Bristol Myers Squibb Opdivo (nivolumab) Monograph

Published: February 09, 2026

Opdivo (nivolumab) is a programmed death receptor-1 (PD-1)-blocking antibody indicated for the treatment of melanoma, non-small cell lung cancer, malignant pleural mesothelioma, renal cell carcinoma, classical Hodgkin lymphoma, squamous cell carcinoma of the head and neck, urothelial carcinoma, colorectal cancer, Hepatocellular carcinoma, esophageal cancer, gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma. Opdivo was first approved in 2014 as a treatment for unresectable or metastatic melanoma.

Today's look at Opdivo includes indications, warnings and precautions, along with some appearances of nivolumab in clinical practice guidelines.

Medication Overview:

Brand Name: Opdivo
Generic Name: nivolumab
Treatment for: Melanoma, NSCLC, malignant pleural mesothelioma, RCC, cHL, SCCHN, urothelial carcinoma, CRC, HCC, esophageal cancer, gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma
Manufacturer: Bristol Myers Squibb
Initial FDA Approval: 2014

Opdivo Indications Overview

Indicated Condition	Indication	Age	Initial Date Approved
Melanoma	Adult and pediatric (12 years and older) patients with unresectable or metastatic melanoma, as a single agent or in combination with ipilimumab; for the adjuvant treatment of adult and pediatric patients 12 years and older with completely resected Stage IIB, Stage IIC, Stage III, or Stage IV melanoma.	Adult and Pediatric (12 and older) Patients	December 2014
Non-Small Cell Lung Cancer (NSCLC)	Adult patients with resectable (tumors ≥4 cm or node positive) non-small cell lung cancer in the neoadjuvant setting, in combination with platinum-doublet chemotherapy; adult patients with resectable (tumors ≥4 cm or node positive) non-small cell lung cancer and no known EGFR mutations or ALK rearrangements, for neoadjuvant treatment, in combination with platinum-doublet chemotherapy, followed by single-agent OPDIVO as adjuvant treatment after surgery; adult patients with metastatic non-small cell lung cancer expressing PD-L1 (≥1%) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations, as first-line treatment in combination with ipilimumab; adult patients with metastatic or recurrent non-small cell lung cancer with no EGFR or ALK genomic tumor aberrations as first-line treatment, in combination with ipilimumab and 2 cycles of platinum-doublet chemotherapy; adult patients with metastatic non-small cell lung cancer and progression on or after platinum-based chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving OPDIVO.	Adults	March 2015
Malignant Pleural Mesothelioma	Adult patients with unresectable malignant pleural mesothelioma, as first-line treatment in combination with ipilimumab.	Adults	October 2020
Renal Cell Carcinoma (RCC)	Adult patients with intermediate or poor risk advanced renal cell carcinoma, as a first-line treatment in combination with ipilimumab; adult patients with advanced renal cell carcinoma, as a first-line treatment in combination with cabozantinib; adult patients with advanced renal cell carcinoma who have received prior anti-angiogenic therapy.	Adults	November 2015
Classical Hodgkin Lymphoma (cHL)	Adult patients with classical Hodgkin lymphoma that has relapsed or progressed after: autologous hematopoietic stem cell transplantation (HSCT) and brentuximab vedotin, or three or more lines of systemic therapy that includes autologous HSCT.	Adults	May 2016
Squamous Cell Carcinoma of the Head and Neck (SCCHN)	Adult patients with recurrent or metastatic squamous cell carcinoma of the head and neck with disease progression on or after a platinum-based therapy.	Adults	November 2016
Urothelial Carcinoma	Adjuvant treatment of adult patients with urothelial carcinoma (UC) who are at high risk of recurrence after undergoing radical resection of UC; adult patients with unresectable or metastatic urothelial carcinoma, as first-line treatment in combination with cisplatin and gemcitabine; adult patients with locally advanced or metastatic urothelial carcinoma who: have disease progression during or following platinum-containing chemotherpy/have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.	Adults	February 2017
Colorectal Cancer (CRC)	Adult and pediatric (12 years and older) patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer (CRC) in combination with ipilimumab; adult and pediatric (12 years and older) patients with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan.	Adult and Pediatric (12 and older) Patients	August 2017
Hepatocellular Carcinoma (HCC)	Adult patients with unresectable or metastatic hepatocellular carcinoma (HCC), as a first-line treatment in combination with ipilimumab; in combination with ipilimumab in adult patients with unresectable or metastatic HCC who have been previously treated with sorafenib.	Adults	September 2017
Esophageal Cancer	Adult patients with completely resected esophageal or gastroesophageal junction cancer with residual pathologic disease, who have received neoadjuvant chemoradiotherapy (CRT); adult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma as first-line treatment in combination with fluoropyrimidine- and platinum-containing chemotherapy whose tumors express PD-L1 (≥1); adult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma as first-line treatment in combination with ipilimumab whose tumors express PD-L1 (≥1); adult patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) after prior fluoropyrimidine- and platinum-based chemotherapy.	Adults	June 2020
Gastric Cancer, Gastroesophageal Junction Cancer, and Esophageal Adenocarcinoma	Adult patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma whose tumors express PD-L1 (≥1) in combination with fluoropyrimidine- and platinum-containing chemotherapy.	Adults	April 2021

