A Phase 2b, Open-Label, Two-cohort Study of Subcutaneous Amivantamab in Combination with Lazertinib as First-Line Treatment, or Subcutaneous Amivantamab in Combination with Platinum-Based Chemotherapy as Second-line Treatment, for Common EGFR-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Date Added
December 18th, 2025
PRO Number
Pro00147387
Researcher
Mariam Alexander

List of Studies

Keywords
Cancer, Cancer/Lung, Drug Studies
Summary

This study is for patients that have been diagnosed with non-small cell lung cancer (NSCLC). This study is testing an investigational drug called Amivantamab. "Investigational" means that is not been approved by United States Food and Drug Administration (FDA). There will be no randomization in this study. Participants will be assigned to treatment upon enrollment based on disease treatment status. The primary purpose of this study is to understand how well the study treatment works and the safety of the combination of Amivantamab and Lazertinib in participants who have NSCLC with a specific eGFR mutation. Amivantamab can be given under the skin (subcutaneous) or by infusion (IV). Participants can be in the study for up to 36 months depending on how the participants disease responds to treatment.

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

A Double-blind, Randomized, Placebo-controlled, Multicenter Study Assessing Olpasiran Use to Prevent First Major Cardiovascular Events in Participants with Elevated Lipoprotein(a)

Date Added
December 9th, 2025
PRO Number
Pro00147257
Researcher
Ashley Waring

List of Studies

Keywords
Drug Studies, Heart
Summary

This study is enrolling participants with risk factors for heart or blood vessel events (e.g. heart attack, stroke, etc) who also have an elevated lipoprotein a (Lp(a)), which is a sticky particle in the blood that carries cholesterol. The first part of the study involves testing the Lp(a) level and if elevated then participants will be invited to be a part of a study testing the investigational medication olpasiran. Investigational means it has not been approved for commercial use by the Food and Drug Administration. The study medication is given as a shot just under the skin every 3 months. This study is a randomized study meaning participants are assigned by chance to either receive olpasiran or placebo. Placebo looks like the real medication but has no active ingredients. Participants have a 50:50 chance of being assigned to either group but will not know which group they are in. Study related procedures include physical exams, blood work, vital signs, electrocardiogram (ECG - a tracing of the heart's electrical activity) and study medication administration. This study is expected to last about three and a half to five and a half years and involve between 16 to 28 visits.

Institution
MUSC
Recruitment Contact
Olivia Washington
843-792-5863
Washoliv@musc.edu

Randomized Phase III Trial of Pembrolizumab vs. Pembrolizumab/Cetuximab in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma with Platinum Refractory Disease

Date Added
November 18th, 2025
PRO Number
Pro00147980
Researcher
John Kaczmar

List of Studies


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

The purpose of this study is to test whether adding cetuximab to standard of care (pembrolizumab) is more effective in shrinking tumor size and increasing survival when compared to being treated with pembrolizumab alone. This study seeks to find if this approach is the same, better, or worse than standard of care for returning or spreading head and neck cancer after previous treatment.

Treatment and follow up for this study may be up to 5 years. The procedures include blood tests, CT or MRI scans, and chemotherapy. Risks include tiredness, anemia, constipation, loss of appetite, joint stiffness, cough, swelling and redness of the skin.

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. Both drugs, pembrolizumab and cetuximab, are already individually approved by the FDA for use in head and neck cancers. However, the benefit of combining the two drugs is being investigated in this study and this study approach is not FDA approved.

There will be about 158 people taking part in this study, approximately 4 subjects will be enrolled at MUSC.

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

A Randomized Phase II Study of Nivolumab versus Nivolumab and BMS-986016 (Relatimab) as Maintenance Treatment after First-line Treatment with Platinum-Gemcitabine-Nivolumab for Patients with Epstein-Barr Virus- Associated Recurrent/Metastatic Nasopharyngeal Carcinoma (REMAIN)

Date Added
November 14th, 2025
PRO Number
Pro00146870
Researcher
John Kaczmar

List of Studies


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

This study is for subjects who have been diagnosed with recurrent or metastatic nasopharyngeal cancer. Subjects are expected to remain in the study for a minimum of 70 months. Drugs are FDA approved and is given through a vein (also called IV or intravenous). The procedures include blood and urine tests, troponin test. Risks include infection, bruising, bleeding, anemia, kidney damage, hearing loss, nausea, vomiting, numbness, pain, rash, blood in urine. You may not receive a 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

GAIN-BCG: Gemcitabine Alternating With Intravesical BCG Randomized Against BCG Alone For Patients With Recurrent High Grade Non-Muscle Invasive Bladder Cancer

Date Added
October 28th, 2025
PRO Number
Pro00147104
Researcher
Robert Grubb

List of Studies


Keywords
Cancer/Genitourinary, Drug Studies
Summary

This study is for people with high-risk, non-muscle invasive bladder cancer that has returned after treatment with BCG. Your cancer either did not fully respond to BCG or came back after initially responding, which is called BCG-exposed NMIBC. The purpose of this study is to find out if adding a chemotherapy drug called gemcitabine, given directly into the bladder through a catheter, to BCG works better than BCG alone. In this study, you will either receive BCG alone for up to 6 weeks or gemcitabine plus BCG for up to 10 weeks, called induction therapy. If the treatment is effective, you may continue with maintenance therapy, which is either BCG alone or gemcitabine plus BCG given over several weeks. After treatment, your doctor will monitor you for 5 years with regular checkups, cystoscopies, and CT scans to watch for side effects or recurrence. The main risks are that the study treatment may not work as well as usual care, and it may cause side effects such as pain with urination, urinary urgency, blood in the urine, bladder inflammation, or urinary tract infection. There may also be risks that study doctors do not yet know about.
There will be a total of 17 patients enrolled locally over the course of 42 months.

