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.

Nivolumab was granted FDA approval on 22 December 2014.

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 deficient metastatic colorectal cancer, hepatocellular carcinoma, and esophageal cancer. The indication for classical Hodgkin lymphoma, microsatellite instability-high or mismatch repair deficient metastatic colorectal cancer, and hepatocellular carcinoma were approved under accelerated approval based on the overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

Nivolumab is also approved for the treatment of HER2-negative advanced or metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma when used in combination with a fluoropyrimidine- and platinum-containing chemotherapy regimen.

In combination with relatlimab, nivolumab is indicated for the treatment of patients ≥12 years old with unresectable or metastatic melanoma.

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

Radio-Immunotherapy Before Cystectomy in Locally Advanced Urothelial Carcinoma of the Bladder

Phase 2

Conditions: Urinary Bladder Cancer

Interventions: Drug: Nivolumab
Radiation: Radiation therapy of the pelvis
Procedure: Radical cystectomy with standardized pelvic lymphadenectomy

First Posted Date: 2018-05-18

Last Posted Date: 2022-10-20

Lead Sponsor: Technical University of Munich

Target Recruit Count: 33

Registration Number: NCT03529890

Locations: 🇩🇪
Department of Urology, Klinikum rechts der Isar der Technischen Universität München, München, Germany
🇩🇪
Universitätsklinikum Ulm; Klinik für Urologie, Ulm, Germany
🇩🇪
Department of Urology, Universitätsklinikum Würzburg, Würzburg, Germany

Study of Adjuvant Ipilimumab and Nivolumab in Subjects With High-risk Ocular Melanoma

Phase 2

Active, not recruiting

Conditions: Melanoma
Ocular Melanoma

Interventions: Drug: Nivolumab
Drug: Ipilimumab

First Posted Date: 2018-05-17

Last Posted Date: 2023-04-11

Lead Sponsor: Suthee Rapisuwon

Target Recruit Count: 52

Registration Number: NCT03528408

Locations: 🇺🇸
Northwestern Univeristy Feinberg School of Medicine, Chicago, Illinois, United States
🇺🇸
MD Anderson Cancer Center, Houston, Texas, United States
🇺🇸
Georgetown University, Washington, District of Columbia, United States

and more 3 locations

Nivolumab Plus Ramucirumab in Patients With Recurrent, Advanced, Metastatic NSCLC

Phase 2

Recruiting

Conditions: Non Small Cell Lung Cancer

Interventions: Drug: Nivolumab
Drug: Ramucirumab

First Posted Date: 2018-05-16

Last Posted Date: 2024-06-06

Lead Sponsor: Fox Chase Cancer Center

Target Recruit Count: 39

Registration Number: NCT03527108

Locations: 🇺🇸
NYU Langone, New York, New York, United States
🇺🇸
Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States

Trastuzumab Deruxtecan With Nivolumab in Advanced Breast and Urothelial Cancer

Phase 1

Conditions: Breast Cancer
Urothelial Carcinoma

Interventions: Drug: Trastuzumab deruxtecan
Drug: Nivolumab

First Posted Date: 2018-05-14

Last Posted Date: 2021-08-12

Lead Sponsor: Daiichi Sankyo

Target Recruit Count: 99

Registration Number: NCT03523572

Locations: 🇺🇸
Yale University, New Haven, Connecticut, United States
🇺🇸
Icahn School of Medicine at Mount Sinai, New York, New York, United States
🇺🇸
Tennessee Oncology - Sara Cannon Research Institute, Nashville, Tennessee, United States

and more 26 locations

Nivolumab Alone or Plus Relatlimab or Ipilimumab for Patients With Locally-Advanced Unresectable or Metastatic Basal Cell Carcinoma

Phase 2

Recruiting

Conditions: Basal Cell Carcinoma

Interventions: Drug: Nivolumab
Drug: Ipilimumab
Drug: Relatlimab

First Posted Date: 2018-05-11

Last Posted Date: 2024-03-22

Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Target Recruit Count: 57

Registration Number: NCT03521830

Locations: 🇺🇸
Johns Hopkins Hospital, Baltimore, Maryland, United States

Intensity-Modulated Radiation Therapy & Nivolumab for Recurrent or Second Primary Head & Neck Squamous Cell Cancer

Phase 2

Active, not recruiting

Conditions: Recurrent Head and Neck Squamous Cell Carcinoma

Interventions: Radiation: IMRT
Biological: Nivolumab

First Posted Date: 2018-05-11

Last Posted Date: 2023-05-09

Lead Sponsor: Emory University

Target Recruit Count: 51

Registration Number: NCT03521570

Locations: 🇺🇸
Froedtert and the Medical College of Wisconsin, Milwaukee, Wisconsin, United States
🇺🇸
Emory University Hospital Midtown, Atlanta, Georgia, United States
🇺🇸
Emory University Hospital/Winship Cancer Institute, Atlanta, Georgia, United States

and more 1 locations

A Study in Ovarian Cancer Patients Evaluating Rucaparib and Nivolumab as Maintenance Treatment Following Response to Front-Line Platinum-Based Chemotherapy

Phase 3

Active, not recruiting

Conditions: Partial Response
Newly Diagnosed
Complete Response
Primary Peritoneal
Epithelial Ovarian Cancer
Fallopian Tube Cancer
FIGO Stage III-IV

Interventions: Drug: Placebo Oral Tablet
Drug: Rucaparib
Drug: Nivolumab
Drug: Placebo IV Infusion

First Posted Date: 2018-05-11

Last Posted Date: 2024-07-12

Lead Sponsor: pharmaand GmbH

Target Recruit Count: 1000

Registration Number: NCT03522246

Locations: 🇺🇸
Northside Hospital, Atlanta, Georgia, United States
🇺🇸
UCLA Women's Health Clinical Research Unit, Los Angeles, California, United States
🇺🇸
Cleveland Clinic, Cleveland, Ohio, United States

and more 234 locations

A Study to Test the Safety of Immunotherapy With Nivolumab Alone or With Ipilimumab Before Surgery for Bladder Cancer Patients Who Are Not Suitable for Chemotherapy

Phase 2

Recruiting

Conditions: Bladder Cancer

Interventions: Drug: Nivolumab
Drug: Ipilimumab
Procedure: Radical cystectomy

First Posted Date: 2018-05-09

Last Posted Date: 2024-10-29

Lead Sponsor: Memorial Sloan Kettering Cancer Center

Target Recruit Count: 45

Registration Number: NCT03520491

Locations: 🇺🇸
Memorial Sloan Kettering Basking Ridge (All Protocol Activities), Basking Ridge, New Jersey, United States
🇺🇸
Memorial Sloan Kettering Monmouth (All Protocol Activities), Middletown, New Jersey, United States
🇺🇸
Memorial Sloan Kettering Bergen (All Protocol Activities), Montvale, New Jersey, United States

and more 4 locations