A Phase 3 Randomized Study of Loncastuximab Tesirine Combined with Rituximab Versus Immunochemotherapy in Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL)

Date Added
June 3rd, 2021
PRO Number
Pro00106658
Researcher
Brian Hess

List of Studies


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

This study is for subjects that have been diagnosed with diffuse large B-cell lymphoma (DLBCL), a type of non-Hodgkin lymphoma (NHL) that has gotten worse or come back after treatment. This study is testing an "investigational" (not yet FDA approved) study drug called Loncastuximab Tesirine. The primary purpose of this study is to evaluate the efficacy of loncastuximab tesirine combined with rituximab compared to standard immunochemotherapy. The subject may remain in the study for up to 5 years, 28 days for screening period, a 16-25 week treatment period, and a follow-up period of 4 years.

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

A Phase II Randomized Trial of Adjuvant Therapy With Pembrolizumab After Resection of Recurrent/Second Primary Head and Neck Squamous Cell Carcinoma With High Risk Features

Date Added
May 14th, 2021
PRO Number
Pro00110906
Researcher
Jennifer Harper

List of Studies


Keywords
Cancer, Cancer/Head & Neck
Summary

This study is for patients that have been diagnosed with recurrent or new head and neck squamous cell carcinoma (HNSCC). Patients either have had a recurrence (the tumor has comeback) or a new head and neck cancer in a different area of the head and neck (second primary) which has been removed by surgery. The study drug used is called pembrolizumab. The purpose of this study is to see if adding pembrolizumab to radiation or if using pembrolizumab by itself after surgery compared to the usual approaches with chemotherapy and radiation will increase life expectancy. Participants can expect to be on this study for up to 12 months and then followed for 5 years.

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

Expanded Access Protocol (EAP) for Subjects Receiving Lisocabtagene Maraleucel That is Nonconforming for Commercial Release

Date Added
May 11th, 2021
PRO Number
Pro00107699
Researcher
Brian Hess

List of Studies


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

This study is for patients who have been diagnosed with relapsed (came back) and/or refractory (not responding to treatment) large B-cell lymphoma (LBCL). The investigational product is Lisocabtagene Maraleucel and is administered by infusion. Participants will have had the blood collection (leukapheresis - a laboratory procedure where white blood cells are separated from a sample of blood) procedure, where the T cells (white blood cells) were collected and genetically modified in a laboratory in order to manufacture the lisocabtagene maraleucel T cells for disease treatment. The lisocabtagene maraleucel T cells that were produced do not meet all of the prespecified release criteria to be used as a routine prescription drug as required by the Food and Drug Administration (FDA). This is called a nonconforming lisocabtagene maraleucel. The purpose of this study is to allow participants to be treated with their nonconforming lisocabtagene maraleucel. Participants can expect to be on the study for up to 3 months following the infusion of nonconforming lisocabtagene maraleucel.

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

An Open-label, Single-arm, Multicohort, Phase 2 Study to Assess the Efficacy and Safety of Tabelecleucel in Subjects with Epstein-Barr Virus-associated Diseases

Date Added
April 27th, 2021
PRO Number
Pro00104445
Researcher
Michelle Hudspeth

List of Studies


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

This study is for children and adults that have been diagnosed with a disease that is associated with Epstein-Barr Virus (EBV) infection.The investigational treatment in this study is called tabelecleucel (also known as ATA129), this treatment is given in the vein. Participants will receive tabelecleucel on Day 1, Day 8 and Day 15 of every 35-day (5-week) period, the number of cycles depends on the response to treatment. The purpose of this study is to assess the safety of tabelecleucel and to assess the effects of tabelecleucel on EBV disease. Participants can expect to be in this study for about 2 years for an estimated 17-20 study visits.

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

Internet-delivered Management of Pain Among Cancer Treatment Survivors (IMPACTS)

Date Added
April 12th, 2021
PRO Number
Pro00109105
Researcher
Sarah Marrison

List of Studies


Keywords
Cancer, Pain
Summary

The study is being done to find out if this approach (8 sessions of the Internet-based program with education) is better or worse than the usual approach plus education only for cancer-related pain. The usual approach is defined as care most people get for cancer-related pain.

