Overview

Nivolumab is a fully human IgG4 antibody targeting the immune checkpoint programmed death receptor-1 (PD-1). This antibody was produced entirely in mice and grafted onto human kappa and IgG4 Fc region with the mutation S228P for additional stability and reduced variability. It was developed by Bristol Myers Squibb. Nivolumab was granted FDA approval on 22 December 2014.

Indication

Nivolumab is indicated to treat unresectable or metastatic melanoma, melanoma as adjuvant treatment, resectable or metastatic non-small cell lung cancer, small cell lung cancer, advanced renal cell carcinoma, classical Hodgkin lymphoma, squamous cell carcinoma of the head and neck, urothelial carcinoma, microsatellite instability-high or mismatch repair deficient metastatic colorectal cancer, hepatocellular carcinoma, and esophageal cancer. The indication for classical Hodgkin lymphoma, microsatellite instability-high or mismatch repair deficient metastatic colorectal cancer, and hepatocellular carcinoma were approved under accelerated approval based on the overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. Nivolumab is also approved for the treatment of HER2-negative advanced or metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma when used in combination with a fluoropyrimidine- and platinum-containing chemotherapy regimen. In combination with relatlimab, nivolumab is indicated for the treatment of patients ≥12 years old with unresectable or metastatic melanoma.

Associated Conditions

Advanced Esophageal Adenocarcinoma
Advanced Gastric Adenocarcinoma
Advanced Gastric Carcinoma
Advanced Gastroesophageal Junction Adenocarcinoma
Advanced Renal Cell Carcinoma
Classical Hodgkin's Lymphoma
Completely resected Stage IIB melanoma
Completely resected Stage III melanoma
Completely resected Stage IV melanoma
Hepatocellular Carcinoma
Locally Advanced Hepatocellular Carcinoma
Locally Advanced Non-Small Cell Lung Cancer
Melanoma
Metastatic Colorectal Cancer (CRC)
Metastatic Esophageal Adenocarcinoma
Metastatic Esophageal Squamous Cell Carcinoma
Metastatic Gastric Adenocarcinoma
Metastatic Gastric Cancers
Metastatic Gastroesophageal Junction Adenocarcinoma
Metastatic Hepatocellular Carcinoma
Metastatic Melanoma
Metastatic Non-Small Cell Lung Cancer
Metastatic Renal Cell Carcinoma ( mRCC)
Metastatic Squamous Cell Carcinoma of the Head and Neck (HNSCC)
Metastatic Urothelial Carcinoma (UC)
Mismatch Repair-deficient (dMMR) Metastatic Colorectal Cancer (CRC)
Muscle-invasive Urothelial Carcinoma
Poor Risk Advanced Renal Cell Cancer
Recurrent Non-small Cell Lung Cancer
Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
Relapsed or Refractory Classical Hodgkin's Lymphoma
Resectable Non-small Cell Lung Cancer
Stage IIB Melanoma
Stage IIC Melanoma
Unresectable Esophageal Squamous Cell Carcinoma
Unresectable Locally Advanced Urothelial Cancer
Unresectable Melanoma
Urothelial Carcinoma
Completely resected Stage IIC melanoma
Intermediate risk Advanced Renal Cell Cancer
Locally advanced Urothelial Carcinoma
Metastatic Microsatellite Instability High Colorectal Cancer
Metastatic Mismatch Repair Deficient Colorectal Cancer
Metastatic gastroesphageal juntion adenocarcinoma
Recurrent Squamous Cell Carcinoma of the Head and Neck (SCCHN)
Relapsed Classical Hodgkin's Lymphoma
Residual Esophageal Cancer
Residual Gastroesophageal Junction Cancer
Unresectable Malignant Pleural Mesothelioma (MPM)
Unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma
Unresectable, advanced Esophageal Squamous Cell Carcinoma (ESCC)
Unresectable, metastatic Esophageal Squamous Cell Carcinoma (ESCC)
Unresectable, recurrent Esophageal Squamous Cell Carcinoma (ESCC)

Research Report

Published: Jul 7, 2025

A Comprehensive Monograph on Nivolumab (Opdivo®): Pharmacology, Clinical Efficacy, and Therapeutic Landscape

Executive Summary & Drug Profile

Overview of Nivolumab

Nivolumab represents a cornerstone of modern immuno-oncology, a therapeutic class that has fundamentally altered the treatment paradigm for a multitude of malignancies. Marketed under the brand name Opdivo®, Nivolumab is a fully human immunoglobulin G4 (IgG4) monoclonal antibody developed by Bristol Myers Squibb.[1] It functions as an immune checkpoint inhibitor by selectively targeting the programmed death receptor-1 (PD-1).[2] First granted approval by the U.S. Food and Drug Administration (FDA) in December 2014, Nivolumab was a pioneering agent in its class and has since garnered approvals for an exceptionally broad range of solid tumors and hematologic cancers.[4]

