Clinical trials in Kentucky

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

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 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

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 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 is a Phase 1/2, open-label, non-randomly assigned, 4-part trial to determine the safety profile and identify the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of INBRX 106 administered as a single agent or in combination with the anti-PD-1 checkpoint inhibitor (CPI) pembrolizumab (Keytruda®). KEYTRUDA is a registered trademark of Merck Sharp \& Dohme LLC, a subsidiary of Merck \& Co., Inc., Rahway, NJ, USA.

NCT04198766 · Official ClinicalTrials.gov record · Inhibrx Biosciences, Inc

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

The program consists of four interconnected components: (1) app, (2) accelerometer, (3) health coaching, and (4) behavioral incentives to increase food and vegetable intake, reduce saturated fat intake, increase physical activity, and decrease sedentary screen time among adults Appalachia Kentuckians.

NCT04309461 · Official ClinicalTrials.gov record · Nancy Schoenberg

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

The purpose of this randomly assigned study is to determine the safety and how well it works of quaratusugene ozeplasmid (Reqorsa) added to osimertinib in NSCLC patients with activating EGFR mutations who have progressed while on treatment with osimertinib. Quaratusugene ozeplasmid consists of non-viral lipid nanoparticles that encapsulate a DNA plasmid with the TUSC2 tumor suppressor gene and is the first systemic gene therapy for cancer.

NCT04486833 · Official ClinicalTrials.gov record · Genprex, Inc.

This is an open-label, multi center study to evaluate safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of PF-07248144 and early signs of clinical how well it works of PF-07248144 as a single agent and in combination with other agents

NCT04606446 · Official ClinicalTrials.gov record · Pfizer

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.

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.

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

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

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)

The main goal of the study is to assess the long-term safety of eptinezumab on children and adolescents ages 6 to 17 with chronic or episodic migraine.

NCT05164172 · Official ClinicalTrials.gov record · H. Lundbeck A/S

The primary objective is to measure the how well it works of carisbamate (YKP509) as added on top of your current treatment treatment in reducing the number of drop seizures (tonic, atonic, and tonic-clonic) compared with dummy treatment (placebo) in pediatric and adult subjects (age 4-55 years) diagnosed with Lennox Gastaut Syndrome (LGS).

NCT05219617 · Official ClinicalTrials.gov record · SK Life Science, Inc.

The main objective of the study is to assess how well it works and safety of dupilumab given up to 24 weeks in adults with CPUO. This is a master protocol which includes 2 parallel-treatment, neither you nor the study doctors know who gets the real treatment, 2- arm Phase 3 staggered studies of similar design (Study A and Study B) in male and female participants aged 18 to 90 years with CPUO.

NCT05263206 · Official ClinicalTrials.gov record · Sanofi

This study collects blood and tissue samples from patients with cancer and without cancer to evaluate tests for early cancer detection. Collecting and storing samples of blood and tissue from patients with and without cancer to study in the laboratory may help researchers develop tests for the early detection of cancers.

NCT05334069 · Official ClinicalTrials.gov record · Alliance for Clinical Trials in Oncology

This is an watch-and-measure (no experimental treatment required) case-control study to train and validate a genome-wide methylome enrichment platform to detect multiple cancer types and to differentiate amongst cancer types. The cancers included in this study are brain, breast, bladder, cervical, colorectal, endometrial, esophageal, gastric, head and neck, hepatobiliary, leukemia, lung, lymphoma, multiple myeloma, ovarian, pancreatic, prostate, renal, sarcoma, and thyroid.

NCT05366881 · Official ClinicalTrials.gov record · Adela, Inc

This phase II trial compares the effect of usual treatment of docetaxel chemotherapy plus trastuzumab, to ado-emtansine (T-DM1) in patients with HER2-positive salivary gland cancer that has come back (recurrent), that has spread from where it first started (primary site) to other places in the body, or cannot be removed by surgery (unresectable). This trial is also testing how well trastuzumab deruxtecan works in treating patients with HER2-low recurrent or metastatic salivary gland cancer.

NCT05408845 · Official ClinicalTrials.gov record · NRG Oncology

This phase I/II trial tests the safety, side effects and best dose of selinexor given in combination with the usual chemotherapy (temozolomide) and compares the effect of this combination therapy versus the usual chemotherapy alone (temozolomide) in treating patients with glioblastoma that has come back (recurrent). Selinexor is in a class of medications called selective inhibitors of nuclear export (SINE).

