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

Preoperative Nivolumab Plus Bevacizumab Combined With Chemotherapy Before Surgery in Patients With pMMR/MSS Colorectal Cancer Liver Metastases

Phase 2

Not yet recruiting

Conditions: Colorectal Cancer Liver Metastases

Interventions: Drug: CapOx(Capecitabine+ Oxaliplatin)
Drug: Bevacizumab
Drug: Nivolumab

First Posted Date: 2022-10-20

Last Posted Date: 2022-10-20

Lead Sponsor: Shanghai Changzheng Hospital

Target Recruit Count: 12

Registration Number: NCT05588297

A Phase 1/2a Study Evaluating Allocetra-OTS as Monotherapy or in Combination With Anti-PD-1 Therapy for the Treatment of Advanced Solid Tumor Malignancy

Phase 1

Terminated

Conditions: Peritoneal Cancer
Solid Tumor
Peritoneal Metastases

Interventions: Drug: Allocetra-OTS
Drug: Nivolumab
Drug: Tislelizumab

First Posted Date: 2022-10-14

Last Posted Date: 2024-04-17

Lead Sponsor: Enlivex Therapeutics RDO Ltd.

Target Recruit Count: 14

Registration Number: NCT05581719

Locations: 🇮🇱
Hadassah Medical Center, Jerusalem, Israel
🇮🇱
Sourasky Medical Center, Tel Aviv, Israel
🇪🇸
Clínica Universidad de Navarra, Madrid, Spain

and more 3 locations

A Clinical Trial of a New Combination Treatment, Domvanalimab and Zimberelimab, Plus Chemotherapy, for People With an Upper Gastrointestinal Tract Cancer That Cannot be Removed With Surgery That Has Spread to Other Parts of the Body

Phase 3

Active, not recruiting

Conditions: Advanced Upper Gastrointestinal Tract Adenocarcinoma

Interventions: Drug: Domvanalimab
Drug: Fluorouracil
Drug: Zimberelimab
Drug: Capecitabine
Drug: Leucovorin
Drug: Nivolumab
Drug: Oxaliplatin

First Posted Date: 2022-10-05

Last Posted Date: 2024-11-15

Lead Sponsor: Arcus Biosciences, Inc.

Target Recruit Count: 1040

Registration Number: NCT05568095

Locations: 🇺🇸
UCLA Ronald Reagan Med Ctr, Santa Monica, California, United States
🇺🇸
Smillow Cancer Hosp, New Haven, Connecticut, United States
🇺🇸
Regions Hospital, Saint Louis Park, Minnesota, United States

and more 199 locations

A Study of BMS-986442 With Nivolumab With or Without Chemotherapy in Solid Tumors and Non-small Cell Lung Cancer

Phase 1

Terminated

Conditions: Advanced Solid Tumors
Non-small Cell Lung Cancer

Interventions: Biological: BMS-986442
Biological: Nivolumab
Drug: Docetaxel
Drug: Carboplatin
Drug: Pemexetred
Drug: Paclitaxel

First Posted Date: 2022-09-16

Last Posted Date: 2024-10-21

Lead Sponsor: Bristol-Myers Squibb

Target Recruit Count: 36

Registration Number: NCT05543629

Locations: 🇺🇸
University of Cincinnati Medical Center, Cincinnati, Ohio, United States
🇺🇸
Mayo Clinic in Arizona - Phoenix, Phoenix, Arizona, United States
🇺🇸
Local Institution - 0096, Costa Mesa, California, United States

and more 29 locations

METIMMOX-2: Metastatic pMMR/MSS Colorectal Cancer - Shaping Anti-Tumor Immunity by Oxaliplatin

Phase 2

Recruiting

Conditions: Colorectal Adenocarcinoma
Mucinous Adenocarcinoma
Signet Ring Cell Adenocarcinoma

Interventions: Drug: Nivolumab
Drug: Oxaliplatin

First Posted Date: 2022-08-17

Last Posted Date: 2024-01-30

Lead Sponsor: University Hospital, Akershus

Target Recruit Count: 80

Registration Number: NCT05504252

Locations: 🇳🇴
St Olavs Hospital, Trondheim, Trondelag, Norway
🇳🇴
Oslo University Hospital, Oslo, Viken, Norway
🇳🇴
Akershus University Hospital, Lørenskog, Viken, Norway

Study of Cabozantinib and Nivolumab in Metastatic Castration Resistant Prostate Cancer

Phase 2

Recruiting

Conditions: Metastatic Cancer
Castration-resistant Prostate Cancer

Interventions: Drug: Cabozantinib
Drug: Nivolumab

First Posted Date: 2022-08-16

Last Posted Date: 2024-07-18

Lead Sponsor: Rana McKay, MD

Target Recruit Count: 50

Registration Number: NCT05502315

Locations: 🇺🇸
University of Chicago Medical Center, Chicago, Illinois, United States
🇺🇸
University of Texas Southwestern Medical Center, Dallas, Texas, United States
🇺🇸
University of California San Diego, La Jolla, California, United States

and more 1 locations

Split Course Adaptive Radiation Therapy With Pembrolizumab With/Without Chemotherapy for Treating Stage IV Lung Cancer

Phase 1

Recruiting

Conditions: Lung Non-Small Cell Carcinoma
Stage IV Lung Cancer AJCC v8
Stage III Lung Cancer

Interventions: Procedure: Biospecimen Collection
Drug: Carboplatin
Procedure: Computed Tomography
Other: Fludeoxyglucose F-18
Biological: Pembrolizumab
Drug: Nab-paclitaxel
Drug: Pemetrexed
Procedure: Positron Emission Tomography
Biological: Atezolizumab
Radiation: Radiation Therapy
Other: [18-F] (fluoropropyl)-L-glutamate (FSPG) PET scan
Biological: Cemiplimab
Biological: Ipilimumab
Biological: Nivolumab

First Posted Date: 2022-08-15

Last Posted Date: 2024-10-17

Lead Sponsor: Vanderbilt-Ingram Cancer Center

Target Recruit Count: 25

Registration Number: NCT05501665

Locations: 🇺🇸
Vanderbilt University/Ingram Cancer Center, Nashville, Tennessee, United States

Phase 1b/2 Trial of Ipilimumab, Nivolumab, and Ciforadenant (Adenosine A2a Receptor Antagonist) in First-line Advanced Renal Cell Carcinoma.

Phase 1

Recruiting

Conditions: Renal Cell Carcinoma

Interventions: Drug: Ipilimumab
Drug: Nivolumab
Drug: Ciforadenant

First Posted Date: 2022-08-15

Last Posted Date: 2024-12-12

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 24

Registration Number: NCT05501054

Locations: 🇺🇸
Abramson Cancer Center of the University of Pennsylvania, Philadelphia, Pennsylvania, United States
🇺🇸
M D Anderson Cancer Center, Houston, Texas, United States
🇺🇸
Duke Cancer Institute, Durham, North Carolina, United States