A Phase 2/3 Adaptive, Double-blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of VX-147 in Adult and Pediatric Subjects with APOL1-mediated Proteinuric Kidney Disease

Date Added
May 11th, 2022
PRO Number
Pro00117678
Researcher
Roberto Pisoni

List of Studies


Keywords
Drug Studies, Genetics, Kidney, Minorities, Rare Diseases
Summary

This randomized, double-blind, placebo-controlled Phase 2/3 adaptive study involves an initial investigational blood test to determine if you have a specific variation related to kidney disease. The investigational blood test is to see if you have changes in your DNA of a gene called APOL1. People who have this gene variation may be at risk of losing their kidney function faster than others. If you have the variants (changes in DNA) you may be eligible to continue participation in the study. If you do not have the variants, you will not be eligible, and the study doctor will discuss your other options with you. If you decide to participate, there will be no cost to you and you will be compensated. This study will start by comparing two doses of VX-147 against placebo in subjects with APOL1-mediated kidney disease for 12 weeks. Subjects in Phase 2 will continue to Phase 3 once a dose for Phase 3 is selected. Then the Phase 3 dose of VX-147 will be evaluated for safety and effectiveness. If you meet the requirements and choose to take part in the study, you will be randomly assigned to a treatment group. You will not know which study treatment group you are assigned to and it is possible that you will receive placebo instead of VX-147. The study includes a screening, treatment, and follow-up period. The study will end after the last patient enrolled has completed 2 years in the study. This means some patients enrolling earlier could be in the study for up to 4 years.

Institution
MUSC
Recruitment Contact
Linda Walker
843-792-6109
walkerlp@musc.edu

Disparities in REsults of Immune Checkpoint Inhibitor Treatment (DiRECT): A Prospective Cohort Study of Cancer Survivors Treated with anti-PD-1/anti-PD-L1 Immunotherapy in a Community Oncology Setting

Date Added
June 22nd, 2022
PRO Number
Pro00121172
Researcher
Albert Lockhart

List of Studies

Keywords
Cancer
Summary

This study is for patients with invasive cancer I-IV and be scheduled to receive anti-PD-1/-L1 ICI-containing therapy. This study is being done to see if we can understand which patients will develop side effects from immune checkpoint inhibitors, and what kind of side effects they will get and can we predict long-term treatment outcomes after immune checkpoint inhibitor treatment, like which patients will have a cancer that shrinks or disappears.

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

Comparison of Anti-coagulation and anti-Platelet Therapies for Intracranial Vascular Atherostenosis

Date Added
June 30th, 2022
PRO Number
Pro00121190
Researcher
Christine Holmstedt

List of Studies


Keywords
Stroke
Summary

The purpose of this research study is to see whether ticagrelor and aspirin or rivaroxaban and aspirin compared to clopidogrel and aspirin will have the most success in preventing another stroke, bleed in the brain, or death in participants who have already had a stroke from a narrowed brain artery.

Institution
MUSC
Recruitment Contact
Caitlan LeMatty
8437928606
lemattyc@musc.edu

A Phase II Open-Label, Study of IMMU-132 in Metastatic Urothelial Cancer After Failure of Platinum-Based Regimen or Anti-PD-1/PD-L1 Based Immunotherapy

Date Added
July 26th, 2022
PRO Number
Pro00118909
Researcher
Theodore Gourdin

List of Studies


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

This study is for subjects that have metastatic urothelial cancer (mUC). Metastatic means your cancer has spread outside the area where it started and has spread to distant parts or organs of the body. This study is testing an "investigational" (not yet Food and Drug Administration, FDA, approved drug) study drug called sacituzumab govitecan. Sacituzumab govitecan is given intravenously, through IV. The primary purpose of this study is to evaluate treatment with sacituzumab govitecan alone and in combination with other treatments namely cisplatin, avelumab and pembrolizumab improves tumor shrinkage. They are antibodies made in a laboratory that blocks signals that the cancer sends to quiet your immune system. By blocking that signal your immune system can see the cancer as foreign and fight it. The subject may remain in the study for 18 months. They may receive additional treatment beyond 18 months if they are tolerating and showing benefit form the treatment.

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

A Phase 1b/2 Study of HCW9218, a Bifunctional TGF-β Antagonist/IL-15 Protein Complex, for Advanced Pancreatic Cancer

