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

Study of Nivolumab in Subjects With Relapsed or Refractory Follicular Lymphoma (FL) (CheckMate 140)

Phase 2
Completed
Conditions
Interventions
First Posted Date
2014-01-17
Last Posted Date
2022-01-04
Lead Sponsor
Bristol-Myers Squibb
Target Recruit Count
116
Registration Number
NCT02038946
Locations
🇺🇸

Mayo Clinic Arizona, Phoenix, Arizona, United States

🇺🇸

Weill Cornell Medical College, New York, New York, United States

🇬🇧

Local Institution, Sutton, Surrey, United Kingdom

and more 18 locations

A Phase 1B Study to Investigate the Safety and Preliminary Efficacy for the Combination of Dasatinib Plus Nivolumab in Patients With Chronic Myeloid Leukemia

Phase 1
Completed
Conditions
Interventions
First Posted Date
2013-12-16
Last Posted Date
2020-03-18
Lead Sponsor
Bristol-Myers Squibb
Target Recruit Count
35
Registration Number
NCT02011945
Locations
🇨🇦

Princess Margaret Cancer Centre, Toronto, Ontario, Canada

🇨🇦

QEII Health Sciences Centre-VG Site, Halifax, Nova Scotia, Canada

🇩🇪

Campus Virchow Klinikum Der Charite, Berlin, Germany

and more 10 locations

A Phase 1 Study of Pegilodecakin (LY3500518) in Participants With Advanced Solid Tumors

First Posted Date
2013-12-12
Last Posted Date
2024-11-15
Lead Sponsor
Eli Lilly and Company
Target Recruit Count
353
Registration Number
NCT02009449
Locations
🇺🇸

UCLA Medical Hematology & Oncology, Los Angeles, California, United States

🇺🇸

Memorial Sloan Kettering Cancer Center, New York, New York, United States

🇺🇸

Florida Cancer Specialists & Research Institute, Sarasota, Florida, United States

and more 7 locations

Combination Checkpoint Inhibitor Plus Erlotinib or Crizotinib for EGFR or ALK Mutated Stage IV Non-small Cell Lung Cancer

First Posted Date
2013-11-28
Last Posted Date
2018-04-02
Lead Sponsor
University of Utah
Target Recruit Count
14
Registration Number
NCT01998126
Locations
🇺🇸

Huntsman Cancer Institute, Salt Lake City, Utah, United States

Phase II Anti-PD1 Epigenetic Therapy Study in NSCLC.

First Posted Date
2013-08-26
Last Posted Date
2024-05-03
Lead Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Target Recruit Count
143
Registration Number
NCT01928576
Locations
🇺🇸

University of Southern California, Los Angeles, California, United States

🇺🇸

UPMC Cancer Center- Hillman Cancer Center, Pittsburgh, Pennsylvania, United States

🇺🇸

Sibley Memorial Hospital, Washington, District of Columbia, United States

and more 1 locations

Study of Nivolumab (BMS-936558) Plus Ipilimumab Compared With Ipilimumab Alone in the Treatment of Previously Untreated, Unresectable, or Metastatic Melanoma

First Posted Date
2013-08-22
Last Posted Date
2022-03-18
Lead Sponsor
Bristol-Myers Squibb
Target Recruit Count
142
Registration Number
NCT01927419
Locations
🇺🇸

Duke University Medical Center, Durham, North Carolina, United States

🇺🇸

Dana Farber Cancer Institute, Boston, Massachusetts, United States

🇺🇸

Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, United States

and more 18 locations

Brentuximab Vedotin and Nivolumab With or Without Ipilimumab in Treating Patients With Relapsed or Refractory Hodgkin Lymphoma

First Posted Date
2013-07-11
Last Posted Date
2024-11-12
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
146
Registration Number
NCT01896999
Locations
🇺🇸

Anchorage Oncology Centre, Anchorage, Alaska, United States

🇺🇸

Katmai Oncology Group, Anchorage, Alaska, United States

🇺🇸

Providence Alaska Medical Center, Anchorage, Alaska, United States

and more 482 locations

Study of Nivolumab (BMS-936558) in Patients With Advanced or Metastatic Squamous Cell Nonsmall-cell Lung Cancer Who Have Received At Least 2 Prior Systemic Regimens

Phase 2
Completed
Conditions
Interventions
First Posted Date
2012-11-06
Last Posted Date
2022-06-28
Lead Sponsor
Bristol-Myers Squibb
Target Recruit Count
117
Registration Number
NCT01721759
Locations
🇺🇸

The Ohio State University, Columbus, Ohio, United States

🇺🇸

Winship Cancer Institute., Atlanta, Georgia, United States

🇺🇸

Providence Cancer Institute, Southfield, Michigan, United States

and more 17 locations

A Study of Brentuximab Vedotin With Hodgkin Lymphoma (HL) and CD30-expressing Peripheral T-cell Lymphoma (PTCL)

First Posted Date
2012-10-30
Last Posted Date
2024-06-11
Lead Sponsor
Seagen Inc.
Target Recruit Count
131
Registration Number
NCT01716806
Locations
🇺🇸

Wenatchee Valley Medical Center, Wenatchee, Washington, United States

🇺🇸

James Cancer Hospital / Ohio State University, Columbus, Ohio, United States

🇺🇸

Swedish Cancer Institute, Seattle, Washington, United States

and more 51 locations

A Study of an Anti-KIR Antibody Lirilumab in Combination With an Anti-PD1 Antibody Nivolumab and Nivolumab Plus an Anti-CTLA-4 Ipilimumab Antibody in Patients With Advanced Solid Tumors

Phase 1
Completed
Conditions
Interventions
First Posted Date
2012-10-26
Last Posted Date
2023-02-02
Lead Sponsor
Bristol-Myers Squibb
Target Recruit Count
337
Registration Number
NCT01714739
Locations
🇺🇸

The Ohio State University Wexner Medical Center, Columbus, Ohio, United States

🇺🇸

UPMC Eye and Ear Institute, Pittsburgh, Pennsylvania, United States

🇺🇸

Beth Israel Deaconess Med Ctr, Boston, Massachusetts, United States

and more 21 locations
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