An Open-Label Extension Study to Assess the Long-Term Safety of Eplontersen (ION-682884) in Patients with Transthyretin-Mediated Amyloid Cardiomyopathy (ATTR-CM)

Date Added
May 14th, 2024
PRO Number
Pro00136776
Researcher
Daniel Judge

List of Studies


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

This study is an open label extension study for those who participated in the ION 682884-CS2 clinical trial for transthyretin-mediated amyloid cardiomyopathy (ATTR-CM). ATTR-CM is a disease caused by change in a protein called transthyretin (TTR) which can result in a build up of this protein in parts of the body including the heart. This build up is called an amyloid deposit, and when this occurs in the heart it can lead to a condition called cardiomyopathy. This study involves the medication eplontersen, which is considered investigational meaning it is not approved for commercial use by the Food and Drug Administration (FDA). Eplontersen is aimed at preventing production of the TTR protein to slow or reverse disease progression. Eplontersen is given as an injection under the skin in the upper arm, stomach or thigh. This study will last about 3 1/2 years and include 16 clinic visits. Study procedures include physical exams, blood work, questionnaires, hall walk tests, electrocardiograms (tracing of the heart's electrical activity), echocardiogram (ultrasound test of the heart) and taking a Vitamin A supplement.

Institution
MUSC
Recruitment Contact
Ellie Cutright
843-876-5011
cutrighe@musc.edu

A Phase 1/2, Open-Label, Dose-Escalation, Dose-Expansion Study of DSP-5336 in Adult Patients with Acute Leukemia and Other Selected Hematologic Malignancies, with and without Mixed Lineage Leukemia (MLL) rearrangement or Nucleophosmin 1 (NPM1) Mutation

Date Added
April 30th, 2024
PRO Number
Pro00133202
Researcher
Praneeth Baratam

List of Studies

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

This study is for participants who have acute leukemia, a type of cancer of the blood and bone marrow. This study will help us learn more about a newly discovered oral drug, DSP-5336, that is being tested in people with acute leukemia and other types of blood cancer. DSP-5336 is a drug that interferes with a protein (Menin) in the body that has been found to have a role in developing leukemia. The main purpose of this study is to evaluate how safe DSP-5336 is at different doses and to find a recommended dose that is safe for further study. The overall planned study duration, including the above visits and periods, is 50 months (4.2 years).

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

A Phase 2a Study with Safety Run-in to Evaluate the Safety, Tolerability, and Preliminary Efficacy of FF-10832 Monotherapy or in Combination with Pembrolizumab in Patients with Advanced Solid Tumors

Date Added
April 22nd, 2024
PRO Number
Pro00135670
Researcher
Theodore Gourdin

List of Studies


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

This study is for patients who have been diagnosed with a solid tumor cancer that has continued to grow despite treatments patients have already received (non-small cell lung cancer or urothelial cancer). The study drug is FF-10832 (gemcitabine liposome injection). Gemcitabine is a cancer treatment registered in the US for the treatment of ovarian, breast, non-small cell lung, and pancreatic carcinomas. The study drug is a new, liposomal formulation of Gemcitabine. This new formula was developed to increase the amount of gemcitabine that goes to tumor cells. The study drug will be given to patients by itself, or in combination with pembrolizumab. Pembrolizumab is an approved treatment for many types of cancer. There are two groups that a participant may be assigned to, which group a participant is assigned on will be determined randomly, in a 1:1 ratio, like flipping a coin. The drugs will be given via an infusion. There is a 50% chance of being assigned to either group. Participation in the study will likely last 12 months, but participants may stay on the study longer if the study treatment continues to benefit them. The study consists of a screening visit, treatment visits, end of study visit, and a long-term follow-up.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
8437929321
hcc-clinical-trials@musc.edu

