Trial of Nivolumab vs Therapy of Investigator's Choice in Recurrent or Metastatic Head and Neck Carcinoma (CheckMate 141)

For more information regarding BMS clinical trial participation, please visit
www.BMSStudyConnect.com

Inclusion Criteria:

- Men and women ≥ 18 years of age with an Eastern Cooperative Oncology Group (ECOG)
performance status ≤ 1

- Histologically confirmed recurrent or metastatic SCCHN (oral cavity, pharynx, larynx),
stage III/IV and not amenable to local therapy with curative intent (surgery or
radiation therapy with or without chemotherapy)

- Tumor progression or recurrence within 6 months of last dose of platinum therapy in
the adjuvant (ie with radiation after surgery), primary (ie, with radiation),
recurrent, or metastatic setting

- Measurable disease by Computed tomography (CT) or Magnetic resonance imaging (MRI) per
Response Evaluation Criteria In Solid Tumors (RECIST 1.1) criteria

Exclusion Criteria:

- Active brain metastases or leptomeningeal metastases are not allowed

- Histologically confirmed recurrent or metastatic carcinoma of the nasopharynx,
squamous cell carcinoma of unknown primary, and salivary gland or non-squamous
histologies (eg: mucosal melanoma) are not allowed

- Subjects with active, known or suspected autoimmune disease