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

Clear Me: Interception Trial to Detect and Clear Molecular Residual Disease in Patients With High-risk Melanoma

Phase 2

Recruiting

Conditions: Melanoma Stage IV
Cutaneous Melanoma
Mucosal Melanoma

Interventions: Drug: Nivolumab
Drug: Opdualag

First Posted Date: 2024-03-19

Last Posted Date: 2024-10-29

Lead Sponsor: University Health Network, Toronto

Target Recruit Count: 54

Registration Number: NCT06319196

Locations: 🇨🇦
UHN- Princess Margaret Cancer Center, Toronto, Ontario, Canada

Neoadjuvant and Adjuvant Anti-PD1 or Combinations for Locoregionally Advanced Melanoma

Phase 2

Recruiting

Conditions: Melanoma Stage III
Advanced Melanoma
Melanoma
Melanoma Stage IV

Interventions: Drug: Nivolumab + Relatlimab
Drug: Nivolumab
Drug: Ipilimumab

First Posted Date: 2024-03-06

Last Posted Date: 2024-12-17

Lead Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Target Recruit Count: 90

Registration Number: NCT06295159

Locations: 🇺🇸
Moffitt Cancer Center, Tampa, Florida, United States

A Phase II Study Bolstering Outcomes by Optimizing Immunotherapy Strategies With Evolocumab and Nivolumab in Patients With Metastatic Renal Cell Carcinoma (BOOST-RCC)

Phase 2

Recruiting

Conditions: Metastatic Renal Cell Carcinoma

Interventions: Drug: Evolocumab
Drug: Nivolumab

First Posted Date: 2024-02-29

Last Posted Date: 2024-11-13

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 29

Registration Number: NCT06284564

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

A Study of BND-35 in Participants With Advanced Solid Tumors

Phase 1

Recruiting

Conditions: Cancer

Interventions: Drug: BND-35
Drug: Nivolumab
Drug: Cetuximab

First Posted Date: 2024-02-23

Last Posted Date: 2024-08-07

Lead Sponsor: Biond Biologics

Target Recruit Count: 280

Registration Number: NCT06274437

Locations: 🇮🇱
Rambam Health Care Campus, Haifa, Israel
🇮🇱
Hadassah University Medical Center, Jerusalem, Israel
🇮🇱
Rabin Medical Center, Petah Tikva, Israel

and more 2 locations

Repositioning Immunotherapy in VetArans With Lung Cancer

Phase 2

Recruiting

Conditions: Non-Small Cell Lung Cancer

Interventions: Drug: Nivolumab

First Posted Date: 2024-02-23

Last Posted Date: 2024-03-12

Lead Sponsor: VA Office of Research and Development

Target Recruit Count: 25

Registration Number: NCT06275360

Locations: 🇺🇸
Durham VA Medical Center, Durham, NC, Durham, North Carolina, United States
🇺🇸
Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE, Omaha, Nebraska, United States
🇺🇸
Louis Stokes VA Medical Center, Cleveland, OH, Cleveland, Ohio, United States

and more 4 locations

VO and Nivolumab vs Physician's Choice in Advanced Melanoma That Progressed on Anti-PD-1 & Anti-CTLA-4 Drugs (IGNYTE-3)

Phase 3

Recruiting

Conditions: Advanced Melanoma

Interventions: Biological: Vusolimogene Oderparepvec
Biological: Nivolumab + Relatlimab
Biological: Nivolumab
Biological: Pembrolizumab
Drug: Single-agent chemotherapy

First Posted Date: 2024-02-16

Last Posted Date: 2024-11-20

Lead Sponsor: Replimune Inc.

Target Recruit Count: 400

Registration Number: NCT06264180

Locations: 🇺🇸
Stony Brook University Cancer Center, Stony Brook, New York, United States
🇺🇸
The Angeles Clinic and Research Institute, Los Angeles, California, United States
🇺🇸
USC Norris Comprehensive Cancer Center, Los Angeles, California, United States

and more 11 locations

A Study to Investigate the Efficacy and Safety of ONO-4578 in Combination With Nivolumab and Chemotherapy in Chemotherapy-naïve Participants With HER2-negative Unresectable Advanced or Recurrent Gastric Cancer (Including Esophagogastric Junction Cancer)

Phase 2

Active, not recruiting

Conditions: Gastric Cancer

Interventions: Drug: ONO-4578
Drug: Capecitabine
Drug: Oxaliplatin
Drug: Nivolumab
Drug: S-1
Drug: Placebo

First Posted Date: 2024-02-13

Last Posted Date: 2024-07-29

Lead Sponsor: Ono Pharmaceutical Co. Ltd

Target Recruit Count: 210

Registration Number: NCT06256328

Locations: 🇰🇷
Chungbuk National University Hospital, Cheongju-si, Chungcheongbuk-do, Korea, Republic of
🇰🇷
CHA Bundang Medical Center, CHA University, Seongnam-si, Gyeonggi-do, Korea, Republic of
🇰🇷
The Catholic University of Korea, St. Vincent's Hospital, Suwon-si, Gyeonggi-do, Korea, Republic of

and more 60 locations

First-line EXL01 With Nivolumab and FOLFOX for PD-L1 CPS ≥5 Metastatic Gastric Cancer

Phase 2

Recruiting

Conditions: Gastric Cancer

Interventions: Drug: Nivolumab
Drug: FOLFOX regimen
Biological: EXL01

First Posted Date: 2024-02-12

Last Posted Date: 2024-07-25

Lead Sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group

Target Recruit Count: 120

Registration Number: NCT06253611

Locations: 🇫🇷
Clinique Sainte Catherine, Avignon, France
🇫🇷
Centre Hospitalier Universitaire Jean Minjoz, Besançon, France
🇫🇷
Centre Hospitalier de Cholet, Cholet, France

and more 15 locations