A Phase 3, Randomized, Double-blind, Placebo- and Active-Comparator-Controlled Clinical Study of Adjuvant V940 (mRNA-4157) Plus Pembrolizumab Versus Adjuvant Placebo Plus Pembrolizumab in Participants with Resected Stage II, IIIA, IIIB (N2) Non-small Cell Lung Cancer

Date Added
April 22nd, 2024
PRO Number
Pro00134671
Researcher
Christopher Rangel

List of Studies

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

This study investigates a new treatment, V940, combined with pembrolizumab for people who've had surgery for non-small cell lung cancer (NSCLC). The goal is to check if this combination is safe, prevents cancer from returning, improves survival, and enhances quality of life compared to a placebo plus pembrolizumab. Participants will receive pembrolizumab, a drug that boosts the immune system to fight cancer. V940, a personalized treatment, uses genetic information from a patient's tumor to create a custom mRNA injection. It's experimental and not FDA-approved, but it offers a novel approach to empower the immune system against cancer, potentially bringing advancements in post-surgery NSCLC care.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
8437929321
hcc-clinicaltrials@musc.edu

A Phase 1/2a, Multicenter, Open-Label, First in Human Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of DB-1311 in Subjects with Advanced/Metastatic Solid Tumors

Date Added
April 17th, 2024
PRO Number
Pro00135654
Researcher
Theodore Gourdin

List of Studies


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

The study is for patients who have been diagnosed with an advanced/metastatic (meaning cancer has spread from where it started) solid tumor (cancer) with no standard treatment available. The investigational drug in this study is DB-1311. DB-1311 infusion is an antibody-drug combination composed of an anti-B7-H3 (a protein associated with worse overall survival and drug resistance) antibody and P1021 (novel topoisomerase I inhibitor). The antibody portion of the drug blocks a protein in the body that help cancer cells live, grow and spread. The purpose of this trial is to find a safe and tolerable dose of the study drug. Participation in this study will last about 24 months. The study consists of a screening visit, treatment visits, and a safety follow up visit.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
8437929321
hcc-clinical-trials@musc.edu

A Phase III Randomized Trial of Heated Intraperitoneal Chemotherapy (HIPEC) with Cisplatin versus no HIPEC at the Time of Optimal Interval Cytoreductive Surgery followed by Niraparib Maintenance in Patients with Newly Diagnosed Stage III and IV Ovarian, Primary Peritoneal, and Fallopian Tube Cancer

Date Added
April 2nd, 2024
PRO Number
Pro00136150
Researcher
Brian Orr

List of Studies

Keywords
Cancer, Cancer/Gynecological, Drug Studies, Women's Health
Summary

This study is for patients that have been diagnosed with high grade serous or endometroid epithelial ovarian, fallopian tube, or primary peritoneal carcinoma. The main purpose of this study is to find out if giving heated chemotherapy into the belly, known as heated intraperitoneal chemotherapy (HIPEC), improves the treatment of this type of cancer. Participants can expect to be in the study for up to 40 months.

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

An Open-label, Multicenter Study of ZL-1310 to Evaluate the Safety, Tolerability, and Pharmacokinetics in Subjects with Small Cell Lung Cancer

Date Added
March 26th, 2024
PRO Number
Pro00135016
Researcher
Mariam Alexander

List of Studies

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

ZL-1310 is a new experimental treatment designed to tackle small cell lung cancer (SCLC), a particularly aggressive form of lung cancer. The drug is an antibody-drug conjugate (ADC) that specifically targets a protein called delta-like protein 3 (DLL3), found in high amounts in SCLC and other neuroendocrine tumors. The study aims to evaluate the safety, effectiveness, and other characteristics of ZL-1310 in patients with SCLC that has relapsed or is resistant to platinum-based treatments. Previous attempts to target DLL3 faced challenges, and ZL-1310 seeks to overcome these issues, providing a potential breakthrough in treating SCLC, where current options are limited, and relapse rates are high. The study hopes to shed light on ZL-1310's potential as a novel and more effective therapy for patients facing few alternatives and poor prognoses.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
8437929321
hcc-clinicaltrials@musc.edu

