovaries.

NCT04251052 · Official ClinicalTrials.gov record · NRG Oncology

This phase III ALCHEMIST treatment trial tests the addition of pembrolizumab to usual chemotherapy for the treatment of stage IIA, IIB, IIIA or IIIB non-small cell lung cancer that has been removed by surgery. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.

NCT04267848 · Official ClinicalTrials.gov record · National Cancer Institute (NCI)

The study investigators are interested in learning more about how drugs, that are given to children by their health care provider, act in the bodies of children and young adults in hopes to find the most safe and effective dose for children. The primary objective of this study is to measure the PK of understudied drugs currently being administered to children per SOC as prescribed by their treating provider.

NCT04278404 · Official ClinicalTrials.gov record · Duke University

ARTFL LEFFTDS Longitudinal Frontotemporal Lobar Degeneration (ALLFTD) represents the formalized integration of ARTFL (U54 NS092089; funded through 2019) and LEFFTDS (U01 AG045390; funded through 2019) as a single North American research consortium to study FTLD for 2019 and beyond.

NCT04363684 · Official ClinicalTrials.gov record · Mayo Clinic

This is a multicenter, Phase 3, randomly assigned, neither you nor the study doctors know who gets the real treatment, compared with a dummy treatment study designed to measure the how well it works and safety of clemizole hydrochloride (EPX-100) as added on top of your current treatment therapy in children and adult participants with Dravet syndrome (DS).

NCT04462770 · Official ClinicalTrials.gov record · Epygenix

This is a Phase 1b open-label, multicenter study, evaluating the safety, tolerability, preliminary clinical activity, pharmacokinetics (PK), and pharmacodynamics of azenosertib (ZN-c3) in combination with other drugs.

NCT04516447 · Official ClinicalTrials.gov record · K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc

NEPTUNE Match is an additional opportunity offered to NEPTUNE study participants to prospectively recruit and communicate patient-specific clinical trial matching with kidney patients and their physician investigators.

NCT04571658 · Official ClinicalTrials.gov record · University of Michigan

This phase I/II trial studies the effects of trastuzumab deruxtecan (DS-8201a) in treating patients with osteosarcoma, Wilms tumor (WT) or desmoplastic small round cell tumor (DSRCT) that is newly diagnosed or has come back after a period of improvement (recurrent) or that has not responded to previous treatment (refractory). Trastuzumab deruxtecan is in a class of medications called antibody-drug conjugates.

NCT04616560 · Official ClinicalTrials.gov record · National Cancer Institute (NCI)

This phase II/III trial compares the effect of adding durvalumab to chemotherapy versus chemotherapy alone before surgery in treating patients with upper urinary tract cancer. Immunotherapy with monoclonal antibodies, such as durvalumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.

NCT04628767 · Official ClinicalTrials.gov record · National Cancer Institute (NCI)

This study wants to test the safety and how well it works of BHV-3000 versus dummy treatment (placebo) in the acute treatment of moderate or severe migraine in children and adolescents.

NCT04649242 · Official ClinicalTrials.gov record · Pfizer

This study wants to test the long-term safety of rimegepant in the acute treatment of migraine in children and adolescents (≥ 6 to \< 18 years of age).

NCT04743141 · Official ClinicalTrials.gov record · Pfizer

This study will measure the how well it works and safety of SPN-812 (viloxazine extended release) in children 4 to 5 years of age with ADHD.

NCT04781140 · Official ClinicalTrials.gov record · Supernus Pharmaceuticals, Inc.

This is a Phase Ib/II, open-label, multicenter, randomly assigned umbrella study in participants with breast cancer. The study is designed with the flexibility to open new treatment arms as new treatments become available, close existing treatment arms that demonstrate minimal clinical activity or unacceptable toxicity, or modify the patient population.

NCT04802759 · Official ClinicalTrials.gov record · Hoffmann-La Roche

A prospective, multicenter, single arm, treatment study. The target patient population for this study are adult subjects with WNBAs of the anterior and posterior intracranial circulation.

NCT04839705 · Official ClinicalTrials.gov record · Microvention-Terumo, Inc.

