A Phase III, Randomized, Placebo-controlled, Double-blind, Multi-center, International Study of Durvalumab Following Stereotactic Body Radiation Therapy (SBRT) for the Treatment of Patients with unresected Stage I/II, lymph-node negative Non-small Cell Lung Cancer (PACIFIC-4/RTOG-3515) Save

Date Added
December 5th, 2019
PRO Number
Pro00091168
Researcher
John Wrangle

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

This study is for patients that have been diagnosed with unresected Stage I/II, lymph-node negative Non-small Cell Lung Cancer (NSCLC). The investigational drug used in this study is durvalumab. This purpose of this study is to see how if durvalumab will work and be safe for the treatment of patients with Stage I/II Non Small Cell Lung Cancer following stereotactic body radiation therapy when compared to placebo. Participants can expect to be in the study for approximately 6 years.

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

A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Phase 3 Study Evaluating the Safety and Efficacy of Intravenous Iloprost in Subjects With Systemic Sclerosis Experiencing Symptomatic Digital Ischemic Episodes (AURORA Study) Save

Date Added
November 12th, 2019
PRO Number
Pro00092860
Researcher
Edwin Smith

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Keywords
Autoimmune disease, Drug Studies, Immune System, Rare Diseases, Scleroderma, Stage III
Summary

The purpose of this study is to find out more information about the study drug iloprost for the treatment of symptomatic Raynaud's phenomenon (RP) attacks in people with scleroderma. A Raynaud's attack is defined as one where you notice at least one color change of your finger(s) (blue, white, or red) associated with at least one symptom (pain, numbness, tingling, and/or discomfort of the finger[s]). Your participation in this study will last approximately 9 weeks and will include 8 visits to the study center and 1 phone call from the study staff.

Institution
MUSC
Recruitment Contact
Nathan Wilson
843-792-8613
wilsonn@musc.edu

Tisagenlecleucel versus standard of care in adult patients with relapsed or refractory aggressive B-cell non-Hodgkin lymphoma: A randomized, open label, phase III trial (BELINDA) Save

Date Added
October 22nd, 2019
PRO Number
Pro00088996
Researcher
Brian Hess

List of Studies

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

This study is for patients who have been diagnosed with relapsed (the disease has gotten worse after a period of improvement) or refractory (the disease does not respond to treatment) aggressive B-cell non-Hodgkin lymphoma .The investigational therapy in this study is tisagenlecleucel treatment. This treatment includes collecting T cells from patient's blood and changing them by gene transfer to make them recognize tumor cells. The purpose of this study is to see how well tisagenlecleucel therapy treats the disease and how safe the treatment is when compared to Standard or Care treatment. Participants can expect to be in this study for up to 60 months and in follow up for up to 15 years.

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

A Phase 2, Randomized, Placebo-controlled, Double-blind, Open-label Extension Multicenter Study to Evaluate the Efficacy and Safety of KD025 in Subjects with Diffuse Cutaneous Systemic Sclerosis Save

Date Added
October 22nd, 2019
PRO Number
Pro00089320
Researcher
Richard Silver

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Keywords
Autoimmune disease, Drug Studies, Rare Diseases, Scleroderma, Skin
Summary

KD025 is an investigational medication undergoing testing to determine if it may be effective in the treatment of diffuse systemic sclerosis (skin thickening on more than just the hands). KD025 has previously been tested in graft-versus-host disease, idiopathic pulmonary fibrosis, and psoriasis. It has shown preliminary effectiveness and safety in the treatment of these conditions. This study will randomly assign subjects to one of three treatment groups, 20mg of KD025 twice per day, 20mg of KD025 once per day, and placebo. The study will measure the improvement, stabilization or worsening of your symptoms, such as changes in your fatigue and pain levels, lung function, skin thickness and other patient reported outcomes. The study treatment period will last 1 year. The drug may help mitigate symptoms of systemic sclerosis and thus may be helpful with the disease in study. The population to be enrolled in this study will involve patients diagnosed with systemic sclerosis, diffuse subset, 18 years of age or older.

Institution
MUSC
Recruitment Contact
Jordan Fash
843-792-8997
fash@musc.edu

A Phase 3, Randomized, Double-blind Study to Compare the Efficacy and Safety of Pembrolizumab (MK-3475) in Combination with Lenvatinib (E7080/MK-7902) Versus Pembrolizumab and Placebo as First Line Treatment for Locally Advanced or Metastatic Urothelial Carcinoma in Cisplatin-ineligible Participants Whose Tumors Express PD-L1, and in Participants Ineligible for Any Platinum-containing Chemotherapy Regardless of PD-L1 Expression (LEAP-011) Save

Date Added
October 10th, 2019
PRO Number
Pro00092018
Researcher
Theodore Gourdin

List of Studies

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

Adult males are being asked to volunteer because they have been diagnosed to have bladder cancer that has spread and subjects tumor has a specific type of biomarker called PD-L1 (biomarkers can help to tell us what is going on in subjects body).This is a research study to find out if experimental medications called pembrolizumab and lenvatinib, when administered together. Participants can expect to be on this study for 2 years.

