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
Nivolumab and the Antagonistic CSF-1R Monoclonal Antibody Cabiralizumab (BMS-986227) in Patients With Relapsed/Refractory Peripheral T Cell Lymphoma
- First Posted Date
- 2019-04-25
- Last Posted Date
- 2024-03-18
- Lead Sponsor
- University of Michigan Rogel Cancer Center
- Target Recruit Count
- 4
- Registration Number
- NCT03927105
- Locations
- 🇺🇸
Unviersity of Wisconsin, Madison, Wisconsin, United States
🇺🇸University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan, United States
🇺🇸Ohio State University Comprehensive Cancer Center, Columbus, Ohio, United States
Efficacy of Nivolumab for Recurrent IDH Mutated High-Grade Gliomas
- First Posted Date
- 2019-04-24
- Last Posted Date
- 2024-04-02
- Lead Sponsor
- Assistance Publique - Hôpitaux de Paris
- Target Recruit Count
- 43
- Registration Number
- NCT03925246
- Locations
- 🇫🇷
AP-HM, La Timone, Hôpital Universitaire, Marseille, France
🇫🇷Groupe Hospitalier Saint-André, Bordeaux, France
🇫🇷Hospices Civils de Lyon, Hôpital Pierre Wertheimer, Bron, France
Study of Immunotherapy Plus ADI-PEG 20 for the Treatment of Advanced Uveal Melanoma
- First Posted Date
- 2019-04-22
- Last Posted Date
- 2023-01-26
- Lead Sponsor
- Memorial Sloan Kettering Cancer Center
- Target Recruit Count
- 9
- Registration Number
- NCT03922880
- Locations
- 🇺🇸
Memorial Sloan Kettering Cancer Center, New York, New York, United States
Microtransplantation and Checkpoint Blockade Immunotherapy for Relapsed or Refractory B Cell Lymphomas
- Conditions
- B Cell Lymphomas
- Interventions
- Biological: MicrotransplantationDrug: Nivolumab
- First Posted Date
- 2019-04-19
- Last Posted Date
- 2021-03-23
- Lead Sponsor
- Ahmed Galal, MD
- Registration Number
- NCT03920631
- Locations
- 🇺🇸
Duke University, Durham, North Carolina, United States
Trial of Nivolumab With FOLFOX After Chemoradiation in Rectal Cancer Patients
- Conditions
- Rectal Cancer
- Interventions
- First Posted Date
- 2019-04-19
- Last Posted Date
- 2019-04-19
- Lead Sponsor
- Baruch Brenner
- Target Recruit Count
- 29
- Registration Number
- NCT03921684
- Locations
- 🇮🇱
Rabin Medical Center, Beilinson Hospital, Petach Tikva, Israel
Testing the Combination of Cabozantinib, Nivolumab, and Ipilimumab (CaboNivoIpi) for Advanced Differentiated Thyroid Cancer
- Conditions
- Differentiated Thyroid Gland CarcinomaFollicular Variant Thyroid Gland Papillary CarcinomaPoorly Differentiated Thyroid Gland CarcinomaRefractory Thyroid Gland CarcinomaRefractory Differentiated Thyroid Gland CarcinomaTall Cell Variant Thyroid Gland Papillary CarcinomaThyroid Gland Follicular CarcinomaThyroid Gland Oncocytic CarcinomaThyroid Gland Papillary Carcinoma
- Interventions
- Procedure: Biospecimen CollectionDrug: Cabozantinib S-malateProcedure: Computed TomographyBiological: IpilimumabProcedure: Magnetic Resonance ImagingBiological: Nivolumab
- First Posted Date
- 2019-04-16
- Last Posted Date
- 2024-12-19
- Lead Sponsor
- National Cancer Institute (NCI)
- Target Recruit Count
- 9
- Registration Number
- NCT03914300
- Locations
- 🇺🇸
USC / Norris Comprehensive Cancer Center, Los Angeles, California, United States
🇺🇸University of Kansas Cancer Center-Overland Park, Overland Park, Kansas, United States
🇺🇸University of Utah Sugarhouse Health Center, Salt Lake City, Utah, United States
Phase 1/2 Trial of Gavo-cel (TC-210) in Patients With Advanced Mesothelin-Expressing Cancer
- Conditions
