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

The Effect of Prebiotic Inulin on Patients Affected by R/M HNSCC Treated With Immune Checkpoint Inhibitors

Not Applicable

Recruiting

Conditions: Head and Neck Squamous Cell Carcinoma

Interventions: Dietary Supplement: inulin
Drug: Nivolumab
Drug: Pembrolizumab

First Posted Date: 2023-04-20

Last Posted Date: 2023-04-20

Lead Sponsor: Fondazione del Piemonte per l'Oncologia

Target Recruit Count: 40

Registration Number: NCT05821751

Locations: 🇮🇹
Fondazione del Piemonte per l'Oncologia-IRCCS Candiolo, Candiolo, Turin, Italy

Axitinib Intensification Plus Nivolumab or Nivolumab Alone After Nivolumab Plus Ipilimumab in mRCC Patients

Phase 2

Recruiting

Conditions: Metastatic Renal Cell Carcinoma

Interventions: Drug: Axitinib
Drug: Nivolumab

First Posted Date: 2023-04-18

Last Posted Date: 2023-05-08

Lead Sponsor: Consorzio Oncotech

Target Recruit Count: 118

Registration Number: NCT05817903

Locations: 🇮🇹
Casa Di Cura La Maddalena S.P.A., Palermo, Italy
🇮🇹
Ospedale di Belcolle, Viterbo, Italy
🇮🇹
ASST degli Spedali Civili di Brescia, Brescia, Italy

and more 20 locations

Study of Induction PD-1 Blockade (Nivolumab) in Patients With Surgically Complete Resectable Mismatch Repair Deficient Endometrial Cancer (NIVEC)

Phase 2

Recruiting

Conditions: Endometrial Cancer
Endometrial Neoplasms

Interventions: Drug: Nivolumab

First Posted Date: 2023-04-03

Last Posted Date: 2024-01-23

Lead Sponsor: Yonsei University

Target Recruit Count: 30

Registration Number: NCT05795244

Locations: 🇰🇷
Severance Hospital, Yonsei University Health System, Seoul, Korea, Republic of

Cryoablation+Ipilimumab+Nivolumab in Melanoma

Phase 2

Recruiting

Conditions: Metastatic Melanoma
Skin Cancer

Interventions: Drug: Ipilimumab
Drug: Nivolumab
Procedure: Cryoablation

First Posted Date: 2023-03-22

Last Posted Date: 2024-03-15

Lead Sponsor: Massachusetts General Hospital

Target Recruit Count: 37

Registration Number: NCT05779423

Locations: 🇺🇸
Massachusetts General Hospital Cancer Center, Boston, Massachusetts, United States

Neoantigen Derived DCs as Cancer Treatment

Phase 1

Recruiting

Conditions: Solid Tumor
Refractory Tumor

Interventions: Biological: Dendritic Cell Vaccine
Drug: Lenvatinib
Drug: Nivolumab

First Posted Date: 2023-03-14

Last Posted Date: 2023-08-25

Lead Sponsor: National Health Research Institutes, Taiwan

Target Recruit Count: 12

Registration Number: NCT05767684

Locations: 🇨🇳
Kaohsiung Medical University Hospital, Kaohsiung, Taiwan
🇨🇳
National Cheng-Kung University Hospital, Tainan, Taiwan
🇨🇳
National Institute of Cancer Research, Tainan, Taiwan

Intraperitoneal Immune Checkpoint Inhibitor for Malignant Ascites

Not Applicable

Conditions: Malignant Ascites

Interventions: Drug: Nivolumab
Drug: Pembrolizumab

First Posted Date: 2023-02-27

Last Posted Date: 2023-08-24

Lead Sponsor: China Medical University Hospital

Target Recruit Count: 30

Registration Number: NCT05745233

Locations: 🇨🇳
China Medical University Hospital, Taichung, Please Select, Taiwan

Immunotherapy in Patients With Early dMMR Rectal Cancer

Phase 2

Recruiting

Conditions: Cancer of Rectum

Interventions: Drug: Nivolumab
Drug: Ipilimumab

First Posted Date: 2023-02-17

Last Posted Date: 2024-04-03

Lead Sponsor: Odense University Hospital

Target Recruit Count: 39

Registration Number: NCT05732389

Locations: 🇩🇰
Department of Oncology, Odense University Hospital, Odense, Denmark

Evaluating Combination of Nivolumab and Axatilimab in Patients With Relapsed/Refractory Classical Hodgkin Lymphoma

Phase 2

Suspended

Conditions: Hodgkin Lymphoma

Interventions: Drug: Axatilimab
Drug: Nivolumab

First Posted Date: 2023-02-10

Last Posted Date: 2024-10-28

Lead Sponsor: University of Utah

Target Recruit Count: 9

Registration Number: NCT05723055

Locations: 🇺🇸
Karmanos Cancer Institute, Detroit, Michigan, United States
🇺🇸
Huntsman Cancer Institute at the University of Utah, Salt Lake City, Utah, United States