Nivolumab and BMS986205 in Treating Patients With Stage II-IV Squamous Cell Cancer of the Head an… (NCT03854032) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Nivolumab and BMS986205 in Treating Patients With Stage II-IV Squamous Cell Cancer of the Head and Neck
United States45 participantsStarted 2019-04-09
Plain-language summary
This phase II trial studies how well nivolumab works, with or without BMS986205, in treating patients with stage II-IV squamous cell cancer of the head and neck. 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. BMS986205 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving nivolumab with BMS986205 may work better than nivolumab alone in treating patients with squamous cell cancer of the head and neck.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Pathologically confirmed head and neck squamous cell carcinoma (HNSC).
* Any stage 2 or greater HNSCC (American Joint Committee on Cancer \[AJCC\] 8th edition) of the 1) oral cavity, 2) larynx, 3) hypopharynx, 4) nasal cavity/paranasal sinuses or 5) stage 1 oropharyngeal with lymphadenopathy. Patients with resectable disease that is amenable to surgery are eligible. Patient must have been determined to be candidates for surgical resection by a multi-disciplinary team including a surgeon, a medical oncologist
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
* White blood cells 2000/ul or more.
* Absolute neutrophil count 1500/ul or more.
* Platelets 100,000/ul or more.
* Hemoglobin 9 g/dl or more.
* Bilirubin less than or equal to 1.5 x the upper limit of normal (except subjects with Gilbert syndrome, who can have total bilirubin \< 3 mg/dl).
* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than or equal to 3 x the upper limit of normal.
* Glomerular filtration rate (GFR) greater than or equal to 40 ml/min using the Cockcroft-Gault formula or serum creatinine less than or equal to 1.5 x ULN.
* Women of child bearing potential (WOCBP) should have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin \[HCG\]) within 21 days of study enrollment.
* WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment…