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.
This study is for patients that have been diagnosed with stage III-IVB Head and Neck cancer. The investigational drug in this study is MEDI4736 (Durvalumab). The purpose of the safety lead-in portion of the study is to determine whether adding the study drug MEDI4736 to radiation is safe in patients with head and neck cancer who cannot take the drug cisplatin. The purpose of the phase II/III portion is to compare any good and bad effects of usual radiation plus the study treatment, MEDI4736 (durvalumab), to the usual therapy of radiation plus cetuximab in patients with head and neck cancer who cannot take the drug cisplatin. Participants in the safety lead-in portion can expect to be in this study for approximately 2.5 years. Participants in the Phase II/III portion can expect to be in the study for up to 32 weeks, and then followed by their study doctor to monitor for side effects every year.
The purpose of this study is to compare the effects, good and/or bad, of three different ways to give radiation therapy. Two of the ways are experimental, while one of them is standard.
Patients who participate in this study will be randomized into one of three study groups. Those in the first group will receive radiotherapy everyday for 3 weeks plus 4 cycles of chemotherapy. Those in the second group will receive radiotherapy everyday for 7 weeks plus 4 cycles of chemotherapy. Those in the third group will receive radiotherapy everyday for 5 weeks plus 4 cycles of chemotherapy.