Nivolumab

Generic Name
Nivolumab
Brand Names
Opdivo, Opdualag
Drug Type
Biotech
Chemical Formula
-
CAS Number
946414-94-4
Unique Ingredient Identifier
31YO63LBSN
Background

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)
Associated Therapies
Complete Surgical Resection, Neoadjuvant Therapies

Immune Checkpoint Inhibitor Nivolumab in People With Recurrent Select Rare CNS Cancers

First Posted Date
2017-06-02
Last Posted Date
2024-12-09
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
180
Registration Number
NCT03173950
Locations
🇺🇸

UT MD Anderson Cancer Center, Houston, Texas, United States

🇺🇸

Northwestern University, Chicago, Illinois, United States

🇺🇸

National Institutes of Health Clinical Center, Bethesda, Maryland, United States

Study of Nivolumab and Axitinib in Patients With Advanced Renal Cell Carcinoma

Phase 1
Active, not recruiting
Conditions
Interventions
First Posted Date
2017-06-01
Last Posted Date
2024-10-26
Lead Sponsor
Fox Chase Cancer Center
Target Recruit Count
98
Registration Number
NCT03172754
Locations
🇺🇸

Johns Hopkins, Baltimore, Maryland, United States

🇺🇸

US Oncology and Hematology, Albany, New York, United States

🇺🇸

Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States

and more 1 locations

Study of Nivolumab Plus Ipilimumab in Patients With Salivary Gland Cancer

Phase 2
Completed
Conditions
Interventions
First Posted Date
2017-06-01
Last Posted Date
2024-12-24
Lead Sponsor
Memorial Sloan Kettering Cancer Center
Target Recruit Count
64
Registration Number
NCT03172624
Locations
🇺🇸

Memorial Sloan Kettering Commack, Commack, New York, United States

🇺🇸

Memorial Sloan Kettering Rockville Centre, Rockville Centre, New York, United States

🇺🇸

Memorial Sloan Kettering Monmouth, Middletown, New Jersey, United States

and more 5 locations

Adjuvant Nivolumab Following Chemo-Radiation in Localized Muscle-Invasive Bladder Cancer

Phase 2
Active, not recruiting
Conditions
Interventions
First Posted Date
2017-05-31
Last Posted Date
2024-03-20
Lead Sponsor
University of Utah
Target Recruit Count
200
Registration Number
NCT03171025
Locations
🇺🇸

Moffitt Cancer Center, Tampa, Florida, United States

🇺🇸

Huntsman Cancer Institute, Salt Lake City, Utah, United States

Radiation and Immune Checkpoints Blockade in Metastatic NSCLC (BMS # CA209-632)

First Posted Date
2017-05-30
Last Posted Date
2023-04-24
Lead Sponsor
Weill Medical College of Cornell University
Target Recruit Count
15
Registration Number
NCT03168464
Locations
🇺🇸

Weill Cornell Medicine, New York, New York, United States

Adoptive Cell Therapy Following a Non-myeloablative, Lymphodepleting Induction Regimen in Metastatic Melanoma Patients

First Posted Date
2017-05-25
Last Posted Date
2023-01-26
Lead Sponsor
Sheba Medical Center
Target Recruit Count
30
Registration Number
NCT03166397
Locations
🇮🇱

Sheba Medical Center, Ramat Gan, Israel

Evaluation of Denosumab in Combination With Immune Checkpoint Inhibitors in Patients With Unresectable or Metastatic Melanoma

First Posted Date
2017-05-22
Last Posted Date
2022-04-07
Lead Sponsor
Melanoma and Skin Cancer Trials Limited
Target Recruit Count
72
Registration Number
NCT03161756
Locations
🇦🇺

Royal Hobart Hospital, Hobart, Tasmania, Australia

🇦🇺

Box Hill Hospital, Box Hill, Victoria, Australia

🇦🇺

Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia

and more 7 locations

GVAX Pancreas Vaccine (With CY) in Combination With Nivolumab and SBRT for Patients With Borderline Resectable Pancreatic Cancer

First Posted Date
2017-05-19
Last Posted Date
2024-02-29
Lead Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Target Recruit Count
28
Registration Number
NCT03161379
Locations
🇺🇸

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland, United States

🇺🇸

Medical College of Wisconsin, Milwaukee, Wisconsin, United States

A Study to Test the Safety and Feasibility of Nivolumab With Drug Eluting Bead Transarterial Chemoembolization in Patients With Liver Cancer

Early Phase 1
Active, not recruiting
Conditions
Interventions
First Posted Date
2017-05-08
Last Posted Date
2024-05-02
Lead Sponsor
Memorial Sloan Kettering Cancer Center
Target Recruit Count
20
Registration Number
NCT03143270
Locations
🇺🇸

Memorial Sloan Kettering Cancer Center, New York, New York, United States

🇺🇸

Memorial Sloan Kettering Bergen, Montvale, New Jersey, United States

🇺🇸

Memorial Sloan Kettering at Basking Ridge, Basking Ridge, New Jersey, United States

and more 6 locations
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