Comparing Oral Drug Dosing Strategies in Older Patients with Metastatic Breast Cancer to Maximize Tolerance and Reduce Discontinuation: The CDK4/6 Inhibitor Dosing Knowledge (CDK) Study

Date Added
May 27th, 2026
PRO Number
Pro00150866
Researcher
Abirami Sivapiragasam

List of Studies

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

This study is for people who have a type of breast cancer that has spread to other parts of the body. Their cancer is hormone receptor (HR) positive and HER2 negative. The study looks at two cancer medicines, called palbociclib and ribociclib. These medicines are a type of targeted therapy. They are taken with standard hormone treatment. The goal of the study is to see how different starting doses of these medicines work in patients age 65 and older.
Participants are placed into one of two groups by chance:
Standard Dose Group: Patients start with the full dose approved by the FDA. If they have side effects, the dose is lowered.
Lower Dose Group: Patients start with a lower dose. The dose may be raised if they do not have strong side effects.

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

BCC021- Phase I/II Study of Silmitasertib (CX-4945) in Combination with Chemotherapy in Children and Young Adults with Relapsed Refractory Solid Tumors

Date Added
May 27th, 2026
PRO Number
Pro00146904
Researcher
Jacqueline Kraveka

List of Studies


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

This study is testing a drug called silmitasertib to see if it is safe and works well when used with chemotherapy in children and young adults whose solid tumors have come back or didn't respond to treatment. In the first part of the study (Phase I), doctors will check how safe the drug is and what side effects it may cause. They will use a dose that is already recommended for adults and may try a slightly higher dose. Patients will take silmitasertib twice a day for 21 days along with chemotherapy. Doctors will then see if this treatment plan is safe and doable. In the second part (Phase II), the study will focus on two types of cancer: neuroblastoma and Ewing sarcoma. It will test how well silmitasertib works with chemotherapy for these cancers. The main goal is to see how many patients respond to the treatment. Other goals include seeing how long patients live without their cancer getting worse and how long they live overall. The study will include up to 104 patients across the country, including 2 at MUSC. The main risk is side effects. The most common ones expected are stomach problems, tiredness, low red blood cell count (anemia), and loss of appetite. There is no direct benefit for patients who join this study.

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

A Phase 1a/1b Open-Label Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of BBO-8520 in Subjects with Advanced KRASG12C Mutant Non-Small Cell Lung Cancer - The ONKORAS-101 Study

Date Added
May 21st, 2026
PRO Number
Pro00148409
Researcher
Christopher Rangel

List of Studies

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

This study is for people with advanced non-small cell lung cancer (NSCLC) who have a KRAS G12C gene mutation. The study is testing a drug called BBO-8520. This drug is investigational, which means it has not been approved by the U.S. Food and Drug Administration (FDA). The drug will be tested by itself or together with another drug called pembrolizumab (also called "pembro"). People who have not taken a KRAS G12C inhibitor before and are in the Dose Expansion part of the study (Phase 1b) will be randomly assigned (like flipping a coin) to get one of two doses chosen by the study review committee (SRC). These doses are based on information from the earlier Dose Escalation part (Phase 1a). People who have taken a KRAS G12C inhibitor before may also be randomly assigned to one of two doses, but only after a first group of participants gets a set dose recommended by the SRC.

During the study, all participants will take BBO-8520 by mouth once or twice a day. If you are getting BBO-8520 with pembrolizumab, you will get pembrolizumab every 21 days. Pembrolizumab will be given through an IV about 30 minutes after you take BBO-8520. Pembrolizumab will continue until your cancer gets worse, you have side effects that are too severe, you choose to stop, or for up to 24 months—whichever happens first.
The whole study is expected to last about 5 years if the cancer does not get worse.

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

A Randomized Phase III Study of Management of Treatment Naive Primary Melanoma in Elderly Patients

Date Added
May 19th, 2026
PRO Number
Pro00151048
Researcher
Andrea Abbott

List of Studies


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

This study is for patients diagnosed with early-stage melanoma and are the age of 75 or older. The usual approach for patients who are not in a study is treatment with two surgical procedures, a wide local excision (WLE) plus a sentinel lymph node (SLN) biopsy, followed by immunotherapy. The purpose of this study is to find if performing the WLE alone is just as effective as the usual approach and if it leads to improvements in patients' overall well-being.

A wide local excision (A wide local excision (WLE) is a surgical procedure performed to cut out an abnormal lesion and some surrounding normal tissue; this is sometimes followed by a sentinel lymph node (SLN) biopsy, in which lymph nodes that cancer cells could spread to are removed as well. Immunotherapy is a type of cancer treatment that uses your body's immune system to identify and attack cancer cells.

Patients may participate in this study for up to 5 years. Procedures include a surgical biopsy, surveys, and regular visits with your doctor including follow-up study visits or phone calls every 6 months. There will be about 428 people taking part in this study, approximately 39 participants will be enrolled at MUSC.

