Aneurysmal Subarachnoid Hemorrhage Trial RandOmizing Heparin Save

Date Added
September 26th, 2017
PRO Number
Pro00051279
Researcher
Alejandro Spiotta
Keywords
Adolescents, Brain, Drug Studies, Men's Health, Minorities, Obesity, Pain, Stroke, Women's Health
Summary

The purpose of this study is to determine if giving the medicine ?heparin? intravenously (through the veins) continuously for up to 14 days to subjects after a brain aneurysm has burst will help improve the chances of subjects having a good recovery after the bleed compared to subjects who get routine brain aneurysm care (standard of care). Patients who get routine care would also get heparin, but they would typically get an overall lower dose and the heparin would be injected under the skin (heparin shot) instead of in the veins.

Institution
MUSC
Recruitment Contact
Amora Mayo-Perez
843-792-1737
mayoaper@musc.edu

QUILT-3.055: A Phase IIb, Single-Arm, Open-Label Study of ALT-803 in Combination with Pembrolizumab or Nivolumab in Patients with Advanced or Metastatic Non-Small Cell Lung Cancer who have Disease Progression Following an Initial Response to Treatment with PD-1 Checkpoint Inhibitor Therapy Save

Date Added
August 22nd, 2017
PRO Number
Pro00068710
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 advanced or metastatic non-small cell lung cancer (NSCLC) whose disease improved or remained unchanged after receiving nivolumab or pembrolizumab and whose disease has now worsened. The investigational drug in this study is called ALT-803. Participants can expect to receive the study drug ALT-803 in combination with an approved drug called pembrolizumab or they will receive ALT-803 in combination with an approved drug called nivolumab. Participants will receive ALT-803 in combination with pembrolizumab if they have previously received pembrolizumab. They will receive ALT-803 in combination with nivolumab if they have previously received nivolumab. The purpose of this research study is to test the effectiveness of the study drug, ALT-803, in combination with either pembrolizumab or nivolumab in patients with advanced or metastatic NSCLC that initially had improvement or no change in disease after receiving pembrolizumab or nivolumab 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 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
Juan Varela
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 3 Randomized, Open-Label Study Comparing Pexa-Vec (Vaccinia GM-CSF / Thymidine Kinase-Deactivated Virus) Followed by Sorafenib Versus Sorafenib in Patients with Advanced Hepatocellular Carcinoma (HCC) Without Prior Systemic Therapy Save

Date Added
June 27th, 2017
PRO Number
Pro00066060
Researcher
Juan Camacho
Keywords
Cancer, Cancer/Gastrointestinal, Liver, Men's Health, Vaccine, Women's Health
Summary

This is a randomized Phase 3 study to determine whether treatment with vaccinia virus based immunotherapy (Pexa-Vec) followed by sorafenib increases survival compared to treatment with sorafenib in patients with advanced hepatocellular carcinoma who have not received prior systemic therapy

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

A Phase 1/2 Study on the Safety of Rovalpituzumab Tesirine Administered in Combination with Nivolumab or Nivolumab and Ipilimumab for Adults with Extensive-Stage Small Cell Lung Cancer Save

Date Added
June 27th, 2017
PRO Number
Pro00065422
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 extensive-stage small cell lung cancer (SCLC). This study is being conducted to test whether or not rovalpituzumab tesirine (SC16LD6.5) combined with nivolumab alone or with nivolumab and ipilimumab are useful treatments for small cell lung cancer, after at least one prior treatment has failed.The investigational drugs in this study are Rovalpituzumab Tesirine (SC16LD6.5), Nivolumab (BMS-936558, MDX1106, ONO-4538, Opdivo®), and Ipilimumab (MDX-010, Yervoy®) . If participants agree to take part in this study, their involvement will last for as long as their study doctor confirms their cancer is not getting worse and there have been no significant side effects. There is no limit to the number of cycles of study treatment participants can receive.