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

A Phase 3, Two-part, Randomized, Open-label, Adaptive Study Comparing BMS-986365 versus Investigator's Choice of Therapy Comprising Either Docetaxel or Second Androgen Receptor Pathway Inhibitor (ARPI), in Participants with Metastatic Castration-resistant Prostate Cancer (mCRPC) - rechARge

Date Added
October 8th, 2025
PRO Number
Pro00144193
Researcher
Theodore Gourdin

List of Studies


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

This study is for male subjects that have been diagnosed with metastatic prostate cancer (that has spread to other parts of the body) and progressed following standard hormonal/radiation therapy and surgery. Subjects are expected to remain in the study for a minimum of 48months or longer. There will be a total of 10 subjects locally enrolled.

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

NRG-CC014: Radiation Therapy for High-Risk Asymptomatic Bone Metastases: A Pragmatic Multicenter Randomized Phase 3 Clinical Trial (Preempt)

Date Added
September 23rd, 2025
PRO Number
Pro00146746
Researcher
Brian Lally

List of Studies

Keywords
Cancer/Genitourinary, Drug Studies
Summary

The purpose of this research study is to find out if giving radiation therapy (RT) early to high-risk bone metastases that are not causing pain can reduce the chance of skeletal-related events (SREs) such as fractures, spinal cord compression, or surgery to bone. This will be compared to the current standard of care (SOC), which usually treats bone metastases only when symptoms like pain occur. The study will enroll 16 participants locally over 25 months, and each subject will remain in the study for at least 40 months. You are being asked to join because you have metastatic cancer that has spread to your bones and is considered "high-risk," though it is not causing pain at this time. High-risk bone metastases are typically located in the spine, hip, shoulder, or long bones, and larger tumors in these areas are more likely to cause complications. If you join this study, you will receive radiation therapy to high-risk bone sites in addition to standard care. The main risk is that radiation therapy may not work better than the usual approach at preventing bone complications. Radiation can also cause side effects, including skin changes, tiredness, and inflammation of the esophagus, bowel, or lungs. There may also be risks that are not yet known to the study doctors.

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

A Phase III Randomized Trial of Dose Escalated Radiation in Locally Advanced Pancreas Cancer (LAPC) Patients (LAP100)

Date Added
September 16th, 2025
PRO Number
Pro00146859
Researcher
Brian Lally

List of Studies

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

The purpose of this study is to compare the usual treatment alone to the usual treatment plus dose escalated radiation. This study seeks to find if this approach is better or worse than standard of care for locally advanced pancreatic cancer. Treatment and follow up for this study may be up to 8 years. The procedures include CT or MRI scans, chemotherapy, and radiation therapy. Risks include stomach pain, diarrhea, nausea, vomiting, tiredness, muscle aches, and weight loss. 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 Randomized Phase III Study of BRAF-Targeted Therapy vs Cabozantinib in RAI-Refractory Differentiated Thyroid Cancer with BRAF V600Em

Date Added
September 5th, 2025
PRO Number
Pro00146753
Researcher
John Kaczmar

List of Studies


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

This study is for subjects who has been diagnosed with radioactive iodine refractory (RAIR) differentiated thyroid cancer. Subjects are expected to remain in the study for a minimum of 96 months. Drugs are FDA approved and is given in the form of Tablet to subjects. The procedures include urine protein test, CT, MRI. Risks include diarrhea, nausea, vomiting, tiredness, weight loss, loss of appetite, changes in taste, redness, pain or peeling of palms and soles, High blood pressure. There is evidence that dabrafenib, trametinib and cabozantinib are effective in stabilizing and shrinking the type of cancer, we do not know which of these approaches are better at prolonging time until tumor growth. 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 3, Single-arm, Multicenter Study to Evaluate the Efficacy and Safety of UGN-104, a Novel Formulation of UGN-101, for the Treatment of Patients With Low-grade Upper Tract Urothelial Cancer (LG-UTUC)

Date Added
September 3rd, 2025
PRO Number
Pro00145445
Researcher
Matvey Tsivian

List of Studies

Keywords
Cancer/Genitourinary, Drug Studies
Summary

This study is for subjects that have been diagnosed with low-grade upper tract urothelial cancer (LG-UTUC). This study is to evaluate the tumor ablative effect of the study drug (UGN-104). Subject are expected to reman in the study for a minimum of 15months or longer.

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



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