Durvalumab With or Without Tremelimumab in Treating Participants With Stage II-IVA Oropharyngeal … (NCT03144778) | Clinical Trial Compass
CompletedPhase 1
Durvalumab With or Without Tremelimumab in Treating Participants With Stage II-IVA Oropharyngeal Squamous Cell Cancer
United States39 participantsStarted 2017-07-12
Plain-language summary
This phase I trial studies how well durvalumab with or without tremelimumab works in treating participants with stage II-IVA oropharyngeal squamous cell cancer. Immunotherapy with monoclonal antibodies, such as durvalumab and tremelimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Written informed consent to participate in the study according to the investigational review board (IRB)
* Suspected or histologically/cytologically confirmed oropharyngeal squamous cell carcinoma (OPSCC), stage II, III, or IVA (according to the American Joint Committee on Cancer \[AJCC\] 7th edition), or patients with loco-regional recurrence from an OPSCC primary, if time of recurrence is at least 6 months after completion of initial curative intent treatment (surgery or radiotherapy +/- chemotherapy or cetuximab). Patients with a suspected lesion may be enrolled and a baseline biopsy will be obtained as part of the study. If squamous cell histology is not confirmed, patients will be discontinued from the study
* Patients must have surgically resectable disease in the opinion of the treating physician. For patients with a primary OPSCC, patients must be eligible for TORS (transoral robotic surgery)
* Available tissue from prior biopsy (minimum of 10 unstained slides), or willing to undergo core biopsy to obtain tumor material. Biopsy will be mandatory for patients with recurrent disease
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Hemoglobin \>= 9.0 g/dL
* Absolute neutrophil count (ANC) \>= 1.5 x 10\^9/L (\> 1500 per mm\^3)
* Platelet count \>= 100 x 10\^9/L (\> 100,000 per mm\^3)
* Serum bilirubin =\< 1.5 x institutional upper limit of normal (ULN). This will not apply to subjects with confirmed Gilbert's syndrome (pers…
What they're measuring
1
Change of CD8+ tumor infiltrating lymphocytes
Timeframe: Before and after treatment, assessed up to 5 years