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Accession NumberDB09035
DescriptionNivolumab is a fully human IgG4 monoclonal antibody that acts as an immunomodulator by blocking ligand activation of programmed cell death 1 (PD-1) receptor on T cells. It is indicated for use in patients with unresectable (cannot be surgically removed) or metastatic melanoma who no longer respond to other drugs. Nivolumab is administered as an intravenous infusion over 60 minutes every 2 weeks.
Protein structureDb09035
Related Articles
Protein chemical formulaC6362H9862N1712O1995S42
Protein average weight143597.3811 Da
>Heavy Chain Sequence
>Light Chain Sequence
Download FASTA Format
SynonymsNot Available
External Identifiers
  • BMS-936558
  • GTPL7335
  • MDX-1106
  • ONO-4538
Approved Prescription Products
NameDosageStrengthRouteLabellerMarketing StartMarketing End
OpdivoSolution10 mgIntravenousBristol Myers Squibb2015-10-23Not applicableCanada
OpdivoSolution10 mgIntravenousBristol Myers Squibb2015-10-23Not applicableCanada
OpdivoInjection10 mg/mLIntravenousE.R. Squibb & Sons, L.L.C.2014-12-22Not applicableUs
OpdivoInjection10 mg/mLIntravenousE.R. Squibb & Sons, L.L.C.2014-12-22Not applicableUs
Approved Generic Prescription ProductsNot Available
Approved Over the Counter ProductsNot Available
Unapproved/Other Products Not Available
International BrandsNot Available
Brand mixturesNot Available
SaltsNot Available
CAS number946414-94-4
IndicationNivolumab is indicated for the treatment of unresectable or metastatic melanoma for patients who no longer respond to treatment with other drugs. It is intended for use in patients who have been previously treated with ipilimumab and is used for melanoma patients after treatment with ipilimumab and a BRAF inhibitor in patients whose tumors express BRAF V600 gene mutations. Historically there have been very few effective treatments for advanced melanoma, which is why this product was approved under an FDA accelerated program to allow earlier patient access.
Structured Indications
Clinical Trials
1Active Not RecruitingBasic ScienceRenal Cell Carcinoma (RCC)1
1Active Not RecruitingTreatmentAdvanced Solid Tumors / Recurrent Solid Tumors1
1Active Not RecruitingTreatmentChronic Myeloid Leukemia (CML)1
1Active Not RecruitingTreatmentMalignant Melanoma1
1Active Not RecruitingTreatmentMelanoma (Skin)1
1CompletedTreatmentAdvanced Solid Tumors / Recurrent Solid Tumors1
1Not Yet RecruitingTreatmentGlioblastomas1
1Not Yet RecruitingTreatmentMalignancies, Hematologic1
1Not Yet RecruitingTreatmentMelanoma1
1Not Yet RecruitingTreatmentNon Small Cell Lung Cancer (NSCLC)1
1RecruitingNot AvailableMelanoma1
1RecruitingTreatmentALK-positive NSCLC1
1RecruitingTreatmentAdvanced Solid Tumors2
1RecruitingTreatmentAdvanced Solid Tumors, Including But Not Limited to Lung Cancer / Cancer, Ovarian / Colorectal Cancers / Glioblastoma Multiforme / Head and Neck Cancers / Head and Neck Squamous Cell Cancer / Malignant Gliomas / Melanoma / Non-Small-Cell Lung Carcinoma (NSCLC) / Pancreatic Cancers / Renal Cell Carcinoma (RCC)1
1RecruitingTreatmentAdvanced Solid Tumors / Cancers1
1RecruitingTreatmentAdvanced Solid Tumors / Head and Neck Carcinoma, Squamous Cell / Non-Small-Cell Lung Carcinoma (NSCLC) / Triple-Negative Breast Neoplasms1
1RecruitingTreatmentAstrocytomas / Glioblastomas / Malignant Gliomas1
