Patients receive nivolumab IV over 30 minutes on days 1, 15, 29, 43, 57, and 71 of course 1 and on days 1 and 15 of course 2, over 60 minutes on days 29 and 57 of course 2 and on days 1, 29, and 57 of subsequent courses. Patients also receive ipilimumab over 90 minutes on days 1 and 43. Courses repeat every 84 days in the absence of disease progression or unexpected toxicity.

Major Salivary Gland Carcinoma

Minor Salivary Gland Carcinoma

Recurrent Salivary Gland Carcinoma

Stage IV Major Salivary Gland Carcinoma

Stage IVA Major Salivary Gland Carcinoma

Stage IVB Major Salivary Gland Carcinoma

Stage IVC Major Salivary Gland Carcinoma

Ipilimumab

Laboratory Biomarker Analysis

Nivolumab

Northwestern University

Nivolumab and Ipilimumab in Treating Patients With Metastatic/Recurrent ACC of All Sites and Non-ACC Salivary Gland Cancer

Phase II Study of Nivolumab and Ipilimumab for Treatment of Metastatic/Recurrent Adenoid Cystic Carcinoma of All Anatomic Sites of Origin and Non-adenoid Cystic Carcinoma Malignant Tumors of the Salivary Gland

Median PFS will be assessed using the Response Evaluation Criteria in Solid Tumors (RECIST 1.1) criteria.

PFS will be assessed at 6 months using RECIST 1.1 criteria.

PFS will be assessed at 12 months using RECIST 1.1 criteria.

RR will be evaluated by RECIST 1.1 in patients with recurrent or metastatic ACC.

DCR will be defined as the sum of Complete Response (CR), Partial Response (PR), and Stable Disease (SD) and will be assessed by RECIST 1.1 in patients with recurrent or metastatic ACC.

Overall survival (OS) is defined as time in months from the date of first study treatment to the date of death and will be evaluated using RECIST 1.1 criteria.

PFS defined as time in months from the date of first study treatment to the date of disease progression or death from any cause, whichever comes first.

ORR will be assessed by immune-related response (irRECIST) criteria in patients with recurrent or metastatic ACC.

DCR will be defined as the sum of Complete Response (CR), Partial Response (PR), and Stable Disease (SD) and will be assessed by irRECIST in patients with recurrent or metastatic ACC.

PFS will be evaluated using irRECIST criteria.

OS is defined as time in months from the date of first study treatment to the date of death and will be evaluated using irRECIST criteria.

Assess the safety and tolerability of the combination of nivolumab and ipilimumab by evaluating the number, frequency, and severity of adverse events using CTCAE version 4.03.

salivary gland neoplasms/phosphatase

Nivolumab and Ipilimumab in Treating Patients With Metastatic/Recurrent ACC of All Sites and Non-ACC Salivary Gland Cancer

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