Unresectable or Metastatic Melanoma

• IV (Adults and Children ≥12 yr and ≥40 kg): As monotherapy: 240 mg every 2 wk until disease progression or unacceptable toxicity or 480 mg every 4 wk until disease progression or unacceptable toxicity; In combination with ipilimumab: 1 mg/kg every 3 wk for a max of 4 doses or until unacceptable toxicity (whichever occurs first) (administer before ipilimumab on same day); then either 240 mg as monotherapy every 2 wk until disease progression or unacceptable toxicity or 480 mg as monotherapy every 4 wk until disease progression or unacceptable toxicity.
• IV (Children ≥12 yr and <40 kg): As monotherapy: 3 mg/kg every 2 wk until disease progression or unacceptable toxicity or 6 mg/kg every 4 wk until disease progression or unacceptable toxicity; In combination with ipilimumab: 1 mg/kg every 3 wk for a max of 4 doses or until unacceptable toxicity (whichever occurs first) (administer before ipilimumab on same day); then either 3 mg/kg as monotherapy every 2 wk until disease progression or unacceptable toxicity or 6 mg/kg as monotherapy every 4 wk until disease progression or unacceptable toxicity.

Adjuvant Treatment of Melanoma

• IV (Adults and Children ≥12 yr and ≥40 kg): 240 mg every 2 wk until disease progression or unacceptable toxicity for up to 1 yr or 480 mg every 4 wk until disease progression or unacceptable toxicity for up to 1 yr.
• IV (Children ≥12 yr and <40 kg): 3 mg/kg every 2 wk until disease progression or unacceptable toxicity for up to 1 yr or 6 mg/kg every 4 wk until disease progression or unacceptable toxicity for up to 1 yr.

Hepatocellular Carcinoma

• IV (Adults ): 1 mg/kg every 3 wk for a max of 4 doses (administer before ipilimumab on same day); then 240 mg as monotherapy every 2 wk until disease progression, unacceptable toxicity, or up to 2 yr or 480 mg as monotherapy every 4 wk until disease progression, unacceptable toxicity, or up to 2 yr.

First-Line Treatment of Unresectable or Metastatic Urothelial Carcinoma

• IV (Adults ): In combination with cisplatin and gemcitabine: 360 mg every 3 wk for up to 6 cycles (administer before cisplatin and gemcitabine on same day); then either 240 mg as monotherapy every 2 wk until disease progression, unacceptable toxicity, or up to 2 yr or 480 mg as monotherapy every 4 wk until disease progression, unacceptable toxicity, or up to 2 yr.

Adjuvant Treatment of Urothelial Carcinoma

• IV (Adults ): 240 mg every 2 wk until disease progression or unacceptable toxicity for up to 1 yr or 480 mg every 4 wk until disease progression or unacceptable toxicity for up to 1 yr.

Classical Hodgkin Lymphoma, Urothelial Carcinoma, or Squamous Cell Carcinoma of Head and Neck

• IV (Adults ): 240 mg every 2 wk until disease progression or unacceptable toxicity or 480 mg every 4 wk until disease progression or unacceptable toxicity.

Esophageal Squamous Cell Carcinoma

• IV (Adults ): As monotherapy: 240 mg every 2 wk until disease progression or unacceptable toxicity or 480 mg every 4 wk until disease progression or unacceptable toxicity. In combination with fluoropyrimidine- and platinum-containing chemotherapy: 240 mg every 2 wk until disease progression, unacceptable toxicity, or for up to 2 yr or 480 mg every 4 wk until disease progression, unacceptable toxicity, or up to 2 yr. In combination with ipilimumab: 3 mg/kg every 2 wk until disease progression, unacceptable toxicity, or up to 2 yr (administer before ipilimumab on same day) or 360 mg every 3 wk until disease progression, unacceptable toxicity, or up to 2 yr (administer before ipilimumab on same day).

Adjuvant Treatment of Resected Esophageal or Gastroesophageal Junction Cancer

• IV (Adults ): 240 mg every 2 wk until disease progression or unacceptable toxicity for a total treatment duration of 1 yr or 480 mg every 4 wk until disease progression or unacceptable toxicity for a total treatment duration of 1 yr.