1RecruitingTreatmentCancer, Advanced Solid Tumors1
1RecruitingTreatmentCancer, Breast / Cancer, Ovarian / Carcinoma, Colorectal / Carcinoma, Pancreatic / Melanoma / Non-Small Cell Lung Carcinoma (NSCLC) / Prostate Cancers / Renal Cell Carcinoma (RCC) / Tumors, Solid1
1RecruitingTreatmentCancer, Ovarian / Fallopian Tubes / Primary Peritoneal Cancer / Recurrent Ovarian Cancer1
1RecruitingTreatmentClear Cell Renal Cell Carcinoma1
1RecruitingTreatmentCcRCC / Clear Cell Renal Cell Carcinoma / Kidney Cancer / RCC / Renal Cell Carcinoma (RCC)1
1RecruitingTreatmentLymphoma NOS / Malignant Solid Tumors1
1RecruitingTreatmentMalignant Tumors1
1RecruitingTreatmentNeoplasms, Breast / Neoplasms, Pancreatic1
1RecruitingTreatmentNon-Small Cell Lung Cancer Metastatic1
1RecruitingTreatmentNon-Small-Cell Lung Carcinoma (NSCLC)1
1RecruitingTreatmentSquamous Cell Carcinoma of the Head and Neck (SCCHN)1
1WithdrawnTreatmentMetastatic Melanoma1
1, 2Active Not RecruitingTreatmentNon-Small-Cell Lung Carcinoma (NSCLC)1
1, 2Not Yet RecruitingTreatmentAdenocarcinoma of the Lung / Lung Cancers1
1, 2Not Yet RecruitingTreatmentImmunotherapy / Neoplasms, Head and Neck1
1, 2Not Yet RecruitingTreatmentLymphoma NOS / Multiple Myeloma (MM)1
1, 2Not Yet RecruitingTreatmentMalignant Neoplasms of Urinary Tract / Other Disorders of Kidney and Ureter / Renal Cell Carcinoma (RCC)1
1, 2Not Yet RecruitingTreatmentMetastatic Brain Cancer1
1, 2Not Yet RecruitingTreatmentNon-Small-Cell Lung Carcinoma (NSCLC)1
1, 2Not Yet RecruitingTreatmentProstate Cancers1
1, 2RecruitingNot AvailableTumors, Solid1
1, 2RecruitingTreatmentAcute Myeloid Leukaemias (AML) / Leukemias / Myelodysplastic Syndrome1
1, 2RecruitingTreatmentB Cell NHL Including DLBCL / Carcinoma, Squamous Cell of Head and Neck / Glioblastomas / HL / Melanoma / Neoplasms, Colorectal / Neoplasms, Ovarian / Non-Small-Cell Lung Carcinoma (NSCLC)1
1, 2RecruitingTreatmentCancer, Advanced2
1, 2RecruitingTreatmentCancer, Advanced / Carcinoma, Colorectal / Endometrial / Non Small Cell Lung Cancer (NSCLC) / Pancreatic Cancers / Renal Cell Cancer / Uterine1
1, 2RecruitingTreatmentCancers2
1, 2RecruitingTreatmentClear Cell Renal Cell Carcinoma1
1, 2RecruitingTreatmentColon Cancer / Colorectal Cancer (CRC) / Glioblastoma (GBM) (Phase ll Only) / Malignant Melanoma of Head and Neck / Melanoma / Non-Small-Cell Lung Carcinoma (NSCLC) / Ovarian Carcinoma / Renal Cell Carcinoma (RCC) (Phase ll Only) / Squamous Cell Carcinoma of the Head and Neck (SCCHN)1
1, 2RecruitingTreatmentGlioblastomas / Hepatocellular Carcinoma Recurrent / Non-Small Cell Lung Cancer Recurrent / Tumors, Solid1
1, 2RecruitingTreatmentHepatocellular Carcinomas1
1, 2RecruitingTreatmentLymphoma, Hodgkins1
1, 2RecruitingTreatmentMSI Negative Colorectal Cancer / MSI Positive Colorectal Cancer1
1, 2RecruitingTreatmentMelanoma / Metastatic (Stage IV) Melanoma / Unresectable (Stage III) Melanoma1
1, 2RecruitingTreatmentMetastatic Melanoma / Stage III Melanoma / Stage IV Melanoma1
1, 2RecruitingTreatmentMetastatic Renal Cell Cancer / Stage IV Renal Cell Cancer1
1, 2RecruitingTreatmentNeoplasms, Hematologic1
1, 2RecruitingTreatmentNon-Hodgkin's Disease1
1, 2RecruitingTreatmentNon-Small-Cell Lung Carcinoma (NSCLC)1
1, 2RecruitingTreatmentPancreatic Cancers1
1, 2RecruitingTreatmentSquamous Non-Small Cell Lung Cancer1
1, 2RecruitingTreatmentTumors, Solid1
1, 2RecruitingTreatmentVarious Advanced Cancer1
