QUILT-3.055: A Phase IIb, Single-Arm, Multicohort, Open-Label Study of ALT-803 in Combination with a PD-1/PD-L1 Checkpoint Inhibitor in Patients who have Disease Progression Following an Initial Response to Treatment with PD-1/PD-L1 Checkpoint Inhibitor Therapy Save

Date Added
August 22nd, 2017
PRO Number
Pro00068710
Researcher
John Wrangle

List of Studies

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

This study is for patients who have been diagnosed with an advanced form of cancer and your disease improved or remained unchanged after receiving PD-1/ PD-L1 Checkpoint Inhibitor Therapy. The investigational drug in this study is called ALT-803. Participants will receive the study drug ALT-803 in combination with an approved PD-1/PD-L1 Checkpoint Inhibitor Therapy (Pembrolizumab, Nivolumab, Atezolizumab, or Avelumab). The purpose of this research study is to test the effectiveness of the study drug, ALT-803, in combination with pembrolizumab, nivolumab, atezolizumab, or avelumab in with advanced forms of cancer that initially had improvement or no change in disease after receiving checkpoint inhibitor therapy and who now have disease worsening. Participation in this study should take approximately 24 months.

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

A Global, Open-Label, Multicenter, Phase 1/2 Study of the Safety and Dose Escalation of BAX 888, an Adeno-Associated Virus Serotype 8 (AAV8) Vector Expressing B-Domain Deleted Factor VIII (BDD-FVIII) in Severe Hemophilia A Subjects Administered a Single Intravenous Infusion Save

Date Added
August 8th, 2017
PRO Number
Pro00068449
Researcher
John Lazarchick

List of Studies


Profiles_link
Keywords
Blood Disorders, Drug Studies, Rare Diseases
Summary

This is a first-in-humans gene therapy study for subjects diagnosed with severe hemophilia A. A one time infusion of the gene therapy product (BAX888) will be given with the hope of eliminating or reducing the need for prophylactic and/or on-demand use of FVIII concentrate therapy. Up to 10 subjects will be enrolled study-wide with up to two subjects enrolled at MUSC. This study will require weekly visits to the study clinic after initial infusion for the first 15 weeks followed by monthly visits for the first year. Compensation will be provided.

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

A Phase I open label study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary clinical efficacy of ONO-7475 in patients with acute leukemias Save

Date Added
July 25th, 2017
PRO Number
Pro00068834
Researcher
Brian Hess

List of Studies

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

This study is for patients that have been diagnosed with a type of cancer called Acute Myeloid Leukemia (AML). The investigational drug in this study is ONO-7475. The purpose of this study is to see whether ONO-7475 slows down the growth of cells that cause cancers like leukemias such as AML. The estimated duration of study participation in Part A is 6 months. You can continue in the study as long as you are gaining benefit from the study treatment.

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

A Phase 2, Double-blind, Randomized, Placebo-controlled Multicenter Study to Evaluate Efficacy, Safety, and Tolerability of JBT-101 in Systemic Lupus Erythematosus (Protocol ALE09) Save

Date Added
July 18th, 2017
PRO Number
Pro00063016
Researcher
Diane Kamen

List of Studies


Profiles_link
Keywords
Autoimmune disease, Drug Studies, Inflammation, Lupus
Summary

This double-blinded placebo-controlled research study is being done to test the effectiveness, safety, and tolerability of the experimental drug JBT-101 in patients with systemic lupus erythematosus (SLE). We will see if JBT-101 taken by mouth stops inflammation and how well JBT-101 is tolerated. The study will evaluate whether JBT-101 will decrease the pain associated with active arthritis or tendonitis in SLE subjects. JBT-101 is manufactured entirely from chemicals and its structure is similar to the end product of a chemical in marijuana. This drug was designed to have the known anti-inflammatory properties of marijuana without the effects on brain function and mood.

