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

Combination of Nivolumab Plus Relatlimab in Patients With Advanced or Metastatic Soft-tissue Sarcoma: a Proof-of-concept Randomized Phase II Study

Phase 2

Recruiting

Conditions: Advanced Cancer
Soft Tissue Sarcoma Adult

Interventions: Drug: Association of Nivolumab + Relatlimab
Drug: Nivolumab

First Posted Date: 2019-09-19

Last Posted Date: 2023-02-22

Lead Sponsor: Institut Bergonié

Target Recruit Count: 67

Registration Number: NCT04095208

Locations: 🇫🇷
Institut Bergonié, Bordeaux, France
🇫🇷
Institut de Cancérologie de l'Ouest - Site René Gauducheau, Nantes, France
🇫🇷
Centre Léon Bérard, Lyon, France

and more 2 locations

Nivolumab/Ipilimumab Plus Cabozantinib in Patients With Unresectable Advanced Melanoma

Phase 2

Active, not recruiting

Conditions: Melanoma

Interventions: Drug: Nivolumab
Drug: Ipilimumab
Drug: Cabozantinib

First Posted Date: 2019-09-17

Last Posted Date: 2024-11-27

Lead Sponsor: Georgetown University

Target Recruit Count: 14

Registration Number: NCT04091750

Locations: 🇺🇸
John Theurer Cancer Center at Hackensack University Medical Center, Hackensack, New Jersey, United States
🇺🇸
Medstar Franklin Square Medical Center, Harry and Jeanette Weinberg Cancer Institute, Baltimore, Maryland, United States
🇺🇸
Lombardi Comprehensive Cancer Center, Washington, District of Columbia, United States

Combination of Nivolumab and DHAP in Patients With Relapsed or Refractory Classical Hodgkin Lymphoma (Nivo-DHAP)

Phase 2

Completed

Conditions: Hodgkin Lymphoma

Interventions: Drug: Nivolumab

First Posted Date: 2019-09-16

Last Posted Date: 2023-09-21

Lead Sponsor: State Budgetary Healthcare Institution, National Medical Surgical Center N.A. N.I. Pirogov, Ministry of Health of Russia

Target Recruit Count: 40

Registration Number: NCT04091490

Locations: 🇷🇺
The Federal Budget-Funded Institution National Medical Surgical Center named after N. I. Pirogov of the Ministry of health of the Russian Federation, Moscow, Russian Federation

Study of Nivolumab for Non-Small Cell Lung Cancer (Stage III) Following Neoadjuvant Chemotherapy Plus Nivolumab and Definitive Concurrent Chemoradiation Therapy

Phase 2

Active, not recruiting

Conditions: Stage III Non-small-cell Lung Cancer

Interventions: Other: Neoadjuvant therapy
Other: Chemotherapy concurrent with radiotherapy
Radiation: Radiotherapy
Other: Observation
Drug: Nivolumab

First Posted Date: 2019-09-11

Last Posted Date: 2024-04-23

Lead Sponsor: Sun Yat-sen University

Target Recruit Count: 264

Registration Number: NCT04085250

Locations: 🇨🇳
Sun yat-sen university cancer center, Guangzhou, Guangdong, China
🇨🇳
The First People's Hospital of Foshan, Foshan, Guangdong, China
🇨🇳
The first affliated hospital of Guangzhou Medical University, Guangzhou, Guangdong, China

Study of SQZ-PBMC-HPV in Patients With HPV16+ Recurrent, Locally Advanced or Metastatic Solid Tumors

Phase 1

Completed

Conditions: Adult Solid Tumor

Interventions: Biological: SQZ-PBMC-HPV
Drug: Atezolizumab
Drug: Ipilimumab
Drug: Nivolumab

First Posted Date: 2019-09-10

Last Posted Date: 2023-04-14

Lead Sponsor: SQZ Biotechnologies

Target Recruit Count: 30

Registration Number: NCT04084951

Locations: 🇺🇸
University of Colorado Anschutz Cancer Pavillion, Aurora, Colorado, United States
🇺🇸
University of Nebraska Medical Center, Omaha, Nebraska, United States
🇺🇸
University of Kansas Cancer Center, Kansas City, Kansas, United States

and more 9 locations

A Study of E7389 Liposomal Formulation (E7389-LF) Plus Nivolumab in Participants With Solid Tumor

Phase 1

Active, not recruiting

Conditions: Solid Neoplasms

Interventions: Drug: E7389-LF
Drug: Nivolumab

First Posted Date: 2019-09-06

Last Posted Date: 2024-12-10

Lead Sponsor: Eisai Co., Ltd.

