A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study of Olezarsen (ISIS 678354) Administered Subcutaneously to Patients with Severe Hypertriglyceridemia

Date Added
July 18th, 2023
PRO Number
Pro00127774
Researcher
Marc-Andre Cornier

List of Studies

Keywords
Cardiovascular, Cholesterol, Drug Studies, Men's Health, Women's Health
Summary

This clinical research study is enrolling adults who have high triglycerides (fats in the blood). The study drug, olezarsen, is an investigational drug designed to reduce triglyceride blood levels. If you meet the requirements to participate in this study, you will be randomly assigned to receive either olezarsen or placebo (an inactive substance that contains no drug). During the treatment period, participants will be asked to complete visits every 4 weeks to include a total of 21 visits over approximately 16 months. If eligible, study medication and study visits will be provided free of charge. Compensation is available.

Institution
MUSC
Recruitment Contact
Kelcey Ladner
843-792-6043
ladnerk@musc.edu

A Phase 1 Study of the SHP2 Inhibitor BBP-398 (formerly known as IACS-15509) in Combination with the Programmed Death Receptor-1 Blocking Antibody Nivolumab in Patients with Advanced Non-Small Cell Lung Cancer with a KRAS Mutation

Date Added
June 27th, 2023
PRO Number
Pro00127111
Researcher
Mariam Alexander

List of Studies

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

This study is recruiting patients who have advanced non-small cell lung cancer (NSCLC) with a KRAS mutation whose cancer has not responded to standard of care treatment. (All human cells have a gene called KRAS. If cells have a KRAS mutation, the cells may multiply out of control which can cause cancer.) This study has two parts. The first part of the study is being done to find the safety, tolerability and safe dose of a study drug called BBP-398 when it is used in combination with another drug that has already been approved for use by the Food and Drug Administration, called Nivolumab. The second part of the study is being done to further understand the how tumors are affected by the study drug, BBP-398, and Nivolumab. About 26 patients in the United States will participate in this study. You may be eligible if you have NSCLC with a KRAS mutation that has not responded to standard treatment. Patients who enroll in this study will be required to come to MUSC for study treatments and follow-up visits. The participation in the study can last up to 2 years with a follow up period of 3 years.

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

A Phase 2 Study of Magrolimab Combination Therapy in Patients With Head and Neck Squamous Cell Carcinoma

Date Added
June 13th, 2023
PRO Number
Pro00127533
Researcher
John Kaczmar

List of Studies


Keywords
Cancer, Cancer/Head & Neck, Drug Studies, Men's Health, Women's Health
Summary

The purpose of this study is to evaluate magrolimab in combination with pembrolizumab only, with pembrolizumab + platinum + 5-FU chemotherapy, and with zimberelimab + platinum + 5-FU chemotherapy in patients with untreated metastatic head and neck cancer. Magrolimab will also be evaluated in combination with docetaxel in patients with metastatic head and neck cancer who have received prior treatment.

This study is split into two phases, the initial phase (safety run-in) is to confirm a safe dose of magrolimab in combination with pembrolizumab + platinum + 5-FU chemotherapy and with docetaxel. The second phase will evaluate the effectiveness of magrolimab in combination with pembrolizumab only (without chemotherapy), with pembrolizumab + platinum + 5-FU chemotherapy, with zimberelimab + platinum + 5-FU, and with docetaxel.

Other purposes of this study include determining the quantity of magrolimab in the blood, your quality of life and the side effects these drugs have on the body.

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

Multicenter Phase 3 Pivotal Study to Evaluate the Safety and Efficacy of TOOKAD (padeliporfin) Vascular Targeted Photodynamic Therapy in the Treatment of Low Grade Upper Tract Urothelial Cancer

Date Added
June 1st, 2023
PRO Number
Pro00118327
Researcher
Robert Grubb

List of Studies


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

The study is for patients that have been diagnosed with low-grade non-invasive upper tract urothelial cancer. The investigational drug used in this study is padeliporfin which is injected into a vein. The main purpose of this study is to learn about the effects and safety of an investigational treatment named padeliporfin Vascular Targeted Photodynamic (VTP) Therapy, in treating low-grade non-invasive upper tract urothelial cancer. Participants can expect to be in this study for up to 18 months. The completion of the study will include up to 9 study visits to the study site and 8 phone visits.

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

UF-HN-004 Risk Adapted De-Intensification of Radio-Chemotherapy for Favorable Prognosis Oropharyngeal Squamous Cell Carcinoma based on HPV subtype and plasma circulating free HPV DNA Level and Clearance Rate.

Date Added
May 16th, 2023
PRO Number
Pro00124145
Researcher
Bhishamjit Chera

List of Studies

Keywords
Cancer, Cancer/Head & Neck, Men's Health, Women's Health
Summary

This study is for patients that have been diagnosed with Oropharyngeal Squamous Cell Carcinoma. The purpose of this research study is to determine if lower doses of radiation therapy are as effective as the standard higher doses. Participants will have tests and procedures that would be performed as part of regular care. Participants will be assigned to one of three study groups based on your risk for cancer recurrence. Depending on the group assigned, participants receive either standard dose of radiation therapy (RT), a moderately reduced dose of RT, or an extremely reduced dose of RT. During the RT treatment, participants will also receive chemotherapy. Chemotherapy will be given at the same dose used in routine care for everybody in the study. Participants will be in the study for up to 5 years.

