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About
Nivolumab is an antibody (a type of human protein) that is designed to boost your body's immune system. It does this by allowing immune cells to grow and fight the cancer. Nivolumab has been approved by the FDA for the treatment of melanoma (a form of skin cancer) and lung cancer. It is currently under study for the treatment of head and neck squamous cell cancer.
Enrollment
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Inclusion criteria
Signed Written Informed Consent
Subjects must have signed and dated an IRB/IEC approved written informed consent form in accordance with regulatory and institutional guidelines.
Subjects must be willing and able to comply with scheduled visits, treatment schedule, laboratory testing, and other study obligations.
Target Population
Males and females ≥ 18 years of age
Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
Histologically confirmed metastatic HNSCC, including nasopharynx WHO Type I-III histologies; patients can have simultaneous loco-regional disease. Central biopsy review at MSKCC is not required.
Subjects must have at least two lesions:
A formalin fixed, paraffin-embedded (FFPE) tumor tissue block or a minimum of 3 unstained slides of tumor sample obtained via excisional, incisional, or core needle biopsy from a metastatic or loco-regionally recurrent lesion. A new baseline biopsy does not need to be obtained for study purposes. If 3 unstained are unavailable from a metastatic or loco-regionally recurrent lesion, with permission of the PI, FFPE tumor tissue from the primary disease site at the time of original diagnosis is acceptable.
For oropharynx or nasopharynx primary lesions, documentation of viral status is required (e.g. high risk HPV sub-type PCR, p16 IHC, HPV ISH, EBER, etc). Tests done on primary tumor specimens from date of initial diagnosis at outside institutions are sufficient to meet this criterion
Prior palliative or curative radiotherapy must be completed at least 14 days prior to randomization.
Immunosuppressive doses of systemic medication, such as steroids or absorbed topical steroids (doses >10mg/day prednisone or equivalent) must be discontinued at least 14 days prior to Nivolumab administration.
Screening laboratory values must meet the following criteria (using CTCAE v4.0) and should be obtained within 28 days prior to randomization:
WBC ≥ 2 K/microliter
Neutrophils ≥ 1.5 ;K/microliter
Platelets ≥ 100 K/microliter
Hemoglobin ≥ 9.0 g/deciliter
Serum Creatinine ≤ 1.5 x ULN or creatinine clearance > 40ml/min using the Cockcroft-Gault formula.
Female CrCl = (140 - age in years) x weight in kg x 0.85 72 x serum creatinine in mg/dL
AST/ALT ≤ 3 x ULN
Total bilirubin <1.5 x ULN (except subjects with Gilbert Syndrome who can have total bilirubin <3.0 mg/deciliter) Calcium levels must be normalized and maintained within normal limits for study entry and while on treatment.
Subjects with an initial magnesium <0.5 mmol/liter (1.2 mg/deciliter) may receive corrective magnesium supplementation but should continue to receive either prophylactic weekly infusion of magnesium and/or oral magnesium supplementation.
Subjects must have a resting baseline O2 saturation by pulse oximetry of >=92% at rest.
Reproductive Status
Women of childbearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 28 days prior to randomization.
Women must not be breastfeeding
Women of childbearing potential must agree to follow instructions for method(s) of contraception from time of enrollment for the duration of treatment with Nivolumab plus 5 half- lives plus 30 days for a total of 23 weeks post treatment completion.
Men who are sexually active with WOCBP must use any contraceptive method with a failure rate of less than 1% per year. Men receiving Nivolumab and who are sexually active with WOCBP will be instructed to adhere to contraception for a period of 31 weeks after the last dose of investigational product.
Women who are not of childbearing potential (i.e., who are postmenopausal or surgically sterile as well as azoospermic men do not require contraception.
Azoospermic males and women of childbearing potential who are continuously not heterosexually active are exempt from contraceptive requirements. However, they still must have a pregnancy test.
Insurance Approval
Insurance approval for SBRT should be obtained prior to randomization
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
65 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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