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
An Investigational Immuno-Therapy Study of Experimental Medication BMS-986178 by Itself or in Combination With Nivolumab and/or Ipilimumab in Participants With Solid Cancers That Are Advanced or Have Spread
- Conditions
- Interventions
- First Posted Date
- 2016-04-14
- Last Posted Date
- 2022-01-25
- Lead Sponsor
- Bristol-Myers Squibb
- Target Recruit Count
- 166
- Registration Number
- NCT02737475
- Locations
- 🇺🇸
John Theurer Cancer Center at Hackensack University Medical Center, Hackensack, New Jersey, United States
🇮🇹IRCCS Istituto Nazionale Tumori Milano, Milano, Italy
🇺🇸Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States
A Phase I Study of WT1 or NY-ESO-1 Vaccine and Nivolumab For Recurrent Ovarian Cancer
- Conditions
- Interventions
- First Posted Date
- 2016-04-14
- Last Posted Date
- 2023-04-07
- Lead Sponsor
- Memorial Sloan Kettering Cancer Center
- Target Recruit Count
- 11
- Registration Number
- NCT02737787
- Locations
- 🇺🇸
Memorial Sloan Kettering Bergen (All Protocol Activities), Montvale, New Jersey, United States
🇺🇸Memorial Sloan Kettering Monmouth (All Protocol Activities), Middletown, New Jersey, United States
🇺🇸Memorial Sloan Kettering Cancer Center (All Protocol Activities), New York, New York, United States
Ipilimumab vs Ipilimumab Plus Nivolumab in Patients With Stage III-IV Melanoma Who Have Progressed or Relapsed on PD-1 Inhibitor Therapy
- First Posted Date
- 2016-04-07
- Last Posted Date
- 2022-12-23
- Lead Sponsor
- Parker Institute for Cancer Immunotherapy
- Target Recruit Count
- 20
- Registration Number
- NCT02731729
- Locations
- 🇺🇸
Lehigh Valley Health Network, Allentown, Pennsylvania, United States
🇺🇸Memorial Sloan Kettering Cancer Center, New York, New York, United States
🇺🇸University of Pennsylvania, Philadelphia, Pennsylvania, United States
Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of Investigational Treatments in Combination With Standard of Care Immune Checkpoint Inhibitors in Participants With Advanced Melanoma
- Conditions
- Interventions
- First Posted Date
- 2016-03-30
- Last Posted Date
- 2024-03-05
- Lead Sponsor
- Millennium Pharmaceuticals, Inc.
- Target Recruit Count
- 22
- Registration Number
- NCT02723006
- Locations
- 🇺🇸
Emory University Hospital, Atlanta, Georgia, United States
🇺🇸Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States
🇺🇸Texas Oncology-Baylor Charles A. Sammons Cancer Center, Dallas, Texas, United States
Nivolumab in Treating Patients With Metastatic Adrenocortical Cancer
- First Posted Date
- 2016-03-28
- Last Posted Date
- 2019-05-01
- Lead Sponsor
- Northwestern University
- Target Recruit Count
- 10
- Registration Number
- NCT02720484
- Locations
- 🇺🇸
Northwestern University, Chicago, Illinois, United States
🇺🇸The Ohio State University Comprehensive Cancer Center, Columbus, Ohio, United States
Continuing Treatment for Participants Who Have Participated in a Prior Protocol Investigating Elotuzumab
- Conditions
- Interventions
- First Posted Date
- 2016-03-25
- Last Posted Date
- 2024-07-26
- Lead Sponsor
- Bristol-Myers Squibb
- Target Recruit Count
- 67
- Registration Number
- NCT02719613
- Locations
- 🇺🇸
Local Institution - 0009, Atlanta, Georgia, United States
🇺🇸Local Institution - 0002, Boston, Massachusetts, United States
🇯🇵Local Institution - 0048, Koto-ku, Tokyo, Japan
Nivolumab Monotherapy or Nivolumab Plus Ipilimumab, for Unresectable Malignant Pleural Mesothelioma (MPM) Patients
- First Posted Date
- 2016-03-23
- Last Posted Date
- 2021-02-10
- Target Recruit Count
- 125
- Registration Number
- NCT02716272
- Locations
- 🇫🇷
CHU, Clermont-Ferrand, France
🇫🇷AP-HP Hôpital Bichat, Paris, France
🇫🇷Gustave Roussy, Villejuif, France
An Open-Label, Dose-Escalation/Dose-Expansion Safety Study of INCB059872 in Subjects With Advanced Malignancies
- Conditions
- Interventions
- First Posted Date
- 2016-03-18
- Last Posted Date
- 2023-06-12
- Lead Sponsor
- Incyte Corporation
- Target Recruit Count
- 116
- Registration Number
- NCT02712905
- Locations
- 🇺🇸
Northwestern University, Chicago, Illinois, United States
🇺🇸University of Texas MD Anderson Cancer Center, Houston, Texas, United States
🇺🇸University of Kansas Center for Research, Inc., Kansas City, Kansas, United States
PAK4 and NAMPT in Patients With Solid Malignancies or NHL (PANAMA)
- First Posted Date
- 2016-03-08
- Last Posted Date
- 2024-11-25
- Lead Sponsor
- Karyopharm Therapeutics Inc
- Target Recruit Count
- 60
- Registration Number
- NCT02702492
- Locations
- 🇺🇸
MD Anderson Cancer Center, Houston, Texas, United States
🇺🇸UCLA Health, Los Angeles, California, United States
🇺🇸University of Colorado Cancer Center, Aurora, Colorado, United States
Nivolumab and Radiation Therapy With or Without Ipilimumab in Treating Patients With Brain Metastases From Non-small Cell Lung Cancer
- Conditions
- Interventions
- First Posted Date
- 2016-03-02
- Last Posted Date
- 2024-11-28
- Lead Sponsor
- M.D. Anderson Cancer Center
- Target Recruit Count
- 80
- Registration Number
- NCT02696993
- Locations
- 🇺🇸
M D Anderson Cancer Center, Houston, Texas, United States
Drug Development Updates
Stay informed with timely notifications on clinical trials, regulatory changes, and research advancements related to this medication.