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A Phase III Randomized Study of Maintenance Nivolumab versus Observation in Patients with Locally Advanced, Intermediate Risk HPV Positive OPSCC

Clinical Trial Details

This study is being done to evaluate if maintenance nivolumab following definitive therapy with radiation and chemotherapy (cisplatin) results in significant improvement in overall survival for patients with intermediate risk HPV positive oropharynx cancer. We are doing this study because we want to find out if this approach is better or worse than the usual approach for HPV positive oropharynx cancer. 
   
The usual approach for patients who are not in a study is treatment with surgery, chemotherapy, and radiation therapy. Usually, combinations of these treatments are used. Cisplatin is the most commonly used chemotherapy drug to use with radiation therapy and is approved by the U.S. Food and Drug Administration (FDA) for this type of cancer. The usual approach for patients who are not in a study includes monitoring the effect of treatment by taking pictures of their tumor(s) with a PET/CT scan at 12 weeks after radiation, and CT scans every 3 months for 3 years after radiation therapy.
   
Participants in this study will get chemotherapy weekly for up to 7 weeks and radiation daily excluding weekends, for up to 7 weeks. Then they will either get nivolumab for up to 12 months and be monitored and observed (group 1), or will be monitored and observed without getting nivolumab (group 2). Nivolumab is given intravenously and is not approved by the FDA for the treatment of this disease.

If the participant's cancer grows during observation, they will then be offered nivolumab for up to 12 months. Participants will be evaluated every 3-6 months for 3 years after treatment, and once a year after that. This means that total study participation may last up to 10 years after treatment.

Key Eligibility: 
  1. Open to men and women, aged 18 or older, who have oropharynx cancer that is p16-positive by immunohistochemistry OR p16 equivocal by IHC and HPV positive by in situ hybridization.
  2. Patients must not have known hypersensitivity to nivolumab or compounds of similar chemical or biologic composition.
  3. Participants must not be pregnant or breast feeding and must be willing to use contraception.

Detailed eligibility will be reviewed when you contact the study team.

Study contact by location

Upper East Side - Manhattan

Contact(s)

June Greenberg, RN
(212) 746-2651
jdg2002@med.cornell.edu

Brooklyn

Contact(s)

Kelsey Maguire Torres, RN
929-470-9507
kem4016@med.cornell.edu

Primary Investigator(s)

Protocol ID(s)

Weill Cornell Medicine IRB #:

2307026302

ClinicalTrials.gov:

NCT03811015

Sponsor:

EA3161

Status

Not Yet Recruiting

Age Group

Adult

Sponsor