Risks include infection, scarring, and bleeding. Participants 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 2 Trial of Fruquintinib and TAS-102 as Compared to Fruquintinib in Patients with Refractory Advanced/Metastatic Microsatellite Stable Colorectal Cancer

Date Added
May 13th, 2026
PRO Number
Pro00148336
Researcher
Toros Dincman

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 locally advanced/metastatic colorectal cancer. This study seeks to see if Fruquintinib in combination with TAS-102 improves overall survival when compared to Fruquintinib alone.The goal is to determine the optimal dose level, safety, and tolerability for the study drug.Treatment for this study may be up to 3 years. The procedures include blood and urine samples, questionnaires, infusions, and CT scans. Risks include high blood pressure, diarrhea, vomiting, reduced appetite, weight loss, hoarse voice, joint pain, and weakness. 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 3, Multicenter, Double-Blind, Placebo-Controlled Study Assessing the Efficacy and Safety of Olomorasib in Combination with Standard of Care Immunotherapy in Participants with Resected or Unresectable KRAS G12C-Mutant, Non-Small Cell Lung Cancer - SUNRAY-02

Date Added
April 23rd, 2026
PRO Number
Pro00148415
Researcher
Mariam Alexander

List of Studies

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

This study is for patients that have been diagnosed with KRAS G12C-Mutant, Non-Small Cell Lung Cancer. This study is testing an investigational drug called olomorasib. "Investigational" means it has not been approved by the United States Food and Drug Administration (FDA). There are 2 parts to the study, Part A and Part B. All participants in Part A will receive the standard of care medication, pembrolizumab, along with olomorasib or placebo (a placebo is an inactive or "pretend" drug that looks like the study drug but contains no active medicine). All participants in Part B will receive the standard of care medication, durvalumab, along with olomorasib or placebo. All participants will be randomized (like flipping a coin) to receive either the study drug or placebo. Olomorasib is a capsule taken by mouth two times a day. Participants in this study can expect to be in this study for about three years. The main side effects of olomorsib include stomach problems (nausea, constipation, low appetite), joint pain, low red blood cell count, tiredness, and swelling.

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

A Phase III Study of Induction Pembrolizumab and Chemotherapy Followed by Chemoradiation and Pembrolizumab vs Chemoradiation and Pembrolizumab Both Followed by Pembrolizumab for High Risk Locally Advanced Cervical Cancer

Date Added
April 16th, 2026
PRO Number
Pro00150355
Researcher
Brian Orr

List of Studies

Keywords
Cancer, Cancer/Gynecological, Drug Studies, Women's Health
Summary

This study is for patients that have been diagnosed with squamous cell, adenocarcinoma, or adenosquamous cervical cancer. This study is testing an investigational drug called pembrolizumab. "Investigational" means it has not been approved by the United States Food and Drug Administration (FDA). A computer will be used to assign you to one of the study groups. This process is called "randomization." Like flipping a coin, everyone has an equal chance of being placed in any group. The primary purpose of this study is to determine whether induction immunotherapy (IO) and chemotherapy prior to concurrent chemoradiotherapy plus immunotherapy (CCRT+IO) improves progression-free survival (PFS) compared to CCRT+IO alone. The study drug is given by infusion. Participants in this study can expect to be on the study for 7 years.

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

A Multi-Center Screening Study to Characterize the Prevalence of the KIT D816V Mutation in Patients with Suspected Clonal Mast Cell Disease

Date Added
April 15th, 2026
PRO Number
Pro00149043
Researcher
Alexander Coltoff

List of Studies

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

This study is for participants with symptoms of mast cell activation (SMAC). The primary purpose of this study is to learn about clonal mast cell diseases. Clonal mast cell diseases are hard to diagnose because symptoms are not specific, and they can overlap with other diseases. The tools currently used by doctors to look for clonal mast cell diseases in the blood may not identify all patients. This study is being done to develop an investigational blood test that looks for a change in a gene called KIT. "Investigational" means it has not been approved by the United States Food and Drug Administration (FDA). Two types of blood tests will be compared against each other. Participants in this study can expect to be in this study for about 6 months.

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

A Phase II Randomized Trial of Neoadjuvant Chemotherapy or Chemo-Immunotherapy in Patients with Recurrent/Persistent PD-L1 Enriched Squamous Cell Carcinoma of the Head and Neck Undergoing Salvage Surgery (NEOPOLIS)

Date Added
March 27th, 2026
PRO Number
Pro00150201
Researcher
Alexandra Kejner

List of Studies

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

This study is for patients diagnosed with recurrent/persistent PD-LI enriched squamous cell carcinoma of the head and neck and undergoing salvage surgery. The purpose of this study is to compare the usual treatment of surgery alone, to using chemotherapy (cisplatin and paclitaxel) or chemo-immunotherapy [carboplatin and paclitaxel with cemiplimab (REGN2810)] plus the usual treatment.

Carboplatin, cisplatin, paclitaxel, and cemiplimab are FDA approved to treat head and neck cancers. This study seeks to answer if adding chemotherapy or chemo-immunotherapy before surgery extends the length of time without your cancer returning compared to the surgery alone.

Patients may participate in this study for up to 3 years. Procedures surgery, blood tests, chemotherapy, and regular visits with your doctor including follow-up study visits or phone calls every 3 months. There will be about 180 people taking part in this study, approximately x participants will be enrolled at MUSC.

Risks include hair loss, diarrhea, nausea, vomiting, anemia, infection, and fever. Participants 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

Empathic Communication Skills Training to Reduce Lung Cancer Stigma

Date Added
March 25th, 2026
PRO Number
Pro00146703
Researcher
Kathryn Engelhardt

List of Studies

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

This study is for patients and providers. It will evaluate Empathic Communication Training (ECT) a new training for cancer providers that aims to improve care providers' awareness and understanding of lung cancer stigma while developing their skills to communicate empathically with patients. The study will provide information about whether Empathic Communication Training (ECT) in care providers is associated with improved outcomes for lung cancer patients. The study will include two groups: lung cancer patients and cancer care providers. Patients may experience the risk of lost time at work, school, or at home, and you may spend more time than usual in the hospital or doctor's office. This study will enroll 66 patients locally for 12 months.

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



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