Changes in Optic Nerve Sheath Diameter in Preeclamptic patients with Severe Features by Neurologic Criteria versus Diagnosis Without Neurologic Criteria, Compared to Controls. Save

Date Added
November 7th, 2018
PRO Number
Pro00078977
Researcher
Mary Sterrett
Keywords
Central Nervous System, Hypertension/ High Blood Pressure, Non-interventional, Obstetrics and Gynecology, Pregnancy, Women's Health
Summary

Preeclamptic patients will have an ultrasound done of their eyes, to look at the size of the nerve behind the eye. We will also recruit women without preeclampsia to be a comparison group.

Institution
MUSC
Recruitment Contact
Mary Sterrett
8434940554
sterretm@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
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 Study of SAR650984 (isatuximab) in Combination with Pomalidomide and Dexamethasone for the Treatment of Relapsed/Refractory Multiple Myeloma Save

Date Added
August 14th, 2018
PRO Number
Pro00078384
Researcher
Amarendra Neppalli
Keywords
Cancer, Drug Studies, Men's Health, Women's Health
Summary

This study is for subjects that have been diagnosed with Relapsed/Refractory
Multiple Myeloma. The investigational drug in this study is SAR650984 (isatuximab), administered via infusion.The main purpose of of this study is to evaluate the possible risks and the effectiveness of SAR650984 when given together with pomalidomide and dexamethasone (the combination being called the study treatment) in patients with multiple myeloma. Your participation in this study may last up to 8 weeks, or possibly longer if you are responding well to treatment.

Institution
MUSC
Recruitment Contact
Shanta Salzer
843-792-9321
hcc-clinical-trials@musc.edu

A Phase 2, Multicenter, Open-label Study to Evaluate the Efficacy and Safety of CDX-3379 in Combination with Cetuximab in Patients with Advanced Head and Neck Squamous Cell Carcinoma Save

Date Added
June 12th, 2018
PRO Number
Pro00076144
Researcher
Paul O'brien
Keywords
Cancer, Cancer/Head & Neck, Drug Studies, Men's Health, Women's Health
Summary

The purpose of this study is to see whether an investigational drug called CDX-3379 combined with cetuximab, a monoclonal antibody that targets a protein called EGFR, will shrink tumors for subjects with head and neck squamous cell carcinoma (HNSCC). This study is for patients who have been diagnosed with HNSCC and who have previously received cetuximab but who have since experienced progression. Both the investigational drug, CDX-3379, and cetuximab are administered intravenously (into a vein). Subjects can expect to participate in the study for 2 years or longer.

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

A PHASE Ib STUDY OF THE SAFETY AND PHARMACOKINETICS OF ATEZOLIZUMAB (ANTI?PD-L1 ANTIBODY) ALONE OR IN COMBINATION WITH AN IMMUNOMODULATORY DRUG AND/OR DARATUMUMAB IN PATIENTS WITH MULTIPLE MYELOMA (RELAPSED/REFRACTORY AND POST-AUTOLOGOUS STEM CELL TRANSPLANTATION) Save

Date Added
May 22nd, 2018
PRO Number
Pro00075616
Researcher
Amarendra Neppalli
Keywords
Cancer, Drug Studies, Men's Health, Women's Health
Summary

This study is for subjects that have been diagnosed with multiple myeloma. The investigational drug in this study is atezolizumab.The purpose of this study is to test the safety of various combinations of an experimental (not yet approved by the U.S. Food and Drug Administration [FDA] or any other regulatory authority outside the United States) drug called atezolizumab given with daratumumab, lenalidomide, and/or pomalidomide with or without dexamethasone (all approved by the FDA for the treatment of multiple myeloma) at different dose levels and to find out what effects, good or bad, the combination of these drugs has on you. Participants can expect to be in this study for 36 months.

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

A Phase III Randomized, Double-Blind Clinical Study of Pembrolizumab + Epacadostat vs Pembrolizumab + Placebo as a Treatment for Recurrent or Progressive Metastatic Urothelial Carcinoma in Patients who have Failed a First-Line Platinum-Containing Chemotherapy Regimen for Advanced/Metastatic Disease (KEYNOTE-698/ECHO-303) Save

Date Added
May 7th, 2018
PRO Number
Pro00077046
Researcher
Theodore Gourdin
Keywords
Cancer/Genitourinary, Drug Studies, Men's Health, Urinary, Women's Health
Summary

This study evaluates the efficacy and safety of pembrolizumab + epacadostat vs pembrolizumab + placebo as a treatment for recurrent or progressive metastatic urothelial carcinoma in patients who have failed a first-line platinum-containing chemotherapy regimen for advanced/metastatic disease.