Randomized Phase II/III Trial of Adjuvant Radiation Therapy with Cisplatin, Docetaxel-Cetuximab, or Cisplatin-Atezolizumab in Pathologic High-Risk Squamous Cell Cancer of the Head and Neck

Date Added
March 25th, 2024
PRO Number
Pro00134487
Researcher
Bhishamjit Chera

List of Studies

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

This study will evaluate possible new treatments for advanced stage head and neck cancer. Patients who have undergone surgery to remove their tumor may qualify if the tissue is positive for a specific type of squamous cell cancer. The purpose of this study is to compare the current standard treatment, radiation therapy along with chemotherapy with a drug called cisplatin, to two other treatments. One experimental treatment is radiation therapy along with two chemotherapy agents, docetaxel and cetuximab, and the other experimental treatment is the standard treatment currently used along with the addition of an immunotherapy drug atezolizumab. Patients who qualify for participation will be randomly assigned to one of the 3 treatment groups (done with a computerized system). In the current standard treatment group, participants will receive radiation therapy 5 days per week for 6 weeks, and cisplatin once a week through a vein for the 6-week treatment period. The group receiving doxetaxel and cetuximab (both FDA approved medications for the treatment of certain cancers) will receive the same 6 weeks of radiation along with cetuximab through a vein 1 week prior to the start of radiation therapy, and then once a week for the 6 weeks of radiation and the doxetaxel will also be given through a vein once a week for the 6 weeks of radiation therapy. The final group will get the current standard treatment with 6 weeks of radiation and 6 weeks of cisplatin, along with atezolizumab through a vein 1 week prior to your starting radiation and then every 3 weeks for a total of 8 doses, There will be twice as many patients in this last group than the other two groups.

Follow-up will be at Month 1 & 3 and then every 3 months for 2 years, and then every 6 months for 3 more years, and then annually for as long as a participant is willing and able. There will be blood tests and CT scans that will occur throughout the study, however they are standard for the type of cancer being treated and how each individual responds to the treatment. The benefit of participation is there may be improved outcomes in this group of patients however the risks involved with receiving new treatments may be more than with the usual standard treatment. Some of the most common side effects that the study doctors know about are infection, nausea, vomiting, diarrhea, pain, tiredness, kidney problems, numbness/tingling in hands and feet. There may be some risks that the study doctors are not aware of at the moment. There will be a total of up to 480 participants across all sites and approximately 24 participants at MUSC.

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

Quantification of Factors Affecting Vaginal Length in Robotic Sacrocolpopexy

Date Added
March 19th, 2024
PRO Number
Pro00134575
Researcher
Faith Dunn

List of Studies

Keywords
Surgery, Women's Health
Summary

The purpose of this study is to better understand how surgical factors affect the length of the vagina after pelvic surgery. This will be accomplished by measuring the length of the vagina during routine surgical steps as well as at the postoperative visit. This information will be used to help continue improving pelvic surgical technique.

Institution
MUSC
Recruitment Contact
Faith Dunn
8437922300
dunnfa@musc.edu

3D MRA Fusion for Uterine Fibroid Embolization: A Randomized Controlled Trial

Date Added
March 5th, 2024
PRO Number
Pro00133923
Researcher
Marcelo Guimaraes

List of Studies


Keywords
Obstetrics and Gynecology, Women's Health
Summary

The study aims to investigate the impact of Magnetic Resonance Angiography (MRA) fusion on the safety and efficiency of Uterine Fibroid Embolization (UFE). UFE is a medical procedure used to treat uterine fibroids. MRA fusion provides a detailed three-dimensional roadmap of blood vessels in the pelvis during the procedure. This technology has the potential to reduce radiation exposure, procedure time, and contrast volume. .

Institution
MUSC
Recruitment Contact
Derek Groskreutz
8432437260
groskreu@musc.edu



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