The therapeutic principle of Nivolumab is not to attack cancer cells directly, but to block a key inhibitory signal used by tumors to evade the host immune system. By binding to the PD-1 receptor on T-cells, Nivolumab prevents their deactivation, thereby unleashing a patient's own T-cells to recognize and eliminate malignant cells.[2] This mechanism has led to durable, long-term responses and significant improvements in overall survival in cancers that were previously considered difficult to treat. However, this potentiation of the immune system is also responsible for a unique and characteristic spectrum of immune-related adverse events (irAEs), which require specialized clinical management.[4] The drug's development and expanding applications, both as a monotherapy and in combination with other agents like the CTLA-4 inhibitor ipilimumab, underscore its central role in the contemporary oncologic armamentarium.

Core Drug Identification and Properties

Continue reading the full research report

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Immunotherapy (Nivolumab and Ipilimumab) With and Without a Live Biotherapeutic Product (EXL01) for the Treatment of Metastatic Renal Cell Cancer	2025/08/19	NCT07128680	Not Applicable	Not yet recruiting	City of Hope Medical Center
Recurrent/Metastatic Olfactory Neuroblastoma: Evaluating the Efficacy and Safety of Nivolumab	2025/08/03	NCT07100704	Not Applicable	Recruiting	National Cancer Center Hospital East
MELAFERT: Impact of Adjuvant Therapy on FERTility in Patients With Resected MELAnoma at High Risk of Relapse.	2025/07/30	NCT07092670	N/A	Recruiting	Mario Mandalà
Real-world Outcomes Among Patients With Melanoma Treated With Neoadjuvant Nivolumab+Relatlimab or Nivolumab+Ipilimumab	2025/07/29	NCT07091695	N/A	Not yet recruiting	Bristol-Myers Squibb
Outcomes of Nivolumab in Combination With Relatlimab in Patients With Advanced Melanoma in the Flatiron Database	2025/07/23	NCT07079644	N/A	Completed	Bristol-Myers Squibb
Peds CHAMP1ON - Hematopoietic Stem Cell And Monoclonal Antibody PD-1 Blockade for RecurreNt Pediatric High-Grade Glioma	2025/06/22	NCT07031765	Phase 1	Recruiting	University of Florida
Long-term Outcomes Among Patients With Programmed Death-ligand 1 <1% Metastatic Non-small Cell Lung Cancer Treated With First-line Nivolumab + Ipilimumab + 2 Cycles of Chemotherapy	2025/06/17	NCT07024862	N/A	Active, not recruiting	Bristol-Myers Squibb
A Phase 0/1 Study of cDNA for TP53, Checkpoint Inhibition and Radiation in Children With Recurrent, Progressive or Refractory CNS Malignancies.	2025/06/12	NCT07017816	Early Phase 1	Not yet recruiting	Children's National Research Institute
Chemoimmunotherapy for ALK+ Relapsed/Refractory ALCL	2025/06/10	NCT07013565	Phase 2	Not yet recruiting	New York Medical College
Phase 2, Single-arm Trial of BMS-986340 in Association With Nivolumab, Trifluridine/Tipiracil and Bevacizumab for Patients Refractory to Standard of Care Treatment and With Microsatellite-stable Colorectal Cancer	2025/06/09	NCT07011550	Phase 2	Not yet recruiting	M.D. Anderson Cancer Center

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
OPDIVO	E.R. Squibb & Sons, L.L.C.	0003-3772	INTRAVENOUS	10 mg in 1 mL	8/30/2021
OPDUALAG	E.R. Squibb & Sons, L.L.C.	0003-7125	INTRAVENOUS	12 mg in 1 mL	3/18/2022
OPDIVO	E.R. Squibb & Sons, L.L.C.	0003-3756	INTRAVENOUS	10 mg in 1 mL	8/30/2021
OPDIVO	E.R. Squibb & Sons, L.L.C.	0003-3734	INTRAVENOUS	10 mg in 1 mL	8/30/2021
OPDIVO	E.R. Squibb & Sons, L.L.C.	0003-3774	INTRAVENOUS	10 mg in 1 mL	8/30/2021

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
Opdualag	Bristol-Myers Squibb Pharma EEIG,Plaza 254,Blanchardstown Corporate Park 2,Dublin 15,D15 T867,Ireland	Authorised	9/15/2022
Opdualag	Bristol-Myers Squibb Pharma EEIG,Plaza 254,Blanchardstown Corporate Park 2,Dublin 15,D15 T867,Ireland	Authorised	9/15/2022
Opdivo	Bristol-Myers Squibb Pharma EEIG,Plaza 254,Blanchardstown Corporate Park 2,Dublin 15,D15 T867,Ireland	Authorised	6/19/2015