Target Recruit Count: 125

Registration Number: NCT04078295

Locations: 🇯🇵
Eisai Trial Site #11, Akashi, Hyogo, Japan
🇯🇵
Eisai Trial Site #18, Kashiwa City, Chiba, Japan
🇯🇵
Eisai Trial Site #2, Kashiwa, Chiba, Japan

and more 16 locations

Study of Safety and Tolerability of Nivolumab Treatment Alone or in Combination With Relatlimab or Ipilimumab in Head and Neck Cancer

Phase 2

Recruiting

Conditions: Head and Neck Squamous Cell Carcinoma (HNSCC)

Interventions: Drug: Nivolumab
Drug: Relatlimab
Drug: Ipilimumab

First Posted Date: 2019-09-06

Last Posted Date: 2024-12-13

Lead Sponsor: Dan Zandberg

Target Recruit Count: 80

Registration Number: NCT04080804

Locations: 🇺🇸
UPMC Hillman Cancer Center, Pittsburgh, Pennsylvania, United States

Testing the Combination of XL184 (Cabozantinib), Nivolumab, and Ipilimumab for Poorly Differentiated Neuroendocrine Tumors

Phase 2

Active, not recruiting

Conditions: Metastatic Large Cell Neuroendocrine Carcinoma
Metastatic Neuroendocrine Carcinoma
Metastatic Small Cell Neuroendocrine Carcinoma
Metastatic Neuroendocrine Neoplasm

Interventions: Drug: Cabozantinib S-malate
Biological: Ipilimumab
Biological: Nivolumab

First Posted Date: 2019-09-06

Last Posted Date: 2024-12-27

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 30

Registration Number: NCT04079712

Locations: 🇺🇸
The University of Kansas Cancer Center - Olathe, Olathe, Kansas, United States
🇺🇸
University of Alabama at Birmingham Cancer Center, Birmingham, Alabama, United States
🇺🇸
Banner University Medical Center - Tucson, Tucson, Arizona, United States

and more 43 locations

Nivolumab Plus FOLFOXIRI/Bevacizumab in First Line Chemotherapy of Advanced Colorectal Cancer RASm/BRAFm Patients

Phase 2

Conditions: Colorectal Cancer

Interventions: Drug: Nivolumab
Drug: Bevacizumab
Drug: Irinotecan
Drug: Oxaliplatin
Drug: Leucovorin
Drug: fluoruracil

First Posted Date: 2019-08-28

Last Posted Date: 2020-07-31

Lead Sponsor: Gruppo Oncologico Italiano di Ricerca Clinica

Target Recruit Count: 70

Registration Number: NCT04072198

Locations: 🇮🇹
Istituto Ospedaliero Fondazione Poliambulanza, Brescia, Italy
🇮🇹
Azienda Ospedaliero-Universitaria Careggi, Firenze, Italy
🇮🇹
AUSL/IRCCS di Reggio Emilia, Reggio Emilia, Italy

and more 5 locations

Encorafenib and Binimetinib With or Without Nivolumab in Treating Patients With Metastatic Radioiodine Refractory BRAF V600 Mutant Thyroid Cancer

Phase 2

Active, not recruiting

Conditions: BRAF V600E Mutation Present
Stage IVA Differentiated Thyroid Gland Carcinoma AJCC v8
Stage IV Differentiated Thyroid Gland Carcinoma AJCC v8
Metastatic Thyroid Gland Carcinoma
Refractory Thyroid Gland Carcinoma
Stage IVB Differentiated Thyroid Gland Carcinoma AJCC v8
BRAF NP_004324.2:p.V600M

Interventions: Drug: Binimetinib
Drug: Encorafenib
Biological: Nivolumab

First Posted Date: 2019-08-20

Last Posted Date: 2024-11-18

Lead Sponsor: Providence Health & Services

Target Recruit Count: 24

Registration Number: NCT04061980

Locations: 🇺🇸
Providence Portland Medical Center, Portland, Oregon, United States

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