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Stereotactic Body Radiation Therapy and Durvalumab With or Without Tremelimumab Before Surgery in Treating Participants With Human Papillomavirus Positive Oropharyngeal Squamous Cell Caner

NCT03618134 · Jonsson Comprehensive Cancer Center · Updated 18 Nov 2023

What is being tested
Durvalumab; Modified Radical Neck Dissection; Quality-of-Life Assessment; Questionnaire Administration; Stereotactic Body Radiation Therapy; Transoral Robotic Surgery; Tremelimumab
For
Clinical Stage I HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC (American Joint Committee on Cancer) v8; Clinical Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8; Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8; Human Papillomavirus Positive; Oropharyngeal Squamous Cell Carcinoma; p16 Positive Neoplastic Cells Present; Pathologic Stage I HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8; Pathologic Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8; Pathologic Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
Kind of study
Tests a treatment or device on volunteers. Phase 1 and Phase 2.
Who can join
Ages 18 years and older. About 19 people. The full rules are on the registry page.
Where
United States
When
Starts or started 4 Oct 2018, ends 30 June 2023. Registered 7 Aug 2018.
Results
None posted yet.

In the researchers' words

This phase Ib/II trial studies the side effects and how well stereotactic body radiation therapy and durvalumab with or without tremelimumab before surgery work in treating participants with human papillomavirus positive oropharyngeal squamous cell cancer. Stereotactic body radiation therapy is a specialized radiation therapy that sends x-rays directly to the tumor using smaller doses over several days and may cause less damage to normal tissue. Monoclonal antibodies, such as durvalumab and tremelimumab, may interfere with the ability of tumor cells to grow and spread. Giving stereotactic body radiation therapy and durvalumab with or without tremelimumab before surgery may work better in treating participants with oropharyngeal squamous cell cancer.
ClinicalTrials.gov, NCT03618134

Sites

  • UCLA / Jonsson Comprehensive Cancer CenterLos Angeles, California, United States