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

Clinical Trials

Nivolumab and Ipilimumab in Treating Patients With HIV Associated Relapsed or Refractory Classical Hodgkin Lymphoma or Solid Tumors That Are Metastatic or Cannot Be Removed by Surgery

Phase 1

Recruiting

Conditions: Kaposi Sarcoma
Recurrent Classic Hodgkin Lymphoma
Metastatic Malignant Solid Neoplasm
HIV Infection
Unresectable Solid Neoplasm
Advanced Malignant Solid Neoplasm
Anal Carcinoma
Lung Carcinoma
Refractory Classic Hodgkin Lymphoma

Interventions: Procedure: Biospecimen Collection
Procedure: Bone Marrow Biopsy
Procedure: Computed Tomography
Biological: Ipilimumab
Biological: Nivolumab
Procedure: Positron Emission Tomography

First Posted Date: 2015-04-06

Last Posted Date: 2024-08-09

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 96

Registration Number: NCT02408861

Locations: 🇺🇸
Washington University School of Medicine, Saint Louis, Missouri, United States
🇺🇸
UC San Diego Moores Cancer Center, La Jolla, California, United States
🇺🇸
UCLA Center for Clinical AIDS Research and Education, Los Angeles, California, United States

and more 31 locations

An Open-Label, Multicenter Clinical Trial With Nivolumab (BMS-936558) Monotherapy in Subjects With Advanced or Metastatic Squamous Cell (Sq) Non-Small Cell Lung Cancer (NSCLC) Who Have Received at Least One Prior Systemic Regimen for the Treatment of Stage IIIb/IV SqNSCLC

Phase 2

Completed

Conditions: Non-Small Cell Lung Cancer

Interventions: Drug: Nivolumab

First Posted Date: 2015-04-06

Last Posted Date: 2022-11-14

Lead Sponsor: Bristol-Myers Squibb

Target Recruit Count: 812

Registration Number: NCT02409368

Locations: 🇦🇹
Local Institution - 0005, Wien, Austria
🇵🇹
Local Institution - 0092, Porto, Portugal
🇦🇹
Local Institution - 0003, Salzburg, Austria

and more 87 locations

A Phase II Trial of Sunitinib and Nivolumab for KIT-mutated Advanced Melanoma

Phase 2

Withdrawn

Conditions: Melanoma

Interventions: Drug: sunitinib
Drug: nivolumab

First Posted Date: 2015-03-27

Last Posted Date: 2017-02-01

Lead Sponsor: California Pacific Medical Center Research Institute

Registration Number: NCT02400385

Locations: 🇺🇸
California Pacific Medical Center Research Institute, San Francisco, California, United States

Nivolumab and Azacitidine With or Without Ipilimumab in Treating Patients With Refractory/Relapsed or Newly Diagnosed Acute Myeloid Leukemia

Phase 2

Completed

Conditions: Acute Bilineal Leukemia
Refractory Acute Myeloid Leukemia
Acute Biphenotypic Leukemia
Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
Chronic Myelomonocytic Leukemia
Secondary Acute Myeloid Leukemia
Myelodysplastic Syndrome
Recurrent Acute Myeloid Leukemia
Therapy-Related Acute Myeloid Leukemia

Interventions: Drug: Azacitidine
Drug: Nivolumab
Drug: Ipilimumab
Drug: Venetoclax

First Posted Date: 2015-03-25

Last Posted Date: 2024-11-04

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 150

Registration Number: NCT02397720

Locations: 🇺🇸
M D Anderson Cancer Center, Houston, Texas, United States

Study of Safety and Efficacy of Ceritinib in Combination With Nivolumab in Patients With ALK-positive Non-small Cell Lung Cancer

Phase 1

Active, not recruiting

Conditions: ALK-positive NSCLC

Interventions: Drug: Ceritinib (LDK378)
Drug: Nivolumab

First Posted Date: 2015-03-19

Last Posted Date: 2024-10-11

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 57

Registration Number: NCT02393625

Locations: 🇪🇸
Novartis Investigative Site, Barcelona, Catalunya, Spain
🇺🇸
Mayo Clinic - Arizona, Scottsdale, Arizona, United States
🇺🇸
Massachusetts General Hospital Thoracic Oncolgoy, Boston, Massachusetts, United States

