A Phase 3 Randomized, Double-Blind, Placebo-Controlled Trial of Pembrolizumab (MK-3475) Plus Chemotherapy Versus Chemotherapy Plus Placebo for the First-Line Treatment of Persistent, Recurrent, or Metastatic Cervical Cancer (KEYNOTE-826) Save

Date Added
May 20th, 2019
PRO Number
Pro00082686
Researcher
Whitney Graybill

List of Studies

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

This clinical trial hopes to test the safety and effectiveness of the study drug, pembrolizumab (MK-3475), in combination with chemotherapy, and if this combination will improve survival in women with persistent, recurrent, or metastatic cervical cancer. You may be able to join this study if you are a female at least 18 years of age with persistent, recurrent, or metastatic cervical cancer and have not been treated with systemic chemotherapy, other than chemotherapy that was received with radiation. Participation will be based on specific criteria.
The study duration is estimated at about 2 years, and in some cases may be longer.

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

Multicenter, Open Label, Phase 3 Study of Tabelecleucel for Solid Organ Transplant Subjects with Epstein-Barr Virus-Associated Post-Transplant Lymphoproliferative Disease after Failure of Rituximab or Rituximab and Chemotherapy (ALLELE Study) Save

Date Added
May 15th, 2019
PRO Number
Pro00081406
Researcher
Michelle Hudspeth

List of Studies


Profiles_link
Keywords
Adolescents, Cancer, Pediatrics
Summary

This study is for patients that have been diagnosed with Epstein-Barr Virus associated Post-Transplant Lymphoproliferative Disorder (EBV-PTLD). The investigational drug in this study is tabelecleucel. Tabelecleucel is a product containing special immune allogeneic cells, called EBV-Cytotoxic T Lymphocytes (EBV-CTLs), that are made in the laboratory starting with cells from a healthy person who is immune to EBV. The purpose of this study is to test how well tabelecleucel works to treat EBV-PTLD following SOT in patients who have not responded to rituximab or rituximab plus chemotherapy treatment and to see what side effects happen. Your participation will help us to understand more about tabelecleucel. In the first 12-month period, participants will be asked to come to the clinic for an estimated 11 to 19 study visits and a minimum of 2 scans, depending on the number of cycles of treatment they are given. After treatment is done, participants will enter into the follow-up phase, and will continue to come into the clinic for scheduled check-ups for up to 24 months after the first dose of tabelecleucel was given. Participant information on the status of their disease and any new treatment will be collected for up to an additional 3 years. Participants can expect to be in this study for up to five years total.

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

Multicenter, Open-Label, Phase 3 Study of Tabelecleucel for Allogeneic Hematopoietic Cell Transplant Subjects with Epstein-Barr Virus-Associated Post-Transplant Lymphoproliferative Disease after Failure of Rituximab (MATCH Study) Save

Date Added
May 8th, 2019
PRO Number
Pro00081745
Researcher
Michelle Hudspeth

List of Studies


Profiles_link
Keywords
Adolescents, Cancer, Pediatrics
Summary

This study is for patients that have been diagnosed with EBV-associated Post-Transplant Lymphoproliferative Disorder (EBV-PTLD). The investigational drug in this study is tabelecleucel. Tabelecleucel is a product containing special immune allogeneic cells, called EBV-Cytotoxic T Lymphocytes (EBV-CTLs), that are made in the laboratory starting with cells from a healthy person who is immune to EBV. Tabelecleucel will be given by vein as an injection. The purpose of this study is to test how well ATA129 works to treat EBV-PTLD following failure of rituximab in patients who have had an alloHCT and to see what side effects happen. Participation will help us to understand more about ATA129. In the first 12-month period, participants will be asked to come to the clinic for an estimated 11 to 19 study visits and a minimum of 2 scans, depending on the number of cycles of treatment they are given. After treatment is done, participants will enter into the follow-up phase, and will continue to come into the clinic for scheduled check-ups for up to 24 months after the first dose of tabelecleucel was given. Participant information on the status of their disease and any new treatment will be collected for up to an additional 3 years. Participants can expect to be in this study for up to five years total.

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

A Phase II Randomized Study of Adjuvant Versus NeoAdjuvant MK-3475 (Pembrolizumab) for Clinically Detectable Stage III-IV High-Risk Melanoma Save

Date Added
May 7th, 2019
PRO Number
Pro00088579
Researcher
Andrea Abbott

List of Studies

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Keywords
Cancer, Cancer/Skin
Summary

This study is for participants that have been diagnosed with clinically detectable stage III-IV high-risk Melanoma. The investigational drug in this study is pembrolizumab. The purpose of this study is to compare outcomes of receiving the study drug either before and after or only after surgery for your type of cancer. Participants can expect to be followed for up to 10 years after they register to the study.

