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 Buparlisib (AN2025) that will be given in combination with Paclitaxel (an approved drug). The study will also use alone.
The main purpose of this research study is to assess the effectiveness and safety of once-daily buparlisib in combination with weekly paclitaxel compared to weekly paclitaxel alone head and neck cancer that has progressed after prior immunotherapy (treatment that uses your immune system to attack your cancer, such as antiPD1/antiPDL1 treatments) with or without prior platinum-based chemotherapy. Participants can expect to be on this study for about 5 years.
This study is for patients that have been diagnosed with stage 3-4 Local-Regionally Advanced Head and Neck Squamous Cell Carcinoma (HNSCC). The purpose of this study is to see if it is safe and tolerable to give M3814 (peposertib) in combination with radiation in patients with advanced head and neck cancer who cannot receive cisplatin. The study drug is M3814 (peposertib). Participants can expect to be on this study receiving treatment for up to 7 weeks, and followed by their study doctor for up to 2 years.
This study is for patients that have been diagnosed with recurrent or new head and neck squamous cell carcinoma (HNSCC). Patients either have had a recurrence (the tumor has comeback) or a new head and neck cancer in a different area of the head and neck (second primary) which has been removed by surgery. The study drug used is called pembrolizumab. The purpose of this study is to see if adding pembrolizumab to radiation or if using pembrolizumab by itself after surgery compared to the usual approaches with chemotherapy and radiation will increase life expectancy. Participants can expect to be on this study for up to 12 months and then followed for 5 years.
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 that have been diagnosed with locally advanced squamous cell carcinoma of the head and neck (LA-SCCHN). The investigational drug used in this study is Debio 1143. The main purpose of this study is to learn how well the study medicine works and how safe the study medicine is compared with placebo. A placebo is an inactive substance that looks like the study medicine but does not contain any active study medicine. Participants can expect to be in this study for up to 7 years. Participation will consist of approximately 56 visits at the study center over a period of 5 years, followed by telephone calls every 6 months over a period of maximum 2 years.
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.
In this study, patients will complete questionnaires to help us determine clinically relevant scores for a new patient-reported measure of body image distress following HNC treatment. A select group of patients will also undergo in-depth discussions to help us determine scores on the patient report measure that correlate with mild, moderate, and severe levels of image distress.
This study is for patients with low-risk, Human Papillomavirus (HPV) positive oropharyngeal cancer. The first part of the study is to determine if a reduced dose of radiation along with chchemotherapy or immunotherapy result in the same length of time without the cancer getting worse as the usual approach. The second part of this study is being done to also see if quality of life with a reduced dose of radiation with chemotherapy or immunotherapy than the usual approach.