Institution
MUSC
Recruitment Contact
Traeannah Chisolm
843-792-4296
chisoltr@musc.edu

Study of Anti-Malarials in Incomplete Lupus Erythematosus Save

Date Added
July 18th, 2017
PRO Number
Pro00060015
Researcher
Diane Kamen

List of Studies


Profiles_link
Keywords
Autoimmune disease, Drug Studies, Lupus
Summary

The primary objective of the trial is to assess the ability of hydroxychloroquine to prevent the development of SLE in persons at risk for the disease. Subjects will be assigned to one of two groups: one with receive oral hydroxychloroquine, and one will receive oral placebo. The study lasts for about two years, with visits being once every 3 months, for a total of 12 visits. Two of those visits will be with an ophthalmologist to monitor eye health. At each visit, the study team will monitor your symptoms and health.

Institution
MUSC
Recruitment Contact
Traeannah Chisolm
843-792-4296
chisoltr@musc.edu

A Phase 1b/2, Open-label, Multicenter, Dose-escalation and Expansion Trial of Intratumoral SD-101 in Combination With Pembrolizumab in Patients With Metastatic Melanoma or Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma. Save

Date Added
June 13th, 2017
PRO Number
Pro00064826
Researcher
Terrence Day

List of Studies


Profiles_link
Keywords
Cancer/Head & Neck, Drug Studies
Summary

This is a phase 1b/2, open-label, multicenter trial designed to look at the safety and efficacy of a study drug called SD 101 when injected into a tumor and used in combination with intravenous (IV) pembrolizumab in subjects with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC). The Medical University of South Carolina will only participate in phase 2 of this study and will include up to 10 subjects. Participation in this study will include up to 40 visits to the research center over approximately 110 weeks.

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

Phase 2 Study of Azacitidine in Combination with Pembrolizumab in Relapsed/Refractory Acute Myeloid Leukemia (AML) Patients and in Newly Diagnosed Older (?65 Years) AML Patients Save

Date Added
April 25th, 2017
PRO Number
Pro00064864
Researcher
Robert Stuart

List of Studies


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

This study is for patients that have been diagnosed with Relapsed/Refractory Acute Myeloid Leukemia (AML) or in Newly Diagnosed Older (?65 Years) AML Subjects. The investigational drug in this study is Azacitidine (AZA) and Pembroluzimab (KEYTRUDA). The purpose of this study is to determine the safety, tolerability and efficacy of Azacitidine (AZA) in combination with Pembrolizumab (also known as KEYTRUDA TM) in relapsed and refractory acute myeloid leukemia (AML) subjects, and also in older (?65 years) newly diagnosed AML subjects who are not candidates for intensive induction chemotherapy. Participants can expect to be in this study for up to 2 1/2 years.

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

Prospective, randomized, placebo controlled trial of the efficacy and safety of inhaled nitric oxide (NO) in cystic fibrosis (CF) patients Save

Date Added
April 11th, 2017
PRO Number
Pro00064789
Researcher
Patrick Flume

List of Studies


Profiles_link
Keywords
Cystic Fibrosis, Drug Studies, Lung, Pulmonary
Summary

This study is being done to evaluate an experimental treatment for people with Cystic Fibrosis who have a bacterial infection in their lungs. Subjects will be randomized (selected by chance) to either be treated with an investigational inhaled gaseous drug (in 99.5% nitrogen) that is mixed with room air or breathe 100% nitrogen that is mixed with room air. If you are randomized to the investigational treatment, we are asking you to breathe in a gas called "nitric oxide". Participation in the study will take about 43 days

Institution
MUSC
Recruitment Contact
Ashley Warden
843-792-4349
jonesash@musc.edu

Accelerated Development of Additive Pharmacotherapy Treatment (ADAPT-2) for Methamphetamine Use Disorder Save

Date Added
March 7th, 2017
PRO Number
Pro00062819
Researcher
Susan Sonne

List of Studies


Profiles_link
Keywords
Drug Studies, Psychiatry, Substance Use
Summary

This study is designed to evaluate the safety and effectiveness of using two different medications (extended release naltrexone and bupropion) compared to matching placebo (an inactive substance) in the treatment of methamphetamine use disorder. Participants will receive study medications along with brief medication management for twelve weeks, with follow up visits at weeks 13 and 16.

Institution
MUSC
Recruitment Contact
Elizabeth Chapman
864-898-5800
echapman@bhspickens.com

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 Save

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

List of Studies

Silhouette
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

Change_preferences

-- OR --

Create_login