IMMUNE CHECKPOINT INHIBITOR TOXICITY (I-CHECKIT): A PROSPECTIVE OBSERVATIONAL STUDY

Date Added
October 5th, 2021
PRO Number
Pro00115072
Researcher
Frank Brescia

List of Studies


Keywords
Cancer
Summary

This study is for people with cancer receiving immunotherapy. The purpose of this study is to try and learn how certain risk factors (such as age, gender, other medical conditions, and the type of immunotherapy used to treat the cancer) affect whether a patient will develop mild or serious side effects from the medication.

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

Effective Quadruplet Utilization After Treatment Evaluation (EQUATE): A Randomized Phase 3 Trial for Newly Diagnosed Multiple Myeloma Not Intended for Early Autologous Transplantation

Date Added
September 28th, 2021
PRO Number
Pro00115401
Researcher
Hamza Hashmi

List of Studies

Keywords
Cancer, Cancer/Myeloma
Summary

This study is for patients that have been diagnosed with multiple myeloma. The usual approach for patients with newly diagnosed multiple myeloma who are not in a study, is lenalidomide and dexamethasone in combination with bortezomib or daratumumab. This approach is approved by the Food and Drug Administration (FDA). The purpose of this study is to see if patients who have a small amount of cancer left after initial treatment (called minimal residual disease (MRD)), could benefit from adding a new drug to the usual treatment. The study approach, using a combination of four drugs, is investigational and not approved by the FDA. Patients can expect to be on this study for up to 2 years. Patients will then be followed by their doctor for up to 15 years after completion of the study or until disease progression..

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

Optimizing Prolonged Treatment in Myeloma Using MRD Assessment (OPTIMUM)

Date Added
September 9th, 2021
PRO Number
Pro00114332
Researcher
Hamza Hashmi

List of Studies

Keywords
Cancer
Summary

This study is for patients that have been diagnosed with multiple myeloma. The study drugs are Ixazomib and lenalidomide. The purpose of this study is to compare using lenalidomide and ixazomib to using lenalidomide and placebo. Participants will be on this study until disease progression or unacceptable toxicity.

Institution
MUSC
Recruitment Contact
Barbara Roe
843-652-1607
broe@tidelandshealth.org

A Phase II/III trial of MEDI4736 (Durvalumab) and Chemotherapy for Patients with High Grade Upper Tract Urothelial Cancer Prior to Nephroureterectomy

Date Added
August 27th, 2021
PRO Number
Pro00113791
Researcher
Theodore Gourdin

List of Studies


Keywords
Cancer, Cancer/Genitourinary, Urinary
Summary

This study is for patients with upper urinary tract cancer. The purpose of this study is to compare a usual treatment alone to using MEDI4736 (durvalumab) plus the usual treatment.

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

Pilot study of group video Yogic breathing app in breast cancer survivors

Date Added
August 25th, 2021
PRO Number
Pro00108511
Researcher
Jennifer Harper

List of Studies


Keywords
Breathing, Cancer, Cancer/Breast
Summary

Cancer survivorship is associated with many long-term chronic health issues that arise as a result of cancer
treatment protocols. Non-pharmacological lifestyle and mind-body interventions have been shown to be
effective and critical components of a total-health strategy for cancer survivors. PranaScience Institute seeks to
develop and test a novel group video app for home-based delivery of a Yogic Breathing intervention that
reduces symptoms of cancer treatment survival and supports total-health.

Institution
MUSC
Recruitment Contact
Emily Richardson
(843) 792- 8352
richaemi@musc.edu

A Phase 2 Randomized Study of Loncastuximab Tesirine Versus Idelalisib in Patients with Relapsed or Refractory Follicular Lymphoma (LOTIS 6)

Date Added
August 24th, 2021
PRO Number
Pro00112787
Researcher
Brian Hess

List of Studies


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

This study is for subjects that have relapsed or refractory follicular lymphoma, which means your lymphoma has worsened after treatment or has not responded to treatment. This study is testing an "investigational" (not yet FDA approved drug) study drug called loncastuximab tesirine (ADCT-402). Treatment will be administered intravenously or via tablet depending on the subject's assigned treatment. The primary purpose of this study is to test whether the investigational drug called loncastuximab tesirine may be more effective treatment for relapsed or refractory follicular lymphoma than treatment with the drug idelalisib. The subject will be seen approximately once every three weeks, and may remain in the study for up to 3 years.

