This study is for patients that have a tumor that cannot be removed through surgery (unresectable) or may have spread (metastasized) to other parts of their body. In this study, ASP1951 will be given alone (monotherapy) or combined with pembrolizumab (combination therapy). Both ASP1951 and pembrolizumab will be considered study drug. Pembrolizumab has been approved by FDA for use in patients with skin, lung, cervical cancer, certain cancers of head and neck and other cancers but may not be approved to treat all types of cancer. However, the use of ASP1951 plus pembrolizumab has not been approved by regulatory authorities and is therefore investigational. The study consists of 3 periods: screening (up to 28 days), treatment (up to 48 weeks [16 cycles]) and follow up (up to 45 weeks), followed by an optional re-treatment period for participants that qualify. The re-treatment period will allow participants to receive study drug treatment again for up to 16 additional cycles (approximately 48 weeks), for a maximum total treatment and re-treatment period of 32 cycles (approximately 96 weeks). Both study drugs are administered intravenously (into the vein).This is the first time the investigational study drug ASP1951 is being tested in humans; however, studies in animals showed that the study drug is safe to be tested in humans.
This study is for patients who have been diagnosed with Head and Neck Cancer that spread to sites distant from the head and neck region (metastatic) or for cancer that returned or got worse after being treated (recurrent), and test positive for High-risk Human Papillomavirus-16 (HPV16) Infection.
The investigational vaccine in this study is called PDS0101. "Investigational" means the study vaccine being tested has not been approved by the United States Food and Drug Administration (FDA). The purpose of this research is to find out if the combination of the investigational vaccine, given by subcutaneous (beneath the skin) injection and the standard of care, Pembrolizumab (KEYTRUDA®), given by IV, are effective and safe. The PDS0101 vaccine designed to boost the body's immune response against HPV 16.Participants can expect to receive treatment for about 2 years. Each person who agrees to take part in the study will be asked to come in for a minimum of 18 cycles and a maximum of 35 cycles.
This study is for patients who have been diagnosed with head and neck squamous cell carcinoma (HNSCC) that has returned (recurrent) or spread after previous treatment (metastatic). The investigational drug in this study is lenvatinib. The study will also use lenvatinib in combination with pembrolizumab, which is also experimental. The purposes of this study are to: test the safety of the study drugs, lenvatinib alone, pembro and lenvatinib together, and standard chemotherapies alone in the treatment of HNSCC; see how well the combination of pembro and lenvatinib works, compared to standard chemotherapies; and see if participants who get pembro and lenvatinib live longer than those who are treated with standard chemotherapies. Participants can expect to be on this study for about 48 months.
This study is for patients that have been diagnosed with advanced or resistant skin cancer (melanoma), non-melanoma skin cancer (NMSC), certain types of solid tumors, or bladder cancer (UBC). The investigational drug in this study is RP1. RP1 is a herpes simplex virus (a microscopic life form commonly known as the "cold sore virus") that has been genetically changed to grow in and destroy cancer cells. This treatment will be injected directly into tumors. The purpose of this study is to test the safety and how well RP1 works when it is injected into certain types of solid tumors in combination with another cancer drug, called nivolumab. Participants can expect to be in this study for about 2 years.
This study is for patients that have been diagnosed with head and neck squamous cell cancer (HNSCC). The investigational drug in this study is ADU-S100. The purpose of this study is to find out how ADU-S100 and pembrolizumab (also called KEYTRUDA®) interact with the immune system to potentially treat cancer and to make sure the drugs are safe to use together. Participants can expect to recieve treatment for up to two years. This would include 2 doses in a3-week cycle for up to 35 cycles. Participants can expect follow-up to continue every eight weeks until completion of the required safety reporting periods, death, withdrawal of consent, loss to follow-up, or close of study by the Sponsor.
This study is for patients with advanced squamous cell carcinoma of the skin. The purpose of this study is to see if adding a new drug called avelumab to another drug call cetuximab can increase the length of time patients are alive without their cancer getting worse.
This study is for patients who have been diagnosed with locally advanced squamous cell carcinoma of the head and neck (SCCHN) and will need additional treatment following surgery. The investigational drug in this study is Durvalumab. The purpose of this study is to investigate other drugs that may be combined with radiation to treat SCCHN. The study focuses on determining whether durvalumab combined with radiation will have improved 3-year disease free survival compared to historical control. Participants can expect to be in this study for 5 years.
This study is for patients that have been diagnosed with with resectable High-risk Locally Advanced Cutaneous Squamous Cell Carcinoma (LA cSCC). The investigational drug used in this study is Pembrolizumab. The purposes of this study are to: determine how well pembrolizumab keeps the cancer from coming back or spreading as compared to placebo, determine if giving pembrolizumab after surgery and radiation helps patients live longer, and to test the safety of the study drug and see how patients' bodies handle it. Participants can expect to be in this study for about 8 years. This includes the time that participants will be on study drug and in follow up to see if the cancer has come back or spread.
This study is for patients who have been diagnosed with squamous cell carcinoma of the head and neck (SCCHN). The investigational drug in this study is Pembrolizumab. The main purpose of this study is to attempt to reduce the risk of cancer recurrence using a drug called pembrolizumab. Participants can expect to be in this study for approximately 5 years.
The purpose of this first in human study is to find a safe dose level of the investigational drug REGN3767 alone or in combination with REGN2810. Other purposes of this study are to measure the levels of REGN3767 and REGN2810 in the subject's blood and to collect any evidence of tumor shrinkage when given alone or in combination with REGN2810.
REGN3767 and REGN2810 are both a type of drug called a monoclonal antibody. Antibodies are proteins that are naturally found in your blood stream that fight infections. A monoclonal antibody is a special kind of antibody that is manufactured as a medication to target a specific protein in the body that may be involved in the subject's cancer.
In this part of the study each participant will receive 1 of 3 different doses of REGN3767 alone or in combination with one dose of REGN2810. There will be a total of 6 different groups of participants the study team plans to study based on what dose of REGN3767 they receive and whether they receive it alone or with REGN2810.
The study is sponsored by Regeneron. The investigator in charge of this study at MUSC is Carolyn Britten, MD. Part 1 of this study is being done at 4-5 sites. Approximately24-48 people will take part study-wide.