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
An Investigational Immuno-therapy Study of Experimental Medication BMS-986156, Given by Itself or in Combination With Nivolumab in Patients With Solid Cancers or Cancers That Have Spread.
- First Posted Date
- 2015-11-06
- Last Posted Date
- 2023-03-06
- Lead Sponsor
- Bristol-Myers Squibb
- Target Recruit Count
- 295
- Registration Number
- NCT02598960
- Locations
- 🇺🇸
UCSD Moores Cancer Center, La Jolla, California, United States
🇺🇸Emory University, Atlanta, Georgia, United States
🇺🇸Thomas Jefferson University Hospital, Philadelphia, Pennsylvania, United States
Nivolumab Combined With Ipilimumab Followed by Nivolumab Monotherapy as First-Line Treatment for Patients With Advanced Melanoma
- First Posted Date
- 2015-11-06
- Last Posted Date
- 2021-06-15
- Lead Sponsor
- Bristol-Myers Squibb
- Target Recruit Count
- 533
- Registration Number
- NCT02599402
- Locations
- 🇬🇧
Mount Vernon Hospital, Northwood, United Kingdom
🇬🇧Local Institution, Truro, United Kingdom
An Investigational Immuno-therapy Safety Trial of Nivolumab in Patients With Advanced or Metastatic Renal Cell Carcinoma
- First Posted Date
- 2015-11-04
- Last Posted Date
- 2022-10-27
- Lead Sponsor
- Bristol-Myers Squibb
- Target Recruit Count
- 197
- Registration Number
- NCT02596035
- Locations
- 🇺🇸
Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins, Baltimore, Maryland, United States
🇺🇸Local Institution - 0039, Seattle, Washington, United States
🇺🇸Baptist Health Medical Group Oncology, Miami, Florida, United States
Nivolumab After Surgery and Chemotherapy in Treating Patients With Stage IB-IIIA Non-small Cell Lung Cancer (An ALCHEMIST Treatment Trial)
- Conditions
- Interventions
- First Posted Date
- 2015-11-04
- Last Posted Date
- 2024-12-19
- Lead Sponsor
- National Cancer Institute (NCI)
- Target Recruit Count
- 903
- Registration Number
- NCT02595944
- Locations
- 🇺🇸
Cancer Center of Kansas - Winfield, Winfield, Kansas, United States
🇺🇸King's Daughter's Medical Center, Ashland, Kentucky, United States
🇺🇸Flaget Memorial Hospital, Bardstown, Kentucky, United States
A Study of Safety, Tolerability and Pharmacokinetics of Nivolumab in Chinese Subjects With Previously Treated Advanced or Recurrent Solid Tumors
- First Posted Date
- 2015-11-01
- Last Posted Date
- 2022-10-24
- Lead Sponsor
- Bristol-Myers Squibb
- Target Recruit Count
- 58
- Registration Number
- NCT02593786
- Locations
- 🇨🇳
Local Institution - 0001, Guangzhou, Guangdong, China
🇨🇳Local Institution, Hangzhou, Zhejiang, China
An Investigational Immuno-therapy Study of Nivolumab Compared to Sorafenib as a First Treatment in Patients With Advanced Hepatocellular Carcinoma
- First Posted Date
- 2015-10-15
- Last Posted Date
- 2024-03-19
- Lead Sponsor
- Bristol-Myers Squibb
- Target Recruit Count
- 743
- Registration Number
- NCT02576509
- Locations
- 🇮🇹
Local Institution - 0055, Milan, Italy
🇦🇹Local Institution - 0039, Graz, Austria
🇧🇪Local Institution - 0075, Bruxelles, Belgium
Study of Neoadjuvant Nivolumab in Patients With Non-metastatic Stage II-IV Clear Cell Renal Cell Carcinoma
- First Posted Date
- 2015-10-14
- Last Posted Date
- 2020-06-12
- Target Recruit Count
- 17
- Registration Number
- NCT02575222
- Locations
- 🇺🇸
The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland, United States
A Study of Nivolumab in Advanced Non-Small Cell Lung Cancer (NSCLC)
- First Posted Date
- 2015-10-12
- Last Posted Date
- 2021-05-06
- Lead Sponsor
- Bristol-Myers Squibb
- Target Recruit Count
- 341
- Registration Number
- NCT02574078
- Locations
- 🇺🇸
Cancer Care Center, Bismarck, North Dakota, United States
🇺🇸Lehigh Valley Hospital, Allentown, Pennsylvania, United States
🇺🇸Texas Oncology Cancer Center - Sugar Land, Sugar Land, Texas, United States
A Study of Brentuximab Vedotin Combined With Nivolumab for Relapsed or Refractory Hodgkin Lymphoma
- First Posted Date
- 2015-10-08
- Last Posted Date
- 2022-11-08
- Lead Sponsor
- Seagen Inc.
- Target Recruit Count
- 93
- Registration Number
- NCT02572167
- Locations
- 🇺🇸
City of Hope National Medical Center, Duarte, California, United States
🇺🇸Dana Farber Cancer Institute, Boston, Massachusetts, United States
🇺🇸Washington University School of Medicine, Saint Louis, Missouri, United States
Study of Nivolumab in Unresectable Advanced or Recurrent Esophageal Cancer
- First Posted Date
- 2015-10-06
- Last Posted Date
- 2022-07-06
- Lead Sponsor
- Ono Pharmaceutical Co. Ltd
- Target Recruit Count
- 419
- Registration Number
- NCT02569242
- Locations
- 🇺🇸
Orlando Health, Inc, Orlando, Florida, United States
🇺🇸Georgetown University Med Ctr, Washington, District of Columbia, United States
🇩🇪Universitatsklinikum Jena, Innere Medizin II, Jena, Germany
Drug Development Updates
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