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

Clinical Trials

A Phase II Study Evaluating an Organ Preservation Strategy Using Immune Checkpoint Blockade for Participants With Primary Colorectal or Gastroesophageal Cancer

Phase 2

Recruiting

Conditions: Colorectal Cancer
Gastroesophageal Cancer

Interventions: Drug: nivolumab
Drug: ipilimumab

First Posted Date: 2024-05-13

Last Posted Date: 2025-05-22

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 65

Registration Number: NCT06410534

Locations: 🇺🇸
National Institutes of Health Clinical Center, Bethesda, Maryland, United States

Neoadjuvant Ipilimumab/Nivolumab for Patients With Recurrent, High Risk, Resectable Melanoma

Phase 2

Recruiting

Conditions: Melanoma

Interventions: Drug: Ipilimumab
Drug: Nivolumab

First Posted Date: 2024-04-15

Last Posted Date: 2025-05-07

Lead Sponsor: University of Utah

Target Recruit Count: 25

Registration Number: NCT06365619

Locations: 🇺🇸
Huntsman Cancer Institute, Salt Lake City, Utah, United States

CARE1 Pragmatic Clinical Trial

Phase 3

Recruiting

Conditions: Metastatic Kidney Cancer
Metastatic Kidney Carcinoma

Interventions: Drug: Nivolumab
Drug: Ipilimumab
Drug: Pembrolizumab
Drug: Cabozantinib
Drug: Axitinib
Drug: Lenvatinib

First Posted Date: 2024-04-15

Last Posted Date: 2025-01-16

Lead Sponsor: Gustave Roussy, Cancer Campus, Grand Paris

Target Recruit Count: 1250

Registration Number: NCT06364631

Locations: 🇦🇹
Medical University of Vienna, Vienna, Austria
🇨🇿
Masarykův onkologický ústav, Masaryk Memorial Cancer Institute (MOU), Brno, Czechia
🇨🇿
Fakultní nemocnice Hradec Králová, University Hospital Hradec Kralove (FNHK), Hradec Kralove, Czechia

and more 43 locations

DISCERN: Dual Versus Single ICB in PDL-1 Negative NSCLC

Phase 2

Not yet recruiting

Conditions: Non Small Cell Lung Cancer

Interventions: Drug: Pembrolizumab
Drug: Carboplatin
Drug: Paclitaxel
Drug: Pemetrexed
Drug: Nivolumab
Drug: Ipilimumab

First Posted Date: 2024-04-15

Last Posted Date: 2025-05-15

Lead Sponsor: University of Alabama at Birmingham

Target Recruit Count: 24

Registration Number: NCT06364917

Locations: 🇺🇸
University of Alabama at Birmingham, Birmingham, Alabama, United States

Real-World Use of Nivolumab for the Treatment of Patients With Metastatic Upper Gastrointestinal Cancer in Canada

Completed

Conditions: Upper Gastrointestinal Cancer

Interventions: Drug: Nivolumab

First Posted Date: 2024-04-12

Last Posted Date: 2024-04-12

Lead Sponsor: Bristol-Myers Squibb

Target Recruit Count: 700

Registration Number: NCT06361576

Locations: 🇨🇦
Bayshore Specialty Rx Ltd., Mississauga, Ontario, Canada

A Study of Oral 7HP349 (Alintegimod) in Combination With Ipilimumab Followed by Nivolumab Monotherapy

Phase 1

Recruiting

Conditions: Pleural Mesothelioma
Renal Cell Cancer
Kidney Cancer
Anaplastic Lymphoma Kinase Genomic Tumor Aberrations
ALK Genomic Tumor Aberrations
Melanoma
Advanced Cancer
Metastasis
Advanced Solid Tumor
Skin Cancer

Interventions: Drug: Alintegimod
Drug: Ipilimumab
Drug: Nivolumab

First Posted Date: 2024-04-12

Last Posted Date: 2024-11-25

Lead Sponsor: 7 Hills Pharma, LLC

Target Recruit Count: 126

Registration Number: NCT06362369

Locations: 🇺🇸
Florida Cancer Specialists, Lake Mary, Florida, United States
🇺🇸
Dartmouth Hitchcock, Lebanon, New Hampshire, United States
🇺🇸
MD Anderson Cancer Center, Houston, Texas, United States

Real-World Use of Adjuvant Nivolumab in Patients With Upper Gastrointestinal Cancer in Canada

Completed

Conditions: Upper Gastrointestinal Cancer

Interventions: Drug: Nivolumab

First Posted Date: 2024-04-12

Last Posted Date: 2024-04-12

Lead Sponsor: Bristol-Myers Squibb

Target Recruit Count: 250

Registration Number: NCT06361563

Locations: 🇨🇦
Bayshore Specialty Rx Ltd., Mississauga, Ontario, Canada

ASTX727 and Nivolumab in Squamous Cell Carcinoma of the Head and Neck

Phase 1

Withdrawn

Conditions: Recurrent Squamous Cell Carcinoma of the Head and Neck
Metastatic Squamous Cell Carcinoma
Head and Neck Squamous Cell Carcinoma

Interventions: Drug: INQOVI (decitabine and cedazuridine)
Drug: Nivolumab

First Posted Date: 2024-04-10

Last Posted Date: 2024-07-03

Lead Sponsor: Case Comprehensive Cancer Center

Registration Number: NCT06357858

Locations: 🇺🇸
University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center, Cleveland, Ohio, United States

Combination of Immune Checkpoint in Locally Advanced or Metastatic MSI/dMMR Esogastric Adenocarcinomas

Phase 3

Not yet recruiting

Conditions: Gastric Cancer
MSI-H
Metastatic Cancer
Advanced Cancer

Interventions: Drug: Folfox Protocol
Drug: Balstilimab
Drug: Botensilimab
Drug: XELOX
Drug: Nivolumab

First Posted Date: 2024-04-03

Last Posted Date: 2024-08-23

Lead Sponsor: Centre Leon Berard

Target Recruit Count: 124

Registration Number: NCT06346197

Locations: 🇫🇷
Centre Léon Bérard, Lyon, France

Anti-Lag-3 (Relatlinib) and Anti-PD-1 Blockade (Nivolumab) Versus Standard of Care (Lomustine) for the Treatment of Patients With Recurrent Glioblastoma

Phase 2

Suspended

Conditions: Recurrent Glioblastoma

Interventions: Procedure: Biopsy Procedure
Procedure: Biospecimen Collection
Procedure: Magnetic Resonance Imaging
Drug: Lomustine
Biological: Nivolumab
Biological: Relatlimab
Procedure: Surgical Procedure

First Posted Date: 2024-03-22

Last Posted Date: 2025-04-09

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 184

Registration Number: NCT06325683

Locations: 🇺🇸
MaineHealth Cancer Care and IV Therapy - South Portland, South Portland, Maine, United States
🇺🇸
Sutter Auburn Faith Hospital, Auburn, California, United States
🇺🇸
Kaiser Permanente Los Angeles Medical Center, Los Angeles, California, United States

and more 114 locations

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