The objective of this registry is to compare outcomes of risankizumab-exposed pregnancies with those of pregnancies that were not exposed to risankizumab among women with plaque psoriasis, psoriatic arthritis (PsA), Crohn's disease (CD), or other conditions for which risankizumab is an FDA-approved treatment. The registry is designed to estimate the association between risankizumab and maternal, fetal, and infant outcomes by comparing the prevalence rates of these outcomes in the exposed and unexposed populations.

NCT04846959 · Official ClinicalTrials.gov record · AbbVie

This phase II trial investigates how well the addition of olaparib following completion of surgery and chemotherapy works in treating patients with pancreatic cancer that has been surgically removed (resected) and has a pathogenic mutation in BRCA1, BRCA2, or PALB2. Olaparib is an inhibitor of PARP, an enzyme that helps repair deoxyribonucleic acid (DNA) when it becomes damaged.

NCT04858334 · Official ClinicalTrials.gov record · National Cancer Institute (NCI)

This study examines how certain risk factors (such as age, gender, other medical conditions, and the type of immunotherapy used to treat the cancer) affect whether a patient with a malignant solid tumor will develop mild or serious side effects from the immunotherapy medications. Immunotherapy is the type of treatment that helps the body's immune system fight cancer.

NCT04871542 · Official ClinicalTrials.gov record · SWOG Cancer Research Network

This open-label, exploratory study is designed to measure the safety and how well it works of targeted therapies or immunotherapy as single agents or combinations, in participants with metastatic colorectal cancer (mCRC) whose tumors are biomarker positive as per treatment arm-specific definition. Eligible participants with mCRC will be enrolled into specific treatment arms based on their biomarker assay results.

NCT04929223 · Official ClinicalTrials.gov record · Hoffmann-La Roche

To find out if eptinezumab is better than dummy treatment (placebo) (normal saline solution) in lowering the number of days with migraine in young people ages 12 to 17 with chronic migraine.

NCT04965675 · Official ClinicalTrials.gov record · H. Lundbeck A/S

The purpose of the study is to evaluate fetal, maternal, and infant outcomes through 12 months of age.

NCT05046613 · Official ClinicalTrials.gov record · Pfizer

This phase II/III trial compares the effect of immunotherapy with atezolizumab in combination with standard chemotherapy with a platinum drug (cisplatin or carboplatin) and etoposide versus standard therapy alone for the treatment of poorly differentiated extrapulmonary (originated outside the lung) neuroendocrine cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) or that has spread from where it first started (primary site) to other places in the body (metastatic). The other aim of this trial is to compare using atezolizumab just at the beginning of treatment versus continuing it beyond the initial treatment.

NCT05058651 · Official ClinicalTrials.gov record · National Cancer Institute (NCI)

This study wants to determine the safety and feasibility of administering the Tetanus Diptheria Vaccine (Td) or Polio Boost Immunization (IPOL) to patients with metastatic melanoma who are receiving immune checkpoint inhibitor (IO) therapy per standard of care. Subjects will have the vaccine at cycle 4 of IO therapy and will have research blood and tissue samples collected prior to starting IO therapy, at cycle 4 prior to vaccine administration, and at 12-17 days post vaccine.

NCT05077137 · Official ClinicalTrials.gov record · Duke University

This phase II trial tests whether the combination of nivolumab and ipilimumab is better than nivolumab alone to shrink tumors in patients with deficient mismatch repair system (dMMR) endometrial carcinoma that has come back after a period of time during which the cancer could not be detected (recurrent). Deoxyribonucleic acid (DNA) mismatch repair (MMR) is a system for recognizing and repairing damaged DNA.

NCT05112601 · Official ClinicalTrials.gov record · National Cancer Institute (NCI)

Anxiety disorders such as post-traumatic stress disorder (PTSD) and generalized anxiety disorder (GAD) affect a large number of individuals with a significant portion of patients failing to improve with current treatments. this study wants to understand the brain mechanisms that produce fear and anxiety in humans.

NCT05120635 · Official ClinicalTrials.gov record · Duke University