Identification

Name
Durvalumab
Accession Number
DB11714
Type
Biotech
Groups
Approved, Investigational
Biologic Classification
Protein Based Therapies
Monoclonal antibody (mAb)
Description

Durvalumab is a a human monoclonal antibody that blocks programmed death ligand 1 (PD-L1), or CD 274. In May, 2017 it received FDA approval for previously treated patients with locally advanced or metastatic cancer in the urinary system (as Imfinzi). It is shown to be effective in patients with continued disease progression after the platinum-based chemotherapy. This drug has a relatively tolerable safety profile and its structural modification advantageously prevents the induction of antibody-dependent cytotoxicity (ADCC) or complement-dependent cytotoxicity (CDC) [5].

Protein chemical formula
C6502H10018N1742O2024S42
Protein average weight
146300.0 Da
Sequences
>Durvalumab heavy chain
EVQLVESGGGLVQPGGSLRLSCAASGFTFSRYWMSWVRQAPGKGLEWVANIKQDGSEKYY
VDSVKGRFTISRDNAKNSLYLQMNSLRAEDTAVYYCAREGGWFGELAFDYWGQGTLVTVS
SASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQS
SGLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKRVEPKSCDKTHTCPPCPAPEFEG
GPSVFLFPPKPKDTLMISRTPEVTCVVVDVSHEDPEVKFNWYVDGVEVHNAKTKPREEQY
NSTYRVVSVLTVLHQDWLNGKEYKCKVSNKALPASIEKTISKAKGQPREPQVYTLPPSRE
EMTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSKLTVDKSR
WQQGNVFSCSVMHEALHNHYTQKSLSLSPGK
>Durvalumab light chain
EIVLTQSPGTLSLSPGERATLSCRASQRVSSSYLAWYQQKPGQAPRLLIYDASSRATGIP
DRFSGSGSGTDFTLTISRLEPEDFAVYYCQQYGSLPWTFGQGTKVEIKRTVAAPSVFIFP
PSDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQESVTEQDSKDSTYSLSSTL
TLSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC
Download FASTA Format
Synonyms
Not Available
External IDs
MEDI 4736 / MEDI-4736 / MEDI4736
Prescription Products
NameDosageStrengthRouteLabellerMarketing StartMarketing End
ImfinziSolution50 mgIntravenousAstra Zeneca2017-11-20Not applicableCanada
ImfinziInjection, solution500 mg/10mLIntravenousAstra Zeneca Lp2017-05-01Not applicableUs
ImfinziInjection, solution120 mg/2.4mLIntravenousAstra Zeneca Lp2017-05-01Not applicableUs
Categories
UNII
28X28X9OKV
CAS number
1428935-60-7

Pharmacology

Indication

Durvalumab is indicated for patients with urothelial carcinoma, such as urinary bladder, urethra or ureter cancer. Patients with prolonged disease progression due to failed platinum-based chemotherapy such as cisplatin and carboplatin are most likely to benefit from durvalumab treatment. Its clinical effectiveness is especially enhanced in PD-L1-positive patient groups [1].

Associated Conditions
Pharmacodynamics

PD-L1 (programmed cell death ligand 1) is a ligand of PD-1 receptor on activated T cells. Tumor cells and tumor-associated immune cells express this inhibitory immune checkpoint molecule that interrupts normal signalling of T cell and subsequent immune responses in the tumor microenvironment by binding to PD-1 receptors. As a novel anticancer immunotherapy, durvalumab enhances T cell responses at tumor sites. Durvalumab acts as a selective antibody against this ligand and prevents its interaction to the PD-1 receptor and promotes normal antitumor T-cell mediated immune activity. It is also referred to as an immune checkpoint inhibitor.

Mechanism of action

Durvalumab is a human immunoglobulin G1 kappa (IgGIk) monoclonal antibody that blocks PD-L1 binding to PD-1 and CD80. PD1 signalling pathway serves to physiologically limit the activity of T cells and autoimmune or inflammatory responses in the body however can be a mechanism of immunity resistance by tumor cells. Blockage of ligand-mediated PD1 pathway enhances further T cell activation, effector T cell proliferation, NK cell activity and cytokine production to minimize the growth of locally advancing or metastasizing solid tumors.

TargetActionsOrganism
AProgrammed cell death 1 ligand 1
binder
Human
AT-lymphocyte activation antigen CD80
binder
Human
Absorption
Not Available
Volume of distribution

Mean Vd approximately 5.6 L with 17% coefficient of variation.