Date Added
July 26th, 2022
PRO Number
Pro00121308
Researcher
Albert Lockhart

List of Studies

Keywords
Cancer, Drug Studies
Summary

An experimental drug called HCW9218 is being tested in this study. HCW9218 is not approved by the Food and Drug Administration (FDA) or any other health authority for the treatment of cancer or any other disease. Since HCW9218 is experimental, it is only available to people taking part in this study. This study is for participants diagnosed with advanced pancreatic and the disease has spread or cannot be surgically corrected. This is a Phase 1b/2 study, meaning that it is a first in human research study and there is no data on HCW9218 in humans. This study tests different doses of HCW9218 to see which dose is safer in people, how well the treatment is tolerated and whether it has effects on the disease. The study doctor will tell participants which part of this study that they will take part in, the dose escalation phase or dose expansion phase. The dose escalation phase the part of a study that determines the best dose of a new drug or treatment. In a dose-escalation study, the dose of the test drug is increased a little at a time in different groups of people until the highest dose that does not cause harmful side effects is found. In the dose-expansion part of a study allows more participants to receive the study drug to further test the potential side effects of the drug. HCW9218 is given as an injection under the skin (subcutaneous injection). If participants continue in this study, he/she will begin receiving HCW9218 treatment every 28 days. HCW9218 is given as an injection under the skin (subcutaneous injection). For each day participants receive HCW9218, participants will be treated as an outpatient in a treatment center. Participants will be asked to stay in the treatment center for up to 6 hours after the first dose, 3 hours after the second dose, and 30 minutes after subsequent doses, so that the study team can carefully monitor the body's functions and closely watch for potential side effects of the study drug. This study will last about 4 years. Participants will be treated with HCW9218 until disease progression or until they can no longer tolerate the study drug. Participants could be in this study for up to 3 years. There may be risks associated with being treated with HCW9218. Some of the most common side effects that the study doctors know about based on drugs that are similar to HCW9218 are: injection site irritation/ reaction, fatigue/ tiredness, and flu-like symptoms.

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

A Randomized Phase II/III Trial of Modern Immunotherapy Based Systemic Therapy With or Without SBRT for PD-L1-Negative, Advanced Non-Small Cell Lung Cancer

Date Added
August 2nd, 2022
PRO Number
Pro00121443
Researcher
Mariam Alexander

List of Studies

Keywords
Cancer, Cancer/Lung, Lung
Summary

This study is for patients who have been diagnosed with advanced non-small cell lung cancer. The purpose of this study is to compare the usual treatment alone to using SBRT plus the usual treatment. This study will help the study doctors find out if this different approach is better than the usual approach. To decide if it is better, the study doctors will be looking to see if the addition of SBRT increases the life of patients by 6 months or more compared to the usual approach. The study drugs are nivolumab and ipilimumab. Participants can expect to be on this study for up to 2 years.

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

PHASE III TRIAL OF SALVAGE STEREOTACTIC RADIOSURGERY (SRS) OR SRS + HIPPOCAMPALAVOIDANT WHOLE BRAIN RADIOTHERAPY (HA-WBRT) FOR FIRST OR SECOND DISTANT BRAIN RELAPSE AFTER UPFRONT SRS WITH BRAIN METASTASIS VELOCITY ≥4 BRAIN METASTASES/YEAR

Date Added
August 4th, 2022
PRO Number
Pro00122545
Researcher
Charlotte Rivers

List of Studies


Keywords
Cancer/Brain
Summary

This study is for men or women who received stereotactic radiosurgery to treat cancer that spread to their brain, and now the cancer has returned in other areas of the brain. This study is being done to see if by adding radiation therapy called whole-brain radiation therapy that avoids the hippocampus to preserver memory plus medication approved to treat dementia can extend these patients lives.

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

Phase III Study of Local or Systemic Therapy INtensification DIrected by PET in Prostate CAncer Patients with Post-ProstaTEctomy Biochemical Recurrence (INDICATE)

Date Added
August 5th, 2022
PRO Number
Pro00122143
Researcher
Harriet Eldredge-Hindy

List of Studies

Keywords
Cancer/Genitourinary, Prostate
Summary

This study is for men with prostate cancer that has come back after surgery. This study is being done to see if PET/CT scans help provide more tailored treatment recommendations and outcomes for men who have prostate cancer after radical prostatectomy (RP) and will adding focal, metastasis directed radiation treatment (e.g.., stereotactic radiation) and/or additional systemic therapy (e.g., apalutamide) to standard of care treatment help to delay progression of prostate cancer in men who have already had an RP and now have recurrence?

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

MEPITEL FILM FOR THE REDUCTION OF RADIATION DERMATITIS IN BREAST CANCER PATIENTS UNDERGOING POST-MASTECTOMY RADIATION THERAPY: A RANDOMIZED PHASE III CLINICAL TRIAL

Date Added
August 15th, 2022
PRO Number
Pro00122724
Researcher
Jennifer Harper

List of Studies


Keywords
Cancer/Breast
Summary

This study is for patients who have been diagnosed with breast cancer and their doctor has recommended that they receive radiation therapy after their mastectomy to reduce the risk of their breast cancer coming back. This study is being done to see if the severity of skin redness and peeling in the area of radiation can be reduced by applying Mepitel Film during radiation therapy.

Institution
MUSC
Recruitment Contact
Barbara Roe
843-652-1607
broe@tidelandshealth.org

ACCESS: A Multi-Center, Phase II Trial of HLA-Mismatched Unrelated Donor Hematopoietic Cell Transplantation with Post-Transplantation Cyclophosphamide for Patients with Hematologic Malignancies.

Date Added
August 16th, 2022
PRO Number
Pro00118834
Researcher
Michelle Hudspeth

List of Studies


Keywords
Adolescents, Cancer, Pediatrics, Transplant
Summary

This study is for patients that have had hematopoietic stem cell transplants and/or have been donors. The purpose of this study is to see how well transplant works in adults with a MMUD using stem cells from a donor's blood, and in children with a MMUD using stem cells from a donor's bone marrow.This study treatment does not include any investigational drugs. The medicines and procedures in this study are standard for transplant. Participants can expect to be on this study for approximately 1 year.

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



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