- MesotheliomaMesotheliomas PleuralMesothelioma PeritoneumCholangiocarcinomaNon Small Cell Lung CancerMesothelioma, MalignantMesothelioma; PleuraCholangiocarcinoma RecurrentOvarian CancerNon Small Cell Lung Cancer Metastatic
- Interventions
- First Posted Date
- 2019-04-09
- Last Posted Date
- 2024-03-06
- Lead Sponsor
- TCR2 Therapeutics
- Target Recruit Count
- 36
- Registration Number
- NCT03907852
- Locations
- 🇺🇸
University of Chicago Medical Center, Chicago, Illinois, United States
🇺🇸University of Pennsylvania, Philadelphia, Pennsylvania, United States
🇺🇸Duke University, Durham, North Carolina, United States
Immunotherapy (Nivolumab or Brentuximab Vedotin) Plus Combination Chemotherapy in Treating Patients With Newly Diagnosed Stage III-IV Classic Hodgkin Lymphoma
- Conditions
- Lymphocyte-Rich Classic Hodgkin LymphomaAnn Arbor Stage III Hodgkin LymphomaClassic Hodgkin LymphomaAnn Arbor Stage III Nodular Sclerosis Classic Hodgkin LymphomaAnn Arbor Stage IV Lymphocyte-Depleted Classic Hodgkin LymphomaAnn Arbor Stage IV Mixed Cellularity Classic Hodgkin LymphomaAnn Arbor Stage IV Nodular Sclerosis Classic Hodgkin LymphomaAnn Arbor Stage III Lymphocyte-Depleted Classic Hodgkin LymphomaAnn Arbor Stage III Mixed Cellularity Classic Hodgkin LymphomaAnn Arbor Stage IV Hodgkin Lymphoma
- Interventions
- Procedure: Biospecimen CollectionDrug: Brentuximab VedotinProcedure: Computed TomographyDrug: DacarbazineDrug: Doxorubicin HydrochlorideBiological: FilgrastimProcedure: Magnetic Resonance ImagingBiological: NivolumabBiological: PegfilgrastimProcedure: Positron Emission TomographyOther: Quality-of-Life AssessmentOther: Questionnaire AdministrationRadiation: Radiation TherapyDrug: Vinblastine Sulfate
- First Posted Date
- 2019-04-09
- Last Posted Date
- 2025-01-03
- Lead Sponsor
- National Cancer Institute (NCI)
- Target Recruit Count
- 994
- Registration Number
- NCT03907488
- Locations
- 🇺🇸
The Carle Foundation Hospital, Urbana, Illinois, United States
🇺🇸Northwestern Medicine Cancer Center Warrenville, Warrenville, Illinois, United States
🇺🇸Illinois CancerCare - Washington, Washington, Illinois, United States
A Study to Evaluate Immune Biomarker Modulation in Response to VTX-2337 in Combination With an Anti- PD-1 Inhibitor in Head and Neck Cancer
- First Posted Date
- 2019-04-08
- Last Posted Date
- 2023-02-24
- Lead Sponsor
- Celgene
- Target Recruit Count
- 15
- Registration Number
- NCT03906526
- Locations
- 🇺🇸
Local Institution - 103, Sioux Falls, South Dakota, United States
🇺🇸University of Alabama at Birmingham, Birmingham, Alabama, United States
🇺🇸University of Cincinnati, Cincinnati, Ohio, United States
Pan Tumor Rollover Study
- Conditions
- Cancer
- Interventions
- Drug: NivolumabDrug: LeucovorinDrug: Nivolumab + RelatlimabDrug: RegorafinibDrug: CapecitabineDrug: PemetrexedDrug: EnzalutamideDrug: SunitinibDrug: PembrolizumabDrug: RelatlimabDrug: TemozolomideDrug: RucaparibDrug: IpilimumabDrug: DaratumumabDrug: FluorouracilDrug: CabozantinibDrug: TrametinibDrug: BevacizumabDrug: Oxaliplatin
- First Posted Date
- 2019-04-02
- Last Posted Date
- 2025-01-07
- Lead Sponsor
- Bristol-Myers Squibb
- Target Recruit Count
- 1500
- Registration Number
- NCT03899155
- Locations
- 🇨🇦
Princess Margaret Cancer Centre, Toronto, Ontario, Canada
🇨🇦Local Institution - 0040, Montreal, Quebec, Canada
🇨🇦Local Institution - 0308, Montreal, Quebec, Canada
Drug Development Updates
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