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

A multi-center phase Ib trial evaluating the safety and efficacy of lacutamab in patients with relapse peripheral T-cell lymphoma that express KIR3DL2

Date Added
August 24th, 2021
PRO Number
Pro00113053
Researcher
Irl Greenwell

List of Studies


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

This study is for subjects that have been diagnosed with peripheral T-cell lymphoma (PTCL) and have received at least one prior systemic therapy for their disease. This study is testing an "investigational" (not yet FDA approved drug) study drug called Lacutamab (IPH4102). The primary purpose of this study is to evaluate the safety and effectiveness of lacutamab. The subject may remain in the study until their disease progresses or they have developed unacceptable toxicity secondary to lacutamab and can expect to be in follow-up for 1 year if they discontinue treatment in the first year.

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

A Phase 1b/2, First-in-Human, Dose Escalation and Expansion Study of XMT-1536 In Patients with Solid Tumors Likely to Express NaPi2b

Date Added
August 10th, 2021
PRO Number
Pro00112310
Researcher
Brian Orr

List of Studies

Keywords
Cancer, Cancer/Gynecological, Drug Studies
Summary

This study is for subjects with ovarian and non-small cell lung cancer. The investigational drug used is XMT-1536 (upifitamab rilsodotin). The drug will be given intravenously "IV" during infusion.
This study will focus on two parts: dose expansion (increasing the dose used) and the pivotal cohort (safety and usefulness of UPLIFT). The purpose of the second part of the study (dose expansion) is to study further the expansion dose (increasing of the dose) of XMT-1536. The research is done based on the data from the first part of the study to ensure that it can be tolerated and is safe. The third part of this study (UPLIFT) will further study the dose recommended in the first part of the study in subjects with ovarian cancer. UPLIFT is used to determine the subjects' response rate to the study drug and the length of time the drug stays in the blood. The subjects will be in the study for 18 months.

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

First-in-Human, Phase 1/1b, Open-label, Multicenter Study of Bifunctional EGFR/TGFβ Fusion Protein BCA101 Alone and in Combination With Pembrolizumab in Patients With EGFR-Driven Advanced Solid Tumors

Date Added
July 27th, 2021
PRO Number
Pro00111442
Researcher
John Kaczmar

List of Studies


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

This study is for patients who have advanced cancers, such as head and neck cancer, colorectal cancer, breast cancer, and others. This study is testing a new treatment for these types of cancer. The new test drug is called BCA101. Pembrolizumab is an approved drug by the United States Food and Drug Administration (FDA) for the diseases described in this study and will be used as approved. The type of cancer a patient has will determine whether he/she will get BCA101 alone or BCA101 in combination with pembrolizumab. Participants will receive either BCA101 alone or BCA101 in combination with pembrolizumab until the cancer gets worse, they experience bad side effects, or until they withdraw consent, or until the Investigator considers it is in his/her best interest to discontinue the study drug.

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

Randomized, Phase III Study of Early Intervention With Venetoclax and Obinutuzumab Versus Delayed Therapy With Venetoclax and Obinutuzumab in Newly Diagnosed Asymptomatic High-Risk Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL): EVOLVE CLL/SLL Study

Date Added
July 22nd, 2021
PRO Number
Pro00111458
Researcher
Brian Hess

List of Studies


Keywords
Cancer, Cancer/Leukemia, Cancer/Lymphoma
Summary

This study is for newly diagnosed asymptomatic high-risk patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). The purpose of this study is to find out if starting treatment with the investigational products, venetoclaz and obinutuzumab (V-O) early (before symptoms occur) affect how long you live compared to the usual approach of starting treatment after showing symptoms. Participants can expect to receive treatment for up to 12 months, until the cancer gets worse or until the side effects are too great. After study completion, participants will continue to be followed for up to 10 years.

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



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