Protein binding
Not Available
Metabolism

Most likely to be degraded into peptides and amino acids by circulating phagocytic cellsor by target antigen-containing cells [4].

Route of elimination
Not Available
Half life

Mean elimination half-life is approximately 12 days with 23.2% coefficient of variation.

Clearance

Mean steady state clearance is approximately 8.24 mL/h (37.3% coefficient of variation).

Toxicity

Many toxic effects of durvalumab therapy are immune-mediated inflammation in various tissues including pneumonitis, hepatitis and colitis. Disturbances in endocrine system are possible adverse effects such as hypo/hyperthyroidism, type I diabetes mellitus and adrenal insufficiency. Cessation of therapy is recommended in case of any immune-mediated or infusion-related adverse reactions. Animal studies suggest a possibility of embryo-fetal toxicity.

Affected organisms
  • Humans and other mammals
Pathways
Not Available
Pharmacogenomic Effects/ADRs
Not Available

Interactions

Drug Interactions
DrugInteraction
AbciximabThe risk or severity of adverse effects can be increased when Abciximab is combined with Durvalumab.
AcetyldigitoxinAcetyldigitoxin may decrease the cardiotoxic activities of Durvalumab.
AcetyldigoxinAcetyldigoxin may decrease the cardiotoxic activities of Durvalumab.
AdalimumabThe risk or severity of adverse effects can be increased when Adalimumab is combined with Durvalumab.
AlemtuzumabThe risk or severity of adverse effects can be increased when Alemtuzumab is combined with Durvalumab.
AncestimThe risk or severity of cytotoxicity can be increased when Ancestim is combined with Durvalumab.
Anthrax immune globulin humanThe therapeutic efficacy of Anthrax immune globulin human can be decreased when used in combination with Durvalumab.
Antithymocyte immunoglobulin (rabbit)The risk or severity of adverse effects can be increased when Antithymocyte immunoglobulin (rabbit) is combined with Durvalumab.
Bacillus calmette-guerin substrain connaught live antigenThe therapeutic efficacy of Bacillus calmette-guerin substrain connaught live antigen can be decreased when used in combination with Durvalumab.
Bacillus calmette-guerin substrain tice live antigenThe therapeutic efficacy of Bacillus calmette-guerin substrain tice live antigen can be decreased when used in combination with Durvalumab.
Food Interactions
Not Available

References

General References
  1. Massard C, Gordon MS, Sharma S, Rafii S, Wainberg ZA, Luke J, Curiel TJ, Colon-Otero G, Hamid O, Sanborn RE, O'Donnell PH, Drakaki A, Tan W, Kurland JF, Rebelatto MC, Jin X, Blake-Haskins JA, Gupta A, Segal NH: Safety and Efficacy of Durvalumab (MEDI4736), an Anti-Programmed Cell Death Ligand-1 Immune Checkpoint Inhibitor, in Patients With Advanced Urothelial Bladder Cancer. J Clin Oncol. 2016 Sep 10;34(26):3119-25. doi: 10.1200/JCO.2016.67.9761. Epub 2016 Jun 6. [PubMed:27269937]
  2. Pardoll DM: The blockade of immune checkpoints in cancer immunotherapy. Nat Rev Cancer. 2012 Mar 22;12(4):252-64. doi: 10.1038/nrc3239. [PubMed:22437870]
  3. Medina PJ, Adams VR: PD-1 Pathway Inhibitors: Immuno-Oncology Agents for Restoring Antitumor Immune Responses. Pharmacotherapy. 2016 Mar;36(3):317-34. doi: 10.1002/phar.1714. [PubMed:26822752]
  4. Keizer RJ, Huitema AD, Schellens JH, Beijnen JH: Clinical pharmacokinetics of therapeutic monoclonal antibodies. Clin Pharmacokinet. 2010 Aug;49(8):493-507. doi: 10.2165/11531280-000000000-00000. [PubMed:20608753]
  5. Durvalumab IMGT/mAb-DB card [Link]
External Links
KEGG Drug
D10808
PubChem Substance
347911229
Drugs.com
Drugs.com Drug Page
Wikipedia
Durvalumab
AHFS Codes
  • 10:00.00 — Antineoplastic Agents
FDA label
Download (576 KB)