Cisplatin Plus Romidepsin & Nivolumab in Locally Recurrent or Metastatic Triple Negative Breast Cancer (TNBC)

Phase 1

Active, not recruiting

Conditions: Breast Cancer
Triple-Negative Breast Cancer

Interventions: Drug: Romidepsin
Drug: Cisplatin
Drug: Nivolumab

First Posted Date: 2015-03-19

Last Posted Date: 2023-04-27

Lead Sponsor: Priyanka Sharma

Target Recruit Count: 51

Registration Number: NCT02393794

Locations: 🇺🇸
University of Kansas Cancer Center - Westwood, Westwood, Kansas, United States
🇺🇸
University of Kansas Cancer Center - West, Kansas City, Kansas, United States
🇺🇸
University of Kansas Cancer Center - Overland Park, Overland Park, Kansas, United States

and more 4 locations

Efficacy Study of Nivolumab Compared to Ipilimumab in Prevention of Recurrence of Melanoma After Complete Resection of Stage IIIb/c or Stage IV Melanoma

Phase 3

Completed

Conditions: Melanoma

Interventions: Drug: Ipilimumab
Drug: Nivolumab
Other: Placebo matching Nivolumab
Other: Placebo matching Ipilimumab

First Posted Date: 2015-03-17

Last Posted Date: 2024-12-04

Lead Sponsor: Bristol-Myers Squibb

Target Recruit Count: 906

Registration Number: NCT02388906

Locations: 🇺🇸
Local Institution - 0157, Columbus, Ohio, United States
🇺🇸
Local Institution - 0013, Boston, Massachusetts, United States
🇺🇸
Local Institution - 0025, Durham, North Carolina, United States

and more 133 locations

A Study of Nivolumab in Participants With Metastatic or Unresectable Bladder Cancer

Phase 2

Completed

Conditions: Various Advanced Cancer

Interventions: Drug: Nivolumab

First Posted Date: 2015-03-13

Last Posted Date: 2022-11-01

Lead Sponsor: Bristol-Myers Squibb

Target Recruit Count: 270

Registration Number: NCT02387996

Locations: 🇺🇸
Local Institution - 0012, Duarte, California, United States
🇺🇸
Local Institution - 0052, Iowa City, Iowa, United States
🇺🇸
Crescent City Research Consortium, LLC, Marrero, Louisiana, United States

and more 61 locations

HPV-16/18 E6/E7-Specific T Lymphocytes, Relapsed HPV-Associated Cancers, HESTIA

Phase 1

Active, not recruiting

Conditions: Human Papillomavirus Positive Oropharyngeal Carcinoma
Human Papillomavirus Positive Cervical Carcinoma
Human Papillomavirus Positive Anal Carcinoma
Human Papillomavirus Positive Vulvar Carcinoma
Human Papillomavirus-Related Carcinoma
Human Papillomavirus Positive Penile Carcinoma

Interventions: Genetic: HPV Specific T Cells
Drug: Cytoxan
Drug: Fludarabine
Biological: Nivolumab

First Posted Date: 2015-03-05

Last Posted Date: 2024-12-04

Lead Sponsor: Baylor College of Medicine

Target Recruit Count: 32

Registration Number: NCT02379520

Locations: 🇺🇸
Houston Methodist Hospital, Houston, Texas, United States

Anti-PD 1 Brain Collaboration for Patients With Melanoma Brain Metastases

Phase 2

Active, not recruiting

Conditions: Brain Metastases
Melanoma

Interventions: Drug: Nivolumab
Drug: Ipilimumab

First Posted Date: 2015-02-27

Last Posted Date: 2024-03-19

Lead Sponsor: Melanoma Institute Australia

Target Recruit Count: 76

Registration Number: NCT02374242

Locations: 🇦🇺
Princess Alexandra Hospital, Woolloongabba, Queensland, Australia
🇦🇺
Melanoma Institute Australia, North Sydney, New South Wales, Australia
🇦🇺
Royal Adelaide Hospital, Adelaide, South Australia, Australia

and more 1 locations

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