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
Study of the Anti-PD-1 Antibody Nivolumab in Combination With Dabrafenib and/or Trametinib
- Conditions
- Interventions
- First Posted Date
- 2015-02-06
- Last Posted Date
- 2015-12-11
- Lead Sponsor
- University of Pittsburgh
- Registration Number
- NCT02357732
Evaluate the Mediators of Sensitivity and Resistance to Nivolumab Plus Ipilimumab in Patients With Advanced NSCLCs
- Conditions
- Interventions
- First Posted Date
- 2015-01-30
- Last Posted Date
- 2024-05-29
- Lead Sponsor
- Memorial Sloan Kettering Cancer Center
- Target Recruit Count
- 29
- Registration Number
- NCT02350764
- Locations
- 🇺🇸
Memorial Sloan Kettering Cancer Center, New York, New York, United States
A Phase II/III Trial of Nivolumab, Ipilimumab, and GM-CSF in Patients With Advanced Melanoma
- Conditions
- Interventions
- First Posted Date
- 2015-01-15
- Last Posted Date
- 2024-12-19
- Lead Sponsor
- National Cancer Institute (NCI)
- Target Recruit Count
- 600
- Registration Number
- NCT02339571
- Locations
- 🇺🇸
Cambridge Medical Center, Cambridge, Minnesota, United States
🇺🇸Mercy Hospital, Coon Rapids, Minnesota, United States
🇺🇸Essentia Health - Deer River Clinic, Deer River, Minnesota, United States
A Study to Evaluate Safety, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of the Combination of Ibrutinib With Nivolumab in Participants With Hematologic Malignancies
- First Posted Date
- 2015-01-01
- Last Posted Date
- 2023-06-15
- Lead Sponsor
- Janssen Research & Development, LLC
- Target Recruit Count
- 144
- Registration Number
- NCT02329847
A Study of the Safety, Tolerability, and Efficacy of Epacadostat Administered in Combination With Nivolumab in Select Advanced Cancers (ECHO-204)
- First Posted Date
- 2014-12-30
- Last Posted Date
- 2023-04-26
- Lead Sponsor
- Incyte Corporation
- Target Recruit Count
- 307
- Registration Number
- NCT02327078
- Locations
- 🇺🇸
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, Maryland, United States
🇺🇸Dana Farber Cancer Institute, Boston, Massachusetts, United States
🇺🇸Duke University Medical Center, Durham, North Carolina, United States
Study of Efficacy and Safety of Nivolumab in Combination With EGF816 and of Nivolumab in Combination With INC280 in Patients With Previously Treated Non-small Cell Lung Cancer
- Conditions
- Interventions
- First Posted Date
- 2014-12-23
- Last Posted Date
- 2022-02-28
- Lead Sponsor
- Novartis Pharmaceuticals
- Target Recruit Count
- 64
- Registration Number
- NCT02323126
- Locations
- 🇺🇸
University of Texas MD Anderson Cancer Center Thoractic Head/Neck Med.Onc(2), Houston, Texas, United States
🇨🇭Novartis Investigative Site, Chur, Switzerland
An Investigational Immuno-therapy Study to Evaluate Safety and Effectiveness in Patients With Melanoma That Has Spread to the Brain, Treated With Nivolumab in Combination With Ipilimumab, Followed by Nivolumab by Itself
- First Posted Date
- 2014-12-19
- Last Posted Date
- 2021-10-05
- Lead Sponsor
- Bristol-Myers Squibb
- Target Recruit Count
- 119
- Registration Number
- NCT02320058
- Locations
- 🇺🇸
UCLA Medical Hematology and Oncology, Los Angeles, California, United States
🇺🇸Abramson Cancer Center of The University of Pennsylvania, Philadelphia, Pennsylvania, United States
🇺🇸Inova Melanoma and Skin Cancer Center, Fairfax, Virginia, United States
Safety Study of Nivolumab With Nab-Paclitaxel Plus or Minus Gemcitabine in Pancreatic Cancer, Nab-Paclitaxel / Carboplatin in Stage IIIB/IV Non-Small Cell Lung Cancer or Nab-Paclitaxel in Recurrent Metastatic Breast Cancer
- Conditions
- Interventions
- First Posted Date
- 2014-12-05
- Last Posted Date
- 2019-05-31
- Lead Sponsor
- Celgene
- Target Recruit Count
- 114
- Registration Number
- NCT02309177
- Locations
- 🇺🇸
Northwestern University-NMDTI, Chicago, Illinois, United States
🇺🇸Dana-Farber / Harvard Cancer Institute, Boston, Massachusetts, United States
🇺🇸Ohio State Medical Center, Columbus, Ohio, United States
A Phase 1, Dose-Escalation Trial of PT2385 Tablets In Patients With Advanced Clear Cell Renal Cell Carcinoma (MK-3795-001)
- Conditions
- Interventions
- First Posted Date
- 2014-11-19
- Last Posted Date
- 2024-06-17
- Target Recruit Count
- 110
- Registration Number
- NCT02293980
- Locations
- 🇺🇸
Rush University Medical Center, Chicago, Illinois, United States
🇺🇸University of Pittsburg Medical Center, Pittsburgh, Pennsylvania, United States
🇺🇸Virginia Cancer Specialists, Fairfax, Virginia, United States
Testing Nivolumab to Prevent Disease From Coming Back After Treatment in Patients With Acute Myeloid Leukemia, REMAIN Trial
- Conditions
- Interventions
- First Posted Date
- 2014-10-27
- Last Posted Date
- 2024-11-05
- Lead Sponsor
- National Cancer Institute (NCI)
- Target Recruit Count
- 82
- Registration Number
- NCT02275533
- Locations
- 🇨🇦
University Health Network-Princess Margaret Hospital, Toronto, Ontario, Canada
🇺🇸Case Western Reserve University, Cleveland, Ohio, United States
🇺🇸Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center, Houston, Texas, United States
Drug Development Updates
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