A Phase 2 Study of Inotuzumab Ozogamicin (NSC# 772518) in Children and Young Adults With Relapsed or Refractory CD22+ B-Acute Lymphoblastic Leukemia (B-ALL)

Date Added
November 23rd, 2021
PRO Number
Pro00116587
Researcher
Jacqueline Kraveka

List of Studies


Keywords
Adolescents, Cancer, Pediatrics
Summary

This study is for patients who have been diagnosed with relapsed or refractory CD22+ B-Acute Lymphoblastic Leukemia (B-ALL). The overall goal of this study is to find out what effect, good and/or bad, the drug inotuzumab ozogamicin has on children and young adults with relapsed or refractory B-ALL. Participants can expect to be on this study for up 2 months and followed for up to 5 years.

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

A Phase 1/2 Study of REGN5093-M114 (METxMET Antibody-Drug Conjugate) in Patients with MET Overexpressing Advanced Cancer

Date Added
November 23rd, 2021
PRO Number
Pro00115889
Researcher
Mariam Alexander

List of Studies

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

This study is for patients who have been diagnosed with advanced non-small cell lung cancer (NSCLC) and have a certain protein, called MET in their tumor. The investigational drug in this study is REGN5093-M114 (study drug). The study drug works by bringing chemotherapy to the cells that express MET protein to kill those cells and not the other tissues in your body. The aim of the study is to see how safe, tolerable (how your body reacts to the drug), and effective the study drug is. Participants will receive the study drug intravenously (in your vein) every 3 weeks for as long as they tolerate the drug well and the cancer is stable or responding to the study drug. There is then 2 follow up visits 30 and 90 days after the last dose of study drug and telephone calls every 30 days until the study ends.

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

A Randomized Phase II Study of CHO(E)P vs CC-486-CHO(E)P vs Duvelisib-CHO(E)P in Previously Untreated CD30 Negative Peripheral T-Cell Lymphomas

Date Added
October 29th, 2021
PRO Number
Pro00115669
Researcher
Irl Greenwell

List of Studies


Keywords
Cancer, Cancer/Lymphoma
Summary

This study is for participants that have been diagnosed with previously untreated CD30 Negative Peripheral T-cell Lymphomas. The purpose of this study is to determine if the effects (good or bad) of adding a study drug (duvelisib or CC-486 (azacitidine)) to the usual combination of drugs. Participants can expect to be on treatment for 18 months and followed by the study team for up to 5 years after study completion.

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

A Phase II/III Randomized Study of R-MiniCHOP With or Without CC-486 (Oral Azacitidine) in Patients Age 75 Years or Older With Newly Diagnosed Diffuse Large B Cell Lymphoma, Grade IIIB Follicular Lymphoma, Transformed Lymphoma, and High-Grade B-Cell Lymphomas With MYC and BCL2 and/or BCL6 Rearrangements

Date Added
October 20th, 2021
PRO Number
Pro00115627
Researcher
Brian Hess

List of Studies


Keywords
Cancer, Cancer/Lymphoma
Summary

This study is for patients with newly diagnosed diffuse Large B Cell Lymphoma.
This study will help the study doctors find out if taking R-mini-CHOP plus the study drug CC-486 (oral azacitidine) is better, the same, or worse than taking the R-mini-CHOP drug combination alone. To decide if it is better, the study doctors will be comparing the drug combinations to see which drug combination allows more patients to have no disease symptoms at 1 year or more after the start of the study treatment and which drug combination extends the overall survival (how long people live) of patients at 5 years after the start of the study treatment.

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

Combination of Autophagy Selective Therapeutics (COAST) in Relapsed Gynecological Cancers, Relapsed Prostate Cancer, or other Advanced Solid Tumors, a Phase I/II Trial

Date Added
October 19th, 2021
PRO Number
Pro00113440
Researcher
Brian Orr

List of Studies

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

This study is for subjects that have been diagnosed with advanced solid cancer tumors or relapsed prostate cancer. The investigational drugs in this study are hydroxychloroquine, nelfinavir, metformin, dasatinib and sirolimus. The purpose of this study is to determine the safety and effectiveness of up to 5 study drugs used together for the treatment of cancer. Subjects can expect to be in this study for about 2.5 years.