NCT05432804 · Official ClinicalTrials.gov record · National Cancer Institute (NCI)

This study wants to measure the whether it is safe and how hard side effects are to live with of: * casdatifan when taken alone in participants with advanced solid tumor malignancies and clear cell renal cell carcinoma (ccRCC) during the dose escalation stage; and * casdatifan this drug alone and casdatifan in combination with cabozantinib or zimberelimab or zimberelimab and ipilimumab in participants with ccRCC in the dose expansion stage.

NCT05536141 · Official ClinicalTrials.gov record · Arcus Biosciences, Inc.

This phase II MyeloMATCH treatment trial tests whether the standard approach of cytarabine and daunorubicin in comparison to the following experimental regimens works to shrink cancer in patients with high risk acute myeloid leukemia (AML): 1) daunorubicin and cytarabine liposome alone; 2) cytarabine and daunorubicin with venetoclax; 3) azacitidine and venetoclax; 4) daunorubicin and cytarabine liposome and venetoclax. "High-risk" refers to traits that have been known to make the AML harder to treat.

NCT05554406 · Official ClinicalTrials.gov record · National Cancer Institute (NCI)

This ComboMATCH patient screening trial is the gateway to a coordinated set of clinical trials to study cancer treatment directed by genetic testing. Patients with solid tumors that have spread to nearby tissue or lymph nodes (locally advanced) or have spread to other places in the body (advanced) and have progressed on at least one line of standard systemic therapy or have no standard treatment that has been shown to prolong overall survival may be candidates for these trials.

NCT05564377 · Official ClinicalTrials.gov record · National Cancer Institute (NCI)

This is a Phase 3, multicenter, randomly assigned, neither you nor the study doctors know who gets the real treatment, compared with a dummy treatment study to measure the clinical how well it works, safety, and tolerability of XEN1101 administered as added on top of your current treatment treatment in primary generalized tonic-clonic seizures (PGTCS).

NCT05667142 · Official ClinicalTrials.gov record · Xenon Pharmaceuticals Inc.

This phase III trial compares the effect of adding immunotherapy (brentuximab vedotin and nivolumab) to standard treatment (chemotherapy with or without radiation) to the standard treatment alone in improving survival in patients with stage I and II classical Hodgkin lymphoma. Brentuximab vedotin is in a class of medications called antibody-drug conjugates.

NCT05675410 · Official ClinicalTrials.gov record · National Cancer Institute (NCI)

This phase III trial compares the effect of modified fluorouracil, leucovorin calcium, oxaliplatin, and irinotecan (mFOLFIRINOX) with or without nivolumab to the effect of modified fluorouracil, leucovorin calcium, and oxaliplatin (mFOLFOX) with or without nivolumab for the treatment of patients with advanced, unresectable, or metastatic HER2 negative esophageal, gastroesophageal junction, or gastric adenocarcinoma. The usual approach for patients who are not in a study is treatment with FOLFOX with some receiving an immunotherapy drug, either nivolumab or pembrolizumab, in addition to FOLFOX chemotherapy.

NCT05677490 · Official ClinicalTrials.gov record · Alliance for Clinical Trials in Oncology

The goal of this clinical trial is to assess the how well it works, whether it is safe and how hard side effects are to live with of the combination of lasofoxifene and abemaciclib compared to fulvestrant and abemaciclib for the treatment of pre- and postmenopausal women and men who have previously received ribociclib or palbociclib-based treatment and have locally advanced or metastatic estrogen receptor positive (ER+)/human epidermal growth factor 2 negative (HER2-) breast cancer with an estrogen receptor 1 (ESR1) mutation. The main question the study aims to answer is: • To compare the how well it works of the combination of lasofoxifene and abemaciclib with that of fulvestrant and abemaciclib Participants will receive either receive 5 mg/d of oral lasofoxifene plus oral abemaciclib 150 mg twice a day or the combination of fulvestrant 500 mg intramuscular (IM) on Days 1, 15, and 29 and then once monthly thereafter plus oral abemaciclib 150 mg twice a day.

NCT05696626 · Official ClinicalTrials.gov record · LeonaBio