A Phase II/III Randomized Study of Maintenance Nivolumab versus Observation in Patients with Locally Advanced, Intermediate Risk HPV Positive OPCA
Patients are asked to take part in this research study because they have HPV positive oropharynx cancer.
This study is being done to answer the following question:
Does maintenance nivolumab following definitive therapy with radiation and chemotherapy (cisplatin) result in significant improvement in overall survival (OS) (time being alive) and progression-free survival (PFS) (time being alive without cancer) for patients with this type of cancer (intermediate risk HPV positive oropharynx cancer).
This study is being done to find out if this approach is better or worse than the usual approach for HPV positive oropharynx cancer.
The purpose of this study is to compare the usual treatment alone (radiation and chemotherapy) to adding maintenance nivolumab to the usual treatment. The addition of nivolumab to the usual treatment could shrink the cancer or prevent it from returning. But, it could also cause side effects.
This study will help the study doctors find out if this different approach is better than the usual approach. To decide if it is better, the study doctors will be looking to see if the nivolumab increases the lifetime of the patient without progression for 10 years.
This immunotherapy drug, nivolumab, is already approved by the FDA for use in advanced and incurable head and neck cancer. But, most of the time it is not used until the cancer is very advanced and chemotherapy stops working. In this study we believe the use of nivolumab has a chance of preventing the cancer from coming back for patients with this type of cancer. There will be about 286 people taking part in the first part (phase II) of the study and 458 more people taking part in second part (phase III), if the results of the phase II portion are promising and if there is evidence that nivolumab may prolong life.
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Principle Investigator: James Lee, M.D.
Contacts for Participation in Clinical Trials:
Virtua Samson Cancer Center
Theresa Carducci, MSN, RN, BA, CCRP
Protocol Coordinator, Cancer Registry & Research
Karen Goldsmith, BSN, RN
Maria Jenkins, CCRP
Clinical Research Coordinator