Nivolumab

Generic Name: Nivolumab

Brand Names: Opdivo, Opdualag

Drug Type: Biotech

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

Zanzalintinib in Combination With Ipilimumab and Nivolumab in Patients With Metastatic Soft Tissue Sarcoma

Phase 1

Not yet recruiting

Conditions: Metastatic Soft-tissue Sarcoma

Interventions: Drug: Zanzalintinib
Drug: Ipilimumab
Drug: Nivolumab

First Posted Date: 2025-05-13

Last Posted Date: 2025-05-13

Lead Sponsor: Washington University School of Medicine

Target Recruit Count: 18

Registration Number: NCT06968988

Locations: 🇺🇸
Washington University School of Medicine, Saint Louis, Missouri, United States

Saci Nivo Rela for TNBC

Phase 1

Not yet recruiting

Conditions: Metastatic Triple-negative Breast Cancer

Interventions: Drug: Relatlimab FDC + Nivolumab
Drug: Sacituzumab Govitecan (SG)
Drug: Nivolumab

First Posted Date: 2025-05-09

Last Posted Date: 2025-05-09

Lead Sponsor: Yale University

Target Recruit Count: 60

Registration Number: NCT06963905

Locations: 🇺🇸
Yale University, New Haven, Connecticut, United States

A Study to Evaluate the Safety and Efficacy of Two Dose Levels of ONO-4578 With Opdivo®, in Combination With mFOLFOX6 and Bevacizumab Versus Standard of Care in Participants With Non-MSI-H/dMMR, PD-L1 Positive Advanced Colorectal Cancer

Phase 2

Not yet recruiting

Conditions: Colorectal Cancer

Interventions: Drug: ONO-4578
Drug: Opdivo®
Drug: Oxaliplatin
Drug: Leucovorin
Drug: 5-Fluorouracil
Drug: Bevacizumab

First Posted Date: 2025-04-29

Last Posted Date: 2025-04-29

Lead Sponsor: Ono Pharmaceutical Co. Ltd

Target Recruit Count: 144

Registration Number: NCT06948448

A Study to Evaluate Two Dosing Regimens of Subcutaneous Nivolumab in Combination With Intravenous Ipilimumab and Chemotherapy in Participants With Previously Untreated Metastatic or Recurrent Non-Small Cell Lung Cancer (NSCLC)

Phase 2

Not yet recruiting

Conditions: Non-Small Cell Lung Cancer

Interventions: Drug: Nivolumab
Drug: Ipilimumab
Drug: Carboplatin
Drug: Paclitaxel
Drug: Pemetrexed
Drug: Cisplatin

First Posted Date: 2025-04-27

Last Posted Date: 2025-05-11

Lead Sponsor: Bristol-Myers Squibb

Target Recruit Count: 76

Registration Number: NCT06946797

Locations: 🇵🇱
Local Institution - 0079, Łódź, Łódzkie, Poland
🇧🇷
Local Institution - 0041, Brasilia, Distrito Federal, Brazil
🇺🇸
Local Institution - 0032, Anchorage, Alaska, United States

and more 45 locations

NC410 and FOLFIRINOX in Combination With Nivolumab With or Without Ipilimumab in Patients With Untreated Metastatic Pancreatic Cancer

Phase 2

Not yet recruiting

Conditions: Pancreatic Cancer

Interventions: Drug: Oxaliplatin
Drug: Irinotecan
Drug: Folinic Acid
Drug: 5-Fluorouracil (5-FU)
Drug: NC410
Drug: Nivolumab
Drug: Ipilimumab

First Posted Date: 2025-04-24

Last Posted Date: 2025-04-24

Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Target Recruit Count: 20

Registration Number: NCT06941857

Locations: 🇺🇸
Sidney Kimmel Comprehensive Cancer Center, Baltimore, Maryland, United States

ONO-4538 Study in Patients With Richter's Transformation

Phase 2

Not yet recruiting

Conditions: Richter's Transformation

Interventions: Drug: ONO-4538

First Posted Date: 2025-04-20

Last Posted Date: 2025-04-20

Lead Sponsor: Ono Pharmaceutical Co. Ltd

Target Recruit Count: 14

Registration Number: NCT06936943

Locations: 🇯🇵
Hokkaido University Hospital, Sapporo, Hokkaido, Japan
🇯🇵
Kyusyu University Hospital, Fukuoka, Japan

Cabozantinib and Nivolumab Among Older Patients With Renal Cell Carcinoma

Phase 4

Not yet recruiting

Conditions: Kidney Cancer
Renal Cell Cancer

Interventions: Drug: Nivolumab
Drug: Cabozantinib

First Posted Date: 2025-04-18

Last Posted Date: 2025-04-18

Lead Sponsor: Gustave Roussy, Cancer Campus, Grand Paris

Target Recruit Count: 50

Registration Number: NCT06934057

Locations: 🇫🇷
Institut de Cancérologie de l'Ouest - Angers, Angers, France
🇫🇷
Centre Georges François Leclerc, Dijon, France
🇫🇷
CHU Tours - Hôpital Bretonneau, Tours, France

and more 4 locations

Autologous Hematopoietic Stem Cell Transplantation in Pediatric Relapsed or Refractory Hodgkin Lymphoma After Nivolumab Treatment

Phase 2

Conditions: Relapsed or Refractory Hodgkin Lymphoma
Children
Nivolumab
Autologous Haemopoietic Stem Cell Transplant

Interventions: Drug: Nivolumab

First Posted Date: 2025-04-17

Last Posted Date: 2025-04-17

Lead Sponsor: St. Petersburg State Pavlov Medical University

Target Recruit Count: 20

Registration Number: NCT06931613

Locations: 🇷🇺
N. N. Blokhin Russian Cancer Research Center, Moscow, Russia, Moscow, Russian Federation
🇷🇺
Pavlov University, RM Gorbacheva Research Institute, Saint-Petersburg, Russian Federation