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

CYTO Reductive Surgery in Kidney Cancer Plus Immunotherapy and Targeted Kinase Inhibition

Phase 2

Recruiting

Conditions: Kidney Cancer
Renal Cell Carcinoma

Interventions: Drug: Cabozantinib
Drug: Nivolumab
Procedure: Cytoreductive nephrectomy

First Posted Date: 2020-03-26

Last Posted Date: 2023-10-23

Lead Sponsor: Mark Stein

Target Recruit Count: 48

Registration Number: NCT04322955

Locations: 🇺🇸
The Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey, United States
🇺🇸
Columbia University Irving Medical Center, New York, New York, United States
🇺🇸
Cleveland Clinic, Cleveland, Ohio, United States

and more 1 locations

Vopratelimab (JTX-2011) Alone and in Combination With Anti-Programmed Cell Death Protein 1 (PD-1) or Anti-Cytotoxic T-Lymphocyte Antigen 4 (CTLA-4) in Subjects With Advanced and/or Refractory Solid Tumors

Phase 1

Terminated

Conditions: Cancer

Interventions: Drug: Vopratelimab
Drug: Nivolumab
Drug: Ipilimumab

First Posted Date: 2020-03-24

Last Posted Date: 2024-05-30

Lead Sponsor: Jounce Therapeutics, Inc.

Target Recruit Count: 4

Registration Number: NCT04319224

Locations: 🇺🇸
The University of Texas - MD Anderson Cancer Center, Houston, Texas, United States
🇺🇸
University of Virginia Health Systems, Charlottesville, Virginia, United States
🇺🇸
Washington University School of Medicine, Saint Louis, Missouri, United States

Testing the Addition of an Anti-cancer Drug, Copanlisib, to the Usual Immunotherapy (Nivolumab With or Without Ipilimumab) in Patients With Advanced Solid Cancers That Have Changes in the Following Genes: PIK3CA and PTEN

Phase 1

Active, not recruiting

Conditions: Unresectable Malignant Solid Neoplasm
Advanced Malignant Solid Neoplasm
Metastatic Malignant Solid Neoplasm

Interventions: Procedure: Biopsy
Procedure: Biospecimen Collection
Procedure: Computed Tomography
Drug: Copanlisib Hydrochloride
Procedure: Echocardiography
Biological: Ipilimumab
Biological: Nivolumab
Procedure: X-Ray Imaging

First Posted Date: 2020-03-23

Last Posted Date: 2024-11-26

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 102

Registration Number: NCT04317105

Locations: 🇺🇸
University of Texas Medical Branch, Galveston, Texas, United States
🇨🇦
University Health Network-Princess Margaret Hospital, Toronto, Ontario, Canada
🇺🇸
Dana-Farber Cancer Institute, Boston, Massachusetts, United States

and more 3 locations

Evaluating Safety & Efficacy Belinostat Combo w Nivo Alone & w Ipi in Patients w Treated Metastatic/Advanced Carcinomas w ARID1A Lof Mutation

Phase 1

Withdrawn

Conditions: Metastatic Adenocarcinoma

Interventions: Drug: Belinostat
Drug: ipilimumab
Drug: nivolumab

First Posted Date: 2020-03-19

Last Posted Date: 2020-10-28

Lead Sponsor: University of Utah

Registration Number: NCT04315155

A Study Evaluating the Drug Levels of Iplimumab Given Under the Skin Alone and in Combination With Nivolumab in Multiple Tumor Types

Phase 1

Terminated

Conditions: Tumor

Interventions: Drug: ipilimumab
Drug: ENHANZE (rHuPH20)
Drug: nivolumab

First Posted Date: 2020-03-17

Last Posted Date: 2023-02-24

Lead Sponsor: Bristol-Myers Squibb

Target Recruit Count: 21

Registration Number: NCT04311710

Locations: 🇳🇿
Local Institution - 0010, Auckland, New Zealand
🇺🇸
Local Institution - 0013, Fort Wayne, Indiana, United States
🇮🇹
Istituto Nazionale Tumori IRCCS Fondazione Pascale-s.c. melanoma, immunoterapia oncologica e terapie, Napoli, Italy

and more 3 locations

Testing the Addition of the Pill Chemotherapy, Cabozantinib, to the Standard Immune Therapy Nivolumab Compared to Standard Chemotherapy for Non-small Cell Lung Cancer

Phase 2

Active, not recruiting

Conditions: Metastatic Lung Non-Squamous Non-Small Cell Carcinoma
Recurrent Lung Non-Squamous Non-Small Cell Carcinoma
Stage IV Lung Cancer AJCC v8

