A Phase 3, Multicenter, Open-label, Randomized Study to Compare the Efficacy and Safety of MK-2870 Versus Treatment of Physicians Choice in 3L+ Advanced/Metastatic Gastroesophageal Adenocarcinoma, Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma, and Esophageal Adenocarcinoma

Date Added
September 13th, 2024
PRO Number
Pro00137754
Researcher
Albert Lockhart

List of Studies

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

The purpose of this study is to evaluate investigational treatments (study drug) in people with gastroesophageal adenocarcinoma that has progressed (become worse) after at least 2 prior treatments.

The goal is to determine the optimal dose level, safety, and tolerability for the study drug MK2870-015. This is a phase 3 study; MK2870-015 is not FDA approved by the U.S. Food and Drug Administration (FDA). Treatment for this study may be up to 3 years. The procedures include taking study drug intravenously, blood and urine samples, MUGA scans and CT scans. Risks include diarrhea, nausea, vomiting, hair loss, weight loss, high blood sugar, and sore throat. You may or may not receive a direct benefit from participating in this trial, however, information learned from the trial may help other people in the future.

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

A Phase I/Randomized Phase II, Open-Label Multicenter Trial to Evaluate the Safety, Tolerability, and Efficacy of mFOLFIRINOX With or Without BNT321 as Adjuvant Therapy Following Curative Resection in Patients with Pancreatic Adenocarcinoma

Date Added
August 13th, 2024
PRO Number
Pro00134872
Researcher
Albert Lockhart

List of Studies

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

The purpose of this study is to evaluate investigational treatments (study drug) for pancreatic adenocarcinoma following surgery in order to determine if any of these study treatments improve overall survival as compared to standard treatments. The goal is to determine the optimal dose level, safety, and tolerability for the study drug BNT321 in combination with mFOLFIRINOX. BNT321 is not FDA approved. mFOLFIRINOX is FDA approved by the U.S. Food and Drug Administration (FDA) to treat various cancers but may not be approved for your type of cancer. Treatment for this study may be up to 3 years. The procedures include blood and urine samples, questionnaires, infusions, and CT scans. Risks include diarrhea, nausea, vomiting, fatigue, headache, fever, and joint pain. You may or may not receive a direct benefit from participating in this trial, however, information learned from the trial may help other people in the future.

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

A Phase 1 Open Label Study to Evaluate the Efficacy and Safety of ABBV-400 in Select Advanced Solid Tumor Indications

Date Added
May 7th, 2024
PRO Number
Pro00136641
Researcher
Albert Lockhart

List of Studies

Keywords
Cancer, Drug Studies
Summary

The purpose of this study is to evaluate ABBV-400 in subjects with select solid tumors. This study will consist of
multiple cohorts with each cohort investigating ABBV-400 at 3 mg/kg Q3W.
The study will consist of a Screening, a Treatment, and a Follow-Up period.
All screening procedures must be performed within 28 days of first dose with the exception of tumor
tissue biopsy, which may occur during screening or any time after disease progression on the most
recent treatment. Subjects will continue treatment with ABBV-400 3 mg/kg Q3W until documented disease progression,
intolerable toxicity, or the subject meets other protocol criteria for discontinuation of treatment
(whichever occurs first). The maximum treatment duration will be 2 years.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
8437929321
hcc-clinical-trials@musc.edu

A Phase 1/2, First-In-Human, Multi-Part, Open-Label Study to Investigate the Safety, Tolerability, Pharmacokinetics, Biological and Clinical Activity of DF9001 as a monotherapy and in combination with nivolumab in Patients With Advanced (Unresectable, Recurrent, or Metastatic) Solid Tumors, and Expansion in Selected Indications

Date Added
April 24th, 2024
PRO Number
Pro00133820
Researcher
Albert Lockhart

List of Studies

Keywords
Cancer, Drug Studies
Summary

A clinical research study is an investigation in humans of a potential medical treatment that is designed to discover or verify whether it works and is safe. This study will test an investigational drug called DF9001. "Investigational" means that it has not been approved by any health authority such as the United States Food and Drug Administration (FDA) or the European Medicines Agency (EMA). Information gathered from this study will be sent to the various health authorities.
The study has two parts: a Dose Escalation part and an Efficacy Expansion part. The main purpose of the Efficacy Expansion part of this study is to test whether the study drug (DF9001) works (if it causes cancer to shrink or disappear). The Dose Escalation part of this study's main purpose is to test different doses of the study drug by itself, and also in combination with a drug called nivolumab, an FDA approved drug. Some foreseeable risks associated with DF9001 include Diarrhea,
Skin problems, Nail changes, Eye problems, Inflammation of the lungs, intestines and liver, as well as unforeseen side effects that may occur. There is no direct benefit in participating in this study.

