Randomized Phase 2 Study of Nivolumab and Ipilimumab With or Without Cabozantinib in Patients With Advanced Nasopharyngeal Carcinoma That Have Progressed After Platinum Treatment and Immunotherapy

Date Added
September 23rd, 2024
PRO Number
Pro00138505
Researcher
John Kaczmar

List of Studies


Keywords
Cancer, Cancer/Head & Neck, Men's Health, Women's Health
Summary

This study is designed to learn more about how nivolumab and ipilimumab, with or without cabozantinib effects the growth and spreading of head and neck cancer. If decided to take part in this study, participants will go through a screening period, treatment period, and follow-up period. During the screening period following signing of consent form participants will be evaluated for screening criteria and determined if they qualify for the study. During treatment period participants will be randomly assigned to either receive the combination of two immunotherapy drugs, nivolumab and ipilimumab for up to 2 years, or the two immunotherapy drugs with an additional targeted drug, cabozantinib, for up to 2 years unless your cancer gets worse or the side effects of the treatment become too severe. In the follow up period the side effects will be observed by the study team every 3 to 4 months for 2 years after treatment. The most common risks and discomforts expected in this study are diarrhea, nausea, vomiting, tiredness, weight loss, loss of appetite, changes in taste or voice, redness, pain or peeling of palms and soles, and high blood pressure which may cause blurred vision. There may not a benefit from joining the study. The head and neck cancer may improve while on this study but it may not, and it may even get worse. It will also help inform how well this combination treatment works at curing this type of cancer. The study results may be used to help others in the future.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinicaltrials@musc.edu

Strategy for Improving Stroke Treatment Response

Date Added
September 26th, 2024
PRO Number
Pro00136289
Researcher
Christine Holmstedt

List of Studies


Keywords
Stroke
Summary

The research is being done to determine if an investigational drug called "TS23" is safe and effective for the treatment of patients with an ischemic stroke that do not meet the criteria for standard treatments to remove the clot. The best dose of TS23 for these patients is unknown. Prior studies have shown that TS23 works without increasing safety concerns.

Institution
MUSC
Recruitment Contact
Caitlan LeMatty
843 792 8606
lemattyc@musc.edu

Adapting and Piloting the Managing Emotions to Reduce Alcohol-Facilitated Aggression (MERA-A) Intervention among Veterans

Date Added
October 1st, 2024
PRO Number
Pro00139264
Researcher
Julianne Flanagan

List of Studies


Keywords
Alcohol
Summary

Rates of heavy episodic drinking (HED) among military veterans are almost double that of the general population. Veterans also experience more serious negative health consequences of HED, including high-risk behaviors such as aggression. Research shows there is a link between HED and aggression. However, no programs exist to reduce alcohol-related aggression among veterans. The purpose of this study is to examine the feasibility and acceptability of adapting a current therapy - Managing Emotions to Reduce Aggression (MERA) - to include alcohol-focused Motivational Interviewing plus Feedback (MIF). We will use a brief, four session protocol that includes an hour of talk therapy, plus completion of surveys at each of the four sessions.

Institution
MUSC
Recruitment Contact
Stacey Sellers
843-792-5807
sellersst@musc.edu

A Phase III, Randomized, Double-blind Study to Evaluate the Effect of Balcinrenone/Dapagliflozin, Compared with Dapagliflozin, on the Risk of Heart Failure Events and Cardiovascular Death in Patients with Heart Failure and Impaired Kidney Function

Date Added
October 8th, 2024
PRO Number
Pro00138745
Researcher
Vishal Rao

List of Studies

Keywords
Cardiovascular, Drug Studies, Heart, Kidney
Summary

We are doing this study to learn more about how effective, safe and tolerable an experimental drug called balcinrenone is when used in combination with dapagliflozin for treating patients with heart failure and impaired kidney function and also to better understand the studied disease and associated health problems. Dapagliflozin is an approved drug to treat patients with heart failure, chronic kidney disease and type 2 diabetes mellitus.

Institution
MUSC
Recruitment Contact
Lauren Wakefield
843-876-5049
wakefila@musc.edu

A Phase 3, Open-label, Efficacy-Assessor-Blinded Study, Comparing the Safety and Efficacy of Upadacitinib to Dupilumab in Children from 2 to Less than 12 Years of Age with Moderate to Severe Atopic Dermatitis (START UP)

Date Added
October 9th, 2024
PRO Number
Pro00138750
Researcher
Lara Wine Lee

List of Studies


Keywords
Skin
Summary

This study is being conducted at approximately 150 research centers worldwide and is expected to enroll approximately 675 pediatric subjects in total with moderately to severely AD. This study will have 2 cohorts, a Randomized Cohort, and a Dupilumab-Inadequate Responder / Dupilumab Medically Inadvisable Cohort. The study comprises a 35-day Screening Period; a 16-week, open-label, efficacy assessor blinded study treatment period for the subjects in the randomized cohort; an open-label period up to Week 160 for subjects in the upadacitinib study treatment arms across both cohorts (Randomized Cohort and Dupi-IR/Dupilumab Medically Inadvisable Cohort); an open label period up to Week 52 for subjects in the dupilumab arm; and a 30-day Follow up Visit/call after the last dose is administered for upadacitinib or dupilumab.

