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.
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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 defi...

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

Intradermal Ipilimumab and Nivolumab in High Risk Stage II Melanoma

Phase 1
Recruiting
Conditions
Interventions
First Posted Date
2024-02-02
Last Posted Date
2024-11-14
Lead Sponsor
The Netherlands Cancer Institute
Target Recruit Count
96
Registration Number
NCT06240143
Locations
🇳🇱

Amsterdam University Medical Center, Amsterdam, Netherlands

🇳🇱

Antoni van Leeuwenhoek Hospital, Amsterdam, Netherlands

🇳🇱

University Medical Center Groningen, Groningen, Netherlands

and more 3 locations

Study of Zanzalintinib (XL092) + AB521 and Zanzalintinib + AB521 + Nivolumab in Participants With Advanced Clear Cell Renal Cell Carcinoma (ccRCC) or Other Advanced Solid Tumors (STELLAR-009)

First Posted Date
2024-01-05
Last Posted Date
2024-08-07
Lead Sponsor
Exelixis
Target Recruit Count
140
Registration Number
NCT06191796
Locations
🇺🇸

Exelixis Site #8, Los Angeles, California, United States

🇺🇸

Exelixis Site #9, Miami, Florida, United States

🇺🇸

Exelixis Clinical Site #1, Orlando, Florida, United States

and more 11 locations

Bevacizumab and ICIs + hSRT in Symptomatic Melanoma Brain Metastases

First Posted Date
2023-12-11
Last Posted Date
2023-12-27
Lead Sponsor
Melanoma and Skin Cancer Trials Limited
Target Recruit Count
46
Registration Number
NCT06163820

A Study to Evaluate Treatment With Nivolumab Alone and Nivolumab Combined With Ipilimumab in Children With Melanoma

First Posted Date
2023-12-08
Last Posted Date
2024-04-18
Lead Sponsor
Bristol-Myers Squibb
Target Recruit Count
100
Registration Number
NCT06163170
Locations
🇺🇸

Cardinal Health, Dublin, Ohio, United States

Nivolumab Dose Optimization in Patients With a Complete, Partial or Stable Response

Phase 4
Recruiting
Conditions
Interventions
First Posted Date
2023-11-03
Last Posted Date
2024-04-22
Lead Sponsor
Erasmus Medical Center
Target Recruit Count
34
Registration Number
NCT06116461
Locations
🇳🇱

Erasmus MC, Rotterdam, Pending, Netherlands

IMC-F106C Regimen Versus Nivolumab Regimens in Previously Untreated Advanced Melanoma (PRISM-MEL-301)

First Posted Date
2023-11-01
Last Posted Date
2024-12-09
Lead Sponsor
Immunocore Ltd
Target Recruit Count
680
Registration Number
NCT06112314
Locations
🇧🇷

Fundacao Pio XII - Hospital de Cancer de Barretos - Hospital de Amor, Barretos, Brazil

🇧🇷

Centro de Pesquisas Oncologicas (CEPON), Florianópolis, Brazil

🇧🇷

Pontificia Universidade Catolica do Rio Grande do Sul (PUCRS) - Hospital Sao Lucas - Centro de Pesquisa Clinica (CPC), Porto Alegre, Brazil

and more 94 locations

A Study to Evaluate Whether Participants With Melanoma Prefer Subcutaneous vs Intravenous Administration of Nivolumab and Nivolumab + Relatlimab Fixed-dose Combinations

First Posted Date
2023-10-26
Last Posted Date
2024-12-06
Lead Sponsor
Bristol-Myers Squibb
Target Recruit Count
100
Registration Number
NCT06101134
Locations
🇺🇸

Local Institution - 0036, Issaquah, Washington, United States

🇺🇸

Local Institution - 0030, Seattle, Washington, United States

🇬🇷

Local Institution - 0019, Thessaloniki, B, Greece

and more 28 locations
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