Nivolumab

(Opdivo)

Nivolumab

Drug updated on 11/13/2023

Dosage FormInjection (intravenous; 40 mg/4 mL, 100 mg/10 mL, 240 mg/24 mL)
Drug ClassProgrammed death receptor-1 (PD-1)-blocking antibodies
Ongoing and Completed StudiesClinicalTrials.gov

Indication

  • Indicated in 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.
  • For the treatment of 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.
  • For the treatment of Non-Small Cell Lung Cancer (NSCLC) in adult patients 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.
  • For the treatment of metastatic or recurrent non-small cell lung cancer in adult patients with no EGFR or ALK genomic tumor aberrations as first-line treatment, in combination with ipilimumab and 2 cycles of platinum-doublet chemotherapy.
  • Indicated in 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.
  • For the treatment of unresectable malignant pleural mesothelioma in adult patients, as first-line treatment in combination with ipilimumab.
  • Used as a first-line treatment in combination with ipilimumab in adult patients with intermediate or poor risk advanced renal cell carcinoma.
  • Used as a first-line treatment in combination with cabozantinib in adult patients with advanced renal cell carcinoma.
  • For the treatment of adult patients with advanced renal cell carcinoma who have received prior anti-angiogenic therapy.
  • For the treatment of adult patients with classical Hodgkin lymphoma that has relapsed or progressed after an autologous hematopoietic stem cell transplantation (HSCT) and brentuximab vedotin, or 3 or more lines of systemic therapy that includes autologous HSCT. • For the treatment of adult patients with recurrent or metastatic squamous cell carcinoma of the head and neck with disease progression on or after a platinum-based therapy. • For the adjuvant treatment of patients with urothelial carcinoma (UC) who are at high risk of recurrence after undergoing radical resection of UC.
  • For the treatment of adult patients with recurrent or metastatic squamous cell carcinoma of the head and neck with disease progression on or after a platinum-based therapy.
  • For the adjuvant treatment of patients with urothelial carcinoma (UC) who are at high risk of recurrence after undergoing radical resection of UC.
  • For the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.
  • For the treatment of 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, as a single agent or in combination with ipilimumab.
  • For the treatment of adult patients with hepatocellular carcinoma who have been previously treated with sorafenib, as a single agent or in combination with ipilimumab.
  • For the treatment ofadult patients with completely resected esophageal or gastroesophageal junction cancer with residual pathologic disease, who have received neoadjuvant chemoradiotherapy.
  • For the treatment of adult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma as first-line treatment in combination with fluoropyrimidine- and platinum containing chemotherapy.
  • For the treatment of adult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma as first-line treatment in combination with ipilimumab.
  • For the treatment of adult patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) after prior fluoropyrimidine- and platinum-based chemotherapy.
  • For the treatment of adult patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma in combination with fluoropyrimidine- and platinum-containing chemotherapy.

Product Monograph / Prescribing Information

Document TitleYearSource
Opdivo (nivolumab) Prescribing Information.2022Bristol-Myers Squibb Company, Princeton, NJ