2Active Not RecruitingNot AvailableNon-Small-Cell Lung Carcinoma (NSCLC)1
2Active Not RecruitingTreatmentAdvanced Non-Small Cell Lung Cancer1
2Active Not RecruitingTreatmentHodgkins Disease (HD)1
2Active Not RecruitingTreatmentLymphoma NOS1
2Active Not RecruitingTreatmentLymphoma. Non-Hodgkin1
2Active Not RecruitingTreatmentMelanoma1
2Active Not RecruitingTreatmentMetastatic Melanoma / Unresectable Melanoma1
2Active Not RecruitingTreatmentSquamous Cell Non-small Cell Lung Cancer1
2Active Not RecruitingTreatmentVarious Advanced Cancer1
2Not Yet RecruitingTreatmentAcral lentiginous melanoma / Mucosal Melanoma1
2Not Yet RecruitingTreatmentAdvanced Non-Small Cell Lung Cancer2
2Not Yet RecruitingTreatmentBrain Metastases, Adult / Clear-cell Metastatic Renal Cell Carcinoma / Non Small Cell Lung Cancer Metastatic1
2Not Yet RecruitingTreatmentMalignant Pleural Mesothelioma (MPM)1
2Not Yet RecruitingTreatmentMesothelioma1
2Not Yet RecruitingTreatmentMetastatic Melanoma1
2Not Yet RecruitingTreatmentMicrosatellite Instability / Neoplasms, Head and Neck / Penile Neoplasms / Renal Cell Carcinoma (RCC) / Skin Neoplasms1
2Not Yet RecruitingTreatmentNon Small Cell Lung Cancer Recurrent / Non-Small Cell Carcinoma of Lung, TNM Stage 4 / Non-Small-Cell Lung Cancer Metastatic / Nonsmall Cell Lung Cancer1
2Not Yet RecruitingTreatmentUveal Melanoma1
2RecruitingDiagnosticBrain Metastasis / Melanoma1
2RecruitingTreatmentAcute Myeloid Leukaemias (AML) / Leukemias1
2RecruitingTreatmentAdvanced Non-Small Cell Lung Cancer / Neoplasms, Lung / Non-Small Cell Lung Cancer Metastatic1
2RecruitingTreatmentAdvanced Stage Non-small Cell Lung Cancer1
2RecruitingTreatmentBladder Cancers / Melanoma1
2RecruitingTreatmentCancer, Breast1
2RecruitingTreatmentChronic Lymphocytic Leukaemia (CLL) / Leukemias1
2RecruitingTreatmentDocumented Stage III NSCLC, Amenable to Concomitant or Sequential Chemoradiotherapy1
2RecruitingTreatmentGastric Adenocarcinoma / Gastroesophageal Junction Adenocarcinoma1
2RecruitingTreatmentGlioblastoma Multiforme1
2RecruitingTreatmentHead and Neck Squamous Cell Carcinoma (HNSCC)1
2RecruitingTreatmentHodgkins Disease (HD)1
2RecruitingTreatmentLeukemias / Myelodysplastic Syndrome1
2RecruitingTreatmentLimited Stage Small Cell Lung Cancer / Small Cell Lung Cancer (SCLC)1
2RecruitingTreatmentLung Cancers / Metastatic Lung Cancer / Non-Small-Cell Lung Carcinoma (NSCLC)1
2RecruitingTreatmentLymphoma NOS1
2RecruitingTreatmentMalignant Melanoma1
2RecruitingTreatmentMalignant Melanoma Stage III1
2RecruitingTreatmentMelanoma / Metastases, Brain1
2RecruitingTreatmentMelanoma / Oligometastatic Melanoma1
2RecruitingTreatmentMelanoma / Uveal Melanoma1
2RecruitingTreatmentMetastatic Melanoma / Stage IV Melanoma1
2RecruitingTreatmentMetastatic Renal Cell Carcinoma1
2RecruitingTreatmentMetastatic or Advanced Non-Small Cell Lung Cancer (NSCLC)1
2RecruitingTreatmentMyeloproliferative Diseases1
2RecruitingTreatmentNeoplasms, Brain1
2RecruitingTreatmentNon Small Cell Lung Cancer (NSCLC)1
2RecruitingTreatmentNon-Small Lung Cancer, Epigenetic Therapy1
2RecruitingTreatmentNon-Small-Cell Lung Carcinoma (NSCLC)2
2RecruitingTreatmentPreviously Treated Metastatic Adenocarcinoma of the Pancreas1
2RecruitingTreatmentRenal Cell Carcinoma (RCC)1
2RecruitingTreatmentTumors, Solid1
3Active Not RecruitingTreatmentGastric Cancers1
