A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-controlled Study to Assess the Efficacy and Safety of Apremilast (CC 10004) in Pediatric Subjects from 6 through 17 Years with Moderate to Severe Plaque Psoriasis Save

Date Added
January 22nd, 2019
PRO Number
Pro00084118
Researcher
Lara Wine lee

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Keywords
Drug Studies, Pediatrics, Skin
Summary

The purpose of this study is to test and compare the effects of an investigational (being tested) drug called apremilast to placebo in pediatric plaque psoriasis.
Participants who are determined to be eligible to participate will be assigned by chance (or randomized) to treatment with apermilast or placebo. At Week 16, participants will receive apremilast regardless of treatment group. Study and safety assessments, including questionnaires and blood draws, will be completed at study visits. The maximum amount of time participants will be in the study is 71 weeks (at least 19 visits).

Institution
MUSC
Recruitment Contact
Reshil-Marie Dukes
843-792-0387
dukesre@musc.edu

A Phase 2, Multicenter, Single-Arm Trial of CV301 in Combination with PD-1/L1 Blockade in Patients with Locally Advanced or Metastatic Urothelial Bladder Cancer Save

Date Added
January 8th, 2019
PRO Number
Pro00081883
Researcher
Michael Lilly

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Keywords
Bladder, Cancer, Drug Studies, Urinary
Summary

The purpose of this study is to is to investigate the combination of CV301 (an experimental cancer vaccine) with anti-PD-1 Therapy (atezolizumab which was approved for the treatment of advanced Urothelial Bladder Cancer) for treatment of locally advanced or metastatic UC.
CV301 involves the use of a two-component dosing regimen; a prime vaccine, MVA-BN-CV301 (the first vaccine generating a response from your immune system) and a boost vaccine, FPV-CV301 (the second vaccine increasing and maintaining the response of your immune system). Treatment with anti-PD-1 therapy may help the immune system detect and attack cancer cells.
In this clinical trial the use of CV301 vaccine in combination with atezolizumab infusion is being investigated to determine whether the overall survival and immune response observed in subjects treated with atezolizumab can be enhanced when combined with CV301.
This clinical trial is being performed at up to 8 clinical trial sites, and 68 people in total will be selected to participate. The trial is scheduled to last up to 104 weeks from the time you are first seen at the trial site until you start the long-term follow-up contacts. Once deemed eligible for participation, visits are every 3 weeks for the first 16 weeks on study. Then, visits will be every 6 weeks until week 28 on study, at which time visits will be every 12 weeks until end of treatment.
Participation in this trial will not guarantee any direct or immediate benefit, but can help gain future knowledge about the treatment of UC that may be beneficial to others with this disease.

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

A Phase 2b, Open-Label, Single Arm, Multi-Center Study to Assess the Efficacy and Safety of BST-236 as a Single Agent in Adults with Newly-Diagnosed Acute Myeloid Leukemia, Not Eligible for Standard Induction Therapy Save

Date Added
January 8th, 2019
PRO Number
Pro00083544
Researcher
Robert Stuart

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

This study is for subjects with newly-diagnosed acute myeloid leukemia (AML) who are not eligible for standard induction chemotherapy. The investigational drug in this study is BST-236, which is given via IV. The purpose of this research study is to measure the safety of BST-236 and how effective it is in treating subjects. Visits will be required for 6 consecutive days during each cycle of treatment. The number of courses you receive will depend on whether you are benefiting from the study drug. Participants can expect to be in this study for 2 years (including treatment and post study follow-up).

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

A Phase 3, Open-Label, Multi-Center Trial to Evaluate the Long-Term Safety and Efficacy of Repeat Treatments of DaxibotulinumtoxinA for Injection in Adults with Isolated Cervical Dystonia (ASPEN-OLS) Save

Date Added
December 11th, 2018
PRO Number
Pro00078648
Researcher
Christine Cooper

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Keywords
Central Nervous System, Drug Studies, Movement Disorders, Muscle, Nerve
Summary

The purpose of this study is to evaluate the safety and effectiveness of daxibotulinumtoxinA for injection (a new investigational study drug) compared to placebo in the treatment of cervical dystonia (CD). DaxibotulinumtoxinA for injection is composed of purified botulinum toxin type A, formulated with a small protein RTP004, and will be used for injection.

If you are eligible and choose to be in the study, the dose of study drug you receive (125 units or 250 units) will depend on your clinical assessment, the severity of your disease, and whether you have had any toxin before.

The study may last up to 55 weeks, including 3 weeks of screening. You will come to the study center up to 15 times.

The study is being done at approximately 80 sites. Approximately 290 adults with moderate to severe isolated CD, who are 18-80 will take part study-wide and 4 will take part at this institution.

Institution
MUSC
Recruitment Contact
Timothy Sheehan
843-792-0372
sheehant@musc.edu

FIGHT: A Phase 3 Randomized, Double-Blind, Controlled Study Evaluating FPA144 and Modified FOLFOX6 in Patients with Previously Untreated Advanced Gastric and Gastroesophageal Cancer: Phase 3 Preceded by Dose-Finding in Phase 1 Save

Date Added
November 30th, 2018
PRO Number
Pro00079574
Researcher
Daniel Reuben

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Keywords
Cancer, Cancer/Gastrointestinal, Drug Studies
Summary

The purpose of this study is to evaluate the safety and effectiveness of a new investigational compound, called FPA144, in combination with chemotherapy (a combination of 5-fluorouracil, oxaliplatin, and leucovorin called mFOLFOX6), for the treatment of gastric and/or gastroesophageal cancer and other solid tumors. The entire study (Phase 1 and Phase 3) is expected to take about 66 months to complete. MUSC is participating in the phase 3 portion only.

