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 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 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate Pembrolizumab Versus Placebo as Adjuvant Therapy Following Surgery and Radiation in Participants with High-risk Locally Advanced Cutaneous Squamous Cell Carcinoma Save

Date Added
July 18th, 2019
PRO Number
Pro00087838
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 that have been diagnosed with with resectable High-risk Locally Advanced Cutaneous Squamous Cell Carcinoma (LA cSCC). The investigational drug used in this study is Pembrolizumab. The purposes of this study are to: determine how well pembrolizumab keeps the cancer from coming back or spreading as compared to placebo, determine if giving pembrolizumab after surgery and radiation helps patients live longer, and to test the safety of the study drug and see how patients' bodies handle it. Participants can expect to be in this study for about 8 years. This includes the time that participants will be on study drug and in follow up to see if the cancer has come back or spread.

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

Phase 1/2 Study of ASP2215 (Gilteritinib) Combined with Atezolizumab in Patients with Relapsed or Treatment Refractory FLT3 Mutated Acute Myeloid Leukemia (AML) Save

Date Added
June 11th, 2019
PRO Number
Pro00088311
Researcher
Robert Stuart

List of Studies


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

This study is for subjects that have been diagnosed with AML, with a mutation, or change, in the FLT3 gene. The investigational drug in this study is gilteritinib (ASP2215). The purpose of this research study is see if a medicine called gilteritinib (ASP2215) given in combination with atezolizumab is both effective and safe as a treatment for AML patients with a mutation, or change, in the FLT3 gene. Participants can expect to be in this study for roughly 2 years.

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

A Randomized, Double-Blind, Phase III Study of Pembrolizumab versus Placebo in Combination with Neoadjuvant Chemotherapy and Adjuvant Endocrine Therapy for the Treatment of High-Risk Early-Stage Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative (HR+/HER2?) Breast Cancer (KEYNOTE-756) Save

Date Added
May 30th, 2019
PRO Number
Pro00086999
Researcher
Antonio Giordano

List of Studies

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

The purpose of the study is to test the safety and effectiveness of the study drug, pembrolizumab (MK-3475) with certain types of chemotherapy and endocrine therapy, as well as, to see how well the subject's body handles the study drug.
If subject's meet the criteria, they will be assigned to 1 of 2 groups by chance, similar to flipping a coin, in order to decide which study treatment they will receive. Group A will receive the study drug, pembrolizumab, with certain types of chemotherapy and endocrine therapy. Group B will receive placebo, with certain types of chemotherapy and endocrine therapy. Pembrolizumab or placebo will be given by vein about once every 3 weeks.
This is a long-term study, if subject's agree to participate, they will be in the study for approximately 12 years.

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

Managed Access Program (MAP) to provide access to CTL019, for acute lymphoblastic leukemia (ALL) or large b-cell lymphoma patients with out of specification leukapheresis product and/or manufactured tisagenlecleucel out of specification for commercial release Save

Date Added
May 28th, 2019
PRO Number
Pro00088512
Researcher
Brian Hess

List of Studies

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

This study is for patients who have been diagnosed with B-cell acute lymphoblastic leukemia (ALL) or large B-cell lymphomas. The investigational drug in this study is CTL019 (Tisagenlecleucel). The purpose of this study is to provide the investigational drug as a possible cancer treatment that would otherwise be unavailable. Patients can expect to be in this study for up to 3 months and in follow up for 15 years.

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

A Randomized, Phase II Study of Ficlatuzumab with or without Cetuximab in Patients with Cetuximab-Resistant, Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma Save

Date Added
March 12th, 2019
PRO Number
Pro00085004
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 Head and Neck Squamous Cell Carcinoma (HNSCC). The investigational drug used in this study is Ficlatuzumab. The main goals of this research study is to study the safety and effectiveness of Ficlatuzumab with or without Cetuximab, to determine which strategy will be more effective, as well as to learn the potential side effects of Ficlatuzumab alone or in combination with Cetuximab. It is unknown exactly how long participants can expect to be in the study. Subjects will receive treatment until the drug is no longer effective on their cancer.

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

A Phase 2b, Open-Label, Single Arm, Multi-Center Study to Assess the Efficacy and Safety of BST-236 as a Single Agent in Adults with Newly-Diagnosed Acute Myeloid Leukemia, Not Eligible for Standard Induction Therapy Save

Date Added
January 8th, 2019
PRO Number
Pro00083544
Researcher
Robert Stuart

List of Studies


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

This study is for subjects with newly-diagnosed acute myeloid leukemia (AML) who are not eligible for standard induction chemotherapy. The investigational drug in this study is BST-236, which is given via IV. The purpose of this research study is to measure the safety of BST-236 and how effective it is in treating subjects. Visits will be required for 6 consecutive days during each cycle of treatment. The number of courses you receive will depend on whether you are benefiting from the study drug. Participants can expect to be in this study for 2 years (including treatment and post study follow-up).

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

A Phase Ib Open-Label, Dose-Finding Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of Avelumab in Combination with M9241 (NHS-IL12) in Subjects with Locally Advanced, Unresectable, or Metastatic Solid Tumors Save

Date Added
November 27th, 2018
PRO Number
Pro00080265
Researcher
Theodore Gourdin

List of Studies

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

The purpose of this study is to assess how effective the combination of avelumab and NHS-IL12 is in subjects with solid tumors. It will also collect more information on how safe and well-tolerated the combined study drugs are. Subjects will undergo a series of treatment cycles, each lasting 28 days. On Day 1 of each cycle, you will receive NHS IL12 immediately followed by avelumab on scheduled days. You will be assigned to receive avelumab every two weeks or to receive avelumab once a week. Both you and your study doctor will know which dose of study drugs you are receiving during the study.

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

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