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

A Phase 3, Randomized Study to Evaluate the Efficacy and Safety of Pembrolizumab (MK-3475) + Lenvatinib (E7080/MK-7902) + Chemotherapy Compared with Standard of Care as First-line Intervention in Participants with Metastatic Esophageal Carcinoma

Date Added
December 20th, 2023
PRO Number
Pro00131028
Researcher
Albert Lockhart

List of Studies

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

The purpose of this study is to evaluate investigational treatments (study drugs) for metastatic esophageal carcinoma to determine if any of these study drugs improve overall survival as compared to standard treatments. The study drugs used in this trial are lenvatinib (E7080/MK‑7902), also called LENVIMA, and pembrolizumab (MK‑3475), also called KEYTRUDA or pembro. Both lenvatinib and pembrolizumab have been approved by the U.S. Food and Drug Administration (FDA) to treat various cancers but may not be approved for your type of cancer. Treatment for this study may be up to 3 years. The procedures include blood and urine samples, questionnaires, infusions, and CT scans. Risks include itchy skin, loose stools, cough, and joint pain. You may or may not receive a direct benefit from participating in this trial, however, information learned from the trial may help other people in the future.

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

A Phase 2, Randomized Study to Evaluate the Safety, Efficacy and Optimal dose of ABBV-400 in Combination with Fluorouracil (5-FU), Folinic Acid and Bevacizumab in Previously Treated Subjects with Unresectable Metastatic Colorectal Cancer (mCRC)

Date Added
December 13th, 2023
PRO Number
Pro00133837
Researcher
Albert Lockhart

List of Studies

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

The purpose of this study is to evaluate investigational treatments (study drug) for unresectable metastatic colorectal cancer to determine if any of these study treatments improve overall survival as compared to standard treatments. The goal is to determine the optimal dose level, safety, and tolerability for the study drug ABBV-400 in combination with fluorouracil, folinic acid, and bevacizumab. The study consists of two stages, Stage 1 - Safety Lead-In Dose Escalation and Stage 2- Dose Optimization. ABBV-400 is not FDA approved. Bevacizumab is FDA approved by the U.S. Food and Drug Administration (FDA) to treat various cancers but may not be approved for your type of cancer. Treatment for this study may be up to 3 years. The procedures include blood and urine samples, questionnaires, infusions, and CT scans. Risks include diarrhea, nausea, vomiting, fatigue, and numbness, tingling, or weakness in arms and legs. You may or may not receive a direct benefit from participating in this trial, however, information learned from the trial may help other people in the future.

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

RANDOMIZED PHASE III TRIAL OF MFOLFIRINOX +/- NIVOLUMAB VS. FOLFOX +/- NIVOLUMAB FOR FIRST-LINE TREATMENT OF METASTATIC HER2-NEGATIVE GASTROESOPHAGEAL ADENOCARCINOMA

Date Added
April 6th, 2023
PRO Number
Pro00128202
Researcher
Albert Lockhart

List of Studies

Keywords
Cancer/Gastrointestinal
Summary

This study is for patients with cancer in the stomach, esophagus, or gastroesophogeal junction. The study is being done to see if by adding a third chemotherapy drug to the usual combination of two chemotherapy drugs is better or worse than the usual approach for treatment.

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

Disparities in REsults of Immune Checkpoint Inhibitor Treatment (DiRECT): A Prospective Cohort Study of Cancer Survivors Treated with anti-PD-1/anti-PD-L1 Immunotherapy in a Community Oncology Setting

Date Added
June 22nd, 2022
PRO Number
Pro00121172
Researcher
Albert Lockhart

List of Studies

Keywords
Cancer
Summary

This study is for patients with invasive cancer I-IV and be scheduled to receive anti-PD-1/-L1 ICI-containing therapy. This study is being done to see if we can understand which patients will develop side effects from immune checkpoint inhibitors, and what kind of side effects they will get and can we predict long-term treatment outcomes after immune checkpoint inhibitor treatment, like which patients will have a cancer that shrinks or disappears.

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

A Randomized Phase III Trial of Olanzapine Versus Megestrol Acetate for Cancer-Associated Anorexia

Date Added
January 11th, 2022
PRO Number
Pro00117676
Researcher
Albert Lockhart

List of Studies

Keywords
Cancer
Summary

This study is for patients who have cancer and are experiencing loss of weight and appetite. The study wants to find out if this taking olanzapine for four weeks will increase your appetite as compared to megestrol acetate. The study is looking to see if that approach is better or worse than the usual approach for your loss of appetite and weight. The usual approach is defined as care most people get for loss of appetite.

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



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