Clinical Trials

Clinical Trials
PhaseStatusPurposeConditionsCount
0RecruitingBasic ScienceBevacizumab-alone Maintenance Treatment Progression / Metastatic Breast Cancer (MBC)1
0RecruitingTreatmentCancer, Breast / Hormone Receptor Positive, HER2 Negative Breast Cancer1
0RecruitingTreatmentMalignant Neoplasms of Oropharynx1
0RecruitingTreatmentMalignant Neoplasms of Urinary Tract1
0RecruitingTreatmentThyroid Cancers1
0WithdrawnTreatmentCutaneous T Cell Lymphomas (CTCL)1
1Active Not RecruitingOtherMetastatic Breast Cancer (MBC)1
1Active Not RecruitingOtherSolid Malignancies1
1Active Not RecruitingTreatmentAdenocarcinoma of the Pancreas / Biliary Tract Cancer / Cancer, Breast / Colorectal Cancers / Gastrooesophageal Cancer / Head and Neck Carcinoma / Lung Cancers / Melanoma1
1Active Not RecruitingTreatmentAdenocarcinomas of the Gastroesophageal Junction / Hepatocellular,Carcinoma / Lung Cancer Non-Small Cell Cancer (NSCLC) / Malignant Neoplasm of Stomach1
1Active Not RecruitingTreatmentAdvanced Solid Tumors3
1Active Not RecruitingTreatmentCancer of the Ovary / Cancer, Breast / Cervical Cancers / Colorectal Cancers / Renal Cell Adenocarcinoma1
1Active Not RecruitingTreatmentLung Cancer Non-Small Cell Cancer (NSCLC) / Patients With Non-Small Cell Lung Cancer(NSCLC)1
1Active Not RecruitingTreatmentMultiple Myeloma (MM)2
1Active Not RecruitingTreatmentPancreatic Cancer Metastatic1
1Active Not RecruitingTreatmentPolycythemia Vera, Post-Polycythemic Myelofibrosis Phase / Primary Myelofibrosis1
1Active Not RecruitingTreatmentRecurrent or Metastatic Solid Tumors1
1CompletedOtherPart A and B: Advanced Solid Malignancies / Part C: Malignant Mesothelioma1
1CompletedTreatmentAdvanced Solid Tumors1
1CompletedTreatmentSquamous Cell Carcinoma of the Head and Neck (SCCHN)1
1Not Yet RecruitingTreatmentCancer of the Ovary / Fallopian Tube Cancer / Primary Peritoneal Carcinoma1
1Not Yet RecruitingTreatmentHead and Neck Squamous Cell Carcinoma (HNSCC) / Larynx / Lip, Oral Cavity and Pharynx / Oral Cavity Squamous Cell Carcinoma / Oropharyngeal Squamous Cell Carcinoma1
1Not Yet RecruitingTreatmentLymphoma, Large B-Cell, Diffuse (DLBCL)1
1Not Yet RecruitingTreatmentSquamous Cell Carcinoma of the Head and Neck (SCCHN)1
1RecruitingBasic ScienceSoft Tissue Sarcoma Adult1
1RecruitingTreatmentAbdominal wall neoplasm / Carcinoma, Squamous Cell of Head and Neck / Esophagogastric Junction Neoplasms / Fallopian Tube Neoplasms / Neoplasms, Ovarian / Pancreatic Ductal Carcinoma / Small Cell Lung Carcinoma / Squamous Cell Carcinoma of Esophagus / Stomach Neoplasms / Triple Negative Breast Neoplasms1
1RecruitingTreatmentAdvanced Non Small Cell Lung Cancer1
1RecruitingTreatmentAdvanced Non-Small Cell Lung Cancer / Lung Cancer Non-Small Cell Cancer (NSCLC)1
1RecruitingTreatmentAdvanced Solid Malignancies1
1RecruitingTreatmentAdvanced Solid Malignancies / Colorectal Carcinoma (CRC) / Lung Cancer Non-Small Cell Cancer (NSCLC) / Metastatic Castrate-Resistant Prostate Carcinoma (mCRPC)1
1RecruitingTreatmentAdvanced Solid Tumors1
1RecruitingTreatmentAdvanced Solid Tumours1
1RecruitingTreatmentAnatomic Stage IV Breast Cancer AJCC v8 / Estrogen Receptor Negative / HER2/Neu Negative / Progesterone Receptor Negative / Prognostic Stage IV Breast Cancer AJCC v8 / Triple-Negative Breast Carcinoma1