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

Brightline-1: A Phase II/III, randomized, open-label, multi-center study of BI 907828 compared to doxorubicin as first line treatment of patients with advanced dedifferentiated liposarcoma

Date Added
May 9th, 2023
PRO Number
Pro00126917
Researcher
Daniel Reuben

List of Studies


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

The primary trial objective is to see if the study drug called BI 907828 may help people with dedifferentiated liposarcoma (DDLPS) and is better than the approved drug, doxorubicin.
Additional trial goals are to find an optimal dose of BI 907828
and to determine whether BI 907828 improves the response
rate, duration of response, overall survival, disease control rate, the tolerability and if the study drug has a positive impact on the quality of life, compared to doxorubicin.

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

Impact of stress and craving on return to cannabis use in postpartum women

Date Added
May 2nd, 2023
PRO Number
Pro00128029
Researcher
Constance Guille

List of Studies


Keywords
Drug Studies, Hormones, Non-interventional, Pregnancy, Substance Use, Women's Health
Summary

Cannabis is the most commonly used illicit substance among pregnant and postpartum women, with the postpartum period being a common time for relapse to cannabis. Currently there are no interventions for preventing return to cannabis use during this vulnerable time. The goal of this research is to better understand risk factors such as stress, craving, anxiety, mood, sleep, and hormone levels that may contribute to return to cannabis use during the postpartum period in order to help develop targeted prevention and treatment interventions in the future.

Institution
MUSC
Recruitment Contact
Lisa Nunn
843-792-0476
jenkinli@musc.edu

Neoadjuvant Screening Trial: LCMC4 Evaluation of Actionable Drivers in Early Stage Lung Cancer

Date Added
April 25th, 2023
PRO Number
Pro00127146
Researcher
Ian Bostock Rosenzweig

List of Studies

Keywords
Cancer/Lung, Lung, Men's Health, Women's Health
Summary

This collaborative study was developed by the Lung Cancer Mutation Consortium (LCMC) and supported by the Thoracic Surgery Oncology Group (TSOG). The purpose of this study is to determine if it is possible to identify genetic changes in the tumors or blood of patients with early-stage lung cancers using both blood-based and tumor-based testing when cancer is suspected or first diagnosed. In this trial, participants will be asked to provide blood samples at three different time points. They will also be asked for permission for tumor tissue to be sent to the researchers. Tumor tissue will be collected if there is a leftover sample from a participant's surgery. These samples will be sent to the researchers to be analyzed for genetic changes. The researchers hope that in the future, genetic changes can help doctors determine what the best treatment is for patients with early-stage lung cancer.

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

A Phase III, Randomized, Open-Label, Multicenter Study of Lurbinectedin in Combination with Atezolizumab Compared with Atezolizumab as Maintenance Therapy in Participants with Extensive Stage Small-Cell Lung Cancer (ES-SCLC) Following First-Line Induction Therapy with Carboplatin, Etoposide and Atezolizumab

Date Added
March 27th, 2023
PRO Number
Pro00118564
Researcher
Mariam Alexander

List of Studies

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

This study is for patients that have been diagnosed with extensive-stage small-cell lung cancer (ES-SCLC). The investigational drug in this study is lurbinectedin. Investigational means it is not yet approved by the Food and Drug Administration (FDA). The purpose of this study is to compare the effects, good or bad, of lurbinectedin in combination with atezolizumab versus atezolizumab alone in participants with ES-SCLC. Atezolizumab is already approved for treatment of ES-SCLC.

There are two phases of treatment. During the induction phase of the treatment, participants will receive 4 cycles of carboplatin, etoposide, and atezolizumab. One treatment cycle is 3 weeks long. During the maintenance phase of the treatment, participants will be placed in one of the following treatment groups: Arm A will receive atezolizumab and lurbinectedin given as an infusion (into the vein) on Day 1 of each 21-day cycle; Arm B will receive atezolizumab given as an infusion (into the vein) on Day 1 of each 21-day cycle.

During this study, participants will have visits approximately every 3 weeks while receiving treatment. Visits may last 3-6 hours. After the final dose, the study doctor will follow up about every 3 months. The total time in the study will depend on how the ES-SCLC responds to treatment. This could range from 1 day to more than 4 years.

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

Synergistic Interplay of Systemic Lupus Erythematosus (SLE) and Hypertension (HTN)

Date Added
January 13th, 2023
PRO Number
Pro00122811
Researcher
Justin Van Beusecum

List of Studies

Keywords
Healthy Volunteer Studies, Hypertension/ High Blood Pressure, Lupus, Women's Health
Summary

This study is to explore the relationship between lupus and hypertension (high blood pressure). Female volunteers between the ages of 18-65 are needed who meet 1 of 4 possible participation types: 1. Participants with diagnosis of lupus and hypertension, 2.Participants with lupus without hypertension, 3.Participants without lupus but have hypertension, or 4. Participants that have no lupus diagnosis or hypertension.

Study participation includes a 1 time visit to the Research Nexus and involves a review of currently available medical records and a brief participant questionnaire specific to demographics and behaviors. The study visit includes a series of 3 blood pressure readings and a blood collection of approximately 2 tablespoons of blood. Compensation is available.

Institution
MUSC
Recruitment Contact
Jonathan Flume
843-792-3926
jof63@musc.edu



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