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.
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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 defi...

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

Platform Study of Neoadjuvant and Adjuvant Immunotherapy for Patients With Resectable Adenocarcinoma of the Pancreas

First Posted Date
2015-05-22
Last Posted Date
2024-12-06
Lead Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Target Recruit Count
76
Registration Number
NCT02451982
Locations
🇺🇸

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

A Study of Anti-PD1 (Nivolumab) Therapy as Pre- and Post-operative Therapy in Metastatic Renal Cell Cancer (ADAPTeR)

Phase 2
Conditions
Interventions
First Posted Date
2015-05-18
Last Posted Date
2018-03-26
Lead Sponsor
Royal Marsden NHS Foundation Trust
Target Recruit Count
19
Registration Number
NCT02446860
Locations
🇬🇧

The Royal Marsden NHS Foundation Trust, London, United Kingdom

A Study of Combination Therapies With Viagenpumatucel-L (HS-110) in Patients With Non-Small Cell Lung Cancer

First Posted Date
2015-05-08
Last Posted Date
2023-09-21
Lead Sponsor
Heat Biologics
Target Recruit Count
121
Registration Number
NCT02439450
Locations
🇺🇸

UC San Diego, La Jolla, California, United States

🇺🇸

Horizon Oncology Research, Lafayette, Indiana, United States

🇺🇸

Ashland-Bellefonte Cancer Center, Ashland, Kentucky, United States

and more 13 locations

NIvolumab COmbination With Standard First-line Chemotherapy and Radiotherapy in Locally Advanced Stage IIIA/B Non-Small Cell Lung Carcinoma

Phase 2
Completed
Conditions
Interventions
First Posted Date
2015-05-05
Last Posted Date
2022-08-24
Lead Sponsor
ETOP IBCSG Partners Foundation
Target Recruit Count
94
Registration Number
NCT02434081
Locations
🇨🇭

HFR Fribourg- Hôpital cantonal, Fribourg, Switzerland

🇳🇱

VUMC, Amsterdam, Netherlands

🇨🇭

Kantonsspital Winterthur, Winterthur, Switzerland

and more 8 locations

Nivolumab Alone or in Combination With Ipilimumab in Treating Patients With Advanced Uterine Leiomyosarcoma

First Posted Date
2015-04-28
Last Posted Date
2024-07-25
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
20
Registration Number
NCT02428192
Locations
🇺🇸

Brigham and Women's Hospital, Boston, Massachusetts, United States

🇺🇸

Dana-Farber Cancer Institute, Boston, Massachusetts, United States

Nivolumab and HPV-16 Vaccination in Patients With HPV-16 Positive Incurable Solid Tumors

Phase 2
Completed
Conditions
Interventions
First Posted Date
2015-04-27
Last Posted Date
2023-04-18
Lead Sponsor
M.D. Anderson Cancer Center
Target Recruit Count
33
Registration Number
NCT02426892
Locations
🇺🇸

University of Texas MD Anderson Cancer Center, Houston, Texas, United States

A Study of Galunisertib (LY2157299) in Combination With Nivolumab in Advanced Refractory Solid Tumors and in Recurrent or Refractory NSCLC, or Hepatocellular Carcinoma

First Posted Date
2015-04-22
Last Posted Date
2021-09-09
Lead Sponsor
Eli Lilly and Company
Target Recruit Count
41
Registration Number
NCT02423343
Locations
🇺🇸

H Lee Moffitt Cancer Center, Tampa, Florida, United States

🇪🇸

Hospital Regional Universitario de Málaga, Malaga, Spain

🇪🇸

Institut Catala d'Oncologia, Barcelona, Spain

and more 6 locations

Study of Nivolumab Plus Chemotherapy in Patients With Advanced Cancer (NivoPlus)

First Posted Date
2015-04-22
Last Posted Date
2018-07-02
Lead Sponsor
Western Regional Medical Center
Target Recruit Count
33
Registration Number
NCT02423954
Locations
🇺🇸

Cancer Treatment Center of America @ Western Regional Medical Center, Goodyear, Arizona, United States

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