A Phase 2, randomized, open-label three-arm clinical study to evaluate the safety and efficacy of lenvatinib (E7080/MK-7902) in combination with pembrolizumab (MK-3475) versus standard of care chemotherapy and lenvatinib monotherapy in participants with recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC) that have progressed after platinum therapy and immunotherapy (PD-1/PD-L1 inhibitors) (LEAP-009)

Date Added
February 1st, 2021
PRO Number
Pro00101229
Researcher
John Kaczmar

List of Studies


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

This study is for patients who have been diagnosed with head and neck squamous cell carcinoma (HNSCC) that has returned (recurrent) or spread after previous treatment (metastatic). The investigational drug in this study is lenvatinib. The study will also use lenvatinib in combination with pembrolizumab, which is also experimental. The purposes of this study are to: test the safety of the study drugs, lenvatinib alone, pembro and lenvatinib together, and standard chemotherapies alone in the treatment of HNSCC; see how well the combination of pembro and lenvatinib works, compared to standard chemotherapies; and see if participants who get pembro and lenvatinib live longer than those who are treated with standard chemotherapies. Participants can expect to be on this study for about 48 months.

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

An Open-Label, Multicenter, Phase 1/2 Study of RP1 as a Single Agent and in Combination with PD1 Blockade in Patients with Solid Tumors

Date Added
November 24th, 2020
PRO Number
Pro00105157
Researcher
John Kaczmar

List of Studies


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

This study is for patients that have been diagnosed with advanced or resistant skin cancer (melanoma), non-melanoma skin cancer (NMSC), non-small cell lung cancer (NSCLC), certain types of solid tumors, or bladder cancer (UBC). The investigational drug in this study is RP1. RP1 is a herpes simplex virus (a microscopic life form commonly known as the "cold sore virus") that has been genetically changed to grow in and destroy cancer cells. This treatment will be injected directly into tumors. The purpose of this study is to test the safety and how well RP1 works when it is injected into certain types of solid tumors in combination with another cancer drug, called nivolumab. Participants can expect to be in this study for about 2 to 3 years.

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

Alcohol Research Center. Shared clinical assessment core for the Alcohol Research Center clinical projects.

Date Added
October 6th, 2020
PRO Number
Pro00103760
Researcher
Konstantin Voronin

List of Studies


Keywords
Alcohol, Drug Studies
Summary

The purpose of this research study is to determine potential subjects eligibility for participation in the Alcohol Research Center clinical projects based on the results of the screening assessments, which they will complete during this protocol.
Participants will undergo 1-2 days screening procedures. Subjects will be asked to fill out questionnaires, they will be interviewed, will need to provide medical history and have physical exam done and provide a blood sample. Total study consists 1-2 visits which will be completed within approximately one-week period.

Institution
MUSC
Recruitment Contact
Konstantin Voronin
843-792-4887
voronin@musc.edu

Effects of a Novel mGluR5 Negative Allosteric Modulator on Alcohol Drinking, Neurochemistry, and Brain Reactivity to Alcohol Cues in Alcohol Use Disorder

Date Added
October 6th, 2020
PRO Number
Pro00102334
Researcher
James Prisciandaro

List of Studies


Keywords
Alcohol, Brain, Drug Studies, Substance Use
Summary

This Phase II clinical research study evaluates both the safety and effectiveness of an FDA-regulated medication presently in the initial stages of development for alcohol use disorder treatment (GET73), and will test whether GET73 alters brain chemicals and function, response to alcohol ingestion, and the desire for alcohol. Participants will be randomly assigned to one of two medication treatment groups (GET73 or placebo). Study medication will be taken for 8 days, with approximately 4 study visits, and a "bar-lab" procedure and 2 MRI brain imaging scans will be completed. Questionnaires and clinical interview measures will be completed at study visits along with consistent assessment of potential side effects from study medication.

Institution
MUSC
Recruitment Contact
Sara Hix
(843) 792-0572
hixs@musc.edu

MPFC Theta Burst Stimulation as a Treatment Tool for Alcohol Use Disorder: Effects on Drinking and Incentive Salience

Date Added
September 1st, 2020
PRO Number
Pro00102709
Researcher
Lisa McTeague

List of Studies


Keywords
Alcohol, Brain, Drug Studies, Psychiatry, Substance Use
Summary

The purpose of this study is to develop transcranial magnetic stimulation (TMS), specifically TMS at a frequency known as theta burst stimulation (TBS), to see how it affects the brain and changes the brain's response to alcohol-related pictures. TMS and TBS are stimulation techniques that use magnetic pulses to temporarily excite specific brain areas in awake people (without the need for surgery, anesthetic, or other invasive procedures). TBS, which is a form of TMS, will be applied over the medial prefrontal cortex, (MPFC), which has been shown to be involved with drinking patterns and alcohol consumption. This study will test whether TBS can be used as an alternative tool to reduce the desire to use alcohol and reducing the brain's response to alcohol-related pictures.