Warnings and Precautions:

Immune-mediated Adverse Reactions:

Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue, including the following: immune-mediated pneumonitis, immune-mediated colitis, immune-mediated hepatitis and hepatotoxicity, immune-mediated endocrinopathies, immune-mediated dermatologic adverse reactions, and immune-mediated nephritis and renal dysfunction.
Monitor for early identification and management. Evaluate liver enzymes, creatinine, and thyroid function at baseline and periodically during treatment.
Withhold or permanently discontinue based on severity and type of reaction.

Infusion-related Reactions: Interrupt, slow the rate of infusion, or permanently discontinue Opdivo based on severity of reaction.

Complications of Allogenic HSCT: Fatal and other serious complications can occur in patients who receive allogenic HSCT before or after being treated with a PD-1/PD-L1 blocking antibody.

Embryo-Fetal Toxicity: Can cause fetal harm. Advise females of reproductive potential of potential risk to a fetus and to use effective contraception.

Treatment of patients with multiple myeloma with a PD-1 or PD-L1 blocking antibody in combination with a thalidomide analogue plus dexamethasone is not recommended outside of controlled clinical trials.

Dosage and Administration:

Administer by intravenous infusion after dilution based upon recommended infuse rate for each indication.

Unresectable or Metastatic Melanoma:

Adult and pediatric patients weighing 40 kg or greater: 240 mg every two weeks or 480 mg every four weeks.
Pediatric patients weighing less than 40 kg: 3 mg/kg every two weeks or 6 mg/kg every four weeks.
Adult and pediatric patients weighing 40 kg or greater: 1 mg/kg followed by ipilimumab 3 mg/kg on the same day every three weeks for four doses, then 240 mg every two weeks or 480 mg every four weeks.
Pediatric patients weighing less than 40 kg: 1 mg/kg followed by ipilimumab 3 mg/kg on the same day every three weeks for four doses; then 3 mg/kg every two weeks or six mg/kg every four weeks.

Adjuvant Treatment of Melanoma:

Adult and pediatric patients weighing 40 kg or greater: 240 mg every two weeks or 480 mg every four weeks.
Pediatric patients weighing less than 40 kg: 3 mg/kg every two weeks or 6 mg/kg every four weeks.

Neoadjuvant Treatment of Resectable (tumors ≥4 cm or node positive) Non-small Cell Lung Cancer:

360 mg with platinum-doublet chemotherapy on the same day every three weeks for three cycles.

Neoadjuvant and Adjuvant Treatment of Resectable Non-small Cell Lung Cancer:

360 mg with platinum-doublet chemotherapy on the same day every three weeks for up to four cycles, then continued as single-agent Opdivo 480 mg every four weeks after surgery for up to 13 cycles (~one year).

Metastatic Non-small Cell Lung Cancer:

360 mg every three weeks with ipilimumab 1 mg/kg every six weeks.
360 mg every three weeks with ipilimumab 1 mg/kg every six weeks and two cycles of platinum-doublet chemotherapy.
240 mg every two weeks or 480 mg every four weeks.

Malignant Pleural Mesothelioma:

360 mg every three weeks with ipilimumab 1 mg/kg every six weeks.

Advanced Renal Cell Carcinoma:

3 mg/kg followed by ipilimumab 1 mg/kg on the same day every three weeks for four doses, then 240 mg every two weeks or 480 mg every four weeks.
240 mg every two weeks or 480 mg every four weeks administered in combination with cabozantinib 40 mg once daily without food.
240 mg every two weeks or 480 mg every four weeks.

Classical Hodgkin Lymphoma:

240 mg every two weeks or 480 mg every four weeks.

Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck:

240 mg every two weeks or 480 mg every four weeks.

Adjuvant Treatment of Urothelial Carcinoma:

240 mg every two weeks or 480 mg every four weeks.

First-line Unresectable or Metastatic Urothelial Carcinoma:

360 mg every three weeks with cisplatin and gemcitabine on the same day for up to six cycles, then 240 mg every two weeks or 480 mg every four weeks.