Interventions: Procedure: Biospecimen Collection
Drug: Cabozantinib S-malate
Procedure: Computed Tomography
Drug: Docetaxel
Procedure: Echocardiography
Biological: Nivolumab
Drug: Gemcitabine Hydrochloride
Drug: Nab-paclitaxel
Drug: Paclitaxel
Biological: Ramucirumab

First Posted Date: 2020-03-17

Last Posted Date: 2024-12-27

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 117

Registration Number: NCT04310007

Locations: 🇺🇸
Advocate Sherman Hospital, Elgin, Illinois, United States
🇺🇸
Illinois CancerCare-Eureka, Eureka, Illinois, United States
🇺🇸
The Carle Foundation Hospital, Urbana, Illinois, United States

and more 614 locations

Adjuvant Nivolumab Treatment in Stage II (IIA, IIB, IIC) High-risk Melanoma

Phase 3

Active, not recruiting

Conditions: Malignant Melanoma Stage II

Interventions: Drug: Nivolumab

First Posted Date: 2020-03-16

Last Posted Date: 2024-05-23

Lead Sponsor: University Hospital, Essen

Target Recruit Count: 374

Registration Number: NCT04309409

Locations: 🇩🇪
Universitätsklinik Carl Gustav Carus der Technischen Universität Dresden - Klinik und Poliklinik für Dermatologie, Dresden, Germany
🇩🇪
St. Josef-Hospital - Dermatologische Studienambulanz, Bochum, Germany
🇩🇪
Universitätsklinikum Würzburg - Klinik für Dermatologie, Venerologie und Allergologie, Würzburg, Bayern, Germany

and more 17 locations

Safety and Efficacy Study of AVB-S6-500 (Batiraxcept) in Patients With Advanced or Metastatic Clear Cell Renal Cell Carcinoma

Phase 1

Terminated

Conditions: Clear Cell Renal Cell Carcinoma

Interventions: Drug: Batiraxcept
Drug: Cabozantinib (Cabo)
Drug: Nivolumab

First Posted Date: 2020-03-09

Last Posted Date: 2023-10-30

Lead Sponsor: Aravive, Inc.

Target Recruit Count: 72

Registration Number: NCT04300140

Locations: 🇺🇸
University of Pennsylvania Abramson Cancer Center, Philadelphia, Pennsylvania, United States
🇺🇸
University of Texas Southwestern, Dallas, Texas, United States
🇺🇸
University of Maryland Greenebaum Comprehensive Cancer Center, Baltimore, Maryland, United States

and more 14 locations

Rollover Study to Provide Continued Access to Napabucasin for Patients Enrolled in Boston Biomedical-sponsored Protocols

Phase 1

Completed

Conditions: Oncology

Interventions: Drug: Napabucasin
Drug: Nivolumab
Drug: Nab-paclitaxel
Drug: Paclitaxel
Drug: Irinotecan
Drug: Leucovorin
Drug: Gemcitabine
Drug: 5Fluorouracil
Drug: Bevacizumab

First Posted Date: 2020-03-09

Last Posted Date: 2023-11-08

Lead Sponsor: Sumitomo Pharma America, Inc.

Target Recruit Count: 7

Registration Number: NCT04299880

Locations: 🇯🇵
Kyorin University Hospital, Tokyo, Japan
🇺🇸
Maine Center for Cancer Medicine, Scarborough, Maine, United States
🇺🇸
Winship Cancer Institute, Emory University, Atlanta, Georgia, United States

and more 4 locations

A First-in-human Study Using BDC-1001 as a Single Agent and in Combination With Nivolumab in Advanced HER2-Expressing Solid Tumors

Phase 1

Active, not recruiting

Conditions: HER2-positive Colorectal Cancer
HER2-positive Solid Tumors
HER2-positive Endometrial Cancer
HER2-positive Breast Cancer
HER2-positive Gastroesophageal Cancer

Interventions: Drug: BDC-1001
Drug: Nivolumab

First Posted Date: 2020-02-20

Last Posted Date: 2024-10-09

Lead Sponsor: Bolt Biotherapeutics, Inc.

Target Recruit Count: 175

Registration Number: NCT04278144

Locations: 🇺🇸
The University of Chicago Medical Center, Chicago, Illinois, United States
🇺🇸
Stanford University, Palo Alto, California, United States
🇺🇸
Georgetown University Medical Center, Washington, District of Columbia, United States

and more 18 locations

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