A Randomized Phase III Trial of Doxorubicin +Pembrolizumab Versus Doxorubicin Alone for the Treatment of Undifferentiated Pleomorphic Sarcoma (UPS) and Related Poorly Differentiated Sarcomas

Date Added
October 25th, 2024
PRO Number
Pro00139599
Researcher
Christopher Rangel

List of Studies

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

This study if for patients with undifferentiated pleomorphic sarcoma (UPS) or a related poorly differentiated sarcoma that has spread from where it first started to other places in the body or it cannot be removed by surgery. This study compares the effect of pembrolizumab plus doxorubicin to doxorubicin alone in treating patients. Doxorubicin damages the cell's DNA and may kill tumor cells. Doxorubicin also blocks a certain enzyme needed for cell division and DNA repair. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attach the cancer and may interfere with the ability of tumor cells to grow and spread. Adding pembrolizumab to the standard chemotherapy, doxorubicin, may help patients with UPS or a related poorly differentiated sarcoma live longer without having disease progression. The duration of the study will be about 12 years, with 6 months of active treatment for those receiving doxorubicin alone and 2 years active treatment for those receiving doxorubicin and pembrolizumab. Each participant will be in follow up for 10 years. Some of the main side effects are nausea, vomiting, low blood count, fatigue and mild diarrhea.

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

Colon Adjuvant Chemotherapy Based on Evaluation of Residual Disease (CIRCULATE-NORTH AMERICA)

Date Added
October 21st, 2024
PRO Number
Pro00138258
Researcher
Toros Dincman

List of Studies

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

The purpose of this study is to determine what kind of chemotherapy to recommend to patients based on the presence or absence of circulating tumor DNA (ctDNA) after surgery for colon cancer? ctDNA, or circulating tumor DNA, is DNA that has been released from tumor cells into your bloodstream. This DNA can be measured using a blood test.

This study seeks to find if this approach is better or worse than standard of care for colon cancer.

Treatment and follow up for this study may be up to 8 years. The procedures include blood samples, tissue samples, and chemotherapy. Risks include diarrhea, nausea, vomiting, hair loss, mouth sores, loss of appetite, tingling or pain in hands/feet/arms/legs, and anemia. 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 2 Study of Nivolumab and Ipilimumab With or Without Cabozantinib in Patients With Advanced Nasopharyngeal Carcinoma That Have Progressed After Platinum Treatment and Immunotherapy

Date Added
September 23rd, 2024
PRO Number
Pro00138505
Researcher
John Kaczmar

List of Studies


Keywords
Cancer, Cancer/Head & Neck, Men's Health, Women's Health
Summary

This study is designed to learn more about how nivolumab and ipilimumab, with or without cabozantinib effects the growth and spreading of head and neck cancer. If decided to take part in this study, participants will go through a screening period, treatment period, and follow-up period. During the screening period following signing of consent form participants will be evaluated for screening criteria and determined if they qualify for the study. During treatment period participants will be randomly assigned to either receive the combination of two immunotherapy drugs, nivolumab and ipilimumab for up to 2 years, or the two immunotherapy drugs with an additional targeted drug, cabozantinib, for up to 2 years unless your cancer gets worse or the side effects of the treatment become too severe. In the follow up period the side effects will be observed by the study team every 3 to 4 months for 2 years after treatment. The most common risks and discomforts expected in this study are diarrhea, nausea, vomiting, tiredness, weight loss, loss of appetite, changes in taste or voice, redness, pain or peeling of palms and soles, and high blood pressure which may cause blurred vision. There may not a benefit from joining the study. The head and neck cancer may improve while on this study but it may not, and it may even get worse. It will also help inform how well this combination treatment works at curing this type of cancer. The study results may be used to help others in the future.

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

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 1/2, Open-label, Dose-escalation, and Dose-expansion Study to Evaluate Safety, Tolerability, and Clinical Activity of SNDX-5613 in Combination with Intensive Chemotherapy in Participants with Newly Diagnosed Acute Myeloid Leukemias Harboring Alterations in Lysine-specific Methyltransferase 2A (KMT2A/MLL), Nucleophosmin 1 (NPM1), and Nucleoporin 98 (NUP98) Genes

Date Added
September 12th, 2024
PRO Number
Pro00136971
Researcher
Praneeth Baratam

List of Studies

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

This is a is a Phase 1, open-label, dose-escalation, and dose-expansion multicenter study to evaluate the safety, tolerability, pharmacokinetic (PK) profile, and clinical activity of SNDX-5613 in combination with intensive chemotherapy in participants with newly diagnosed Acute Myeloid Leukemias harboring alterations in KMT2A, NPM1, or NUP98 genes. The primary purpose of this study is to identify the maximum tolerated dose of SNDX-5613 (Revumenib) to be used in both a combination with intensive chemotherapy and alone. SNDX-5613 (Revumenib) is an "investigational" (not yet FDA approved) treatment. The study will enroll approximately 76 patients in 3 phases with each receiving cycles of chemotherapy followed by SNDX-5613 in the Induction and Consolidation phases followed by SNDX-5613 alone in the Maintenance Monotherapy phase if eligible. The study includes screening, treatment, safety follow-up, and survival follow-up periods over the course of 18 months. The main risk is that medical treatments often cause side effects. Patients may have none, some, or all of the effects listed or not listed in the protocol, and they may be mild, moderate, or severe. There is no direct benefit in participating in this study.