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
NIVOLUMAB BMS CONCENTRATE FOR SOLUTION FOR INFUSION 10MG/ML	Bristol-Myers Squibb Holdings Pharma, Ltd. Liability Company	SIN15117P	INFUSION, SOLUTION CONCENTRATE	10 mg/mL	11/9/2016
OPDUALAG CONCENTRATE FOR SOLUTION FOR INFUSION 240MG/80MG	Catalent Indiana LLC	SIN16852P	INFUSION, SOLUTION CONCENTRATE	240mg per vial	8/31/2023
OPDIVO CONCENTRATE FOR SOLUTION FOR INFUSION 10 MG/ML	Bristol-Myers Squibb Holdings Pharma, Ltd. Liability Company, Vetter Pharma-Fertigung GmBH & Co. KG	SIN14975P	INFUSION, SOLUTION CONCENTRATE	10mg/mL	4/4/2016

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
OPDIVO CONCENTRATE FOR SOLUTION FOR INFUSION 40MG/4ML	N/A	Bristol-Myers Squibb Pharma Company	N/A	N/A	12/22/2015

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
OPDIVO nivolumab 100 mg in 10 mL (10 mg/mL) concentrated solution for IV infusion vial	231868	Bristol-Myers Squibb Australia Pty Ltd	Medicine	A	1/11/2016
OPDIVO nivolumab 40 mg in 4 mL (10 mg/mL) concentrated solution for IV infusion vial	231867	Bristol-Myers Squibb Australia Pty Ltd	Medicine	A	1/11/2016
OPDUALAG nivolumab 240mg and relatlimab 80mg in 20mL concentrate solution for IV infusion vial	372783	Bristol-Myers Squibb Australia Pty Ltd	Medicine	A	10/7/2022
OPDIVO nivolumab 240 mg in 24 mL (10 mg/mL) concentrate solution for IV infusion vial	318057	Bristol-Myers Squibb Australia Pty Ltd	Medicine	A	4/9/2020

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
OPDUALAG	bristol-myers squibb canada	02541416	Solution - Intravenous	240 MG / 20 ML	2/12/2024
OPDIVO	bristol-myers squibb canada	02446626	Solution - Intravenous	10 MG / ML	10/23/2015
OPDIVO SC	bristol-myers squibb canada	02557320	Solution - Subcutaneous	120 MG / ML	N/A

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
OPDIVO 10 MG/ML CONCENTRADO PARA SOLUCION PARA PERFUSION	Bristol-Myers Squibb Pharma Eeig	1151014002IP	CONCENTRADO PARA SOLUCIÓN PARA PERFUSIÓN	Uso Hospitalario	Commercialized
OPDIVO 10 MG/ML CONCENTRADO PARA SOLUCION PARA PERFUSION	Bristol-Myers Squibb Pharma Eeig	1151014001IP1	CONCENTRADO PARA SOLUCIÓN PARA PERFUSIÓN	Uso Hospitalario	Commercialized
OPDIVO 10 MG/ML CONCENTRADO PARA SOLUCION PARA PERFUSION	Bristol-Myers Squibb Pharma Eeig	1151014001	CONCENTRADO PARA SOLUCIÓN PARA PERFUSIÓN	Uso Hospitalario	Commercialized
OPDIVO 10 MG/ML CONCENTRADO PARA SOLUCION PARA PERFUSION	Bristol-Myers Squibb Pharma Eeig	1151014002	CONCENTRADO PARA SOLUCIÓN PARA PERFUSIÓN	Uso Hospitalario	Commercialized
OPDIVO 10 MG/ML CONCENTRADO PARA SOLUCION PARA PERFUSION	Bristol-Myers Squibb Pharma Eeig	1151014001IP	CONCENTRADO PARA SOLUCIÓN PARA PERFUSIÓN	Uso Hospitalario	Commercialized
OPDIVO 600 MG SOLUCION INYECTABLE	Bristol-Myers Squibb Pharma Eeig	1151014005	SOLUCIÓN INYECTABLE	Uso Hospitalario	Not Commercialized
OPDIVO 10 MG/ML CONCENTRADO PARA SOLUCION PARA PERFUSION	Bristol-Myers Squibb Pharma Eeig	1151014002IP1	CONCENTRADO PARA SOLUCIÓN PARA PERFUSIÓN	Uso Hospitalario	Commercialized
OPDUALAG 240 MG/80 MG CONCENTRADO PARA SOLUCION PARA PERFUSION	Bristol-Myers Squibb Pharma Eeig	1221679001	CONCENTRADO PARA SOLUCIÓN PARA PERFUSIÓN	Uso Hospitalario	Not Commercialized

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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