Previously Treated Locally Advanced or Metastatic Urothelial Carcinoma:

240 mg every two weeks or 480 mg every four weeks.

Microsatellite Instability-high (MSI-H) or Mismatch Repair Deficient (dMMR) Metastatic Colorectal Cancer:

Adult and pediatric patients weighing 40 kg or greater: 240 mg followed by ipilimumab 1 mg/kg on the same day every three weeks for a maximum of four doses, then 240 mg every two weeks or 480 mg every four weeks.
Pediatric patients weighing less than 40 kg: 3 mg/kg followed by ipilimumab 1 mg/kg on the same day every three weeks for a maximum of four doses, then 3 mg/kg every two weeks or 6 mg/kg every four weeks.

Microsatellite Instability-high (MSI-H) or Mismatch Repair Deficient (dMMR) Metastatic Colorectal Cancer That Has Progressed Following Prior Treatment for Metastatic Disease:

Adult and pediatric patients weighing 40 kg or greater: 240 mg every two weeks or 480 mg every four weeks.
Pediatric patients weighing less than 40 kg: 3 mg/kg every two weeks.

Hepatocellular Carcinoma:

1 mg/kg followed by ipilimumab 3 mg/kg on the same day every three weeks for four doses, then 240 mg every two weeks or 480 mg every four weeks.

Adjuvant Treatment of Resected Esophageal or Gastroesophageal Cancer:

240 mg every two weeks or 480 mg every four weeks for total treatment duration of one year.

Esophageal Squamous Cell Carcinoma:

240 mg every two weeks or 480 mg every four weeks in combination with chemotherapy regimen of fluoropyrimidine- and platinum-containing chemotherapy.
3 mg/kg every two weeks or 360 mg every three weeks with ipilimumab 1 mg/kg every six weeks.
240 mg every two weeks or 480 mg every four weeks.

Gastric Cancer, Gastroesophageal Junction Cancer, and Esophageal Adenocarcinoma (GC, GEJC, or EAC):

360 mg every three weeks with fluoropyrimidine- and platinum-containing chemotherapy every three weeks.
240 mg every two weeks with fluoropyrimidine- and platinum-containing chemotherapy every two weeks.

Contraindications:

None listed.

Adverse Reactions:

Most common adverse reactions (incidence ≥20%) in patients were:

As a single agent: fatigue, rash, musculoskeletal pain, pruritus, diarrhea, nausea, asthenia, cough, dyspnea, constipation, decreased appetite, back pain, arthralgia, upper respiratory tract infection, pyrexia, headache, abdominal pain, vomiting, and urinary tract infection.
In combination with ipilimumab: fatigue, diarrhea, rash, pruritus, nausea, musculoskeletal pain, pyrexia, cough, decreased appetite, vomiting, abdominal pain, dyspnea, upper respiratory tract infection, arthralgia, headache, hypothyroidism, constipation, decreased weight, and dizziness.
In combination with platinum-doublet chemotherapy: nausea, fatigue, musculoskeletal pain, constipation, decreased appetite, rash, vomiting, and peripheral neuropathy.
In combination with ipilimumab and platinum-doublet chemotherapy: fatigue, musculoskeletal pain, nausea, diarrhea, rash, decreased appetite, constipation, and pruritus.
In combination with cabozantinib: diarrhea, fatigue, hepatotoxicity, palmar-plantar erythrodysesthesia syndrome, stomatitis, rash, hypertension, hypothyroidism, musculoskeletal pain, decreased appetite, nausea, dysgeusia, abdominal pain, cough, and upper respiratory tract infection.
In combination with fluoropyrimidine- and platinum-containing chemotherapy: nausea, peripheral neuropathy, decreased appetite, fatigue, constipation, stomatitis, diarrhea, vomiting, abdominal pain, and musculoskeletal pain.

Examples of Nivolumab in Guidelines

Treatment of Malignant Pleural Mesothelioma

American Society of Clinical Oncology (ASCO), January 2025
“In patients with newly diagnosed pleural mesothelioma, ipilimumab plus nivolumab immunotherapy should be offered as a first-line systemic treatment option.”

Systemic Therapy for Melanoma

American Society of Clinical Oncology (ASCO), August 2023
“Adjuvant pembrolizumab or nivolumab should be offered to patients with resected stage IIB or IIC melanoma.”

Immunotherapy for the Treatment of Lymphoma

Society for Immunotherapy of Cancer (SITC), December 2020
“For the first-line therapy of stage III–IV cHL, nivolumab-AVD is recommended.”

Please note: This article is current as of February 5, 2026. Consult our clinical guidelines library or drug information tool to ensure you always have the most up-to-date information.