Systematic Reviews / Meta-Analyses

Document TitleYearSource
Nivolumab with chemotherapy for neoadjuvant treatment of resectable non-small-cell lung cancer.2023NICE
Clinical, pharmacoeconomic, and stakeholder input combined report.2023CADTH
Anti-TIGIT therapies for solid tumors: a systematic review. 2023ESMO
Long-term comparative efficacy and safety of nivolumab plus ipilimumab relative to other first-line therapies for advanced non-small-cell lung cancer: A systematic literature review and network meta-analysis.2023Lung Cancer
Immune checkpoint inhibitors as first-line therapy for non-small cell lung cancer: A systematic evaluation and meta-analysis2023Human vaccines & immunotherapeutics
Safety and efficacy of PD-1 and PD-L1 inhibitors in relapsed and refractory Hodgkin's lymphoma: a systematic review and meta-analysis of 20 prospective studies 2023Hematology
Neoadjuvant immunotherapy prior to surgery for mucosal head and neck squamous cell carcinoma: systematic review.2022Head & Neck
First-line treatments for extensive-stage small-cell lung cancer with immune checkpoint inhibitors plus chemotherapy: a network meta-analysis and cost-effectiveness analysis.2022Frontiers in Oncology
The efficacy and safety of combined ipilimumab and nivolumab versus ipilimumab in patients with stage III/IV unresectable melanoma: a systematic review and meta‑analysis.2022Journal of Cancer Research and Therapeutics
Autoimmune retinopathy with associated anti-retinal antibodies as a potential immune-related adverse event associated with immunotherapy in patients with advanced cutaneous melanoma: case series and systematic review. 2022BMJ Open Ophthalmology
Immune checkpoint inhibitor–induced diarrhea and colitis: incidence and management. a systematic review and meta-analysis.2022Cancer Treatment Reviews
Efficacy and safety of first-line systemic therapy for metastatic renal cell carcinoma: a systematic review and network meta-analysis.2022European Urology Open Science
Clinical Benefit of First-Line Programmed Death-1 Antibody Plus Chemotherapy in Low Programmed Cell Death Ligand 1–Expressing Esophageal Squamous Cell Carcinoma: A Post Hoc Analysis of JUPITER-06 and Meta-Analysis.2022Journal of Clinical Oncology
A comprehensive evaluation of the safety of ipilimumab, nivolumab and their combination therapy: A systematic review and network meta-analysis.2022Journal of Oncology Pharmacy Practice
Clinical and pharmacoeconomic combined report: nivolumab (Opdivo) in combination with ipilimumab (Yervoy) for malignant pleural mesothelioma. 2021CADTH
Final clinical guidance report: nivolumab (Opdivo) with ipilimumab (Yervoy) for non-small cell lung cancer.2021CADTH
Selection of optimal first-line immuno-related therapy based on specific pathological characteristics for patients with advanced driver-gene wild-type non-small cell lung cancer: a systematic review and network meta-analysis.2021Therapeutic Advances in Medical Oncology
Prevalence of dermatological toxicities in patients with melanoma undergoing immunotherapy: systematic review and meta-analysis.2021PLoS One
Chemotherapy in focus: a meta-analysis confronts immunotherapy in the treatment of advanced melanoma.2021Critical Reviews in Oncology/Hematology
Systematic review and meta‑analysis efficacy and safety of immune checkpoint inhibitors in advanced melanoma patients with anti‑PD‑1 progression: a systematic review and meta‑analysis.2021Clinical & Translational Oncology
Single or combined immune checkpoint inhibitors compared to first‐line platinum‐based chemotherapy with or without bevacizumab for people with advanced non‐small cell lung cancer.2021Cochrane Database of Systematic Reviews
Nivolumab for adjuvant treatment of resected oesophageal or gastro-oesophageal junction cancer.2021NICE
Anti–pd-1 and anti–pd-l1 in head and neck cancer: a network meta-analysis.2021Frontiers in Immunology
Comparison of atezolizumab, durvalumab, pembrolizumab, and nivolumab as first-line treatment in patients with extensive-stage small cell lung cancer: A systematic review and network meta-analysis.2021Medicine
Efficacy and safety of first-line immunotherapy combinations for advanced nsclc: a systematic review and network meta-analysis.2021Journal of Thoracic Oncology
Nivolumab vs pembrolizumab for treatment of us patients with platinum-refractory recurrent or metastatic head and neck squamous cell carcinoma. A network meta-analysis and cost-effectiveness analysis.2021JAMA Network
First-line Immunotherapy-based Combinations for Metastatic Renal Cell Carcinoma: A Systematic Review and Network Meta-analysis. 2021European urology oncology
Nivolumab plus ipilimumab versus existing immunotherapies in patients with PD-L1-positive advanced non-small cell lung cancer: a systematic review and network meta-analysis.2020Cancers
Potential immune-related adverse events associated with monotherapy and combination therapy of ipilimumab, nivolumab, and pembrolizumab for advanced melanoma: a systematic review and meta-analysis.2020Frontiers in Oncology
Immune checkpoint inhibitors in advanced acral melanoma: a systematic review.2020Frontiers in Oncology
First-line treatments for advanced renal cell carcinoma with immune checkpoint inhibitors: systematic review, network meta-analysis and cost-effectiveness analysis.2020Therapeutic Advances in Medical Oncology
Economic evaluation of systemic treatments for advanced melanoma: a systematic review.2020Value in Health
Immune checkpoint inhibitors and immune-related adverse events in patients with advanced melanoma.2020JAMA Network Open
Targeted therapy for metastatic renal cell carcinoma.2020Cochrane Database of Systematic Reviews
Systemic therapy and sequencing options in advanced hepatocellular carcinoma: a systematic review and network meta-analysis.2020JAMA Oncology
The differences in the safety and tolerability of immune checkpoint inhibitors as treatment for non–small cell lung cancer and melanoma: network meta-analysis and systematic review.2019Frontiers in Pharmacology
Final clinical guidance report: nivolumab (Opdivo) for adjuvant melanoma.2019CADTH
Role of immune checkpoint inhibitor-based therapies for metastatic renal cell carcinoma in the first-line setting: a Bayesian network analysis. 2019EBioMedicine
Dosing and Timing of Immuno-Oncology Drugs 2019CADTH
Final clinical report: nivolumab (Opdivo) with ipilimumab (Yervoy) for renal cell carcinoma.2018CADTH
Nivolumab for adults with Hodgkin's lymphoma (a rapid review using the software RobotReviewer).2018Cochrane Database of Systematic Reviews
Immune-related adverse events for anti-PD-1 and anti-PD-L1 drugs: systematic review and meta-analysis.2018BMJ
Gastrointestinal adverse events with combination of checkpoint inhibitors in advanced melanoma: a systematic review.2018Melanoma Management
Comparative safety of immune checkpoint inhibitors in cancer: systematic review and network meta-analysis.2018BMJ
Final clinical guidance report: nivolumab (Opdivo) for hepatocellular carcinoma.2018CADTH
Risk of immune-related pancreatitis in patients with solid tumors treated with immune checkpoint inhibitors: systematic assessment with meta-analysis.2018Journal of Immunology Research
Final clinical guidance report: nivolumab (Opdivo) for classical Hodgkin lymphoma.2018CADTH

