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

A Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of IPI-549

First Posted Date
2015-12-22
Last Posted Date
2022-04-04
Lead Sponsor
Infinity Pharmaceuticals, Inc.
Target Recruit Count
219
Registration Number
NCT02637531
Locations
🇺🇸

Massachusetts General Hospital, Boston, Massachusetts, United States

🇺🇸

UCSD, San Diego, California, United States

🇺🇸

UCLA, Santa Monica, California, United States

and more 8 locations

Selective HDAC6 Inhibitor ACY 241 in Combination With Nivolumab in Patients With Unresectable Non Small Cell Lung Cancer

Phase 1
Terminated
Conditions
Interventions
First Posted Date
2015-12-18
Last Posted Date
2024-05-07
Lead Sponsor
Celgene
Target Recruit Count
17
Registration Number
NCT02635061
Locations
🇺🇸

Local Institution - 350, Boston, Massachusetts, United States

Sequential Combo Immuno and Target Therapy (SECOMBIT) Study

First Posted Date
2015-12-16
Last Posted Date
2024-06-07
Lead Sponsor
Fondazione Melanoma Onlus
Target Recruit Count
251
Registration Number
NCT02631447
Locations
🇨🇭

University Hospital Zurich, Zurich, Switzerland

🇮🇹

IRCCS Casa Sollievo della Sofferenza, San Giovanni Rotondo, Italy

🇪🇸

Clinica Universidad de Navarra, Pamplona, Spain

and more 27 locations

Immune Modulation Study in Patients With Metastatic Melanoma Treated With Anti-PD1 Monoclonal Antibodies

First Posted Date
2015-12-10
Last Posted Date
2017-08-22
Lead Sponsor
Hospices Civils de Lyon
Target Recruit Count
32
Registration Number
NCT02626065
Locations
🇫🇷

Centre Hospitalier Lyon Sud, Pierre Benite, France

Trial of Nivolumab in Combination With Ipilimumab in Subjects With Previously Untreated Metastatic Uveal Melanoma

Phase 2
Completed
Conditions
Interventions
First Posted Date
2015-12-10
Last Posted Date
2022-03-22
Lead Sponsor
Grupo Español Multidisciplinar de Melanoma
Target Recruit Count
52
Registration Number
NCT02626962
Locations
🇪🇸

H. C. U. de Valladolid, Valladolid, Spain

🇪🇸

H. U. Virgen de la Victoria, Malaga, Spain

🇪🇸

Hospital La Paz, Madrid, Spain

and more 7 locations

Nivo/Ipi Combination Therapy in Symptomatic Brain Metastases

Phase 2
Terminated
Conditions
Interventions
First Posted Date
2015-12-03
Last Posted Date
2024-05-06
Lead Sponsor
University Medical Center Groningen
Target Recruit Count
7
Registration Number
NCT02621515
Locations
🇳🇱

Dutch Cancer Institute/ A v. Leeuwenhoek Hospital, Amsterdam, Netherlands

🇳🇱

University Medical Center Groningen, Groningen, Netherlands

🇳🇱

Erasmus Medical Center, Rotterdam, Netherlands

and more 1 locations

An Investigational Immuno-therapy Study of Nivolumab Compared to Temozolomide, Each Given With Radiation Therapy, for Newly-diagnosed Patients With Glioblastoma (GBM, a Malignant Brain Cancer)

First Posted Date
2015-12-01
Last Posted Date
2023-03-28
Lead Sponsor
Bristol-Myers Squibb
Target Recruit Count
560
Registration Number
NCT02617589
Locations
🇺🇸

Johns Hopkins University School Of Medicine, Baltimore, Maryland, United States

🇺🇸

Local Institution - 0090, Chattanooga, Tennessee, United States

🇺🇸

Dana-Farber Cancer Institute, Boston, Massachusetts, United States

and more 112 locations

A Study of Elotuzumab in Combination With Pomalidomide and Low Dose Dexamethasone and Elotuzumab in Combination With Nivolumab in Patients With Multiple Myeloma Relapsed or Refractory to Prior Treatment With Lenalidomide.

First Posted Date
2015-11-24
Last Posted Date
2021-07-02
Lead Sponsor
Bristol-Myers Squibb
Target Recruit Count
74
Registration Number
NCT02612779
Locations
🇺🇸

Bay Hematology Oncology, Easton, Maryland, United States

🇺🇸

Southern Cancer Center, Mobile, Alabama, United States

🇺🇸

Virginia Cancer Specialists (Leesburg) - USOR, Leesburg, Virginia, United States

and more 19 locations

Efficacy Study of Nivolumab Compared to Docetaxel in Subjects Previously Treated With Advanced or Metastatic Non Small Cell Lung Cancer

Phase 3
Completed
Conditions
Interventions
First Posted Date
2015-11-24
Last Posted Date
2024-11-19
Lead Sponsor
Bristol-Myers Squibb
Target Recruit Count
504
Registration Number
NCT02613507
Locations
🇨🇳

Local Institution - 0051, Beijing, Beijing, China

🇨🇳

Local Institution - 0007, Beijing, Beijing, China

🇷🇺

Local Institution - 0039, Chelyabinsk, Russian Federation

and more 30 locations

Lirilumab and Nivolumab With 5-Azacitidine in Patients With Myelodysplastic Syndromes (MDS)

Phase 2
Terminated
Conditions
Interventions
First Posted Date
2015-11-06
Last Posted Date
2020-01-14
Lead Sponsor
M.D. Anderson Cancer Center
Target Recruit Count
10
Registration Number
NCT02599649
Locations
🇺🇸

University of Texas MD Anderson Cancer Center, Houston, Texas, United States

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