A Phase III, Double-blind, Placebo-controlled, Multi-center International Study of Neoadjuvant/Adjuvant Durvalumab for the Treatment of Patients with Resectable Stages II and III Non-small Cell Lung Cancer (AEGEAN) Save

Date Added
September 12th, 2019
PRO Number
Pro00090077
Researcher
John Wrangle

List of Studies

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

This study is for patients that have been diagnosed with Resectable Stages II and III Non-small Cell Lung Cancer (NSCLC). The investigational drug in this study is durvalumab. The purpose of this study is to see if durvalumab will work and be safe for the treatment of resectable NSCLC. Participants can expect to be on this study for about 5 years.

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

A Randomized, Placebo-Controlled, Double-Blind Phase 3 Study to Evaluate the Efficacy and Safety of Tislelizumab (BGB-A317) in Combination with Chemotherapy as First-Line Treatment in Patients with Unresectable, Locally Advanced Recurrent or Metastatic Esophageal Squamous Cell Carcinoma Save

Date Added
August 28th, 2019
PRO Number
Pro00086110
Researcher
Daniel Reuben

List of Studies

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Keywords
Cancer, Cancer/Gastrointestinal, Drug Studies
Summary

This is a research study to compare the effects and safety, good or bad, of tislelizumab (also known as BGB-A317) plus chemotherapy against placebo (an inactive substance) plus chemotherapy for adults with locally advanced recurrent or metastatic esophageal squamous cell carcinoma to find out which is better. Subjects may continue study treatment during their participation in the study as long as there is no worsening of disease and they don't have intolerable side effects from the study treatment

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

Sea Island Community Approach To Cancer-Free Health (Sea Island CATCH) Save

Date Added
August 13th, 2019
PRO Number
Pro00090658
Researcher
Mohan Madisetti

List of Studies

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Keywords
Cancer
Summary

The purpose of Sea Island CATCH is to assess the knowledge, attitudes and practices of the Gullah Geechee community residing with the Gullah Geechee Cultural Heritage Corridor towards cancer prevention and screening measures, and to identify barriers and enablers to accessing cancer-related medical health care.

Institution
MUSC
Recruitment Contact
Ashley Green
843-872-2427
greenan@musc.edu

A Randomized, Multicenter, Phase III Trial of Tacrolimus/Methotrexate versus Post-Transplant Cyclophosphamide/Tacrolimus/Mycophenolate Mofetil in Non-Myeloablative/Reduced Intensity Conditioning Allogeneic Peripheral Blood Stem Cell Transplantation Save

Date Added
August 7th, 2019
PRO Number
Pro00089654
Researcher
Amarendra Neppalli

List of Studies

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Keywords
Cancer, Transplant
Summary

This study is for participants that require an allogenic peripheral blood stem cell transplant. The purpose of this study is to compare 2 combinations of drugs to prevent graft-versus-host disease (GVHD), a serious complication of a stem cell transplant. These combinations are either Tacrolimus/methotrexate or Tacrolimus/mycophenolate mofetil/cyclophosphamide. Doctors want to know which combination is better or if they give the same results. The study will help doctors decide which treatment is best at preventing GVHD for future transplant patients. Participants can expect to be in this study for up to 2 years after transplant.

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

INSIGNA : A Randomized, Phase III Study of Firstline Immunotherapy Alone or in Combination With Chemotherapy in Induction/Maintenance or Postprogression in Advanced Nonsquamous Non-Small Cell Lung Cancer (NSCLC) With Immunobiomarker SIGNature-Driven Analysis Save

Date Added
July 29th, 2019
PRO Number
Pro00089504
Researcher
John Wrangle

List of Studies

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Keywords
Cancer, Cancer/Lung
Summary

This study is for patients that have been diagnosed with non-squamous non-small cell lung cancer. The investigational drug used is MK-3475 (pembrolizumab). The purpose of this study is to compare any good and bad effects of using only the immunotherapy drug, MK-3475 (pembrolizumab), alone first versus the combination of the immunotherapy drug, MK-3475 (pembrolizumab), and chemotherapy. Participants can expect to be on this study for up to 2 years and followed for up to 5 years from when they began taking part in the study.

