Trial Summary
What is the purpose of this trial?This phase II trial studies the side effects and best dose of ipilimumab, nivolumab, and radiation therapy and how well they work in treating patients with advanced human papillomavirus (HPV) positive oropharyngeal squamous cell carcinoma. Immunotherapy with monoclonal antibodies, such as ipilimumab and nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving ipilimumab, nivolumab, and radiation therapy may work better in treating patients with HPV positive oropharyngeal squamous cell carcinoma.
Eligibility Criteria
This trial is for adults with advanced HPV-positive oropharyngeal squamous cell carcinoma. Participants must have certain blood counts, organ function tests within normal ranges, and a confirmed diagnosis through specific tests. Pregnant women, those with other cancers (except some skin cancers), previous radiation in the same area, severe allergies to contrast material, active infections or autoimmune diseases are excluded.Inclusion Criteria
I have had a neck FDG-PET/CT scan within the last 28 days.
I've had a detailed chest scan within the last 28 days.
My kidney function is normal, with creatinine levels below 1.5 mg/dl or clearance above 50 ml/min.
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Exclusion Criteria
My cancer is in the neck but its original source is unknown.
I have not had chemotherapy for my current cancer but may have for another.
My scans show cancer has spread below my collarbone.
+11 more
Participant Groups
The study is testing the combination of two immunotherapy drugs—Ipilimumab and Nivolumab—with intensity-modulated radiation therapy to see if they improve outcomes for patients. The trial will also determine the best doses of these drugs when used together with radiation.
1Treatment groups
Experimental Treatment
Group I: Treatment (nivolumab, ipilimumab, IMRT)Experimental Treatment5 Interventions
Patients receive nivolumab IV over 30 minutes on days 1, 15, and 29 and ipilimumab IV over 30 minutes on day 1. Treatment repeats every for 6 weeks for 2 cycles in the absence of disease progression or unacceptable toxicity. Beginning on day 1 of cycle 2, patients also undergo IMRT 5 days a week (Monday-Friday) for 6 weeks in the absence of disease progression or unacceptable toxicity.
Intensity-Modulated Radiation Therapy is already approved in United States, European Union, Canada for the following indications:
🇺🇸 Approved in United States as IMRT for:
- Oropharyngeal cancer
- Head and neck cancers
- Prostate cancer
- Breast cancer
- Lung cancer
🇪🇺 Approved in European Union as IMRT for:
- Oropharyngeal cancer
- Head and neck cancers
- Prostate cancer
- Breast cancer
- Lung cancer
🇨🇦 Approved in Canada as IMRT for:
- Oropharyngeal cancer
- Head and neck cancers
- Prostate cancer
- Breast cancer
- Lung cancer
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
M D Anderson Cancer CenterHouston, TX
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Who Is Running the Clinical Trial?
M.D. Anderson Cancer CenterLead Sponsor
National Cancer Institute (NCI)Collaborator