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
Tepotinib vs Standard Treatment in Patients With Advanced MET Exon 14 Mutated Non-Small Cell Lung Cancer Previously Treated
- Conditions
- Advanced Non Small Cell Lung CancerMET Exon 14 Mutation
- Interventions
- First Posted Date
- 2025-04-03
- Last Posted Date
- 2025-04-03
- Lead Sponsor
- Intergroupe Francophone de Cancerologie Thoracique
- Target Recruit Count
- 133
- Registration Number
- NCT06908993
- Locations
- 🇫🇷
Montpellier - CHU, Montpellier, France
🇫🇷Centre Antoine Lacassagne, Nice, France
🇫🇷AP-HP Hôpital Cochin, Paris, France
Intrathecal Azacitidine and Nivolumab in Patients with Recurrent High-grade Glioma
- Conditions
- Glioblastoma (GBM)Diffuse Midline Glioma (DMG)Astrocytoma, IDH-Mutant, Grade 4Diffuse Hemispheric Glioma, H3 G34-MutantGliosarcoma of Brain
- Interventions
- First Posted Date
- 2025-03-26
- Last Posted Date
- 2025-03-30
- Lead Sponsor
- Andrew P. Groves
- Target Recruit Count
- 34
- Registration Number
- NCT06896110
- Locations
- 🇺🇸
Holden Comprehensive Cancer Center, Iowa City, Iowa, United States
Neoadjuvant Zanzalintinib Plus Nivolumab in Patients With Locally Advanced and/or Inoperable Clear Cell Renal Cell Carcinoma With or Without Non-measurable Metastasis
- Conditions
- Locally Advanced Renal Cell Carcinoma
- Interventions
- First Posted Date
- 2025-03-25
- Last Posted Date
- 2025-04-01
- Lead Sponsor
- Qian Qin
- Target Recruit Count
- 69
- Registration Number
- NCT06794229
SVV-001 With Nivolumab and Ipilimumab in Patients With Poorly Differentiated Neuroendocrine Carcinomas (NEC) or Well-Differentiated High-Grade Neuroendocrine Tumors (NET)
- Conditions
- Neuroendocrine CarcinomaNeuroendocrine Tumors
- Interventions
- First Posted Date
- 2025-03-21
- Last Posted Date
- 2025-05-02
- Lead Sponsor
- Aman Chauhan, MD
- Target Recruit Count
- 36
- Registration Number
- NCT06889493
- Locations
- 🇺🇸
University of Miami, Miami, Florida, United States
Nivolumab and DA-EPOCH-R in Pediatric Primary Mediastinal (Thymic) Large B-cell Lymphoma
- Conditions
- Primary Mediastinal (Thymic) Large B-cell LymphomaChildrenNivolumab
- Interventions
- First Posted Date
- 2025-03-11
- Last Posted Date
- 2025-03-11
- Lead Sponsor
- St. Petersburg State Pavlov Medical University
- Target Recruit Count
- 22
- Registration Number
- NCT06871007
- Locations
- 🇷🇺
Dmitry Rogachev National Research Center, Moscow, Russian Federation
🇷🇺Pavlov University, RM Gorbacheva Research Institute, Saint-Petersburg, Russian Federation
Inulin Gel in Combination With Ipilimumab and Nivolumab for the Treatment of Metastatic or Locally Advanced Kidney Cell Cancer, ICON Trial
- Conditions
- Locally Advanced Clear Cell Renal Cell CarcinomaLocally Advanced Sarcomatoid Renal Cell CarcinomaMetastatic Sarcomatoid Renal Cell CarcinomaMetastatic Clear Cell Renal Cell CarcinomaStage III Renal Cell Cancer AJCC v8Stage IV Renal Cell Cancer AJCC v8
- Interventions
- Procedure: BiopsyProcedure: Biospecimen CollectionProcedure: Computed TomographyDietary Supplement: InulinProcedure: Magnetic Resonance ImagingOther: Questionnaire Administration
- First Posted Date
- 2025-03-10
- Last Posted Date
- 2025-05-02
- Lead Sponsor
- University of Michigan Rogel Cancer Center
- Target Recruit Count
- 55
- Registration Number
- NCT06866262
- Locations
- 🇺🇸
University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan, United States
Trial of XL092 in Combination With Immunotherapy in Patients Who Progress on Adjuvant Therapy in Clear Cell RCC
- Conditions
- Advanced Renal Cell CarcinomaMetastatic Renal Cell CarcinomaClear Cell Renal Cell Carcinoma
- Interventions
- First Posted Date
- 2025-03-07
- Last Posted Date
- 2025-05-04
- Lead Sponsor
- Karie Runcie
- Target Recruit Count
- 70
- Registration Number
- NCT06863311
- Locations
- 🇺🇸
Columbia University Irving Medical Center, New York, New York, United States
Towards Cure Via Only Ultra-short ICB in CSCC
- Conditions
- Cutaneous Squamous Cell Carcinoma (CSCC)Cutaneous Squamous Cell CancerCutaneous Squamous Cell Carcinoma of the Head and NeckCutaneous Squamous Cell Carcinoma
- Interventions
- Drug: Ipilumimab
- First Posted Date
- 2025-02-12
- Last Posted Date
- 2025-02-12
- Lead Sponsor
- The Netherlands Cancer Institute
- Target Recruit Count
- 41
- Registration Number
- NCT06823479
- Locations
- 🇳🇱
Maastricht UMC, Maastricht, Limburg, Netherlands
🇳🇱Netherlands Cancer Institute - Antoni van Leeuwenhoek, Amsterdam, Noord-Holland, Netherlands
🇳🇱Amsterdam UMC, Amsterdam, Noord-Holland, Netherlands
Trial of Glioblastoma Immunotherapy Advancement With Nivolumab and Relatlimab
- Conditions
- Newly Diagnosed Glioblastoma
- Interventions
- First Posted Date
- 2025-02-10
- Last Posted Date
- 2025-02-10
- Lead Sponsor
- Duke University
- Target Recruit Count
- 92
- Registration Number
- NCT06816927
- Locations
- 🇺🇸
Duke University, Durham, North Carolina, United States
A Phase I, Single-Arm, Single-Institution Study Evaluating Neoadjuvant Chemoimmunotherapy with Immunosensitizing Radiation for Borderline Resectable Non-Small Cell Lung Cancer
- Conditions
- Non-Small Cell Lung Cancer
- Interventions
- First Posted Date
- 2025-01-30
- Last Posted Date
- 2025-01-30
- Lead Sponsor
- University of Maryland, Baltimore
- Target Recruit Count
- 18
- Registration Number
- NCT06800339
- Locations
- 🇺🇸
Maryland Proton Treatment Center, Baltimore, Maryland, United States
🇺🇸University of Maryland Greenebaum Cancer Center, Baltimore, Maryland, United States
🇺🇸Upper Chesapeake- Kaufman Cancer Center, Bel Air, Maryland, United States
Drug Development Updates
Stay informed with timely notifications on clinical trials, regulatory changes, and research advancements related to this medication.