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

A Phase 2 Study of Sitravatinib in Combination With PD-(L)1 Checkpoint Inhibitor Regimens in Patients With Advanced or Metastatic Urothelial Carcinoma

Phase 2

Terminated

Conditions: Urothelial Carcinoma
Urothelial Carcinoma Bladder
Urothelial Carcinoma of the Renal Pelvis and Ureter
Urothelial Carcinoma Ureter
Urothelial Carcinoma Urethra

Interventions: Drug: Sitravatinib
Drug: Nivolumab
Drug: Pembrolizumab
Drug: Enfortumab vedotin

First Posted Date: 2018-07-30

Last Posted Date: 2023-08-24

Lead Sponsor: Mirati Therapeutics Inc.

Target Recruit Count: 260

Registration Number: NCT03606174

Locations: 🇺🇸
University of California Irvine, Irvine, California, United States
🇺🇸
The University of Arizona Cancer Center, Tucson, Arizona, United States
🇺🇸
Dana Farber Cancer Institute, Boston, Massachusetts, United States

and more 33 locations

Nivolumab and Ipilimumab in Treating Patients With Esophageal and Gastroesophageal Junction Adenocarcinoma Undergoing Surgery

Phase 2

Suspended

Conditions: Clinical Stage II Esophageal Adenocarcinoma AJCC v8
Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8
Clinical Stage IVA Gastroesophageal Junction Adenocarcinoma AJCC v8
Esophageal Adenocarcinoma
Clinical Stage IVA Esophageal Adenocarcinoma AJCC v8
Clinical Stage II Gastroesophageal Junction Adenocarcinoma AJCC v8
Clinical Stage III Esophageal Adenocarcinoma AJCC v8
Gastroesophageal Junction Adenocarcinoma

Interventions: Procedure: Biospecimen Collection
Drug: Carboplatin
Procedure: Computed Tomography
Biological: Ipilimumab
Biological: Nivolumab
Drug: Paclitaxel
Procedure: Positron Emission Tomography
Radiation: Radiation Therapy

First Posted Date: 2018-07-30

Last Posted Date: 2024-12-27

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 278

Registration Number: NCT03604991

Locations: 🇺🇸
Anchorage Associates in Radiation Medicine, Anchorage, Alaska, United States
🇺🇸
Alaska Breast Care and Surgery LLC, Anchorage, Alaska, United States
🇺🇸
Alaska Oncology and Hematology LLC, Anchorage, Alaska, United States

and more 487 locations

Nivolumab and Multi-fraction Stereotactic Radiosurgery With or Without Ipilimumab in Treating Patients With Recurrent Grade II-III Meningioma

Phase 1

Recruiting

Conditions: Recurrent Meningioma
Grade 3 Meningioma
Grade 2 Meningioma

Interventions: Procedure: Biospecimen Collection
Procedure: Echocardiography
Biological: Ipilimumab
Procedure: Magnetic Resonance Imaging
Biological: Nivolumab
Radiation: Stereotactic Radiosurgery

First Posted Date: 2018-07-30

Last Posted Date: 2024-12-18

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 38

Registration Number: NCT03604978

Locations: 🇺🇸
Mayo Clinic Hospital in Arizona, Phoenix, Arizona, United States
🇺🇸
City of Hope Comprehensive Cancer Center, Duarte, California, United States
🇺🇸
UC San Diego Moores Cancer Center, La Jolla, California, United States

and more 27 locations

pTVG-HP and Nivolumab in Patients With Non-Metastatic PSA-Recurrent Prostate Cancer

Phase 2

Active, not recruiting

Conditions: Prostate Cancer

Interventions: Biological: pTVG-HP
Drug: Nivolumab
Drug: GM-CSF

First Posted Date: 2018-07-26

Last Posted Date: 2024-07-09

Lead Sponsor: University of Wisconsin, Madison

Target Recruit Count: 19

Registration Number: NCT03600350

Locations: 🇺🇸
University of Wisconsin Carbone Cancer Center, Madison, Wisconsin, United States

Nivolumab and Ipilimumab After Donor Stem Cell Transplant in Treating Patients With High Risk Refractory or Relapsed Acute Myeloid Leukemia or Myelodysplastic Syndrome

Phase 1

Completed

Conditions: Allogeneic Hematopoietic Stem Cell Transplantation Recipient
Myelodysplastic Syndrome
Recurrent Acute Myeloid Leukemia
Refractory Acute Myeloid Leukemia

Interventions: Biological: Ipilimumab
Biological: Nivolumab

First Posted Date: 2018-07-26

Last Posted Date: 2024-12-12

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 29

Registration Number: NCT03600155

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

A Study of Nivolumab and Intrapleural Talimogene Laherparepvec for Malignant Pleural Effusion

