Nivolumab
- Generic Name
- Nivolumab
- Brand Names
- Opdivo, Opdualag
- Drug Type
- Biotech
- 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
MAPK Inhibition Combined with Anti-PD1 Therapy for BRAF-altered Pediatric Gliomas
- Conditions
- Low Grade GliomaHigh Grade Glioma
- Interventions
- First Posted Date
- 2024-12-02
- Last Posted Date
- 2025-02-12
- Target Recruit Count
- 27
- Registration Number
- NCT06712875
- Locations
- 🇺🇸
Children's National Hospital, Washington DC, District of Columbia, United States
🇺🇸Memorial Sloan Kettering Cancer Center, New York, New York, United States
🇺🇸Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago, Illinois, United States
A Study of BMS-986482 Alone or as Combination Therapy in Participants With Advanced Solid Tumors
- Conditions
- Advanced Solid Tumors
- Interventions
- First Posted Date
- 2024-11-20
- Last Posted Date
- 2025-05-09
- Lead Sponsor
- Bristol-Myers Squibb
- Target Recruit Count
- 413
- Registration Number
- NCT06697197
- Locations
- 🇺🇸
Fred Hutchinson Cancer Center, Seattle, Washington, United States
🇺🇸Local Institution - 0005, Irvine, California, United States
🇺🇸Local Institution - 0030, Los Angeles, California, United States
Study of Precision Treatment for Rare Tumours in China Guided by PDO and NGS
- Conditions
- Rare Tumour
- Interventions
- Drug: Other
- First Posted Date
- 2024-11-18
- Last Posted Date
- 2024-11-18
- Lead Sponsor
- Peking University Shenzhen Hospital
- Target Recruit Count
- 200
- Registration Number
- NCT06692491
Adjuvant Sacituzumab Govitecan and Nivolumab in Muscle-Invasive Urothelial Carcinoma At High-Risk Recurrence
- Conditions
- Urothelial CarcinomaMuscle-invasive Bladder Cancer
- Interventions
- Drug: Sacituzumab Govitecan (SG)
- First Posted Date
- 2024-11-12
- Last Posted Date
- 2025-03-26
- Lead Sponsor
- University of California, Irvine
- Target Recruit Count
- 23
- Registration Number
- NCT06682728
- Locations
- 🇺🇸
Chao Family Comprehensive Cancer Center, University of California, Irvine, Orange, California, United States
Phase I/IIa Dose Finding Study of Triplet Regimen of Relatlimab Ipilimumab and NIvolumab in First Line Therapy of Metastatic Melanoma (TRINITY)
- Conditions
- Melanoma
- Interventions
- First Posted Date
- 2024-11-11
- Last Posted Date
- 2024-11-11
- Lead Sponsor
- M.D. Anderson Cancer Center
- Target Recruit Count
- 30
- Registration Number
- NCT06683755
- Locations
- 🇺🇸
The University of Texas M. D. Anderson Cancer Center, Houston, Texas, United States
Agnostic Therapy in Rare Solid Tumors
- Conditions
- FibrosarcomaUrachal CancerParathyroid CarcinomaFibrolamellar CarcinomaAngiosarcomaSecretory Carcinoma of BreastAnal NeoplasmsMetaplastic Breast CarcinomaTranslocation Renal Cell CarcinomaCarcinosarcoma
- Interventions
- First Posted Date
- 2024-10-15
- Last Posted Date
- 2024-10-15
- Lead Sponsor
- Instituto do Cancer do Estado de São Paulo
- Target Recruit Count
- 28
- Registration Number
- NCT06638931
- Locations
- 🇧🇷
Hospital São Rafael, Salvador, Bahia, Brazil
🇧🇷Hospital São Carlos, Fortaleza, Ceará, Brazil
🇧🇷Hospital Santa Cruz, Curitiba, Paraná, Brazil
PEP-CMV + Nivolumab for Newly Diagnosed Diffuse Midline Glioma/High-grade Glioma and Recurrent Diffuse Midline Glioma/High-grade Glioma, Medulloblastoma, and Ependymoma
- Conditions
- Diffuse Midline GliomaDiffuse Midline High-grade GliomaMedulloblastomaEpendymoma
- Interventions
- First Posted Date
- 2024-10-15
- Last Posted Date
- 2025-01-14
- Lead Sponsor
- Washington University School of Medicine
- Target Recruit Count
- 68
- Registration Number
- NCT06639607
- Locations
- 🇺🇸
Washington University School of Medicine, Saint Louis, Missouri, United States
🇺🇸Duke University Medical Center, Durham, North Carolina, United States
🇺🇸MD Anderson Cancer Center, Houston, Texas, United States
Clinical Study of the Efficacy and Safety of BCD-263 and Opdivo® As Monotherapy in Subjects with Advanced Melanoma of the Skin
- First Posted Date
- 2024-10-14
- Last Posted Date
- 2024-10-14
- Lead Sponsor
- Biocad
- Target Recruit Count
- 392
- Registration Number
- NCT06640530
- Locations
- 🇧🇾
Healthcare Institution "Brest Regional Oncological Dispensary", Brest, Belarus
🇧🇾Health Institution "Gomel Regional Clinical Oncology Center", Gomel, Belarus
🇧🇾Healthcare Institution "Minsk City Clinical Cancer Center", Minsk, Belarus
Comparing Impact of Treatment Before or After Surgery in Patients With Stage II-IIIB Resectable Non-small Cell Lung Cancer
- Conditions
- Resectable Lung Non-Small Cell CarcinomaStage II Lung Cancer AJCC v8Stage IIIA Lung Cancer AJCC v8Stage IIIB Lung Cancer AJCC v8
- Interventions
- Procedure: Surgical ProcedureProcedure: Computed TomographyProcedure: Magnetic Resonance ImagingProcedure: Positron Emission Tomography
- First Posted Date
- 2024-10-09
- Last Posted Date
- 2025-03-30
- Lead Sponsor
- Alliance for Clinical Trials in Oncology
- Target Recruit Count
- 1100
- Registration Number
- NCT06632327
- Locations
- 🇺🇸
South Sacramento Cancer Center, Sacramento, California, United States
🇺🇸Kaiser Permanente-San Francisco, San Francisco, California, United States
🇺🇸Kaiser Permanente-Santa Teresa-San Jose, San Jose, California, United States
Neoadjuvant Opdualag Versus Nivolumab for Resectable High-Risk Basal Cell Carcinoma
- First Posted Date
- 2024-10-03
- Last Posted Date
- 2025-03-14
- Lead Sponsor
- University of California, San Diego
- Target Recruit Count
- 30
- Registration Number
- NCT06624475
- Locations
- 🇺🇸
University of California, San Diego Moores Cancer Center, La Jolla, California, United States
Drug Development Updates
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