A Phase 1b, Randomized, Open-Label Study Of PEGylated Recombinant Human Hyaluronidase (PEGPH20) In Combination With Cisplatin Plus Gemcitabine And PEGPH20 In Combination With Atezolizumab And Cisplatin Plus Gemcitabine Compared With Cisplatin Plus Gemcitabine In Hyaluronan-High (HA-high) Subjects With Previously Untreated Unresectable, Locally Advanced Or Metastatic Intrahepatic And Extrahepatic Cholangiocarcinoma And Gallbladder Cancer Save

Date Added
October 24th, 2017
PRO Number
Pro00071570
Researcher
Carolyn Britten

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

The purpose of this study is to study test investigational drugs PEGPH20 and Atezolizumab in combination with the current standard of care medications Cisplatin and Gemcitabine.

Subjects are being asked to participate in this study because they are/have intrahepatic and extra hepatic cholangiocarcinoma or gallbladder adenocarcinoma which are types of cancers associated with the liver or biliary system. The study is sponsored by Halozyme.

This study involves the adiminstration of an invetigational drug (not approved by the FDA) PEGPH20 in order to determine what a safe dose is when given with Cisplatin and Gemcitabine, what the side effects are, and whether or not it will help treat the kind of cancer you have. PEGPH20 is an enzyme (protein that can speed biochemical reactions) that breaks down a specific substance called hyaluronan produced by some tumors. The removal of hyaluronan from tumors has been shown to inhibit tumor growth.

Atezolizumab is an immunotherapy drug which means it assists your immune system in fighting your cancer. This drug has been approved by the United States Food and Drug Administration (FDA) to treat bladder and lung cancer, but is investigational with the drugs described above and for the diagnosis of intrahepatic and extra hepatic cholangiocarcinoma or gallbladder adenocarcinoma . The other therapy that is given in this study is standard of care chemotherapy drugs Cisplatin and Gemcitabine, which are drugs that are routinely given to treat patients with cholangiocarcinoma or gallbladder adenocarcinoma cancers who are not in research studies.

The investigator in charge of this study at MUSC is Dr. Carolyn Britten. Approximately 70 subjects will take part study wide at about 20 centers in the United States and 10 centers in Asia. Halozyme will be providing funding to MUSC and Dr. Britten for conducting this research.

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

A Phase 1 Dose Escalation and Cohort Expansion Study of TSR-022, an Anti-TIM-3 Monoclonal Antibody, in Patients With Advanced Solid Tumors Save

Date Added
October 10th, 2017
PRO Number
Pro00069285
Researcher
Carolyn Britten

Silhouette
Keywords
Cancer, Men's Health, Women's Health
Summary

The purpose of this study to learn more about a new experimental drug called TSR-022 and its effect on the subject's cancer when used either alone or with another experimental drug called TSR-042. TSR-022 is considered investigational, which means that TSR-022 alone or in combination with TSR-042 has not been approved by any regulatory authorities, including the United States Food and Drug Administration (FDA), and is not available in stores or by prescription.
The main purposes of Part 2 are to:
Look at the ability of TSR-022 when taken alone or in combination with TSR-042 to make the cancer smaller
Confirm the recommended phase 2 dose and dosing schedule of TSR-022 when taken by itself
Confirm the recommended phase 2 dose and dosing schedule of TSR-022 when taken with TSR-042 as Combination Therapy.
This study will enroll patients with advanced melanoma, advanced colorectal cancer and advanced non-small cell lung cancer (NSCLC).

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

Aneurysmal Subarachnoid Hemorrhage Trial RandOmizing Heparin Save

Date Added
September 26th, 2017
PRO Number
Pro00051279
Researcher
Alejandro Spiotta

Silhouette
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

Silhouette
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
Brian Hess

Silhouette
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 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

Silhouette
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

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

Silhouette
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

Communicating & disseminating research findings to study participants Save

Date Added
June 16th, 2017
PRO Number
Pro00067659
Researcher
Teresa Kelechi

Silhouette
Keywords
Adolescents, Cancer, Diabetes, Healthy Volunteer Studies, Infectious Diseases, Lung, Men's Health, Mental Health, Obesity, Rehabilitation Studies, Stroke, Women's Health
Summary

Many individuals who volunteer to participate in research studies are never informed about the results of those studies, and what the researchers learned from having conducted them. We believe that if researchers share results of studies with those who participated in them as volunteers, these past participants may be more likely to feel positively that they have contributed to improving the health in their communities, be more likely to enroll in other studies in the future, share their experience with others, encourage others to participate in research, and experience other positive outcomes. We want to know people's feelings about the importance of receiving study findings and how they would prefer to receive such information (what channels/formats, what kinds of messages, etc). In this study, we are looking to get the feedback of adolescents (ages 15 through 24) and older adults (50 and over) who completed their participated in an MUSC study between January 1, 2010 and present. We are also looking for MUSC researchers whose research studies have included adolescents and older adults between January 1, 2010 and the present, to get their feedback on their current strategies of sharing findings and what they believe might be best practices for doing so. Participation in our study will involve surveys and focus groups interviews.

Institution
MUSC
Recruitment Contact
Dana Burshell
843-792-1497
burshell@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

Silhouette
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

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
Robert Stuart

Silhouette
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

Change_preferences

-- OR --

Create_login