Metastatic Non-Small Cell Lung Cancer

• IV (Adults ): As monotherapy: 240 mg every 2 wk until disease progression or unacceptable toxicity or 480 mg every 4 wk until disease progression or unacceptable toxicity; In combination with ipilimumab (for metastatic tumors expressing PD-L1): 3 mg/kg every 3 wk until disease progression, unacceptable toxicity, or up to 2 yr (if no disease progression) (administer before ipilimumab on same day). In combination with ipilimumab (for metastatic or recurrent tumors not expressing PD-L1): 360 mg every 3 wk until disease progression, unacceptable toxicity, or up to 2 yr (if no disease progression) (when given just with platinum-based chemotherapy on same day, administer nivolumab then platinum-based chemotherapy; when given with ipilimumab and platinum-based chemotherapy on same day, administer nivolumab, then ipilimumab, then platinum-based chemotherapy).

Neoadjuvant Treatment of Resectable Non-Small Cell Lung Cancer

• IV (Adults ): 360 mg every 3 wk (when given with platinum-doublet chemotherapy on same day) for 3 cycles.

Neoadjuvant and Adjuvant Treatment of Resectable Non-Small Cell Lung Cancer

• IV (Adults ): Neoadjuvant treatment: 360 mg every 3 wk (when given with platinum-doublet chemotherapy on same day) for up to 4 cycles, or until disease progression or unacceptable toxicity. Adjuvant treatment: 480 mg as monotherapy after surgery every 4 wk for up to 13 cycles (1 yr), or until disease recurrence or unacceptable toxicity.

Advanced Renal Cell Carcinoma

• IV (Adults ): As monotherapy: 240 mg every 2 wk until disease progression or unacceptable toxicity or 480 mg every 4 wk until disease progression or unacceptable toxicity; In combination with ipilimumab: 3 mg/kg every 3 wk for 4 doses (administer before ipilimumab on same day); then 240 mg as monotherapy every 2 wk until disease progression or unacceptable toxicity or 480 mg as monotherapy every 4 wk until disease progression or unacceptable toxicity. In combination with cabozantinib: 240 mg every 2 wk until disease progression, unacceptable toxicity, or up to 2 yr or 480 mg every 4 wk until disease progression, unacceptable toxicity, or up to 2 yr.

Microsatellite Instability-High or Mismatch Repair Deficient Metastatic Colorectal Cancer

• IV (Adults and Children ≥12 yr and ≥40 kg): As monotherapy: 240 mg every 2 wk until disease progression or unacceptable toxicity or 480 mg every 4 wk until disease progression or unacceptable toxicity; In combination with ipilimumab: 240 mg every 3 wk for a max of 4 doses (administer before ipilimumab on same day); then 240 mg as monotherapy every 2 wk until disease progression, unacceptable toxicity, or up to 2 yr or 480 mg as monotherapy every 4 wk until disease progression, unacceptable toxicity, or up to 2 yr.
• IV (Children ≥12 yr and <40 kg): As monotherapy: 3 mg/kg every 2 wk until disease progression or unacceptable toxicity; In combination with ipilimumab: 3 mg/kg every 3 wk for a max of 4 doses (administer before ipilimumab on same day), then 3 mg/kg as monotherapy every 2 wk until disease progression, unacceptable toxicity, or up to 2 yr or 6 mg/kg as monotherapy every 4 wk until disease progression, unacceptable toxicity, or up to 2 yr.

Gastric Cancer, Gastroesophageal Junction Cancer, and Esophageal Adenocarcinoma

• IV (Adults ): 240 mg every 2 wk until disease progression, unacceptable toxicity, or up to 2 yr (administer before fluoropyrimidine- and platinum-containing chemotherapy on same day) or 360 mg every 3 wk until disease progression, unacceptable toxicity, or up to 2 yr (administer before fluoropyrimidine- and platinum-containing chemotherapy on same day).

Malignant Pleural Mesothelioma

• IV (Adults ): 360 mg every 3 wk until disease progression, unacceptable toxicity, or up to 2 yr (if no disease progression) (administer before ipilimumab on same day).