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
Relationship Between Tumor Mutation Burden and Predicted Neo-antigen Burden in Patients With Advanced Melanoma or Bladder Cancer Treated With Nivolumab or Nivolumab Plus Ipilimumab (CA209-260)
- Conditions
- Interventions
- First Posted Date
- 2015-09-17
- Last Posted Date
- 2024-07-30
- Lead Sponsor
- Memorial Sloan Kettering Cancer Center
- Target Recruit Count
- 81
- Registration Number
- NCT02553642
- Locations
- 🇺🇸
University of Connecticut Health Center, Farmington, Connecticut, United States
🇺🇸Memorial Sloan Kettering Cancer Center, New York, New York, United States
🇺🇸Lehigh Valley Health Network, Allentown, Pennsylvania, United States
Neoadjuvant Nivolumab in Glioblastoma
- First Posted Date
- 2015-09-15
- Last Posted Date
- 2017-04-11
- Target Recruit Count
- 29
- Registration Number
- NCT02550249
- Locations
- 🇪🇸
Clinica Universidad de Navarra, Pamplona, Navarra, Spain
Study of Urelumab in Subjects With Advanced and/or Metastatic Malignant Tumors
- First Posted Date
- 2015-08-27
- Last Posted Date
- 2020-05-18
- Lead Sponsor
- Bristol-Myers Squibb
- Target Recruit Count
- 18
- Registration Number
- NCT02534506
- Locations
- 🇯🇵
Local Institution, Kobe-shi, Hyogo, Japan
Nivolumab in AML in Remission at High Risk for Relapse
- First Posted Date
- 2015-08-25
- Last Posted Date
- 2024-10-24
- Lead Sponsor
- M.D. Anderson Cancer Center
- Target Recruit Count
- 15
- Registration Number
- NCT02532231
- Locations
- 🇺🇸
M D Anderson Cancer Center, Houston, Texas, United States
Nivolumab With DC Vaccines for Recurrent Brain Tumors
- Conditions
- Interventions
- First Posted Date
- 2015-08-19
- Last Posted Date
- 2020-03-26
- Lead Sponsor
- Gary Archer Ph.D.
- Target Recruit Count
- 6
- Registration Number
- NCT02529072
- Locations
- 🇺🇸
Duke University Medical Center, Durham, North Carolina, United States
A Phase I, Open-Label, Multiple Ascending Dose Study of RRx-001 and Nivolumab
- First Posted Date
- 2015-08-10
- Last Posted Date
- 2019-11-18
- Lead Sponsor
- EpicentRx, Inc.
- Target Recruit Count
- 12
- Registration Number
- NCT02518958
- Locations
- 🇺🇸
Walter Reed National Military Medical Center, Bethesda, Maryland, United States
Nivolumab After Induction Treatment in Triple-negative Breast Cancer (TNBC) Patients
- Conditions
- Interventions
- First Posted Date
- 2015-07-16
- Last Posted Date
- 2022-03-22
- Lead Sponsor
- The Netherlands Cancer Institute
- Target Recruit Count
- 84
- Registration Number
- NCT02499367
- Locations
- 🇳🇱
Antoni van Leeuwenhoek, Amsterdam, Netherlands
Nivolumab With or Without Ipilimumab in Treating Patients With Persistent or Recurrent Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
- Conditions
- Interventions
- First Posted Date
- 2015-07-15
- Last Posted Date
- 2024-12-19
- Lead Sponsor
- National Cancer Institute (NCI)
- Target Recruit Count
- 100
- Registration Number
- NCT02498600
- Locations
- 🇺🇸
Sutter Cancer Centers Radiation Oncology Services-Cameron Park, Cameron Park, California, United States
🇺🇸Sutter Davis Hospital, Davis, California, United States
🇺🇸Palo Alto Medical Foundation-Gynecologic Oncology, Mountain View, California, United States
Cabozantinib S-malate and Nivolumab With or Without Ipilimumab in Treating Patients With Metastatic Genitourinary Tumors
- Conditions
- Clear Cell Renal Cell CarcinomaRenal Cell CarcinomaSarcomatoid Renal Cell CarcinomaStage III Bladder Cancer AJCC v8Stage III Urethral Cancer AJCC v8Bladder Urothelial CarcinomaInvasive Bladder Plasmacytoid Urothelial CarcinomaInvasive Bladder Sarcomatoid Urothelial CarcinomaStage III Renal Pelvis Cancer AJCC v8Stage IV Penile Cancer AJCC v8
- Interventions
- First Posted Date
- 2015-07-14
- Last Posted Date
- 2024-07-03
- Lead Sponsor
- National Cancer Institute (NCI)
- Target Recruit Count
- 152
- Registration Number
- NCT02496208
- Locations
- 🇺🇸
City of Hope Comprehensive Cancer Center, Duarte, California, United States
🇺🇸University of California Davis Comprehensive Cancer Center, Sacramento, California, United States
🇺🇸Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey, United States
Nivolumab in Patients With Recurrent Malignant Mesothelioma
- First Posted Date
- 2015-07-14
- Last Posted Date
- 2017-09-14
- Lead Sponsor
- The Netherlands Cancer Institute
- Target Recruit Count
- 33
- Registration Number
- NCT02497508
Drug Development Updates
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