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

A Phase 2 Study of Mecbotamab Vedotin (BA3011) Alone and in Combination with Nivolumab in Adult Patients with Metastatic Non-Small Cell Lung Cancer (NSCLC) Who Had Prior Disease Progression on or Are Intolerant to a PD-1/L-1, EGFR, or ALK Inhibitor

Date Added
October 12th, 2021
PRO Number
Pro00113721
Researcher
Mariam Alexander

List of Studies

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

This study is for patients who have been diagnosed with metastatic Non-Small Cell Lung Cancer (NSCLC). The investigational drug in this study is Mecbotamab Vedotin (BA3011). Investigational means the drug is currently being tested and has not been approved by the U.S. Food and Drug Administration (FDA). Participants will receive Mecbotamab Vedotin by intravenous (IV) infusion. The purpose of this study is to understand how Mecbotamab Vedotin works with and without nivolumab in fighting cancer cells; to see what side effects Mecbotamab Vedotin has when given alone and in combination with nivolumab; to understand how the body absorbs and processes Mecbotamab Vedotin; and to understand whether Mecbotamab Vedotin, alone or in combination with nivolumab, causes a response by the immune system that leads to the development of antibodies (proteins made in the body that respond to a substance that is foreign to the body). Participants can expect to be in this study for about 2 and a half years.

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

A Phase 1/2 Dose Escalation and Dose Expansion Study of Ozuriftamab Vedotin (BA3021) Alone and in Combination With Nivolumab In Patients With Advanced Solid Tumors

Date Added
October 12th, 2021
PRO Number
Pro00114862
Researcher
Mariam Alexander

List of Studies

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

This study is for patients who have been diagnosed with non-small cell lung cancer. The investigational drug in this study is Ozuriftamab Vedotin (BA3021). Investigational means the drug is currently being tested and has not been approved by the U.S. Food and Drug Administration (FDA). Participants will receive Ozuriftamab Vedotin by intravenous (IV) infusion. The purpose of this study is to see how Ozuriftamab Vedotin alone, and in combination with another drug called nivolumab, affects growth and formation of tumors; to see how safe Ozuriftamab Vedotin is alone and in combination with nivolumab; to understand how the body absorbs and processes Ozuriftamab Vedotin; to understand whether Ozuriftamab Vedotin, alone or in combination with Nivolumab, causes a response by the immune system that leads to the development of antibodies (proteins made in the body that respond to a substance that is foreign to the body) which may prevent the study drug from working and/or increase your risk of side effects. Participants can expect up to 75 clinic visits over a period of about 3 years.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinicaltrials@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
Kimberly Green

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

A Phase 1/2 Open-Label, Multicenter Study to Assess the Safety, Pharmacokinetics, and Antitumor Activity of UCB6114 Administered Intravenously to Participants With Advanced Solid Tumors

Date Added
September 14th, 2021
PRO Number
Pro00113625
Researcher
Toros Dincman

List of Studies

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

This study is enrolling participants with advanced solid tumors. The purpose of the study is to see how safe the study drug Ginisortamab is and how the body processes the drug when given alone or in combination with selected standard of care (SOC) regimens. Participants will receive Ginisortamab via intravenous (IV; injected into a vein) infusion (drip) every 2 weeks, on Days 1 and Day 15 of each treatment cycle. If they continue to additional cycles, the infusions will continue to take place every 2 weeks according to the same schedule. Participants will be in this trial for a planned period of at least 2 cycles of study treatment (around 8 weeks) but should the Study Doctor decide that he/she is benefiting from treatment, he/she can remain in the study for additional cycles of treatment until he/she decide to withdraw from the study, he/she experiences any unacceptable side effects due to the treatment or if the disease worsens.

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



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