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

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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

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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

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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

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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

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Selonsertib, GS-0976, GS-9674, and Combinations in Subjects with Bridging (F3) Fibrosis or Compensated Cirrhosis (F4) due to Nonalcoholic Steatohepatitis (NASH) Save

Date Added
April 10th, 2018
PRO Number
Pro00076641
Researcher
Don Rockey

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Keywords
Diabetes, Digestive System, Drug Studies, Exercise, Hypertension/ High Blood Pressure, Liver, Men's Health, Metabolism, Nutrition, Obesity
Summary

This is a Phase 2, randomized, double-blind, placebo-controlled study
evaluating the safety and efficacy of SEL, GS-0976, GS-9674, and
combinations in subjects with bridging fibrosis or compensated
cirrhosis due to NASH.
Subjects meeting the study's entry criteria will be randomly assigned in
a 2:2:1:1:1:1:2 ratio to 1 of 7 treatment groups, with approximately
70 subjects in each combination treatment group and approximately 35
subjects in each single agent or placebo group.

Institution
MUSC
Recruitment Contact
Megan Bickford
843-876-8439
liverstudies@musc.edu

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

Silhouette
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

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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

Silhouette
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

Evaluating Precision Medicine among Male Primary Care Patients Save

Date Added
February 9th, 2018
PRO Number
Pro00074274
Researcher
Chanita Hughes-halbert

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Keywords
Immune System, Inflammation, Men's Health
Summary

It is important to understand multiple personal-level factors that impact disease risks and outcomes to determine the most effective ways to establish precise medical strategies to prevent, diagnose, and treat chronic health conditions and diseases. This is especially important among minority and underserved populations that would benefit from more tailored healthcare approaches. This study will develop and assess strategies for circulating evidence about precision medicine and improving precision medicine approaches.

Institution
MUSC
Recruitment Contact
Melanie Jefferson
843-876-2430
sweatma@musc.edu

A phase 1b dose-escalation and dose-expansion study of enfortumab vedotin (ASG-22CE) in combination with immune checkpoint inhibitor (CPI) therapy for treatment of patients with locally advanced or metastatic urothelial cancer Save

Date Added
December 12th, 2017
PRO Number
Pro00072223
Researcher
Theodore Gourdin

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

This is a study that will test how an experimental drug (enfortumab vedotin) combined with a kind of anticancer drug called an immune checkpoint inhibitor (CPI) affects patients with cancer of the urinary system (urothelial cancer). This type of cancer includes cancer of the bladder, renal pelvis, ureter or urethra that has spread to nearby tissues or to other areas of the body.

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

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