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

A Multicenter, Randomized Trial of Photodynamic Therapy versus Argon Plasma Coagulation for Lung Cancer with Endobronchial Obstruction Save

Date Added
April 29th, 2019
PRO Number
Pro00081628
Researcher
Nicholas Pastis

List of Studies


Profiles_link
Keywords
Cancer, Lung, Pulmonary
Summary

Other than Nd:YAG laser, no other comparative studies of thermal ablative therapies with PDT for malignant airway obstruction have been performed. Little has been published about need for additional therapies and changes in quality of life following airway de-obstruction procedures in a randomized fashion comparing different modalities. The aim of this multicenter, prospective, randomized clinical study is to evaluate the efficacy of PDT vs APC.

Institution
MUSC
Recruitment Contact
Michael Balassone
843-792-6696
Balassom@musc.edu

A Randomized Phase 2 Trial of Axitinib/Nivolumab Combination Therapy vs. Single Agent Axitinib or Nivolumab for the Treatment of TFE/Translocation Renal Cell Carcinoma (tRCC) Across All Age Groups Save

Date Added
April 29th, 2019
PRO Number
Pro00088789
Researcher
Jacqueline Kraveka

List of Studies


Profiles_link
Keywords
Cancer, Pediatrics
Summary

This study is for patients that have been diagnosed kidney cancer called TFE/Translocation Renal Cell Carcinoma (tRCC). The investigational drugs in this study are axitinib and nivolumab. Both axitinib and nivolumab have been approved by the FDA for treating RCC. However, using these 2 drugs together is considered experimental. The purpose of this study is to find out what effects, good and/or bad, axitinib and nivolumab have on subjects with tRCC when the drugs are given alone or in combination. Participants can expect to be on this study for about to years and followed for up to 5 years.

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

Pharmacologic Reversal of Ventricular Remodeling in Childhood Cancer Survivors at Risk for Heart Failure (PREVENT-HF): A Phase 2b Randomized Placebo-Controlled (Carvedilol) Trial Save

Date Added
March 26th, 2019
PRO Number
Pro00087159
Researcher
Jacqueline Kraveka

List of Studies


Profiles_link
Keywords
Cancer, Heart, Pediatrics
Summary

This study is for patients that are survivors of childhood cancer who received a type of treatment called anthracycline chemotherapy at a young age. The investigational drug in this study is carvedilol. Medications such as carvedilol have been shown to improve heart function and delay the onset of heart failure. However, carvedilol has not been studied in a large group of childhood cancer survivors who received anthracycline chemotherapy. The purpose of this study is to see if a two-year course of carvedilol in childhood cancer survivors to see if it will have the same effects as shown in these prior studies of people with mild heart failure or who were at risk for heart failure. People in this clinical trial are expected to receive treatment on this study for about 2 years.

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

PHASE III RANDOMIZED TRIAL OF STANDARD SYSTEMIC THERAPY (SST) VERSUS STANDARD SYSTEMIC THERAPY PLUS DEFINITIVE TREATMENT (SURGERY OR RADIATION) OF THE PRIMARY TUMOR IN METASTATIC PROSTATE CANCER Save

Date Added
March 19th, 2019
PRO Number
Pro00086529
Researcher
David Marshall

List of Studies


Profiles_link
Keywords
Cancer, Cancer/Genitourinary, Prostate
Summary

This study is for men who have prostate cancer. The purpose of this study is to compare the effects, good and/or bad, of adding either prostate removal surgery or radiation therapy of the prostate to standard systemic therapy (SST), which is used to treat prostate cancer.

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

Long-Term Prospective Registry to Evaluate Treatment Decisions and Clinical Outcomes in Patients With Favorable Intermediate-Risk Localized Prostate Cancer Following Cell Cycle Progression (CCP) Testing (Prolaris® Test) Save

Date Added
March 13th, 2019
PRO Number
Pro00085807
Researcher
Thomas Keane

List of Studies


Profiles_link
Keywords
Cancer, Prostate
Summary

The main purpose of this study is to find out if getting a test, called the Prolaris cell cycle progression test (CCP), changes decisions about how prostate cancer is treated and how these decisions affect the course of the disease. Researchers want to look at the treatments that men and their doctors choose to manage prostate cancer and how the treatments change over time.
This study is called a registry study. A registry study collects information about a group of people who have the same medical condition. This study will enroll men who have had Prolaris testing and men who have not had Prolaris testing. During the course of this registry study demographic and health information will be collected from you or from your medical records several times over the course of 8 years.
The Prolaris test would like to improve the impacts of individual risk assessment, as well as, to help researchers to better understand prostate cancer and how decisions are made about prostate cancer treatment.

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

A Randomized Phase III Study of the Addition of Venetoclax to Ibrutinib and Obinutuzumab Versus Ibrutinib and Obinutuzumab in Untreated Younger Patients with Chronic Lymphocytic Leukemia (CLL) Save

Date Added
March 12th, 2019
PRO Number
Pro00086655
Researcher
Irl Greenwell

List of Studies

Silhouette
Keywords
Cancer, Cancer/Leukemia
Summary

This study is for patients that have been diagnosed with chronic lymphocytic leukemia (CLL). The investigational drugs in this study are ibrutinib, obinutuzumab and venetoclax. The purpose of this study is to compare the usual treatment of ibrutinib and obinutuzumab to a combination treatment of ibrutinib and obinutuzumab plus the study drug, venetoclax.

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

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