Clinical Practice Guidelines

Document TitleYearSource
Immunotherapy and targeted therapy for advanced gastroesophageal cancer: asco guideline.2023Journal of Clinical Oncology
Systemic therapy in metastatic renal cell carcinoma (mRCC): an evidence‑based recommendation of the German interdisciplinary RCC guidelines group.2022World Journal of Urology
The 2022 updated european association of urology guidelines on the use of adjuvant immune checkpoint inhibitor therapy for renal cell carcinoma.2022European Urology
Management of immune-related adverse events in patients treated with immune checkpoint inhibitor therapy: ASCO guideline update.2021Journal of Clinical Oncology
SEOM clinical guideline for the management of cutaneous melanoma (2020).2021Clinical & Translational Oncology
ESMO clinical practice guideline update on the use of immunotherapy in early stage and advanced renal cell carcinoma. 2021Annals of Oncology
Systemic therapy for melanoma: ASCO guideline.2020Journal of Clinical Oncology
Systemic therapy for advanced hepatocellular carcinoma: ASCO guideline.2020Journal of Clinical Oncology
Argentinian clinical practice guideline for surveillance, diagnosis, staging and treatment of hepatocellular carcinoma.2020Annals of Hepatology
Systemic therapy for stage IV non-small-cell lung cancer: American Society of Clinical Oncology clinical practice guideline update.2020Journal of Clinical Oncology
SEOM clinical guideline for treatment of kidney cancer (2019).2020Clinical & Translational Oncology
Systemic adjuvant therapy for adult patients at high risk for recurrent cutaneous or mucosal melanoma: an Ontario Health (Cancer Care Ontario) clinical practice guideline.2020Current Oncology
Cutaneous melanoma: ESMO clinical practice guidelines for diagnosis, treatment and follow-up.2019Annals of Oncology
An update on the Society for Immunotherapy of Cancer consensus statement on tumor immunotherapy for the treatment of cutaneous melanoma: version 2.0.2018Journal for the ImmunoTherapy of Cancer