This phase II/III trials studies whether maintenance immunotherapy (nivolumab) following
definitive treatment with radiation and chemotherapy (cisplatin) result in significant
improvement in overall survival (time being alive) and progression-free survival (time being
alive without cancer) for patients with intermediate risk human papillomavirus (HPV) positive
oropharynx cancer (throat cancer) that has spread to nearby tissue or lymph nodes. Drugs used
in chemotherapy such as cisplatin work in different ways to stop the growth of tumor cells,
either by killing the cells, by stopping them from dividing, or by stopping them from
spreading. Radiation therapy uses high energy rays to kill tumor cells and shrink tumors.
Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune
system attack the cancer, and may interfere with the ability of tumor cells to grow and
spread. It is not yet known whether chemotherapy and radiation therapy followed by
maintenance nivolumab therapy works better than chemotherapy and radiation therapy alone in
treating patients with HPV positive oropharyngeal cancer.
I. To assess the efficacy of concurrent definitive therapy followed by nivolumab compared
with concurrent definitive therapy followed by observation in terms of progression-free
survival (PFS). (Phase II) II. To assess the efficacy of concurrent definitive therapy
followed by nivolumab compared with concurrent definitive therapy followed by observation in
terms of overall survival (OS). (Phase III)
I. To further assess the efficacy of nivolumab compared with observation in terms of:
Ia. The relationship of baseline PD-L1 expression to clinical outcome. Ib. To evaluate the
association of 12 week post therapy fludeoxyglucose F-18 (FDG) positron emission
tomography(PET)/computed tomography (CT) with PFS and OS.
Ic. To establish the prognostic value of standardized uptake value (SUV)max of primary tumor
or neck nodal metastasis of baseline FDG PET/CT for OS (and/or PFS).
Id. To correlate SUVmax of primary tumor or nodal metastasis of baseline FDG PET/CT with
PD-L1 expression (positive vs. negative).
Ie. To compare the PET based therapy response assessment (Hopkins criteria) to the Response
Evaluation Criteria in Solid Tumors (RECIST) 1.1 assessment at 12 week post chemoradiation
therapy, for patients who have a PET/CT scan at 12 weeks.
OUTLINE: Patients are randomized to Arm A or Arm B. Patients in Arm B may cross-over to Arm C
with clearly documented disease progression.
ARM A: Patients receive cisplatin intravenously (IV) over 60 minutes weekly and intensity
modulated radiation therapy (IMRT) 5 days a week for 7 weeks for a total of 35 fractions.
Within 4 weeks after completion of concurrent therapy, patients receive nivolumab IV once
weekly over 30 minutes every 4 weeks for 12 months in the absence of disease progression or
ARM B: Patients receive cisplatin IV over 60 minutes weekly and IMRT 5 days a week for 7
weeks for a total of 35 fractions, and then go on observation. Patients will be offered the
option to cross-over to Arm C if they have clearly documented progression within 12 months
from the end of cisplatin/radiation therapy.
ARM C: Patients receive nivolumab IV over 30 minutes every 4 weeks for 12 months in the
absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3-6 months for 3 years
and then annually for a total of 10 years.
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.