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

A Study to Evaluate the Efficacy and Safety of Autogene Cevumeran With Nivolumab Versus Nivolumab Alone in Participants With High-Risk Muscle-Invasive Urothelial Carcinoma (MIUC)

Phase 2

Recruiting

Conditions: Muscle Invasive Urothelial Carcinoma

Interventions: Drug: Nivolumab
Drug: Autogene Cevumeran
Drug: Saline

First Posted Date: 2024-08-02

Last Posted Date: 2024-12-03

Lead Sponsor: Hoffmann-La Roche

Target Recruit Count: 362

Registration Number: NCT06534983

Locations: 🇺🇸
Memorial Sloan Kettering Cancer Center, New York, New York, United States
🇩🇪
Uniklinikum Heidelberg, Heidelberg, Germany
🇮🇹
IFO - Istituto Regina Elena; Oncologia Medica, Roma, Lazio, Italy

and more 4 locations

CD8 PET Imaging in Metastatic Solid Tumours

Phase 2

Not yet recruiting

Conditions: Locally Advanced Solid Tumor

Interventions: Radiation: 89Zr-Df-crefmirlimab PET scan
Drug: Nivolumab
Drug: Cetrelimab
Other: zirconium Zr 89 crefmirlimab berdoxam

First Posted Date: 2024-08-02

Last Posted Date: 2024-12-13

Lead Sponsor: University Medical Center Groningen

Target Recruit Count: 30

Registration Number: NCT06534190

Locations: 🇳🇱
VUMC, Amsterdam, Netherlands
🇳🇱
University Medical Center Groningen, Groningen, Netherlands
🇬🇧
University of Cambridge, Cambridge, United Kingdom

and more 1 locations

ERectile Dysfunctions, gOnadotoxicity and Sexual Health Assessment in Men With Lung Cancer

Recruiting

Conditions: Hypogonadism, Male
NSCLC Stage IV
Sex Disorder
Erectile Dysfunction

Interventions: Drug: Alectinib
Drug: Osimertinib
Drug: Pembrolizumab
Drug: Cemiplimab
Drug: Brigatinib
Drug: Sotorasib
Drug: Lorlatinib 100 mg
Drug: Dabrafenib
Drug: Nivolumab
Drug: Trametinib
Drug: Carboplatin
Drug: Pemetrexed
Drug: Selpercatinib
Drug: Paclitaxel

First Posted Date: 2024-08-01

Last Posted Date: 2024-08-09

Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Target Recruit Count: 80

Registration Number: NCT06532149

Locations: 🇮🇹
Fondazione Policlinico Gemelli IRCCS, Rome, Italy

Nivolumab in Multiple Myeloma Patients After Idecabtagene Vicleucel

Phase 2

Not yet recruiting

Conditions: Multiple Myeloma

Interventions: Drug: Nivolumab

First Posted Date: 2024-07-26

Last Posted Date: 2024-12-04

Lead Sponsor: Wake Forest University Health Sciences

Target Recruit Count: 50

Registration Number: NCT06523621

Locations: 🇺🇸
Atrium Health Wake Forest Baptist Comprehensive Cancer Center, Winston-Salem, North Carolina, United States
🇺🇸
Levine Cancer Institute, Charlotte, North Carolina, United States

A Pilot Study Investigating Upfront Adaptive Immunotherapy Approach in Children, Adolescent and Young Adult (CAYA) Patients with Replication-Repair Deficient (RRD) High-Grade Gliomas (HGG)

Not Applicable

Not yet recruiting

Conditions: High Grade Glioma
Replication Repair Deficient

Interventions: Drug: Nivolumab
Radiation: Radiation

First Posted Date: 2024-07-25

Last Posted Date: 2024-12-04

Lead Sponsor: Daniel Morgenstern

Target Recruit Count: 20

Registration Number: NCT06519682

Retrospective Evaluation of Nivolumab in Adjuvant Esophageal Cancer/Gastroesophageal Junction Cancer

Active, not recruiting

Conditions: Esophageal Cancer
Gastroesophageal Junction Cancer

Interventions: Drug: Nivolumab

First Posted Date: 2024-07-12

Last Posted Date: 2024-12-11

Lead Sponsor: Bristol-Myers Squibb

Target Recruit Count: 115

Registration Number: NCT06499298

Locations: 🇨🇳
Local Institution - 0001, Shanghai, China

The Sagittarius Trial

Phase 3

Recruiting

Conditions: Colon Cancer Stage II
Colon Cancer Stage III

Interventions: Drug: Oxaliplatin
Drug: Nivolumab
Drug: Capecitabine
Drug: Ipilimumab
Drug: Folinic acid
Drug: Trastuzumab
Drug: Fluorouracil
Drug: Pertuzumab
Drug: Temozolomide
Drug: Panitumumab
Drug: Irinotecan

First Posted Date: 2024-07-08

Last Posted Date: 2024-11-11

Lead Sponsor: IFOM ETS - The AIRC Institute of Molecular Oncology

Target Recruit Count: 700

Registration Number: NCT06490536

Locations: 🇮🇹
Istituto Clinico Humanitas, Rozzano, Milano, Italy
🇮🇹
Istituto di Candiolo, Candiolo, Torino, Italy
🇮🇹
Azienda Sanitaria Locale di Biella, Biella, Italy

and more 11 locations