Institution
MUSC
Recruitment Contact
Courtney Rowley
843-792-9784
rowle@musc.edu

Evaluation of Low- and High-Nicotine Tobacco-Free Nicotine Pouches as a Harm Reducing Substitute for Combustible Cigarettes

Date Added
October 15th, 2024
PRO Number
Pro00139710
Researcher
Amanda Palmer

List of Studies

Keywords
Smoking
Summary

Tobacco-free oral nicotine pouches (such as Zyn brand) are a less harmful alternative to combustible tobacco (cigarette/cigarillo/little cigar) smoking. Pouches, however, contain nicotine, and addictive substance that is not risk-free. The present study is evaluating how well nicotine pouches, at different nicotine levels, help people switch away from smoking combustible tobacco. People who smoke will be asked to answer questions about their tobacco product use and provide breath samples and cheek swab samples at an in-person visit to MUSC Charleston. Participants will then be provided with a 28-day supply of nicotine pouches, and will be asked to switch from smoking to pouches over the course of 4 weeks. Finally, participants will complete a final visit at MUSC, and will answer more questions about their tobacco use 1-month later.

Institution
MUSC
Recruitment Contact
Talia Ogretmen
843-259-8111
ogretmet@musc.edu

A Phase 3, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of subcutaneous sonelokimab in adult participants with moderate to severe hidradenitis suppurativa

Date Added
October 24th, 2024
PRO Number
Pro00137663
Researcher
Lara Wine Lee

List of Studies


Keywords
Skin
Summary

This is a Phase 3, multicenter, randomized, parallel-group, double-blind, placebo-controlled study to evaluate the efficacy and safety of sonelokimab in adults with moderate to severe HS. Following a Screening Period of up to 28 days, each participant will enter a Placebo-controlled Period of 16 weeks (Part A) and subsequently a Crossover/Maintenance Period of 36 weeks (Part B). In Part A subjects will be randomly assigned in a 2:1 ratio to sonelokimab 120 mg or placebo. In Part B, participants who were initially randomized to placebo will cross over to sonelokimab and will receive this treatment for the remainder of the study. An End of Treatment (EOT) Visit will be performed at Week 52. After the EOT Visit, all participants who complete Week 52 will be offered the opportunity to enter an optional long-term open label extension (OLE) study under a separate protocol. For participants who do not progress to the OLE study, a Safety Follow-up Visit will be required 8 weeks after the last dose of study treatment.

Institution
MUSC
Recruitment Contact
Courtney Rowley
843-792-9784
rowle@musc.edu

A Randomized Phase III Trial of Doxorubicin +Pembrolizumab Versus Doxorubicin Alone for the Treatment of Undifferentiated Pleomorphic Sarcoma (UPS) and Related Poorly Differentiated Sarcomas

Date Added
October 25th, 2024
PRO Number
Pro00139599
Researcher
Christopher Rangel

List of Studies

Keywords
Cancer, Cancer/Sarcoma, Drug Studies, Men's Health, Women's Health
Summary

This study if for patients with undifferentiated pleomorphic sarcoma (UPS) or a related poorly differentiated sarcoma that has spread from where it first started to other places in the body or it cannot be removed by surgery. This study compares the effect of pembrolizumab plus doxorubicin to doxorubicin alone in treating patients. Doxorubicin damages the cell's DNA and may kill tumor cells. Doxorubicin also blocks a certain enzyme needed for cell division and DNA repair. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attach the cancer and may interfere with the ability of tumor cells to grow and spread. Adding pembrolizumab to the standard chemotherapy, doxorubicin, may help patients with UPS or a related poorly differentiated sarcoma live longer without having disease progression. The duration of the study will be about 12 years, with 6 months of active treatment for those receiving doxorubicin alone and 2 years active treatment for those receiving doxorubicin and pembrolizumab. Each participant will be in follow up for 10 years. Some of the main side effects are nausea, vomiting, low blood count, fatigue and mild diarrhea.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinicaltrials@musc.edu

Developing brain imaging biomarkers to quantify the effects of at-home taVNS treatment in ASD

Date Added
November 5th, 2024
PRO Number
Pro00140411
Researcher
Xiaolong Peng

List of Studies


Keywords
Adolescents, Anxiety, Autism
Summary

The purpose of this study is to explore whether a non-invasive form of ear stimulation called transcutaneous auricular vagus nerve stimulation (taVNS) can manage symptoms in patients with autism spectrum disorder (ASD). Additionally, this study also uses magnetic resonance imaging (MRI) to capture images of participants' brains and apply an image processing method called INSCAPE to track brain state changes during taVNS treatment in ASD. We will recruit up to 16 participants with ASD.

Institution
MUSC
Recruitment Contact
Nicole Cash
843-792-9502
cashni@musc.edu

Prospective Placebo-Controlled Trial of Intramuscular Steroid Administration for the Treatment of Unexplained Chronic Cough

Date Added
November 5th, 2024
PRO Number
Pro00140403
Researcher
Lauren Howser

List of Studies

Keywords
Throat
Summary

This study is being done to see if injections in different locations can help to minimize chronic cough. This is done through the injection of an anti-inflammatory medication (steroid) into your upper arm muscle. The procedure takes less than 5 minutes. There has not yet been a study completed using arm muscle injections. The safety profile of arm muscle injections is expected to be the same as the superior laryngeal nerve (SLN) injection which is in the neck is already used at MUSC in regular practice. This is the same medication and the same dosage as the arm injection in this study. By better understanding if this treatment helps improve chronic cough, an additional treatment option could be utilized for this patient population. SLN injections are usually only performed by fellowship trained laryngologists (an extra specialized year of training after ENT residency). However, if arm muscle injections are found to be equivalent in treating chronic cough, general ENT physicians could likely provide this treatment to their patients without the need to see a specialized laryngologist. This study will evaluate safety and effectiveness of the arm muscle injection. Steroids are investigational for the purpose of this study.

Institution
MUSC
Recruitment Contact
Kirsten Meenan
843-792-6755
meenan@musc.edu



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