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

A Phase Ib Open-Label, Dose-Finding Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of Avelumab in Combination with M9241 (NHS-IL12) in Subjects with Locally Advanced, Unresectable, or Metastatic Solid Tumors Save

Date Added
November 27th, 2018
PRO Number
Pro00080265
Researcher
Theodore Gourdin

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

The purpose of this study is to assess how effective the combination of avelumab and NHS-IL12 is in subjects with solid tumors. It will also collect more information on how safe and well-tolerated the combined study drugs are. Subjects will undergo a series of treatment cycles, each lasting 28 days. On Day 1 of each cycle, you will receive NHS IL12 immediately followed by avelumab on scheduled days. You will be assigned to receive avelumab every two weeks or to receive avelumab once a week. Both you and your study doctor will know which dose of study drugs you are receiving during the study.

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

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multi-Center Trial to Evaluate the Efficacy and Safety of a Single Treatment of DaxibotulinumtoxinA for Injection in Adults with Isolated Cervical Dystonia (ASPEN-1) Save

Date Added
November 13th, 2018
PRO Number
Pro00078538
Researcher
Christine Cooper

List of Studies

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Keywords
Central Nervous System, Drug Studies, Movement Disorders, Muscle, Nerve
Summary

The purpose of this study is to evaluate the safety and effectiveness of daxibotulinumtoxinA for injection (a new investigational study drug) compared to placebo in the treatment of cervical dystonia (CD). DaxibotulinumtoxinA for injection is composed of purified botulinum toxin type A, formulated with a small protein RTP004, and will be used for injection. Placebo means it doesn't contain botulinum toxin type A.

If you are eligible and choose to be in the study, the dose of study drug you receive will depend on the group that you will be put into after randomization at the time of your entry.

You will be assigned, by chance, to 1 of the 3 groups below:
? Group 1: High-dose (250 Units of daxibotulinumtoxinA for injection)
? Group 2: Low-dose (125 Units of daxibotulinumtoxinA for injection)
? Group 3: Placebo (a substance that looks like daxibotulinumtoxinA for injection but has no drug in it)

Study lasts aproximately 39 weeks, including 3 weeks of screening. You will come to the study center up to 12 times during the research study.

The study is being done at approximately 80 sites. Approximately 300 people will take part study-wide and 4 will take part at this institution.

Institution
MUSC
Recruitment Contact
Timothy Sheehan
843-792-0372
sheehant@musc.edu

A Phase 2 Open-Label Single-Arm Study to Evaluate the Efficacy and Safety of Loncastuximab Tesirine in Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL) Save

Date Added
November 13th, 2018
PRO Number
Pro00083282
Researcher
Brian Hess

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

This study is for subjects that have been diagnosed with diffuse large B-cell lymphoma (DLBCL). The investigational drug in this study is loncastuximab tesirine (ADCT-402). The purpose of this Phase 2 study is to evaluate the effectiveness and safety of loncastuximab tesirine in subjects with DLBCL that has not responded to treatment or has come back after treatment.Treatment will occur every 3 weeks. The follow up treatment period will last up to approximately 3 years.

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

A PHASE 2, OPEN-LABEL, RANDOMIZED STUDY OF ALT-803, A FUSION PROTEIN ACTIVATOR OF NATURAL KILLER AND T CELLS, IN COMBINATION WITH PEMBROLIZUMAB VS PEMBROLIZUMAB ALONE AS FIRST-LINE TREATMENT FOR PATIENTS WITH METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) Save

Date Added
September 25th, 2018
PRO Number
Pro00080330
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 who have been diagnosed with metastatic, non-small cell lung cancer (NSCLC), have not received any prior chemotherapy for metastatic disease, and are eligible to receive pembrolizumab, a FDA approved standard therapy for NSCLC. The investigational drug in this study is ALT-803. In this research study, participants will be selected by chance to receive either the study drug ALT-803 in combination with pembrolizumab or will receive pembrolizumab alone. The purpose of this research study is to test the effectiveness of the study drug, ALT-803, in combination with pembrolizumab compared to pembrolizumab alone. Participants can expect to be in this study for 24 months.

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

A Phase 1b-2 Study of Niraparib Combination Therapies for the Treatment of Metastatic Castration-Resistant Prostate Cancer Save

Date Added
September 25th, 2018
PRO Number
Pro00080886
Researcher
Michael Lilly

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Keywords
Cancer, Cancer/Genitourinary, Drug Studies, Prostate
Summary

The purpose of this research study is to determine the effectiveness and safety of niraparib used in combination with JNJ-63723283 in the treatment of subjects with advanced prostate cancer. The study medication, niraparib and JNJ-63723283 are given in cycles, with each cycle lasting 28 days. You will continue study medication for as long as your disease does not appear to be getting worse based on assessments by your doctor.

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

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