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.
...

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

A Study of Nivolumab Intravenous (IV) to Subcutaneous (SC) Switch in Adjuvant Melanoma and Bladder Cancer

Phase 2

Withdrawn

Conditions: Melanoma
Urothelial Carcinoma

Interventions: Drug: Nivolumab/rHuPH20
Drug: Nivolumab

First Posted Date: 2022-08-11

Last Posted Date: 2023-04-14

Lead Sponsor: Bristol-Myers Squibb

Registration Number: NCT05496192

Locations: 🇩🇪
Local Institution - 0001, Berlin, Germany
🇪🇸
Local Institution - 0002, Sevilla, Spain
🇩🇪
Local Institution - 0020, Essen, North Rhine-Westphalia, Germany

Nivolumab During Active Surveillance After Neoadjuvant Chemoradiation for Esophageal Cancer: SANO-3 Study

Phase 2

Recruiting

Conditions: Esophageal Cancer

Interventions: Drug: Nivolumab

First Posted Date: 2022-08-08

Last Posted Date: 2024-03-12

Lead Sponsor: Erasmus Medical Center

Target Recruit Count: 74

Registration Number: NCT05491616

Locations: 🇳🇱
Erasmus MC, Rotterdam, Netherlands

Nivolumab and All-trans Retinoic Acid for Pancreatic Cancer

Early Phase 1

Active, not recruiting

Conditions: Effect of Drug

Interventions: Drug: Nivolumab
Drug: all trans retinoic acid

First Posted Date: 2022-08-01

Last Posted Date: 2024-08-21

Lead Sponsor: China Medical University Hospital

Target Recruit Count: 10

Registration Number: NCT05482451

Locations: 🇨🇳
China Medical University Hospital, Taichung, Please Select, Taiwan

Adjuvant Trastuzumab Deruxtecan (Enhertu) & Nivolumab For Patients Who Are Disease Free After Completion of Trimodality Treatment For HER-2+ Cancers of Esophagus & Gastroesophageal Junction

Phase 2

Recruiting

Conditions: Gastroesophageal-junction Cancer
Esophageal Adenocarcinoma
Esophageal Cancer
HER-2 Protein Overexpression

Interventions: Drug: Nivolumab
Drug: Trastuzumab deruxtecan

First Posted Date: 2022-07-29

Last Posted Date: 2024-11-25

Lead Sponsor: Brown University

Target Recruit Count: 25

Registration Number: NCT05480384

Locations: 🇺🇸
Weill Cornell Medicine/New York-Presbyterian, New York, New York, United States
🇺🇸
Lifespan Cancer Institute, Providence, Rhode Island, United States

Oxaliplatin ± Nivolumab in Combination With Trifluridine/Tipiracil or 5-fluorouracile in Frail Patients With Advanced, Recurrent or Metastatic Gastric, Oesophageal or Gastroesophageal Junction Cancer

Phase 2

Recruiting

Conditions: Gastric Adenocarcinoma
Esophagus Adenocarcinoma
Gastroesophageal Junction Adenocarcinoma

Interventions: Drug: Trifluridine/Tipiracil
Drug: FOLFOX regimen
Drug: Nivolumab
Drug: Oxaliplatin

First Posted Date: 2022-07-27

Last Posted Date: 2024-10-24

Lead Sponsor: UNICANCER

Target Recruit Count: 118

Registration Number: NCT05476796

Locations: 🇫🇷
CHU d'Estaing, Clermont-Ferrand, France
🇫🇷
Institut Andrée Dutreix - Clinique de Flandre, Coudekerque-Branche, France
🇫🇷
Clinique de l'Europe, Amiens, France

and more 26 locations

Neoadjuvant Anti-PD1 in HCC

Phase 2

Completed

Conditions: Hepatocellular Carcinoma
HCC
Liver Cancer

Interventions: Drug: Nivolumab
Procedure: Hepatectomy

First Posted Date: 2022-07-25

Last Posted Date: 2023-02-01

Lead Sponsor: Dr Tan-to CHEUNG

Target Recruit Count: 20

Registration Number: NCT05471674

Locations: 🇭🇰
Queen Mary Hospital, Hong Kong, Hong Kong

Nivolumab and Tovorafenib for Treatment of Craniopharyngioma in Children and Young Adults

Phase 2

Recruiting

Conditions: Recurrent Craniopharyngioma
Craniopharyngioma, Child
Craniopharyngioma

Interventions: Drug: Nivolumab
Drug: Tovorafenib

First Posted Date: 2022-07-19

Last Posted Date: 2024-12-19

Lead Sponsor: Sabine Mueller, MD, PhD

Target Recruit Count: 56

Registration Number: NCT05465174

Locations: 🇺🇸
University of Michigan, Ann Arbor, Michigan, United States
🇺🇸
University of Alabama at Birmingham, Birmingham, Alabama, United States
🇺🇸
Rady Children's Hospital/University of California, San Diego, San Diego, California, United States

and more 12 locations