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

Comparison of Length of Stay for Infants with GBS Unknown Mothers with Adequate vs Inadequate Treatment Save

Date Added
April 6th, 2018
PRO Number
Pro00077255
Researcher
Rachel Sigrest
Keywords
Children's Health, Disease Prevention, Infant, Non-interventional, Obstetrics and Gynecology, Pediatrics, Pregnancy, Women's Health
Summary

The primary investigators/residents have noted during clinical rotations that a significant number of GBS unknown mothers at SRHS are being treated with intrapartum antibiotics even without the presence of risk factors, presumably to decrease postpartum/neonatal length of stay.
Our study, a retrospective chart review, will determine whether or not length of stay is affected by treating GBS unknown mothers with intrapartum antibiotics in the absence of the aforementioned risk factors.
Potential benefits include the cost-effectiveness of decreased length of stay for these patients as well as decreased exposure to nosocomial infections for neonates. However, antibiotic stewardship and patient safety are also considerations. Another potential option for these patients is rapid GBS testing with PCR which can provide results in 1-2 hours compared with 24-48 hours for the standard culture. PCR is not currently available at SMC.

Institution
Spartanburg
Recruitment Contact
Rachel Sigrest
8643800885
racheljames1985@gmail.com

A randomized, double-blind Phase II study of pembrolizumab versus placebo in patients with head and neck cancers at high risk for recurrence or low-volume residual disease ? the PATHWay Study Save

Date Added
March 27th, 2018
PRO Number
Pro00076352
Researcher
John Kaczmar
Keywords
Cancer, Cancer/Head & Neck, Drug Studies, Men's Health, Women's Health
Summary

This study is for patients who have been diagnosed with squamous cell carcinoma of the head and neck (SCCHN). The investigational drug in this study is Pembrolizumab. The main purpose of this study is to attempt to reduce the risk of cancer recurrence using a drug called pembrolizumab. Participants can expect to be in this study for approximately 5 years.

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

A Phase 2, Prospective, Randomized, Open-label Study on the Efficacy of Defibrotide Added to Standard of Care Immunoprophylaxis for the Prevention of Acute Graft-versus- Host-Disease in Adult and Pediatric Patients After Allogeneic Hematopoietic Stem Cell Transplant Save

Date Added
February 27th, 2018
PRO Number
Pro00072922
Researcher
Michelle Hudspeth
Keywords
Cancer, Cancer/Leukemia, Children's Health, Drug Studies, Men's Health, Women's Health
Summary

This study is for subjects who have been diagnosed with acute leukemia or myelodysplastic syndrome (MDS) and are a candidate for allogeneic hematopoietic stem cell transplant (HSCT). The study is being done to learn if adding defibrotide to the standard medicines for prevention of acute Graft-versus-Host Disease (aGvHD), which is called immunoprophylaxis, will help to prevent aGvHD better than using the usual immunoprophylaxis medicines alone. The investigational drug in this study is called Defibrotide. The duration of participation for each patient is approximately 6 months.

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

A Multi-center, Randomized, Double-blind, Placebo-controlled Phase III Trial of the FLT3 Inhibitor Gilteritinib Administered as Maintenance Therapy Following Allogeneic Transplant for Patients with FLT3/ITD AML Save

Date Added
February 13th, 2018
PRO Number
Pro00072488
Researcher
Robert Stuart
Keywords
Cancer, Cancer/Leukemia, Drug Studies, Men's Health, Women's Health
Summary

This study is for patients who have been diagnosed with acute myeloid leukemia (AML) with a genetic mutation called FLT3/ITD. The investigational drug in this study is called gilteritinib (ASP2215). The main purpose of this study is to learn if it is safe and effective to treat patients who have FLT3/ITD AML with a study drug called gilteritinib (ASP2215) after transplant. The sponsor wants to know if this drug works better than a placebo to stop the AML from coming back. Participants can expect to be in this study for up to 7 years after they start the study drug.

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

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