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
Study of CG0070 Combined With Nivolumab in Cisplatin Ineligible Patients With MIBC
- Conditions
- Interventions
- First Posted Date
- 2020-10-30
- Last Posted Date
- 2024-12-13
- Target Recruit Count
- 21
- Registration Number
- NCT04610671
- Locations
- 🇺🇸
Moffitt Cancer Center, Tampa, Florida, United States
Testing the Addition of Lenalidomide and Nivolumab to the Usual Treatment for Primary CNS Lymphoma
- Conditions
- Interventions
- Procedure: Bone Marrow Aspiration and BiopsyProcedure: Computed TomographyProcedure: EchocardiographyDrug: LenalidomideProcedure: Lumbar PunctureProcedure: Magnetic Resonance ImagingDrug: MethotrexateBiological: NivolumabProcedure: Positron Emission TomographyBiological: RituximabProcedure: Ultrasound Imaging
- First Posted Date
- 2020-10-30
- Last Posted Date
- 2024-12-27
- Lead Sponsor
- National Cancer Institute (NCI)
- Target Recruit Count
- 47
- Registration Number
- NCT04609046
- Locations
- 🇺🇸
Cedars Sinai Medical Center, Los Angeles, California, United States
🇺🇸UCSF Medical Center-Parnassus, San Francisco, California, United States
🇺🇸UM Sylvester Comprehensive Cancer Center at Coral Gables, Coral Gables, Florida, United States
Surgical Nivolumab And Ipilimumab For Recurrent GBM
- Conditions
- Interventions
- First Posted Date
- 2020-10-28
- Last Posted Date
- 2024-07-16
- Lead Sponsor
- Patrick Wen, MD
- Target Recruit Count
- 63
- Registration Number
- NCT04606316
- Locations
- 🇺🇸
Memorial Sloan Kettering Cancer Center, New York, New York, United States
🇺🇸Stanford University, Stanford, California, United States
🇺🇸University of California Los Angeles, Los Angeles, California, United States
A Study for Identification of Immune Determinants for Response to Nivolumab in Recurrent and/or Metastatic Head and Neck Squamous Cell Carcinoma
- First Posted Date
- 2020-10-26
- Last Posted Date
- 2022-02-11
- Lead Sponsor
- Yonsei University
- Target Recruit Count
- 50
- Registration Number
- NCT04603248
- Locations
- 🇰🇷
Yonsei Severance Hospital, Seoul, Korea, Republic of
NT-I7 in Combination With Nivolumab in Advanced Gastric, Gastro-Esophageal Junction or Esophageal Adenocarcinoma
- Conditions
- Interventions
- First Posted Date
- 2020-10-20
- Last Posted Date
- 2024-08-16
- Lead Sponsor
- NeoImmuneTech
- Target Recruit Count
- 10
- Registration Number
- NCT04594811
- Locations
- 🇵🇱
Centrum Medyczne Klara, Czestochowa, Poland
🇵🇱Pratia Poznań, Skorzewo, Poland
🇺🇸The Center for Cancer & Blood Disorders, Fort Worth, Texas, United States
The Rome Trial From Histology to Target: the Road to Personalize Target Therapy and Immunotherapy
- Conditions
- Interventions
- Drug: Oncology DrugsDrug: ErlotinibDrug: TrastuzumabDrug: Trastuzumab emtansineDrug: PertuzumabDrug: LapatinibDrug: EverolimusDrug: VemurafenibDrug: CobimetinibDrug: AlectinibDrug: BrigatinibDrug: PalbociclibDrug: PonatinibDrug: VismogedibDrug: ItacitinibDrug: IpatasertibDrug: EntrectinibDrug: AtezolizumabDrug: NivolumabDrug: IpilimumabDrug: PemigatinibDrug: PralsetinibDrug: SelpercatinibDrug: TalazoparibDrug: TepotinibDrug: Alpelisib
- First Posted Date
- 2020-10-19
- Last Posted Date
- 2023-10-03
- Lead Sponsor
- Fondazione per la Medicina Personalizzata
- Target Recruit Count
- 400
- Registration Number
- NCT04591431
- Locations
- 🇮🇹
I.R.S.T. Srl Irccs, Meldola, Italy
🇮🇹Ospedale Classificato Sacro Cuore - Don Calabria, Negrar, Italy
🇮🇹I.R.C.C.S. Istituto Oncologico Veneto, Padova, Italy
Nivolumab+Ipilimumab+RT in MSS mCRC
- Conditions
- Interventions
- First Posted Date
- 2020-10-05
- Last Posted Date
- 2022-09-08
- Lead Sponsor
- Massachusetts General Hospital
- Target Recruit Count
- 32
- Registration Number
- NCT04575922
- Locations
- 🇺🇸
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
🇺🇸Massachusetts General Hospital Cancer Center, Boston, Massachusetts, United States
🇺🇸Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States
Safety of SBRT With Anti-PD1 and Anti-IL-8 for the Treatment of Multiple Metastases in Advanced Solid Tumors and Melanoma
- Conditions
- Interventions
- First Posted Date
- 2020-10-01
- Last Posted Date
- 2024-08-16
- Lead Sponsor
- Jason J. Luke, MD
- Target Recruit Count
- 50
- Registration Number
- NCT04572451
- Locations
- 🇺🇸
University of Chicago Medical Center, Chicago, Illinois, United States
🇺🇸UPMC Hillman Cancer Center, Pittsburgh, Pennsylvania, United States
A Study of Relatlimab in Combination With Nivolumab in Participants With Advanced Liver Cancer Who Have Never Been Treated With Immuno-oncology Therapy After Prior Treatment With Tyrosine Kinase Inhibitors
- Conditions
- Interventions
- First Posted Date
- 2020-09-28
- Last Posted Date
- 2024-12-20
- Lead Sponsor
- Bristol-Myers Squibb
- Target Recruit Count
- 266
- Registration Number
- NCT04567615
- Locations
- 🇧🇷
Local Institution - 0016, Barretos, SAO Paulo, Brazil
🇦🇷Local Institution - 0010, Ciudad de Buenos Aires, Buenos Aires, Argentina
🇦🇷Local Institution - 0019, Buenos Aires, Distrito Federal, Argentina
New Adjuvant Trial of Chemotherapy vs Chemo-immunotherapy
- Conditions
- Interventions
- First Posted Date
- 2020-09-25
- Last Posted Date
- 2024-01-18
- Lead Sponsor
- Fundación GECP
- Target Recruit Count
- 210
- Registration Number
- NCT04564157
- Locations
- 🇪🇸
Hospitalario Universitario A Coruña, A Coruña, La Coruña, Spain
🇪🇸ICO Hospitalet, Hospitalet de Llobregat, Barcelona, Spain
🇪🇸Hospital Universitario Insular de Gran canaria, Las Palmas De Gran Canaria, Gran Canaria, Spain
Drug Development Updates
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