The purpose of this study is to test the effectiveness and safety of the combination of an investigational vaccine, PDS0101, given by subcutaneous (beneath the skin) injection and the standard of care, Pembrolizumab (KEYTRUDA), given intravenously ("IV;" into the vein) compared to pembrolizumab (KEYTRUDA) alone for those with unresectable recurrent or metastatic head and neck cancer and high risk papillomavirus infection. "Investigational" means the combination of the study vaccine and pembrolizumab being tested has not been approved by the US Food and Drug Administration (FDA) nor any other Health Authority.
This study is for patients that have been diagnosed with advanced solid tumors. This study is testing an investigational drug called BNT317. "Investigational" means it has not been approved by the United States Food and Drug Administration (FDA). The primary purpose of this study is to evaluate the safety, tolerability, absorption of BNT317. BNT317 is administered via intravenous (IV) infusion. Participants can continue to receive this study drug until it no longer gives them benefit. Researchers will continue to follow-up with patients long-term.
This research is being done to see if the drug suvorexant is effective as treatment for insomnia in people who have opioid use disorder and who are utilizing stable medications for opioid use disorder (MOUD). It is a 13-week study, and the study drug will be compared to a placebo.
This is a randomized, phase II study for patients with Relapsed/Refractory Large B-Cell Lymphoma. The purpose of this study is to determine how long people with Large B-Cell Lymphoma can live without their disease getting worse when treated with two different combinations of cancer drugs. One group will get tafasitamab + lenalidomide + tazemetostat, and the other group will get tafasitamab + lenalidomide + zanubrutinib. The researchers want to see which combination works better. They also want to figure out the best and safest dose of each drug combination to use in future studies. Tafasitamab is a lab-made antibody that helps the immune system find and attack cancer cells. Lenalidomide is a drug that boosts the immune system and helps fight cancer. Tazemetostat is a drug that blocks a protein (EZH2) that helps cancer cells grow. Zanubrutinib is a drug that blocks another protein (BTK) involved in cancer cell survival. The treatment period may last approximately 1 year and the follow up period may last up to 3 years.
The purpose of this study is to compare the progression-free survival (PFS) of sacituzumab govitecan with pembrolizumab to that of sacituzumab govitecan alone in patients with PD-L1-negative metastatic TNBC, who have not received prior therapy for metastatic breast cancer and who have not received a prior PD-1/L1 inhibitor.
Subjects can remain on study for as long as they are benefitting from treatment - there are no set number of visits required to participate in this study. Sacituzumab govitecan and pembrolizumab are taken via intravenous (IV) infusion. Risks include decrease in white blood cell count, anemia, nausea, joint pain, and headache.
The U.S. Food and Drug Administration (FDA) has approved Sacituzumab govitecan for metastatic triple-negative breast cancer, however, it is considered experimental in this study because it is currently only approved for patients who have had more treatment than patients eligible to participate in this study. The FDA has approved Pembrolizumab for metastatic triple-negative breast cancer, but it is also considered experimental in this study because it is not currently approved for patients with PD-L1 negative cancer.
This study is for patients that have been diagnosed with recurrent, progressive as well as advanced, metastatic hepatocellular carcinoma (HCC), cervical cancer (CC), melanoma, head and neck squamous cell carcinoma (HNSCC) or non-small cell lung cancer (NSCLC). The study is testing an investigational drug called DB-1311. Investigational means it has not been approved by the United States Food and Drug Administration (FDA). The primary purpose of the study is to determine the recommended phase II dose of DB-1311 in combination with BNT327 or DB-1311 in combination with DB-1305 by assessing the safety and tolerability. The drug is given to participants by IV infusion. Participants in this study can expect to be in this study for 72 months.
This study is enrolling participants with calcific aortic valve stenosis (CAVS) which is a heart valve disease. Blood pumped out of the heart goes through the aortic valve, and in CAVS, calcium builds up causing the valve to thicken over time so it is not able to open as much or as easily and over time this restricts blood flow. This study involves an investigational medication called ataciguat which is being studied to see how well it can slow the progression of CAVS. Investigational means it has not been approved for commercial use by the Food and Drug Administration (FDA). Ataciguat is taken by mouth daily.
Participation in this study will last about 3 years and include about 14 visits. Study procedures include collection of medical data, physical exams, electrocardiogram (ECG - a recording of your heart's electrical activity), bloodwork, echocardiogram (ultrasound test of the heart), CT scan, questionnaires and home monitoring of your blood pressure and heart rhythm.
Risks related to ataciguat include headache, nausea, abdominal pain, diarrhea and dizziness. Study procedure risks include radiation risks, risks of drawing blood and loss of confidentiality.
This study is for subjects that have been diagnosed with prostate cancer. Subjects can expect to remain in the study for up to 39 months or longer. There will be a total of 16 enrolled locally. The study is set to enroll subjects for 39 months.
The purpose of this study is to determine if we lower the chance of your prostate cancer growing or spreading by adding the drug relugolix to the usual radiation therapy? This study seeks to find if this approach is better or worse than standard of care for prostate cancer.
Treatment and follow up for this study may be up to 5 years. The procedures include blood samples, PET scans, hormone therapy and radiation therapy. Risks include diarrhea, back pain, weight gain, and headache. 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.
This study is for patients with resectable oligometastatic pulmonary osteosarcoma. The purpose of this phase three study is to determine if open surgical resection is superior to thoracoscopic resection for thoracic event-free survival (tEFS) in patients with resectable oligometastatic pulmonary osteosarcoma. The risks from this study are the usual risk of surgery such as bleeding, infection, injury to chest area, and pain after surgery. There is also the risk that additional surgery may be required to remove all cancer from the patient's lung. People in this clinical trial will receive surgery as the study therapy. The length of time surgery lasts can vary. After treatment, the patient will have follow-up examinations and medical tests.