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

A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Clinical Study Comparing the Efficacy and Safety of Tislelizumab (BGB-A317) plus Platinum and Fluoropyrimidine Versus Placebo plus Platinum and Fluoropyrimidine as First-Line Treatment in Patients with Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma Save

Date Added
October 7th, 2019
PRO Number
Pro00090649
Researcher
Paul O'brien

List of Studies

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Keywords
Cancer, Cancer/Gastrointestinal, Drug Studies
Summary

This is a research study to compare the effects and safety, of tislelizumab plus chemotherapy to placebo (an inactive substance) plus chemotherapy on you and your Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma (GC/GEJ) to find out the most effective treatment. The study will take place over 3 years 4 months and will include about 17-18 office -visits to the study doctor.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9300
hcc-clincal-trials@musc.edu

Assessing the Efficacy of a Serotonin and Norepinephrine Reuptake Inhibitor for Improving Meniere's Disease Outcomes Save

Date Added
October 1st, 2019
PRO Number
Pro00091200
Researcher
Habib Rizk

List of Studies


Profiles_link
Keywords
Drug Studies, Ears
Summary

As of yet, the cause of Meniere's disease is uncertain and there is no cure. Given the lack of high level evidence for treatments, we seek to perform a randomized, placebo-controlled, double-blind, crossover, pilot trial of venlafaxine for treating Meniere's disease. Venlafaxine is a safe and well-tolerated medication. It has never been trialed in Meniere's disease, but there is evidence that it could be effective in helping with vertigo attacks and other aspects of the disorder.

Institution
MUSC
Recruitment Contact
Habib Rizk
2154590435
rizkh@musc.edu

A Phase 2 Efficacy and Safety Trial of ADU-S100 and Pembrolizumab in Adults with Head and Neck Cancer Save

Date Added
September 24th, 2019
PRO Number
Pro00091445
Researcher
John Kaczmar

List of Studies

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

This study is for patients that have been diagnosed with head and neck squamous cell cancer (HNSCC). The investigational drug in this study is ADU-S100. The purpose of this study is to find out how ADU-S100 and pembrolizumab (also called KEYTRUDA®) interact with the immune system to potentially treat cancer and to make sure the drugs are safe to use together. Participants can expect to recieve treatment for up to two years. This would include 2 doses in a3-week cycle for up to 35 cycles. Participants can expect follow-up to continue every eight weeks until completion of the required safety reporting periods, death, withdrawal of consent, loss to follow-up, or close of study by the Sponsor.

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

A Phase 3b Multicenter, Randomized, Double-Blind, Double-Dummy, Active Controlled Study Comparing the Safety and Efficacy of Upadacitinib to Dupilumab in Adult Subjects with Moderate to Severe Atopic Dermatitis Save

Date Added
September 24th, 2019
PRO Number
Pro00090285
Researcher
Lara Wine lee

List of Studies

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Keywords
Drug Studies, Skin
Summary

This is a study of upadacitinib versus dupilimab in adult subjects (18-75 years of age) with moderate to severe atopic dermatitis. The study drug, upadacitinib, is an oral medical that is a tablet taken once a day. Dupilimab is given as an injection under the skin every other week. The subject's participation includes a 35-day screening period, a 24-week double-blind treatment period, and an End of Treatment Follow-up visit 12 weeks after the last injection.

Institution
MUSC
Recruitment Contact
Reshil-Marie Dukes
757-668-0387
dukesre@musc.edu

A Randomized, Controlled Phase 3 Study of Cabozantinib (XL184) in Combination with Atezolizumab versus Sorafenib in Subjects with Advanced Hepatocellular Carcinoma Who Have Not Received Previous Systemic Anticancer Therapy Save

Date Added
September 23rd, 2019
PRO Number
Pro00091128
Researcher
Paul O'brien

List of Studies

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Keywords
Cancer, Cancer/Gastrointestinal, Drug Studies
Summary

The purpose of this study is to find out if cabozantinib in combination with atezolizumab is effective in treating liver cancer compared to sorafenib alone in people who have not received prior treatment. Subjects are being asked to take part in this clinical research study because they have hepatocellular carcinoma (liver cancer) that has not been previously treated for advanced disease.It is estimated that subjects will take study drug(s) for this study for approximately 1 to 6 months.

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

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