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
SWE-NEO: Swedish NeoAdjuvant Trial Comparing Monotherapy to Combined Immunotherapy in Resectable Stage III Melanoma
- Conditions
- Malignant Melanoma Stage III
- Interventions
- First Posted Date
- 2025-01-27
- Last Posted Date
- 2025-01-29
- Lead Sponsor
- Hildur Helgadottir
- Target Recruit Count
- 128
- Registration Number
- NCT06794775
- Locations
- 🇸🇪
Sahlgrenska University Hospital, Gothenburg, Sweden
🇸🇪Karolinska University Hospital, Stockholm, Sweden
🇸🇪Skane University Hospital, Lund, Sweden
Real-world Study of First Line Pembrolizumab- or Nivolumab-treated HPV-positive Recurrent/Metastatic Oropharyngeal Squamous Cell Carcinoma
- Conditions
- Oropharyngeal Squamous Cell Carcinoma
- Interventions
- First Posted Date
- 2025-01-13
- Last Posted Date
- 2025-03-11
- Lead Sponsor
- Hookipa Biotech GmbH
- Target Recruit Count
- 663
- Registration Number
- NCT06771674
- Locations
- 🇺🇸
Cardinal Health, Dublin, Ohio, United States
Golcadomide and Nivolumab in Patients with Non-Hodgkin Lymphoma with Refractory Disease After Chimeric Antigen T-cell Therapy
- Conditions
- Non Hodgkin Lymphoma
- Interventions
- First Posted Date
- 2025-01-10
- Last Posted Date
- 2025-01-10
- Lead Sponsor
- Natalie Galanina
- Target Recruit Count
- 30
- Registration Number
- NCT06767956
- Locations
- 🇺🇸
UPMC Hillman Cancer Center, Pittsburgh, Pennsylvania, United States
A Study of BMS-986488 as Monotherapy and Combination Therapy in Participants With Advanced Malignant Tumors
- Conditions
- Advanced Malignant Tumors
- Interventions
- First Posted Date
- 2025-01-08
- Last Posted Date
- 2025-05-14
- Lead Sponsor
- Bristol-Myers Squibb
- Target Recruit Count
- 437
- Registration Number
- NCT06764771
- Locations
- 🇺🇸
John Theurer Cancer Center at Hackensack University Medical Center, Hackensack, New Jersey, United States
🇺🇸Local Institution - 0020, Allentown, Pennsylvania, United States
🇺🇸The West Clinic, PLLC dba West Cancer Center, Germantown, Tennessee, United States
Personalized Reduction of Chemotherapy Intensity Through ctDNA Evaluation for the Treatment of Patients With Advanced Hodgkin Lymphoma
- Conditions
- Advanced Hodgkin LymphomaClassic Hodgkin LymphomaLugano Classification Stage III Hodgkin Lymphoma AJCC v8Lugano Classification Stage IV Hodgkin Lymphoma AJCC v8
- Interventions
- Procedure: Biospecimen CollectionProcedure: Computed TomographyProcedure: EchocardiographyProcedure: Multigated Acquisition ScanProcedure: Positron Emission TomographyOther: Questionnaire
- First Posted Date
- 2024-12-20
- Last Posted Date
- 2025-03-10
- Lead Sponsor
- University of Washington
- Target Recruit Count
- 125
- Registration Number
- NCT06745076
- Locations
- 🇺🇸
Fred Hutch/University of Washington Cancer Consortium, Seattle, Washington, United States
SUPRAME-ACTengine® IMA203 vs. Investigator's Choice of Treatment in Previously Treated, Unresectable or Metastatic Cutaneous Melanoma
- Conditions
- Melanoma, Cutaneous Malignant
- Interventions
- First Posted Date
- 2024-12-19
- Last Posted Date
- 2025-05-20
- Lead Sponsor
- Immatics US, Inc.
- Target Recruit Count
- 360
- Registration Number
- NCT06743126
- Locations
- 🇺🇸
SCRI Oncology Partners, Nashville, Tennessee, United States
🇺🇸UCLA Hematology/Oncology, Los Angeles, California, United States
🇺🇸Honor Health Research Institute, Scottsdale, Arizona, United States
Clinical Outcomes of Patients With Resectable Non-Small Cell Lung Cancer Receiving Neoadjuvant Nivolumab Plus Chemotherapy in France
- First Posted Date
- 2024-12-16
- Last Posted Date
- 2024-12-16
- Lead Sponsor
- Bristol-Myers Squibb
- Target Recruit Count
- 101
- Registration Number
- NCT06735781
- Locations
- 🇫🇷
Centre François Baclesse, Caen, France
🇫🇷Centre Léon Bérard, Lyon, France
🇫🇷Hospices Civils de Lyon, Lyon, France
Diclofenac for the Treatment of Patients with Metastatic Non-small Cell Lung Cancer on Single Agent Immunotherapy
- Conditions
- Advanced Lung Non-Small Cell CarcinomaMetastatic Lung Non-Small Cell CarcinomaStage III Lung Cancer AJCC V8Stage IV Lung Cancer AJCC V8
- Interventions
- Procedure: Biospecimen CollectionProcedure: Computed TomographyOther: Electronic Health Record ReviewProcedure: Magnetic Resonance ImagingProcedure: Positron Emission Tomography
- First Posted Date
- 2024-12-12
- Last Posted Date
- 2025-03-19
- Lead Sponsor
- Emory University
- Target Recruit Count
- 20
- Registration Number
- NCT06731270
- Locations
- 🇺🇸
Emory University Hospital Midtown, Atlanta, Georgia, United States
🇺🇸Emory University Hospital/Winship Cancer Institute, Atlanta, Georgia, United States
Observational Study of the Effectiveness of Funded Drugs for Genitourinary Tumors.
- Conditions
- Genitourinary Cancers
- Interventions
- First Posted Date
- 2024-12-09
- Last Posted Date
- 2025-05-21
- Lead Sponsor
- Spanish Oncology Genito-Urinary Group
- Target Recruit Count
- 500
- Registration Number
- NCT06724159
- Locations
- 🇪🇸
Hospital Universitario Torrecárdenas, Almería, Andalucia, Spain
🇪🇸Hospital Universitario Reina Sofía, Córdoba, Andalucia, Spain
🇪🇸Hospital Universitario Clínico San Cecilio, Granada, Andalucia, Spain
Trial of Relatlimab, Nivolumab, and Ipilimumab in Patients With Asymptomatic and Symptomatic Melanoma Brain Metastases
- Conditions
- MelanomaBrain Metastases
- Interventions
- First Posted Date
- 2024-12-03
- Last Posted Date
- 2025-04-08
- Lead Sponsor
- Stanford University
- Target Recruit Count
- 60
- Registration Number
- NCT06712927
- Locations
- 🇺🇸
Stanford University, Palo Alto, California, United States
Drug Development Updates
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