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

A Phase 1/2a, Open-Label, Multi-Center Trial to Assess Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of CLN-081 in Patients With Non-Small Cell Lung Cancer Harboring EGFR Exon 20 Insertion Mutations

Date Added
August 24th, 2020
PRO Number
Pro00096015
Researcher
John Wrangle

List of Studies


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

This study is for patients that have been diagnosed with Non-Small Cell Lung Cancer (NSCLC).The investigational drug used in this study is CLN-081.

This study has 3 parts; Phase 1 Dose Escalation, Phase 1 Dose Expansion, and Phase 2a Dose Expansion:
-Phase 1 Dose Escalation: The main aim of this part of the study is to find a maximum tolerated dose for CLN-081. This will be done by slowly increasing the dose given to each participant or to small groups of participants until certain adverse effects are seen. All participants will be closely monitored by the study doctor and team. When the maximum tolerated dose has been found, it will be used in the subsequent parts of the study.
-Phase 1 Dose Expansion: In this part of the study more participants will receive the maximum tolerated dose to confirm the safety of this dose of the study medicine and to explore different dosing schedules, for example, taking the study medicine once a day versus twice a day.
-Phase 2a Dose Expansion: The main aim of this part of the study will be to see how well the study medicine works in reducing tumor size.

Participants can expect to be on this study for about 3 years.

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

A phase II trial of tisagenlecleucel in first-line high-risk (HR) pediatric and young adult patients with B-cell acute ymphoblastic leukemia (B-ALL) who are minimal residual isease (MRD) positive at the end of consolidation (EOC) therapy

Date Added
October 22nd, 2019
PRO Number
Pro00092378
Researcher
Michelle Hudspeth

List of Studies


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

This study is for subjects that have been diagnosed with B-cell Acute Lymphoblastic Leukemia (B-ALL). The study treatment is called tisagenlecleucel (you may also see it referred to as CTL019, CART-19 or Kymriah™). The purpose of the study is to test an experimental approach called gene transfer in subjects that are considered to have high-risk Acute Lymphoblastic Leukemia (ALL), a type of blood cancer that involves cells in your blood called B cells.
Your study participation in this study will not last for more than 8 years. You will be asked to join another study after this trial so your study doctor can check on you for as long as 15 years after the treatment.

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

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)

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

List of Studies


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

DORA Trial: Phase III Trial of Docetaxel vs. Docetaxel and Radium-223 for Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Date Added
August 27th, 2019
PRO Number
Pro00091613
Researcher
Toros Dincman

List of Studies

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

This study is for patients that have been diagnosed with advanced prostate cancer with bone metastases.The purpose of this research study is to compare any good and bad effects of using radium-223 along with docetaxel chemotherapy treatment versus using docetaxel alone. The addition of radium-223 to docetaxel could have an overall survival benefit, but it could also cause side effects. The study drugs, radium-223 and docetaxel, are considered experimental drugs that are being evaluated together as a combination therapy for participants with certain solid tumors (cancer). Patients will be seen at MUSC for about 8 months. After they finish the treatment, the doctor will continue to watch the patient for side effects and follow their condition for the rest of their life, or for as long as they wish to remain on the study.

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

Date Added
July 18th, 2019
PRO Number
Pro00087838
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 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

A Phase 1, Open-Label, Dose-Escalation and Cohort Expansion First-in-Human Study of the Safety, Tolerability, Activity and Pharmacokinetics of REGN3767 (anti-LAG-3 mAb) Administered Alone or in Combination with REGN2810 (anti-PD-1 mAb) in Patients with Advanced Malignancies

Date Added
November 14th, 2017
PRO Number
Pro00067774
Researcher
John Kaczmar

List of Studies


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

The purpose of this first in human study is to find a safe dose level of the investigational drug REGN3767 alone or in combination with REGN2810. Other purposes of this study are to measure the levels of REGN3767 and REGN2810 in the subject's blood and to collect any evidence of tumor shrinkage when given alone or in combination with REGN2810.
REGN3767 and REGN2810 are both a type of drug called a monoclonal antibody. Antibodies are proteins that are naturally found in your blood stream that fight infections. A monoclonal antibody is a special kind of antibody that is manufactured as a medication to target a specific protein in the body that may be involved in the subject's cancer.
In this part of the study each participant will receive 1 of 3 different doses of REGN3767 alone or in combination with one dose of REGN2810. There will be a total of 6 different groups of participants the study team plans to study based on what dose of REGN3767 they receive and whether they receive it alone or with REGN2810.
The study is sponsored by Regeneron. The investigator in charge of this study at MUSC is Carolyn Britten, MD. Part 1 of this study is being done at 4-5 sites. Approximately24-48 people will take part study-wide.

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

A Phase 1, Multicenter, Open-Label, Dose-Escalation and Expansion, Safety, Pharmacokinetic, Pharmacodynamic, and Clinical Activity Study of Orally Administered AG-120 in Subjects with Advanced Hematologic Malignancies with an IDH1 Mutation

Date Added
October 13th, 2015
PRO Number
Pro00048303
Researcher
Praneeth Baratam

List of Studies

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

This study is for patients that have been diagnosed with acute myelogenous leukemia (AML) . The investigational drug in this study is AG-120. The purpose of this study is to identify and test the highest dose of AG-120 that can be given safely. Participants can expect to be in the study for as long as the study doctor feels it is in the participants best interest.

Institution
MUSC
Recruitment Contact
Shanta Salzer
843-792-1463
salzers@musc.edu

A Phase III Prospective Randomized Trial Of Dose-Escalated Radiotherapy With Or Without Short-Term Androgen Deprivation Therapy For Patients With Intermediate-Risk Prostate Cancer

Date Added
August 19th, 2013
PRO Number
Pro00027510
Researcher
David Marshall

List of Studies


Keywords
Cancer, Cancer/Genitourinary, Drug Studies, Men's Health, Prostate
Summary

This study is for patients with prostate cancer. The purpose of this study is to compare the effects of dose-escalated radiation therapy with or without hormone therapy on your prostate cancer.
There are 2 treatment groups in this study:
1) Patients who receive radiation therapy only
2) Patients who receive radiation therapy plus hormone therapy
Patients will receive 44 radiation treatments over approximately 2 months. If the patient chooses to receive the brachytherapy implant, he will receive 25 daily treatments plus the implant procedure over a timeframe of approximately 6 weeks. Hormone therapy, if given, will last 6 months. After patients are finished receiving therapy, the study doctor will ask them to visit the office for follow-up exams at 3, 6, 9, and 12 months after finishing radiation treatment, every 6 months for 4 years, and yearly thereafter.

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

A multicenter access and distribution protocol for unlicensed cryopreserved cord blood units (CBUs) for transplantation in pediatric and adult patients with hematologic malignancies and other indications

Date Added
August 16th, 2011
PRO Number
Pro00011805
Researcher
Michelle Hudspeth

List of Studies


Keywords
Cancer, Children's Health, Men's Health, Minorities, Pediatrics, Transplant, Women's Health
Summary

The primary purposes of this study are to:
•Provide access to cord blood units for recipients whose best choice for a cord blood unit(s) do not meet all FDA standards, but do meet standards set by the NMDP on this study.
•Assess how well and how quickly blood counts return to normal after transplant in recipients on this study.

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



-- OR --