MedPath

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.

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

Biomarker-Driven Therapy Using Immune Activators With Nivolumab in Patients With First Recurrence of Glioblastoma

Phase 1
Terminated
Conditions
Glioblastoma Multiforme
Glioblastoma
Interventions
Drug: Nivolumab
Drug: Anti-GITR Monoclonal Antibody MK-4166
Drug: IDO1 inhibitor INCB024360
Drug: Ipilimumab
First Posted Date
2018-10-16
Last Posted Date
2020-07-02
Lead Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Target Recruit Count
3
Registration Number
NCT03707457
Locations
🇺🇸

Johns Hopkins University/Sidney Kimmel Cancer Center, Baltimore, Maryland, United States

Nivolumab and Ipilimumab in Mucinous Colorectal and Appendiceal Tumors

Phase 2
Terminated
Conditions
Mucinous Adenocarcinoma of the Colon
Mucinous Adenocarcinoma of the Rectum
Interventions
First Posted Date
2018-10-03
Last Posted Date
2022-10-20
Lead Sponsor
Abramson Cancer Center at Penn Medicine
Target Recruit Count
11
Registration Number
NCT03693846
Locations
🇺🇸

Abramson Cancer Center of the University of Pennsylvania, Philadelphia, Pennsylvania, United States

Safety and Efficacy of Nivolumab in Treating Oral Proliferative Verrucous Leukoplakia

Phase 2
Completed
Conditions
Leukoplakia, Oral
Interventions
First Posted Date
2018-10-02
Last Posted Date
2024-09-30
Lead Sponsor
Dana-Farber Cancer Institute
Target Recruit Count
33
Registration Number
NCT03692325
Locations
🇺🇸

Dana Farber Cancer Institute, Boston, Massachusetts, United States

Nivolumab and BMS-986253 for Hormone-Sensitive Prostate Cancer (MAGIC-8)

Phase 1
Active, not recruiting
Conditions
Prostate Cancer
Adenocarcinoma of the Prostate
Interventions
First Posted Date
2018-09-28
Last Posted Date
2023-12-22
Lead Sponsor
Mark Stein
Target Recruit Count
60
Registration Number
NCT03689699
Locations
🇺🇸

Winship Cancer Institute, Emory University, Atlanta, Georgia, United States

🇺🇸

Sidney Kimmel Cancer Center- Thomas Jefferson University, Philadelphia, Pennsylvania, United States

🇺🇸

Columbia University Irving Medical Center, New York, New York, United States

and more 1 locations

Evaluating the Effect of Nivolumab for Patients With In-transit Metastases Treated With Isolated Limb Perfusion

Phase 1
Recruiting
Conditions
Melanoma
In-Transit Metastasis
Interventions
Drug: Nivolumab
Procedure: Isolated limb perfusion (ILP)
First Posted Date
2018-09-26
Last Posted Date
2024-04-25
Lead Sponsor
Vastra Gotaland Region
Target Recruit Count
74
Registration Number
NCT03685890
Locations
🇳🇱

Erasmus MC Cancer Institute, Rotterdam, Netherlands

🇸🇪

Sahlgrenska University Hospital, Gothenburg, Sweden

🇳🇱

Netherlands Cancer Institute, Amsterdam, Netherlands

Nivolumab With Ruxolitinib in Relapsed or Refractory Classical Hodgkin Lymphoma

Phase 1
Recruiting
Conditions
Hodgkin Lymphoma
Interventions
First Posted Date
2018-09-24
Last Posted Date
2024-10-21
Lead Sponsor
Veronika Bachanova
Target Recruit Count
54
Registration Number
NCT03681561
Locations
🇺🇸

University of Iowa Hospitals and Clinics, Iowa City, Iowa, United States

🇺🇸

Indiana Melvin and Bren Simon Comprehensive Cancer Center, Indianapolis, Indiana, United States

🇺🇸

University of Illinois Cancer Center, Chicago, Illinois, United States

and more 2 locations

Neoadjuvant Sitravatinib in Combination With Nivolumab in Patients With Clear Cell Renal Cell Carcinoma

Phase 2
Completed
Conditions
Clear Cell Renal Cell Carcinoma
Interventions
First Posted Date
2018-09-21
Last Posted Date
2023-10-04
Lead Sponsor
Mirati Therapeutics Inc.
Target Recruit Count
25
Registration Number
NCT03680521
Locations
🇺🇸

MD Anderson Cancer Center, Houston, Texas, United States

Radiation and Chemotherapy With Ipilimumab Followed by Nivolumab for Patients With Stage III Unresectable Non-Small Cell Lung Cancer (NSCLC)

Phase 1
Terminated
Conditions
Carcinoma, Non-Small-Cell Lung
Interventions
First Posted Date
2018-09-10
Last Posted Date
2023-02-15
Lead Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Target Recruit Count
19
Registration Number
NCT03663166
Locations
🇺🇸

H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida, United States

🇺🇸

UNC Limeberger Comprehensive Cancer Center, Chapel Hill, North Carolina, United States

🇺🇸

Duke University, Durham, North Carolina, United States

Nivolumab in Patients With Advanced Non-Small Cell Lung Cancer and Pre-existing Autoimmune Disease

Phase 1
Terminated
Conditions
Rheumatoid Arthritis
Crohn Disease
Multiple Sclerosis
Ulcerative Colitis
Autoimmune Diseases
Psoriasis
Polymyalgia Rheumatica
Systemic Lupus Erythematosus
Non-small Cell Lung Cancer
Giant Cell Arteritis
Interventions
First Posted Date
2018-09-04
Last Posted Date
2023-02-15
Lead Sponsor
Alliance Foundation Trials, LLC.
Target Recruit Count
7
Registration Number
NCT03656627
Locations
🇺🇸

The Ohio State University Wexner Medical Center - Thoracic Oncology Clinic, Columbus, Ohio, United States

🇺🇸

Metro Minnesota Community Oncology Research Consortium, Saint Louis Park, Minnesota, United States

🇺🇸

Dartmouth Hitchcock Norris Cotton Cancer Center, Lebanon, New Hampshire, United States

and more 6 locations

A Study of Subcutaneous Nivolumab Monotherapy With or Without Recombinant Human Hyaluronidase PH20 (rHuPH20)

Phase 1
Completed
Conditions
Neoplasms by Site
Interventions
First Posted Date
2018-09-04
Last Posted Date
2024-12-06
Lead Sponsor
Bristol-Myers Squibb
Target Recruit Count
139
Registration Number
NCT03656718
Locations
🇺🇸

Local Institution - 0012, Eugene, Oregon, United States

🇺🇸

Greenville Health System, Greenville, South Carolina, United States

🇺🇸

Local Institution - 0011, Tyler, Texas, United States

and more 33 locations
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