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

67Cu-SARTATE Peptide Receptor Radionuclide Therapy Administered to Pediatric Patients With High-Risk Neuroblastoma: A Multi-center, Dose-escalation, Open-label, Non-randomized, Phase 1-2a Theranostic Clinical Trial

Date Added
February 9th, 2021
PRO Number
Pro00105726
Researcher
Jacqueline Kraveka

List of Studies


Keywords
Adolescents, Cancer, Cancer/Brain, Pediatrics
Summary

This study is for participants that have been diagnosed with a high-risk neuroblastoma that cannot be treated or did not improve with existing therapies, or the cancer came back after treatment with existing therapies. This study involves investigational drugs called 64Cu-SARTATE and 67Cu-SARTATE. The investigational drugs will be given as an IV injection. The study is divided into 2 parts: The Dose Escalation Phase and the Cohort Expansion Phase. The phase that participants will enroll to will depend on when they enter the study. The age range for participants is from 12 months to 25 years. Participants can expect to be in this study for approximately 14 months. Then followed by remote or virtual visits every 6 months for up to 36 months (3 years) after the initial dose of study therapy drug 67Cu-SARTATE.

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

A Phase 2, randomized, open-label three-arm clinical study to evaluate the safety and efficacy of lenvatinib (E7080/MK-7902) in combination with pembrolizumab (MK-3475) versus standard of care chemotherapy and lenvatinib monotherapy in participants with recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC) that have progressed after platinum therapy and immunotherapy (PD-1/PD-L1 inhibitors) (LEAP-009)

Date Added
February 1st, 2021
PRO Number
Pro00101229
Researcher
John Kaczmar

List of Studies


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) that has returned (recurrent) or spread after previous treatment (metastatic). The investigational drug in this study is lenvatinib. The study will also use lenvatinib in combination with pembrolizumab, which is also experimental. The purposes of this study are to: test the safety of the study drugs, lenvatinib alone, pembro and lenvatinib together, and standard chemotherapies alone in the treatment of HNSCC; see how well the combination of pembro and lenvatinib works, compared to standard chemotherapies; and see if participants who get pembro and lenvatinib live longer than those who are treated with standard chemotherapies. Participants can expect to be on this study for about 48 months.

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

A Phase 3 Randomized Trial of Inotuzumab Ozogamicin (NSC#: 772518) for Newly Diagnosed High-Risk B-ALL; Risk-Adapted Post-Induction Therapy for High-Risk B-ALL, Mixed Phenotype Acute Leukemia, and Disseminated B-LLy

Date Added
December 22nd, 2020
PRO Number
Pro00106138
Researcher
Jacqueline Kraveka

List of Studies


Keywords
Adolescents, Cancer, Cancer/Leukemia, Pediatrics
Summary

This study is for patients that have newly diagnosed High-Risk B-ALL, Risk-Adapted Post-Induction therapy for High-Risk B-ALL, Mixed Phenotype Acute Leukemia, and Disseminated B-LLy. The treatment involves medicine called chemotherapy, which fights cancer. Some patients may also need radiation therapy depending on whether the cancer has spread to the brain and spinal fluid, or the testes for males. The investigational drug on this study is inotuzumab ozogamicin. Participants can expect to be on this study for a little over 2 years and followed for up to 10 years.

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

An Open-Label, Multicenter, Phase 1/2 Study of RP1 as a Single Agent and in Combination with PD1 Blockade in Patients with Solid Tumors

Date Added
November 24th, 2020
PRO Number
Pro00105157
Researcher
John Kaczmar

List of Studies


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

This study is for patients that have been diagnosed with advanced or resistant skin cancer (melanoma), non-melanoma skin cancer (NMSC), non-small cell lung cancer (NSCLC), certain types of solid tumors, or bladder cancer (UBC). The investigational drug in this study is RP1. RP1 is a herpes simplex virus (a microscopic life form commonly known as the "cold sore virus") that has been genetically changed to grow in and destroy cancer cells. This treatment will be injected directly into tumors. The purpose of this study is to test the safety and how well RP1 works when it is injected into certain types of solid tumors in combination with another cancer drug, called nivolumab. Participants can expect to be in this study for about 2 to 3 years.

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

Treatment of Newly Diagnosed Diffuse Anaplastic Wilms Tumors (DAWT) and Relapsed Favorable Histology Wilms Tumors (FHWT)

Date Added
November 19th, 2020
PRO Number
Pro00105634
Researcher
Jacqueline Kraveka

List of Studies


Keywords
Adolescents, Cancer, Pediatrics
Summary

This study is for patients that have been diagnosed with Newly Diagnosed Diffuse Anaplastic Wilms Tumors (DAWT) and Relapsed Favorable Histology Wilms Tumors (FHWT). The treatment involves cancer fighting medicine called chemotherapy plus radiation therapy and/or surgery. Participants can expect to be on this study for up to 10 months and be followed by the treatment team for up to 5 years.

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



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