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
A Study Evaluating Bemarituzumab in Combination With Other Anti-cancer Therapies in Subjects With Previously Untreated Advanced Gastric or Gastroesophageal Junction Cancer.
- Conditions
- Interventions
- First Posted Date
- 2022-04-12
- Last Posted Date
- 2024-11-08
- Lead Sponsor
- Amgen
- Target Recruit Count
- 80
- Registration Number
- NCT05322577
- Locations
- 🇯🇵
Ishikawa Prefectural Central Hospital, Kanazawa-shi, Ishikawa, Japan
🇯🇵Kagawa University Hospital, Kita-gun, Kagawa, Japan
🇺🇸Northport Veterans Affairs Medical Center, Northport, New York, United States
5-Azacytidine and/or Nivolumab in Resectable HPV-Associated HNSCC
- Conditions
- Interventions
- First Posted Date
- 2022-04-07
- Last Posted Date
- 2024-11-25
- Lead Sponsor
- Barbara Burtness
- Target Recruit Count
- 50
- Registration Number
- NCT05317000
- Locations
- 🇺🇸
Yale University, New Haven, Connecticut, United States
Nivolumab and Ipilimumab in Patients With dMMR and/or MSI Metastatic Colorectal Cancer Resistant to Anti-PD1 Monotherapy
- First Posted Date
- 2022-04-05
- Last Posted Date
- 2023-03-07
- Target Recruit Count
- 30
- Registration Number
- NCT05310643
- Locations
- 🇫🇷
Centre Léon Bérard, Lyon, France
🇫🇷CHU Jean Minjoz, Besançon, France
🇫🇷ICM Val d'Aurelle, Montpellier, France
Testing the Addition of Nivolumab to Standard Treatment for Patients With Metastatic or Unresectable Colorectal Cancer That Have a BRAF Mutation
- Conditions
- Interventions
- First Posted Date
- 2022-04-04
- Last Posted Date
- 2024-12-17
- Lead Sponsor
- National Cancer Institute (NCI)
- Target Recruit Count
- 84
- Registration Number
- NCT05308446
- Locations
- 🇺🇸
Cancer Hematology Centers - Flint, Flint, Michigan, United States
🇺🇸CTCA at Western Regional Medical Center, Goodyear, Arizona, United States
🇺🇸Mercy Cancer Center - Carmichael, Carmichael, California, United States
Neoadjuvant Dual Checkpoint Inhibition and Cryoablation in Relapsed/Refractory Pediatric Solid Tumors
- First Posted Date
- 2022-03-31
- Last Posted Date
- 2023-09-05
- Lead Sponsor
- Children's National Research Institute
- Target Recruit Count
- 5
- Registration Number
- NCT05302921
- Locations
- 🇺🇸
Children's National Hospital, Washington, District of Columbia, United States
A Study of BMS-986406 as Monotherapy and Combination Therapies in Participants With Advanced Tumors
- Conditions
- Interventions
- First Posted Date
- 2022-03-28
- Last Posted Date
- 2024-07-03
- Lead Sponsor
- Bristol-Myers Squibb
- Target Recruit Count
- 154
- Registration Number
- NCT05298592
- Locations
- 🇺🇸
Local Institution - 0021, Birmingham, Alabama, United States
🇺🇸University California San Diego Moores Cancer Center, La Jolla, California, United States
🇺🇸The Angeles Clinic and Research Institute, A Cedars-Sinai Affiliate, Los Angeles, California, United States
CD8+ T Cell Imaging During Pre-surgery Immunotherapy in People With Melanoma
- Conditions
- Interventions
- First Posted Date
- 2022-03-21
- Last Posted Date
- 2024-04-17
- Lead Sponsor
- Memorial Sloan Kettering Cancer Center
- Target Recruit Count
- 28
- Registration Number
- NCT05289193
- Locations
- 🇺🇸
Memorial Sloan Kettering Monmouth (Limited Protocol Activities), Middletown, New Jersey, United States
🇺🇸Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities), Basking Ridge, New Jersey, United States
🇺🇸Memorial Sloan Kettering Westchester (Limited Protocol Activities), Harrison, New York, United States
Testing the Combination of Nivolumab and ASTX727 for Relapsed or Refractory B-Cell Lymphoma
- Conditions
- Interventions
- First Posted Date
- 2022-03-09
- Last Posted Date
- 2024-11-08
- Lead Sponsor
- National Cancer Institute (NCI)
- Target Recruit Count
- 27
- Registration Number
- NCT05272384
- Locations
- 🇺🇸
NYU Langone Hospital - Long Island, Mineola, New York, United States
🇺🇸University of Alabama at Birmingham Cancer Center, Birmingham, Alabama, United States
🇺🇸University of Chicago Comprehensive Cancer Center, Chicago, Illinois, United States
Trial of an Alternative Cabozantinib Dosing Schedule in Metastatic Renal Cell Carcinoma
- Conditions
- Interventions
- First Posted Date
- 2022-03-02
- Last Posted Date
- 2024-11-12
- Lead Sponsor
- Fox Chase Cancer Center
- Target Recruit Count
- 86
- Registration Number
- NCT05263050
- Locations
- 🇺🇸
Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States
A Study to Evaluate the Safety, Tolerability, Drug Levels, and Preliminary Efficacy of Relatlimab Plus Nivolumab in Pediatric and Young Adults With Hodgkin and Non-Hodgkin Lymphoma
- Conditions
- Interventions
- First Posted Date
- 2022-02-24
- Last Posted Date
- 2024-12-19
- Lead Sponsor
- Bristol-Myers Squibb
- Target Recruit Count
- 68
- Registration Number
- NCT05255601
- Locations
- 🇮🇹
Local Institution - 0010, Aviano, Italy
🇮🇹Local Institution - 0007, Bologna, Italy
🇮🇹Azienda Ospedaliero Universitaria Meyer, Florence, Italy
Drug Development Updates
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