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
Expanded Access Program With Nivolumab to Treat Melanoma
- First Posted Date
- 2014-05-20
- Last Posted Date
- 2016-09-29
- Lead Sponsor
- Bristol-Myers Squibb
- Registration Number
- NCT02142218
- Locations
- 🇺🇸
Cancer Specialists Of North Florida, Jacksonville, Florida, United States
🇺🇸Oncology Hematology Associates Of Sw In, Newburgh, Indiana, United States
🇺🇸Mount Sinai Comprehensive Cancer Center, Miami Beach, Florida, United States
A Phase Ib Study of Neoadjuvant of Cetuximab Plus Motolimod and Cetuximab Plus Motolimod Plus Nivolumab
- Conditions
- Interventions
- First Posted Date
- 2014-04-28
- Last Posted Date
- 2019-10-25
- Lead Sponsor
- Celgene
- Target Recruit Count
- 18
- Registration Number
- NCT02124850
- Locations
- 🇺🇸
University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, United States
Trial of Nivolumab vs Therapy of Investigator's Choice in Recurrent or Metastatic Head and Neck Carcinoma (CheckMate 141)
- Conditions
- Interventions
- First Posted Date
- 2014-04-07
- Last Posted Date
- 2022-10-05
- Lead Sponsor
- Bristol-Myers Squibb
- Target Recruit Count
- 361
- Registration Number
- NCT02105636
- Locations
- 🇨🇳
Local Institution - 0064, Taipei, Taiwan
🇨🇭Local Institution - 0051, Zuerich, Switzerland
🇺🇸Local Institution - 0004, Metairie, Louisiana, United States
A Study Evaluating the Safety, Pharmacokinetics (PK), and Preliminary Efficacy of ABBV-399 in Participants With Advanced Solid Tumors
- Conditions
- Interventions
- First Posted Date
- 2014-03-28
- Last Posted Date
- 2024-06-18
- Lead Sponsor
- AbbVie
- Target Recruit Count
- 237
- Registration Number
- NCT02099058
- Locations
- 🇺🇸
University of California, Los Angeles /ID# 148295, Los Angeles, California, United States
🇺🇸Massachusetts General Hospital /ID# 129804, Boston, Massachusetts, United States
🇺🇸Duke Cancer Center /ID# 123763, Durham, North Carolina, United States
Study of IDO Inhibitor in Combination With Checkpoint Inhibitors for Adult Patients With Metastatic Melanoma
- Conditions
- Interventions
- First Posted Date
- 2014-02-27
- Last Posted Date
- 2020-06-05
- Lead Sponsor
- NewLink Genetics Corporation
- Target Recruit Count
- 132
- Registration Number
- NCT02073123
- Locations
- 🇺🇸
Huntsman Cancer Institute, Salt Lake City, Utah, United States
🇺🇸Penn State Hershey Cancer Institue, Hershey, Pennsylvania, United States
🇺🇸Augusta University, Augusta, Georgia, United States
A Safety Trial of Nivolumab in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Progressed During or After Receiving At Least One Prior Chemotherapy Regimen
- First Posted Date
- 2014-02-19
- Last Posted Date
- 2022-10-27
- Lead Sponsor
- Bristol-Myers Squibb
- Target Recruit Count
- 1428
- Registration Number
- NCT02066636
- Locations
- 🇺🇸
Comprehensive Blood And Cancer Center, Bakersfield, California, United States
🇺🇸Ucla Hema/Onc-Santa Monica, Los Angeles, California, United States
🇺🇸Central Georgia Cancer Care, Pc, Macon, Georgia, United States
A Study of Nivolumab Alone or Nivolumab Combination Therapy in Colon Cancer That Has Come Back or Has Spread
- First Posted Date
- 2014-02-11
- Last Posted Date
- 2024-11-19
- Lead Sponsor
- Bristol-Myers Squibb
- Target Recruit Count
- 385
- Registration Number
- NCT02060188
- Locations
- 🇺🇸
Local Institution - 0028, Gilbert, Arizona, United States
🇺🇸Local Institution - 0004, Los Angeles, California, United States
🇺🇸Local Institution - 0036, Boston, Massachusetts, United States
Immunotherapy Study for Patients With Stage IV Melanoma
- Conditions
- Interventions
- First Posted Date
- 2014-02-04
- Last Posted Date
- 2023-04-18
- Lead Sponsor
- NewLink Genetics Corporation
- Target Recruit Count
- 47
- Registration Number
- NCT02054520
- Locations
- 🇺🇸
University of Tennessee Medical Center, Knoxville, Tennessee, United States
🇺🇸University of Kansas Cancer Center, Westwood, Kansas, United States
🇺🇸Oncology Specialists, Niles, Illinois, United States
Small Cell Lung Carcinoma Trial With Nivolumab and IpiliMUmab in LImited Disease
- Conditions
- Interventions
- First Posted Date
- 2014-01-28
- Last Posted Date
- 2024-11-08
- Lead Sponsor
- ETOP IBCSG Partners Foundation
- Target Recruit Count
- 222
- Registration Number
- NCT02046733
- Locations
- 🇦🇺
Royal Hobart Hospital, Hobart, Australia
🇪🇸Hospital Universitario 12 Octubre, Madrid, Spain
🇦🇺Coffs Harbour Health Campus, Coffs Harbour, Australia
Study of Nivolumab in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL) That Have Either Failed or Are Not Eligible for Autologous Stem Cell Transplant (CheckMate 139)
- First Posted Date
- 2014-01-17
- Last Posted Date
- 2021-10-14
- Lead Sponsor
- Bristol-Myers Squibb
- Target Recruit Count
- 121
- Registration Number
- NCT02038933
- Locations
- 🇬🇧
Local Institution, Sutton, Surrey, United Kingdom
🇫🇷Hopital Saint Eloi, Montpellier Cedex 05, France
🇺🇸John Theurer Cancer Center at Hackensack University Medical Center, Hackensack, New Jersey, United States
Drug Development Updates
Stay informed with timely notifications on clinical trials, regulatory changes, and research advancements related to this medication.