Institution
MUSC
Recruitment Contact
Nancy McGaha
864-725-7129
nmcgaha@selfregional.org

Daratumumab to Enhance Therapeutic Effectiveness of Revlimid in Smoldering Myeloma (DETER-SMM) Save

Date Added
July 29th, 2019
PRO Number
Pro00090904
Researcher
Amarendra Neppalli

List of Studies

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Keywords
Cancer, Cancer/Myeloma
Summary

This study is for patients that have been diagnosed with smoldering multiple myeloma (SMM). The drugs used in this study are daratumumab, lenalidomide and dexamethasone which are all commercially used drugs. The purpose of this study is to compare overall survival in patients with high-risk smoldering multiple myeloma randomized to daratumumab revlimid-dexamethasone or revlimid-dexamethasone. Participants can expect to be on this study for up to two years and followed by your doctor for up to 15 years.

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

A Phase 1b Study of ASP1948, Targeting an Immune Modulatory Receptor, as a Single Agent and in Combination with Nivolumab in Subjects with Advanced Solid Tumors Save

Date Added
July 23rd, 2019
PRO Number
Pro00087949
Researcher
John Wrangle

List of Studies

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Keywords
Cancer, Cancer/Breast, Cancer/Genitourinary, Cancer/Gynecological, Cancer/Head & Neck, Cancer/Lung
Summary

The purpose of this study is to determine at what dose the study drug (ASP1948) is safe and tolerated and how it is processed in the blood of patients with tumors that cannot be removed (unresectable) or has spread (metastasized) to a different part of the body. When the safe dose is identified, it will be used to evaluate if the study treatment causes tumors to shrink in patients.The screening period for this study can take up to 28 days. The treatment period consists of up to 48 weeks of initial treatment, followed by up to 45 weeks of follow up. If you quality and are willing to continue in the re-treatment period (receiving the study drug again), you will be in the study for an additional 48 weeks.

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

A Phase 2 Study of BC-819 in Patients With Non-Muscle Invasive Bladder Cancer Whose Disease is Unresponsive to Bacillus Calmette-Guerin Save

Date Added
July 23rd, 2019
PRO Number
Pro00089429
Researcher
Robert Grubb

List of Studies

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

This study is for patient that have bladder cancer and have been treated with BCG (Bacillus Calmette-Guerin), but the cancer has returned after treatment(s). This research study is designed to test if an investigational agent named BC-819 can prevent or delay tumor recurrence in non-muscle invasive bladder cancer patients who have become unresponsive to BCG treatment.
The primary objective is to determine, for the patients with baseline CIS:The proportion that achieves a complete response after treatment with inodiftagene vixteplasmid Participants can expect to be in this study for102 weeks.

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

A Phase II Study of Durvalumab (MEDI 4736) with Radiotherapy for the adjuvant treatment of Intermediate Risk Head and Neck Squamous Cell Carcinoma Save

Date Added
July 23rd, 2019
PRO Number
Pro00089876
Researcher
John Kaczmar

List of Studies

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

This study is for patients who have been diagnosed with locally advanced squamous cell carcinoma of the head and neck (SCCHN) and will need additional treatment following surgery. The investigational drug in this study is Durvalumab. The purpose of this study is to investigate other drugs that may be combined with radiation to treat SCCHN. The study focuses on determining whether durvalumab combined with radiation will have improved 3-year disease free survival compared to historical control. Participants can expect to be in this study for 5 years.

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

A Phase 1 Study of ALKS 4230 Administered Subcutaneously as Monotherapy and in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors Save

Date Added
July 23rd, 2019
PRO Number
Pro00088438
Researcher
John Wrangle

List of Studies

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Keywords
Cancer, Cancer/Breast, Cancer/Gastrointestinal, Cancer/Lung, Cancer/Skin
Summary

The study will have 2 parts (Part A and Part B). Part A of this research study (the dose escalation phase) will test the safety and effectiveness of the different doses of ALKS 4230 (study drug) to find the one that is the safest and most effective. Part B of this study (the dose expansion phase) will use the safe dosing determined in Part A to see how effectively the combination of ALKS 4230 and pembrolizumab treats your solid tumors.LKS 4230 is an investigational (experimental) drug; this means that is has not been approved by the US Food and Drug Administration (FDA) to treat your disease. This is an open-label study which means that all subjects will be taking the active study drugs.You can be in the study for as long as it is clinically beneficial to you.

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

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