3Active Not RecruitingTreatmentMelanoma1
3Active Not RecruitingTreatmentNon Small Cell Lung Cancer (NSCLC)1
3Active Not RecruitingTreatmentSquamous Cell Carcinoma of the Head and Neck (SCCHN)1
3Not Yet RecruitingTreatmentGastric Cancers1
3RecruitingTreatmentBrain Cancer1
3RecruitingTreatmentCancer, Advanced1
3RecruitingTreatmentEsophageal Cancers1
3RecruitingTreatmentGastric Cancers / Gastroesophageal Junction Cancer1
3RecruitingTreatmentHepatocellular Carcinomas / I.V Advanced Cancer1
3RecruitingTreatmentLung Cancers2
3RecruitingTreatmentMetastases, Brain1
3RecruitingTreatmentNon-Small-Cell Lung Carcinoma (NSCLC)2
4RecruitingNot AvailableMetastatic Melanoma1
4RecruitingNot AvailableRenal Cell Carcinoma (RCC)1
4RecruitingTreatmentRenal Cell Carcinoma (RCC)1
Not AvailableAvailableNot AvailableMalignant Melanoma1
Not AvailableAvailableNot AvailableStage III (Unresectable) or Stage IV Advanced Melanoma1
Not AvailableNo Longer AvailableNot AvailableNon-Squamous Non-Small Cell Lung Cancer / Squamous Non-Small Cell Lung Cancer1
Not AvailableRecruitingTreatmentKidney Cancer1
Not AvailableRecruitingTreatmentMelanoma (Skin) / Skin Cancers1
PharmacodynamicsNot Available
Mechanism of actionNivolumab is a human immunoglobulin G4 (IgG4) monoclonal antibody that binds to the programmed cell death 1 (PD-1) receptor and selectively blocks interaction with its programmed death ligands PD-L1 and PD-L2. Upregulation of PD-1 ligands occurs in some tumors and signalling through this pathway can contribute to inhibition of active T-cell immune surveillance of tumour tissue. The inhibitory effect of PD-1 and its ligands occurs through the promotion of apoptosis in antigen specific T cells while simultaneously blocking apoptosis in suppressor T cells. Blocking PD-1 activity has been shown to lead to decreased tumour growth in mouse tumour models.
TargetKindPharmacological actionActionsOrganismUniProt ID
Programmed cell death protein 1Proteinyes
HumanQ15116 details
Related Articles
AbsorptionThe intended route of administration is intravenous, therefore bioavailability is expected to be 100%.
Volume of distribution

8.0 L

Protein bindingNot Available

As nivolumab is an antibody, the expected consequence of metabolism is proteolytic degradation to small peptides and individual amino acids, and receptor-mediated clearance.

Route of eliminationRenal clearance is negligible as vedolizumab is a high molecular weight protein.
Half life26.7 days

9.5 mL/hr

ToxicityBased on data from animal studies, there is risk of fetal harm when administered to pregnant women. It is therefore advisable for pregnant women to use contraception during treatment and for 5 months afterwards. There have been reported cases of severe pneumonitis or interstitial lung disease, including fatal cases, with the use of nivolumab during clinical trials. Therefore, patients taking this drug should be monitored for signs and symptoms of pneumonitis. During clinical trials there have also been reports of the development of immune-mediated colitis, immune-mediated hepatitis with increased liver test abnormalities, immune-mediated nephritis and renal dysfunction, immune-mediated hypothyroidism and hyperthyroidism, and rare cases of other immune-mediated reactions such as pancreatitis, uveitis, demyelination, autoimmune neuropathy, adrenal insufficiency, and facial and abducens nerve paresis.
