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
An Investigational Immuno-therapy Study to Investigate the Safety and Effectiveness of Nivolumab, and Nivolumab Combination Therapy in Virus-associated Tumors
- Conditions
- Interventions
- First Posted Date
- 2015-07-02
- Last Posted Date
- 2023-11-13
- Lead Sponsor
- Bristol-Myers Squibb
- Target Recruit Count
- 578
- Registration Number
- NCT02488759
- Locations
- 🇺🇸
Local Institution - 0003, Atlanta, Georgia, United States
🇧🇪Local Institution - 0012, Brussels, Belgium
🇺🇸Local Institution - 0033, Tampa, Florida, United States
A Study of BBI503 in Combination With Selected Anti-Cancer Therapeutics in Adult Patients With Advanced Cancer
- Conditions
- Interventions
- First Posted Date
- 2015-06-26
- Last Posted Date
- 2023-11-14
- Lead Sponsor
- Sumitomo Pharma America, Inc.
- Target Recruit Count
- 165
- Registration Number
- NCT02483247
- Locations
- 🇺🇸
Indiana University Health Goshen, Goshen, Indiana, United States
🇺🇸Louisiana State Univesity, New Orleans, Louisiana, United States
🇨🇦Ottawa Hospital Research Institute, Ottawa, Ontario, Canada
Effectiveness Study of Nivolumab Compared to Chemotherapy in Patients With Relapsed Small-cell Lung Cancer
- First Posted Date
- 2015-06-25
- Last Posted Date
- 2023-07-27
- Lead Sponsor
- Bristol-Myers Squibb
- Target Recruit Count
- 569
- Registration Number
- NCT02481830
- Locations
- 🇺🇸
Local Institution - 0024, New Haven, Connecticut, United States
🇺🇸Local Institution - 0173, Johnson City, New York, United States
🇧🇷Local Institution - 0093, Barretos, Sao Paulo, Brazil
An Investigational Immuno-therapy Trial of Nivolumab, or Nivolumab Plus Ipilimumab, or Nivolumab Plus Platinum-doublet Chemotherapy, Compared to Platinum Doublet Chemotherapy in Patients With Stage IV Non-Small Cell Lung Cancer (NSCLC)
- Conditions
- Interventions
- First Posted Date
- 2015-06-23
- Last Posted Date
- 2024-11-19
- Lead Sponsor
- Bristol-Myers Squibb
- Target Recruit Count
- 2748
- Registration Number
- NCT02477826
- Locations
- 🇺🇸
Local Institution - 0017, San Francisco, California, United States
🇺🇸Local Institution - 0115, Saint Louis, Missouri, United States
🇺🇸Local Institution - 0014, Cleveland, Ohio, United States
Expanded Access Program With Nivolumab Therapy for Treatment of Advanced/Metastatic SqNSCLC or Non-SqNSCLC After One Prior Systemic Regimen
- First Posted Date
- 2015-06-18
- Last Posted Date
- 2020-11-27
- Lead Sponsor
- Bristol-Myers Squibb
- Registration Number
- NCT02475382
- Locations
- 🇨🇦
Local Institution, Montreal, Quebec, Canada
🇨🇦Centre De Sante Et De Services Sociaux Rimouski Neigette, Rimouski, Quebec, Canada
Safety and Efficacy Study of Ulocuplumab and Nivolumab in Subjects With Solid Tumors
- First Posted Date
- 2015-06-16
- Last Posted Date
- 2018-11-01
- Lead Sponsor
- Bristol-Myers Squibb
- Target Recruit Count
- 61
- Registration Number
- NCT02472977
- Locations
- 🇺🇸
Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins, Baltimore, Maryland, United States
🇺🇸University Of Colorado Hosp, Aurora, Colorado, United States
🇺🇸Columbia University Medical Center (Cumc), New York, New York, United States
A Study of BBI608 Administered in Combination With Immune Checkpoint Inhibitors in Adult Patients With Advanced Cancers
- Conditions
- Interventions
- First Posted Date
- 2015-06-10
- Last Posted Date
- 2023-11-14
- Lead Sponsor
- Sumitomo Pharma America, Inc.
- Target Recruit Count
- 104
- Registration Number
- NCT02467361
- Locations
- 🇺🇸
Massachusetts General Hospital Cancer Center, Boston, Massachusetts, United States
🇺🇸Emory University Winship Cancer Institute, Atlanta, Georgia, United States
🇺🇸University of Colorado Cancer Center, Denver, Colorado, United States
Study of Nivolumab in Combination With GM.CD40L Vaccine in Adenocarcinoma of the Lung
- Conditions
- Interventions
Study of Idarubicin, Cytarabine, and Nivolumab in Patients With High-Risk Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia (AML)
- Conditions
- Interventions
- First Posted Date
- 2015-06-08
- Last Posted Date
- 2021-10-07
- Lead Sponsor
- M.D. Anderson Cancer Center
- Target Recruit Count
- 44
- Registration Number
- NCT02464657
- Locations
- 🇺🇸
University of Texas MD Anderson Cancer Center, Houston, Texas, United States
Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial)
- Conditions
- Interventions
- Drug: AfatinibDrug: CapivasertibDrug: BinimetinibDrug: AdavosertibProcedure: Biospecimen CollectionOther: Cytology Specimen Collection ProcedureDrug: Afatinib DimaleateDrug: DabrafenibDrug: DefactinibDrug: FexagratinibDrug: DasatinibDrug: IpatasertibProcedure: BiopsyDrug: CrizotinibDrug: Dabrafenib MesylateDrug: TaselisibDrug: SapanisertibDrug: PI3K-beta Inhibitor GSK2636771Drug: Defactinib HydrochlorideDrug: PalbociclibBiological: NivolumabDrug: CopanlisibDrug: UlixertinibBiological: Trastuzumab EmtansineDrug: Copanlisib HydrochlorideBiological: RelatlimabProcedure: Computed TomographyDrug: TrametinibBiological: PertuzumabDrug: ErdafitinibProcedure: Radiologic ExaminationProcedure: Multigated Acquisition ScanDrug: LarotrectinibProcedure: EchocardiographyDrug: OsimertinibBiological: TrastuzumabDrug: Larotrectinib SulfateOther: Laboratory Biomarker AnalysisProcedure: Magnetic Resonance ImagingDrug: VismodegibDrug: Sunitinib MalateProcedure: Radionuclide Imaging
- First Posted Date
- 2015-06-08
- Last Posted Date
- 2024-12-19
- Lead Sponsor
- National Cancer Institute (NCI)
- Target Recruit Count
- 6452
- Registration Number
- NCT02465060
- Locations
- 🇺🇸
Alaska Women's Cancer Care, Anchorage, Alaska, United States
🇺🇸Anchorage Oncology Centre, Anchorage, Alaska, United States
🇺🇸Katmai Oncology Group, Anchorage, Alaska, United States
Drug Development Updates
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