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

An Open-Label, Multicenter, Dose-Escalation Phase I Study To Evaluate The Safety, Pharmacokinetics, And Therapeutic Activity Of Ro6958688, A Novel T-Cell Bispecific Antibody That Targets The Human Carcinoembryonic Antigen (Cea) On Tumor Cells And Cd3 On T Cells, Administered Intravenously In Patients With Locally Advanced And/Or Metastatic Cea(+) Solid Tumors Save

Date Added
May 23rd, 2017
PRO Number
Pro00065238
Researcher
Michael Lilly
Keywords
Men's Health, Women's Health
Summary

The purpose of this study is to find out, as a main objective, at which doses RO6958688 (study drug) can be administered safely to subjects and what the side effects are. Additionally, the effects of RO6958688 in the subject's body, and particularly in the subject's tumor, will be evaluated. The study also aims to find out if RO6958688 can slow down the growth of tumors or stop the cancer, in subjects with locally advanced and/or metastatic solid tumors.
RO6958688 is an investigational study drug which means it has not been approved by the FDA.
Subjects will receive RO6958688 weekly for several weeks or once every three weeks for several weeks. Depending on when the subject will be enrolled into the study, they will receive RO6958688 according to one of 3 different dosing schedules. The dose to be received will depend upon the observations made in all patients who have received the RO6958688 before you. Approximately 180 subjects will enroll into this part of the study, approximately 10 will take part at MUSC. Dr. Lilly will be the Primary Investigator at MUSC.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-4271
hcc-clinical-trials@musc.edu

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Active Comparator, Parallel-Group Study of the Efficacy and Safety of Lemborexant in Subjects 55 Years and Older with Insomnia Disorder Save

Date Added
May 9th, 2017
PRO Number
Pro00066197
Researcher
Thomas Uhde
Keywords
Aging, Men's Health, Sleep Disorders, Women's Health
Summary

The study is a multicenter, randomized, double-blind, placebo-controlled, active comparator, parallel-group study of 2 dose levels of lemborexant for approximately 6 weeks in approximately 950 participants, 55 years or older with insomnia disorder. Participants will be males 65 years or older or females 55 years or older. At least 60% of the participants will be age 65 years or older. The study will have 2 phases: The Prerandomization Phase and the Randomization Phase. Including both phases, the study will last for a minimum of 65 and a maximum of 81 days per participant.

Institution
MUSC
Recruitment Contact
Allison Wilkerson
8437924636
wilkersa@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
Juan Varela
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

AN OPEN-LABEL PHASE 2 STUDY OF DENINTUZUMAB MAFODOTIN (SGN-CD19A) IN COMBINATION WITH RCHOP (RITUXIMAB, CYCLOPHOSPHAMIDE, DOXORUBICIN, VINCRISTINE, AND PREDNISONE) OR RCHP (RITUXIMAB, CYCLOPHOSPHAMIDE, DOXORUBICIN, AND PREDNISONE) COMPARED WITH RCHOP ALONE AS FRONTLINE THERAPY IN PATIENTS WITH DIFFUSE LARGE B-CELL LYMPHOMA (DLBCL) OR FOLLICULAR LYMPHOMA (FL) GRADE 3B Save

Date Added
April 11th, 2017
PRO Number
Pro00064390
Researcher
Brian Hess
Keywords
Cancer, Cancer/Lymphoma, Drug Studies, Men's Health, Women's Health
Summary

This study is for patients that have been diagnosed with diffuse large B-cell lymphoma (DLBCL) or Grade 3b follicular lymphoma that has never been treated. The investigational drug in this study is denintuzumab mafodotin. The purpose of this study is to find out what the side effects are and whether it is more or less effective when it is given together with other drugs that are a standard approved treatment for use in patients with lymphoma (DLBCL or FL3B). Participants can expect to be in the study for 4 years or until the study is closed or until they stop taking part.

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

An Open-label, Multicenter, Dose Escalation and Expansion Phase Ib Study to Evaluate the Safety, Pharmacokinetics, and Therapeutic Activity of Ro6958688 in Combination With Atezolizumab in Patients With Locally Advanced and/or Metastatic Cea-positive Solid Tumors Save

Date Added
March 28th, 2017
PRO Number
Pro00064800
Researcher
Michael Lilly
Keywords
Men's Health, Women's Health
Summary

The purpose of this study is to find out at which doses the investigational drug RO6958688 (study drug) can be administered safely to patients in combination with atezolizumab (study drug), and what the side effects are when both drugs are given together.
The study will be conducted in two parts.
Part I ? Patients will receive the study drug RO6958688 every week or every 3 weeks and atezolizumab every 3 weeks
Part II ? Patients will receive study drugs with the dose and schedule of RO6958688 determined in the Part I of the study and atezolizumab at 1200 mg every 3 weeks. Approximately 25 patients may be enrolled for this expansion part.
The investigator in charge of this study at MUSC is Dr. Michael Lilly. The study is being done at 26 sites in Europe and in the USA . Approximately 125 people will take part study-wide, and approximately 5 at MUSC.

Institution
MUSC
Recruitment Contact
James Brisendine
843-792-4271
hcc-clinical-trials@musc.edu

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