A Phase 3, Randomized, 52-week, Placebo-controlled, Double-blind Study With Rerandomization to Assess the Efficacy, Safety, and Tolerability of Rocatinlimab (AMG 451) in Adolescent Subjects With Moderate-to-severe Atopic Dermatitis (AD)

Date Added
April 12th, 2023
PRO Number
Pro00127271
Researcher
Lara Wine Lee

List of Studies


Keywords
Children's Health, Skin
Summary

The study is being conducted to learn more about rocatinlimab in people with AD. It will see if rocatinlimab is effective to treat people with AD and whether it causes side effects. It will also help to establish the beneficial impact of the study treatment with rocatinlimab on the related outcomes including skin itching, skin pain, sleep loss, and impaired quality of life in people with AD. The study duration will last a maximum of 68 weeks (about 1 year 3 months), including a screening period of minimum of 8 days and up to 30 days, a 52-week study treatment period, and a safety follow-up (SFU) visit 16 weeks after the last dose of study drug in case you do not continue into the long-term maintenance study.

Institution
MUSC
Recruitment Contact
Madeline Richmond
843-792-1436
richmoma@musc.edu

A Randomized Phase III Trial of Intravesical BCG veRsus Intravesical Docetaxel and GEmcitabine Treatment in BCG Naïve High Grade Non-Muscle Invasive Bladder Cancer (BRIDGE)

Date Added
April 17th, 2023
PRO Number
Pro00128249
Researcher
Stephen Savage

List of Studies


Keywords
Bladder, Cancer/Genitourinary
Summary

This study is for patients with bladder cancer. The study is being done to see if by using one type of chemotherapy instilled in the bladder, Gemcitabine and Docetaxel, instead of the usual BCG therapy can lower the chance of the patient's bladder cancer from growing or spreading.

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

A Randomized Phase III Trial of Intravesical BCG veRsus Intravesical Docetaxel and GEmcitabine Treatment in BCG Naïve High Grade Non-Muscle Invasive Bladder Cancer (BRIDGE)

Date Added
April 17th, 2023
PRO Number
Pro00128249
Researcher
Stephen Savage

List of Studies


Keywords
Bladder, Cancer/Genitourinary
Summary

This study is for patients with bladder cancer. The study is being done to see if by using one type of chemotherapy instilled in the bladder, Gemcitabine and Docetaxel, instead of the usual BCG therapy can lower the chance of the patient's bladder cancer from growing or spreading.

Institution
MUSC Health Florence Medical Center
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinical-trials@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

A Phase III Randomized Trial of Radiotherapy Optimization for Low-Risk HER2-Positive Breast Cancer" (HERO)

Date Added
May 17th, 2023
PRO Number
Pro00128928
Researcher
Harriet Eldredge-Hindy

List of Studies

Keywords
Cancer/Breast
Summary

This study is for people with low-risk HER-2 positive breast cancer. The study is being done to see if treatment with HER2-targeted therapy without radiation therapy as good as the usual treatment of radiation and HER2-targeted therapy in patients who have had surgery, chemotherapy, and HER2-targeted therapy.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-7929321
hcc-clinical-trials@musc.edu

A Multicentre, Randomised, Double-blind, Parallel Group, Placebo-controlled, Time-to-first Asthma Exacerbation Phase III Efficacy and Safety Study of Benralizumab in Paediatric Patients with Severe Eosinophilic Asthma (DOMINICA)

Date Added
June 6th, 2023
PRO Number
Pro00126684
Researcher
Kelli Williams

List of Studies


Keywords
Allergy, Asthma, Pediatrics
Summary

The main purpose of this study is to see if taking benralizumab is effective in treating Severe Eosinophilic Asthma in patients 6 to 17 years old compared with placebo. Benralizumab is administered through a subcutaneous injection (shot). Participation in the study is divided into two parts. The first part will last up to 16 weeks or until an asthma attack or flare is experienced. The second part will last up to two years.

Institution
MUSC
Recruitment Contact
Natalie Naylon
8437925824
naylon@musc.edu

POST-APPROVAL STUDY 2: HINTERMANN SERIES H3® TOTAL ANKLE REPLACEMENT SYSTEM

Date Added
June 12th, 2023
PRO Number
Pro00127864
Researcher
Christopher Gross

List of Studies


Keywords
Arthritis, Joint, Pain
Summary

Total ankle replacement has become an increasingly recommended treatment option for endstage ankle osteoarthritis over the last decades. As a result of this progress, a large variety of implant systems exist.

The Hintermann Series H3 Total Ankle Replacement System (H3) is a three-piece, mobile-bearing implant. The H3 is indicated for use as a non-cemented implant to replace a painful arthritic ankle joint due to primary osteoarthritis, post-traumatic osteoarthritis, or arthritis secondary to inflammatory disease.

The purpose of this study is to investigate long-term (up to 5 years) how the H3 implant is performing, collect information about the device through x-rays of the joint, document any complications from the device implant, see how the device affects patient quality of life.

Institution
MUSC
Recruitment Contact
Joshua Morningstar
843-792-1383
Morninjo@musc.edu

The Janus Rectal Cancer Trial: A Randomized Phase II Trial Testing the Efficacy of Triplet versus Doublet Chemotherapy to Achieve Clinical Complete Response in Patients with Locally Advanced Rectal Cancer

Date Added
June 21st, 2023
PRO Number
Pro00129646
Researcher
Toros Dincman

List of Studies

Keywords
Cancer/Gastrointestinal
Summary

This study is for patients with advanced rectal cancer. This study is being done to see if we can increase the clinical complete response rate (tumor disappears by exam, endoscopy, and imaging) by adding a 3rd drug (irinotecan) to the standard regimen of FOLFOX or CAPOX given following long-course chemoradiation.
We are doing this study because we want to find out if this approach is better or worse than the usual approach for your rectal cancer. The usual approach is defined as care most people get for locally advanced rectal cancer.

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

A Prospective Randomized Study of Ramucirumab (LY3009806; NSC 749128) plus Pembrolizumab (MK-3475; NSC 776864) versus Standard of Care for Participants Previously Treated with Immunotherapy for Stage IV or Recurrent NonSmall Cell Lung Cancer

Date Added
July 10th, 2023
PRO Number
Pro00129897
Researcher
Christopher Rangel

List of Studies

Keywords
Cancer/Lung
Summary

This study is for people with non-small cell lung cancer that has come back or grown after receiving immunotherapy treatment. This study is being done to see if a new combination of 2 non-chemotherapy drugs will help patients live longer than the usual approach.

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

A Randomized Phase II Study of INC280 (Capmatinib) plus Osimertinib with or without Ramucirumab in Participants with EGFR-Mutant, MET-Amplified Stage IV or Recurrent Non-Small Cell Lung Cancer (Lung-MAP Sub-Study)

Date Added
July 19th, 2023
PRO Number
Pro00130230
Researcher
Christopher Rangel

List of Studies

Keywords
Cancer/Lung
Summary

This study is for patients who have advanced non-small cell lung cancer who in addition to the EGFR gene change (mutation) that was previously found in their tumor, testing found that their tumor also now has MET gene changes. The study is checking to see if a combination of 3 targeted drugs work together to lower the chance of lung cancer growing or spreading.

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



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