Affected organismsNot Available
PathwaysNot Available
SNP Mediated EffectsNot Available
SNP Mediated Adverse Drug ReactionsNot Available
Drug Interactions
DrugInteractionDrug group
AcetyldigitoxinAcetyldigitoxin may decrease the cardiotoxic activities of Nivolumab.Approved
ALT-110The therapeutic efficacy of ALT-110 can be decreased when used in combination with Nivolumab.Investigational
AnvirzelAnvirzel may decrease the cardiotoxic activities of Nivolumab.Investigational
BelimumabThe risk or severity of adverse effects can be increased when Nivolumab is combined with Belimumab.Approved
BevacizumabBevacizumab may increase the cardiotoxic activities of Nivolumab.Approved, Investigational
CabazitaxelThe risk or severity of adverse effects can be increased when Cabazitaxel is combined with Nivolumab.Approved
CDX-110The therapeutic efficacy of CDX-110 can be decreased when used in combination with Nivolumab.Investigational
CyclophosphamideCyclophosphamide may increase the cardiotoxic activities of Nivolumab.Approved, Investigational
DeslanosideDeslanoside may decrease the cardiotoxic activities of Nivolumab.Approved
DigitoxinDigitoxin may decrease the cardiotoxic activities of Nivolumab.Approved
DigoxinDigoxin may decrease the cardiotoxic activities of Nivolumab.Approved
DocetaxelThe risk or severity of adverse effects can be increased when Docetaxel is combined with Nivolumab.Approved, Investigational
G17DTThe therapeutic efficacy of G17DT can be decreased when used in combination with Nivolumab.Investigational
GI-5005The therapeutic efficacy of GI-5005 can be decreased when used in combination with Nivolumab.Investigational
INGN 201The therapeutic efficacy of INGN 201 can be decreased when used in combination with Nivolumab.Investigational
INGN 225The therapeutic efficacy of INGN 225 can be decreased when used in combination with Nivolumab.Investigational
OuabainOuabain may decrease the cardiotoxic activities of Nivolumab.Approved
PaclitaxelThe risk or severity of adverse effects can be increased when Paclitaxel is combined with Nivolumab.Approved, Vet Approved
Rabies vaccineThe therapeutic efficacy of Rabies vaccine can be decreased when used in combination with Nivolumab.Approved
SRP 299The therapeutic efficacy of SRP 299 can be decreased when used in combination with Nivolumab.Investigational
TG4010The therapeutic efficacy of TG4010 can be decreased when used in combination with Nivolumab.Investigational
TrastuzumabTrastuzumab may increase the cardiotoxic activities of Nivolumab.Approved, Investigational
Food InteractionsNot Available
Synthesis ReferenceNot Available
General References
  1. Taneja SS: Re: Safety, activity, and immune correlates of anti-PD-1 antibody in cancer. J Urol. 2012 Dec;188(6):2149. [PubMed:23289116 ]
  2. Tsai KK, Zarzoso I, Daud AI: PD-1 and PD-L1 antibodies for melanoma. Hum Vaccin Immunother. 2014;10(11):3111-6. doi: 10.4161/21645515.2014.983409. [PubMed:25625924 ]
  3. Topalian SL, Sznol M, McDermott DF, Kluger HM, Carvajal RD, Sharfman WH, Brahmer JR, Lawrence DP, Atkins MB, Powderly JD, Leming PD, Lipson EJ, Puzanov I, Smith DC, Taube JM, Wigginton JM, Kollia GD, Gupta A, Pardoll DM, Sosman JA, Hodi FS: Survival, durable tumor remission, and long-term safety in patients with advanced melanoma receiving nivolumab. J Clin Oncol. 2014 Apr 1;32(10):1020-30. doi: 10.1200/JCO.2013.53.0105. Epub 2014 Mar 3. [PubMed:24590637 ]
External Links
ATC CodesL01XC17
AHFS Codes
  • 10:00
PDB EntriesNot Available
FDA labelDownload (315 KB)
MSDSNot Available
ManufacturersNot Available
PackagersNot Available
Dosage forms
InjectionIntravenous10 mg/mL
SolutionIntravenous10 mg
PricesNot Available
Patent NumberPediatric ExtensionApprovedExpires (estimated)
US2013173223 No2013-05-132033-05-13Us
Experimental PropertiesNot Available
DescriptionNot Available
KingdomOrganic Compounds
Super ClassOrganic Acids
ClassCarboxylic Acids and Derivatives
Sub ClassAmino Acids, Peptides, and Analogues
Direct ParentPeptides
Alternative ParentsNot Available
SubstituentsNot Available
Molecular FrameworkNot Available
External DescriptorsNot Available


Pharmacological action
General Function:
Signal transducer activity
Specific Function:
Inhibitory cell surface receptor involved in the regulation of T-cell function during immunity and tolerance. Upon ligand binding, inhibits T-cell effector functions in an antigen-specific manner. Possible cell death inducer, in association with other factors.
Gene Name:
Uniprot ID:
Molecular Weight:
31646.635 Da
  1. Taneja SS: Re: Safety, activity, and immune correlates of anti-PD-1 antibody in cancer. J Urol. 2012 Dec;188(6):2149. [PubMed:23289116 ]
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Drug created on February 24, 2015 16:02 / Updated on August 17, 2016 12:24