Axitinib and Avelumab in Treating Patients With Recurrent or Metastatic Adenoid Cystic Carcinoma

Inclusion Criteria

• Eastern Cooperative Oncology Group ECOG performance status 0 or 1
• Histologically confirmed recurrent or metastatic adenoid cystic carcinoma not amenable to curative intent surgery or radiotherapy
• Measurable disease per RECIST 1.1
• Evidence of disease progression within 6 months of study enrollment or worsening disease-related symptoms
• Previously untreated subjects and subject treated with any number of prior lines of therapy are eligible
• Absolute neutrophil count (ANC) >= 1.5 x 10^9/L
• Platelet count >= 100 x 10^9/L
• Hemoglobin >= 9 g/dL (may have been transfused)
• Total bilirubin level = = 30 mL/min according to the Cockcroft-Gault formula (or local institutional standard method)
• Must have archival tissue (formalin-fixed, paraffin-embedded [FFPE] tissue available-minimum of 15 unstained slides) or be willing to undergo a biopsy
• For patients receiving anti-therapeutic coagulation, patients must be on stable anticoagulant regimen and international normalized ratio (INR) or activated partial thromboplastin time (aPTT) must be = = 50 years old: they would be considered post-menopausal if they have been amenorrheic for the past 12 months or more following cessation of all exogenous hormonal treatments, or have had radiation-induced oophorectomy with the last menses > 1 year ago, or have had chemotherapy-induced menopause with > 1 year interval since last menses, or have had surgical sterilization by either bilateral oophorectomy or hysterectomy
• Non-sterilized males who are sexually active with a female partner of childbearing potential must use adequate contraception for the duration of the study and 30 days after the last dose of study medication. Adequate contraception methods include: birth control pills (e.g. combined oral contraceptive pill), barrier protection (e.g. condom plus spermicide, cervical/vault cap or intrauterine device), and abstinence. Patients should not father a child for 6 months after completion of the study medication. Patients should refrain from donating sperm from the start of dosing until 6 months after discontinuing the study medication. If male patients wish to father children they should be advised to arrange for freezing of sperm samples prior to the start of the study medication
• For patients with hypertension, upon entry into study must have blood pressure of = 3)
• Clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident/stroke ( = New York Heart Association Classification class II), or serious cardiac arrhythmia requiring medication
• Persisting toxicity related to prior therapy (NCI CTCAE v. 4.03 grade > 1); however, alopecia, sensory neuropathy grade = 140 mmHg and/or diastolic blood pressure > 90 mmHg). Anti-hypertensive therapy to maintain a systolic blood pressure 470 ms
• Serious non-healing or dehiscing wound, active ulcer or untreated bone fracture
• Proteinuria as demonstrated by urine dipstick or > 1 g of protein in a 24 hour urine collection. All patients with >= 2+ protein on dipstick urinalysis at baseline must undergo a 24 hour urine collection for protein
• Evidence of bleeding diathesis or clinically significant coagulopathy (in the absence of therapeutic anticoagulation)
• Other severe acute or chronic medical conditions including immune colitis, inflammatory bowel disease, immune pneumonitis, pulmonary fibrosis or psychiatric conditions including recent (within the past year) or active suicidal ideation or behavior; or laboratory abnormalities that may increase the risk associated with study participation or study treatment administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study
• Subject with an uncontrolled seizure disorder, active neurologic disease, or active central nervous system (CNS) involvement except for individuals who have previously-treated CNS metastases, are asymptomatic