Phase 1

Terminated

Conditions: Malignant Pleural Effusion
Stage IV Metastatic Cancer
Lung Cancer

Interventions: Drug: Talimogene laherparepvec (TVEC)
Drug: Nivolumab

First Posted Date: 2018-07-24

Last Posted Date: 2021-04-20

Lead Sponsor: UNC Lineberger Comprehensive Cancer Center

Target Recruit Count: 1

Registration Number: NCT03597009

Locations: 🇺🇸
Lineberger Comprehensive Cancer Center, Chapel Hill, North Carolina, United States

A Study to Compare Treatments for a Type of Kidney Cancer Called TFE/Translocation Renal Cell Carcinoma (tRCC)

Phase 2

Active, not recruiting

Conditions: Metastatic Renal Cell Carcinoma
Stage III Renal Cell Cancer AJCC v8
Stage IV Renal Cell Cancer AJCC v8
Unresectable Renal Cell Carcinoma
TFE3-Rearranged Renal Cell Carcinoma

Interventions: Drug: Axitinib
Biological: Nivolumab

First Posted Date: 2018-07-23

Last Posted Date: 2024-11-15

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 15

Registration Number: NCT03595124

Locations: 🇺🇸
Nebraska Medicine Heartland Hematology Oncology, Kearney, Nebraska, United States
🇺🇸
CTCA at Western Regional Medical Center, Goodyear, Arizona, United States
🇺🇸
Children's Hospital of Alabama, Birmingham, Alabama, United States

and more 269 locations

Nivolumab +/- Ipilimumab in Patients with Advanced, Refractory Pulmonary or Gastroenteropancreatic Poorly Differentiated Neuroendocrine Tumors (NECs)

Phase 2

Active, not recruiting

Conditions: Neuroendocrine Carcinoma

Interventions: Drug: Nivolumab
Drug: Ipilimumab

First Posted Date: 2018-07-19

Last Posted Date: 2024-10-18

Lead Sponsor: Intergroupe Francophone de Cancerologie Thoracique

Target Recruit Count: 185

Registration Number: NCT03591731

Locations: 🇫🇷
Paris - Curie, Paris, France
🇫🇷
CHU d'Angers, Angers, France
🇫🇷
Avignon - CH, Avignon, France

and more 4 locations

Combined Treatment With Nivolumab and Trabectedin in Patients With Metastatic or Inoperable Soft Tissue Sarcomas

Phase 2

Completed

Conditions: Metastatic Adult Soft Tissue Sarcoma

Interventions: Drug: Trabectedin
Drug: Nivolumab

First Posted Date: 2018-07-18

Last Posted Date: 2022-11-08

Lead Sponsor: University Medicine Greifswald

Target Recruit Count: 92

Registration Number: NCT03590210

Locations: 🇩🇪
Helios Klinikum Bad Saarow, Klinik für Hämatologie, Onkologie und Palliativmedizin, Sarkomzentrum Berlin-Brandenburg, Bad Saarow, Germany
🇩🇪
Medizinische Fakultät "Carl Gustav Carus" der TU Dresden, Medizinische Klinik I, Dresden, Germany
🇩🇪
Universitätsmedizin Greifswald, Klinik und Poliklinik für Innere Medizin C, Hämatologie und Onkologie, Greifswald, Germany

and more 6 locations

NBTXR3 Activated by Radiotherapy for Patients With Advanced Cancers Treated With An Anti-PD-1 Therapy

Phase 1

Recruiting

Conditions: Metastatic Triple-Negative Breast Carcinoma
Metastasis From Malignant Tumor of Bladder (Disorder)
Immunotherapy
Radiotherapy
Squamous Cell Carcinoma of Head and Neck
Metastatic Renal Cell Carcinoma
Microsatellite Instability-High Solid Malignant Tumour
Metastasis From Malignant Melanoma of Skin (Disorder)
Metastasis From Malignant Tumor of Liver
Metastasis From Malignant Tumor of Cervix

Interventions: Drug: NBTXR3
Radiation: SABR
Drug: Nivolumab
Drug: Pembrolizumab

First Posted Date: 2018-07-17

Last Posted Date: 2024-03-22

Lead Sponsor: Nanobiotix

Target Recruit Count: 145

Registration Number: NCT03589339

Locations: 🇺🇸
Christus St. Vincent Regional Cancer Center, Santa Fe, New Mexico, United States
🇺🇸
St Luke's University Health Network, Bethlehem, Pennsylvania, United States
🇺🇸
Sanford Cancer Center, Sioux Falls, South Dakota, United States

and more 10 locations

Drug Development Updates

Stay informed with timely notifications on clinical trials, regulatory changes, and research advancements related to this medication.

Home Terms & Conditions Privacy Policy