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

A Global Pivotal Study in Patients with KRAS G12C-Mutant, Locally Advanced or Metastatic Non-Small Cell Lung Cancer Comparing First-Line Treatment of Pembrolizumab and LY3537982 vs Pembrolizumab and Placebo in those with PD-L1 50% or Pembrolizumab, Pemetrexed, Platinum Chemotherapy and LY3537982 vs Pembrolizumab, Pemetrexed, Platinum Chemotherapy and Placebo regardless of PD-L1 Expression

Date Added
September 5th, 2024
PRO Number
Pro00135211
Researcher
Mariam Alexander

List of Studies

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

Study JZQB is a global research effort investigating a potential treatment for lung cancer. The study involves patients with a specific type of lung cancer that has certain genetic features. Researchers aim to compare the effectiveness of a new drug, LY3537982, when used in combination with pembrolizumab, against a placebo combined with pembrolizumab. The goal is to understand how well the new drug combination works in preventing the cancer from returning and whether it improves patients' overall quality of life. The study is carefully designed to align with real-world medical practices and will evaluate different doses of the new drug. It emphasizes safety, efficacy, and patient outcomes to provide valuable insights for future lung cancer treatments.

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

A Randomized Phase 3 Trial of Continuous vs. Intermittent Maintenance Therapy with Zanubrutinib as Upfront Treatment in Older Patients with Mantle Cell Lymphoma (INTERCON)

Date Added
August 26th, 2024
PRO Number
Pro00136417
Researcher
Katherine Antel

List of Studies

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

This study is for subjects that have been diagnosed with mantle cell lymphoma. The purpose of this study is to compare continuous treatment with zanubrutinib to treatment with zanubrutinib that is stopped after the initial six 28-day cycles of chemotherapy and restarted at the first time your disease gets worse following the initial six 28-day cycles of chemotherapy. The subject may remain in the study for up to 10 years.

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

A Phase 3, Multicenter, Randomized, Open-Label Trial to Evaluate the Safety and Efficacy of Epcoritamab + Rituximab and Lenalidomide (R2) Compared to Chemoimmunotherapy in Previously Untreated Follicular Lymphoma (EPCORE™FL-2)

Date Added
August 9th, 2024
PRO Number
Pro00133370
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 been diagnosed with Follicular Lymphoma.
This study is testing an investigational drug(s) called Epcoritamab that is not approved by the FDA (Food and Drug Administration). The purpose of this study is to see if the combination of the study drug epcoritamab with rituximab and lenalidomide has a better response rate than standard of care chemoimmunotherapy in the treatment of follicular lymphoma. The total study treatment duration is up to 2.5 years. You may stop the study treatment early if you do not respond after 6 months, your disease worsens, you no longer tolerate the study drug(s), or you withdraw from the study.

Once you finish the study treatment or discontinued study treatment early, you will continue to the Post-Study Treatment Follow Up Period, you will come back to the study clinic every 6 months for the first 3 years and then yearly to have imaging scans and blood work to check if your disease is in remission or worsen.

If your disease worsens or if you start a new FL treatment, you will enter the Long-term Follow Up Period, you will be called by telephone or your health record will be reviewed to check on your well-being and to see what your next treatment plan will be. This follow-up may last up to 15 years.

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

A Phase II Study of Naxitamab Added to Induction Therapy for Subjects With Newly Diagnosed High-Risk Neuroblastoma

Date Added
August 8th, 2024
PRO Number
Pro00134887
Researcher
Jacqueline Kraveka

List of Studies


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

This study is for patient that have been diagnosed with High Risk Neuroblastoma. The investigational drug in this study is naxitamab. The purpose of this study is to test the safety of adding an Anti-GD2 Immunotherapy agent (naxitamab) to your standard therapy during the induction phase of care. Read the sections on risks and benefits carefully and be sure you understand them. This study will also look at the effectiveness of this treatment.

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

EMPWR Pilot Trial: Treatment Retention in Medication for Opioid Use Disorder Among Pregnant and Postpartum Women

Date Added
August 6th, 2024
PRO Number
Pro00137982
Researcher
Sara Witcraft

List of Studies

Keywords
Anxiety, Mental Health, Pregnancy, Psychiatry, Sleep Disorders, Substance Use, Women's Health
Summary

This study involves testing how useful a technology-enhanced intervention is for pregnant people prescribed buprenorphine for the management of opioid use disorder. The intervention being studied is a brief skill building protocol and a mobile application. Participation involves three 60-90-minute skill building appointments during pregnancy, and four 30-minute check-in visits at the end of pregnancy through 3 months postpartum. The mobile application will be accessible for at least the duration of the study. Participants will also be asked to complete questionnaires at enrollment and again at 1-month postpartum and 3-months postpartum, will send monthly photos of their prescription bottle/box, and will be contacted randomly throughout the study to perform a medication count. The total duration of the study is between 5-9 months depending on when you enroll. Compensation is provided.

Institution
MUSC
Recruitment Contact
Maham Dilawar
843-214-4496
dilawarm@musc.edu



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