Institution
MUSC
Recruitment Contact
Charleston Alcohol Research Center
(843) 792-1222
alcoholstudy@musc.edu

A Phase II Study of Metronomic and Targeted Anti-Angiogenesis Therapy for Children With Recurrent/Progressive Medulloblastoma

Date Added
September 1st, 2020
PRO Number
Pro00091939
Researcher
Jacqueline Kraveka

List of Studies


Keywords
Brain, Brain Tumor, Cancer, Central Nervous System, Children's Health, Drug Studies, Pediatrics, Spinal Cord
Summary

This study is for patients with recurrent/progressive medulloblastoma, which is a type of childhood brain tumor. Participants in this study will receive intravenous (IV, into the veins) bevacizumab and intrathecal (into the spinal fluid) or intraventricular (into the fluid surrounding the brain) etoposide and cytarabine in combination with five oral (taken by mouth) chemotherapy drugs as a possible treatment for recurrent/progressive medulloblastoma. Total study duration is about 1 year and depending on how well a participant tolerates the medications and the response of the disease, the patient may continue the treatment after the first year.

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

DORA Trial: Phase III Trial of Docetaxel vs. Docetaxel and Radium-223 for Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Date Added
August 27th, 2019
PRO Number
Pro00091613
Researcher
Toros Dincman

List of Studies

Keywords
Cancer, Cancer/Lymphoma, Drug Studies, Men's Health
Summary

This study is for patients that have been diagnosed with advanced prostate cancer with bone metastases.The purpose of this research study is to compare any good and bad effects of using radium-223 along with docetaxel chemotherapy treatment versus using docetaxel alone. The addition of radium-223 to docetaxel could have an overall survival benefit, but it could also cause side effects. The study drugs, radium-223 and docetaxel, are considered experimental drugs that are being evaluated together as a combination therapy for participants with certain solid tumors (cancer). Patients will be seen at MUSC for about 8 months. After they finish the treatment, the doctor will continue to watch the patient for side effects and follow their condition for the rest of their life, or for as long as they wish to remain on the study.

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

Managed Access Program (MAP) to provide access to CTL019, for acute lymphoblastic leukemia (ALL) or large b-cell lymphoma patients with out of specification leukapheresis product and/or manufactured tisagenlecleucel out of specification for commercial release

Date Added
May 28th, 2019
PRO Number
Pro00088512
Researcher
Brian Hess

List of Studies


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

This study is for patients who have been diagnosed with B-cell acute lymphoblastic leukemia (ALL) or large B-cell lymphomas. The investigational drug in this study is CTL019 (Tisagenlecleucel). The purpose of this study is to provide the investigational drug as a possible cancer treatment that would otherwise be unavailable. Patients can expect to be in this study for up to 3 months and in follow up for 15 years.

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

A Phase 3, Prospective, Multicenter, Uncontrolled, Open-Label Clinical Study to Determine the Efficacy, Safety, and Tolerability of rVWF with or without ADVATE in the Treatment and Control of Bleeding Episodes, the Efficacy and Safety of rVWF in Elective and Emergency Surgeries, and the Pharmacokinetics (PK) of rVWF in Children Diagnosed with Severe von Willebrand Disease

Date Added
February 28th, 2017
PRO Number
Pro00062418
Researcher
Shayla Bergmann

List of Studies


Keywords
Drug Studies, Pediatrics
Summary

This is a study to determine the use of recombinant Von Willebrand Factor (rVWF) in the treatment and control of nonsurgical bleeding episodes and bleeding during elective and emergency surgery in children with severe Von Willebrand Disease. The study will last approximately 14 months and will involve regular visits to a research clinic.

Institution
MUSC
Recruitment Contact
Lauren Card
843-792-5935
cardl@musc.edu

Comparative Effectiveness of Pulmonary Embolism Prevention after Hip and Knee Replacement: Balancing Safety and Effectiveness

Date Added
April 19th, 2016
PRO Number
Pro00053742
Researcher
Vincent Pellegrini

List of Studies


Keywords
Drug Studies, Joint
Summary

PEPPER is a randomized study comparing the three most commonly used blood thinners in North America in patients who have elected to undergo primary or revision hip or knee joint replacement surgery. The blood thinners being compared are enteric coated aspirin, low intensity warfarin, and rivaroxaban.

Institution
MUSC
Recruitment Contact
Monica Baczko
843-792-8169
baczko@gmail.com



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