1RecruitingTreatmentBCL2 Gene Rearrangement / BCL6 Gene Rearrangement / CD19 Positive / Diffuse Large B-Cell Lymphoma, Not Otherwise Specified / High-Grade B-Cell Lymphoma With MYC and BCL2 and/or BCL6 Rearrangements / High-Grade B-Cell Lymphoma With MYC, BCL2, and BCL6 Rearrangements / MYC Gene Rearrangement / Recurrent Diffuse Large B-Cell Lymphoma / Recurrent Mediastinal (Thymic) Large B-Cell Cell Lymphoma / Refractory Diffuse Large B Cell Lymphoma / Refractory Mediastinal (Thymic) Large B-Cell Cell Lymphoma1
1RecruitingTreatmentCancers / CTCL / Tumors, Solid1
1RecruitingTreatmentCancer, Advanced / Colorectal Cancers / Malignant Neoplasm of Pancreas / Metastatic Cancers1
1RecruitingTreatmentCancer, Breast1
1RecruitingTreatmentCancer, Breast / Lung Cancer Non-Small Cell Cancer (NSCLC) / Malignant Neoplasm of Pancreas / Melanoma / Metastatic1
1RecruitingTreatmentCarcinoma, Squamous Cell of Head and Neck / Lung Cancer Non-Small Cell Cancer (NSCLC) / Small Cell Lung Carcinoma1
1RecruitingTreatmentCervical Cancers / Malignant Neoplasms of Female Genital Organs / Vaginal Cancers / Vulvar Cancers1
1RecruitingTreatmentColorectal Cancers / Hepatic Metastases1
1RecruitingTreatmentDigestive Organs--Diseases / Larynx / LIP / Oral Cancers1
1RecruitingTreatmentExtensive-Stage Small Cell Lung Cancer1
1RecruitingTreatmentExtrahepatic Bile Duct Adenocarcinoma, Biliary Type / Gallbladder Adenocarcinoma, Biliary Type / Pancreatic Adenocarcinoma Metastatic / Recurrent Cholangiocarcinoma / Recurrent Gallbladder Carcinoma / Recurrent Hepatocellular Carcinoma / Recurrent Intrahepatic Cholangiocarcinoma / Recurrent Pancreatic Carcinoma / Stage III Gallbladder Cancer AJCC V7 / Stage III Hepatocellular Carcinoma AJCC v7 / Stage III Intrahepatic Cholangiocarcinoma AJCC v7 / Stage III Pancreatic Cancer AJCC v6 and v7 / Stage IIIA Gallbladder Cancer AJCC v7 / Stage IIIA Hepatocellular Carcinoma AJCC v7 / Stage IIIB Gallbladder Cancer AJCC v7 / Stage IIIB Hepatocellular Carcinoma AJCC v7 / Stage IIIC Hepatocellular Carcinoma AJCC v7 / Stage IV Gallbladder Cancer AJCC v7 / Stage IV Hepatocellular Carcinoma AJCC v7 / Stage IV Pancreatic Cancer AJCC v6 and v7 / Stage IVA Gallbladder Cancer AJCC v7 / Stage IVA Hepatocellular Carcinoma AJCC v7 / Stage IVA Intrahepatic Cholangiocarcinoma AJCC v7 / Stage IVB Gallbladder Cancer AJCC v7 / Stage IVB Hepatocellular Carcinoma AJCC v7 / Stage IVB Intrahepatic Cholangiocarcinoma AJCC v7 / Unresectable Gallbladder Carcinoma / Unresectable Pancreatic Carcinoma1
1RecruitingTreatmentHead and Neck Carcinoma1
1RecruitingTreatmentHer2-negative Metastatic Breast Cancer / Recurrent Ovarian Cancer1
1RecruitingTreatmentLocally Advanced Malignant Neoplasm / Metastatic Tumors / Tumors, Solid / Unresectable Malignant Neoplasm1
1RecruitingTreatmentLymphoma, Large B-Cell, Diffuse (DLBCL)1
1RecruitingTreatmentMetastatic Carcinoma in the Liver / MLH1 Gene Mutation / MSH6 Gene Mutation / PMS2 Gene Mutation / Stage IV Colorectal Cancer / Stage IVA Colorectal Cancer / Stage IVB Colorectal Cancer1
1RecruitingTreatmentMalignant Lymphomas / Tumors, Central Nervous System / Tumors, Solid1
1RecruitingTreatmentMalignant Neoplasm of Pancreas1
1RecruitingTreatmentMetastatic Anaplastic Thyroid Cancer1
1RecruitingTreatmentMetastatic Endometrial cancer / Metastatic Vaginal Cancer / Metastatic Vulvar Cancer / Ovarian Cancer Metastatic / Recurrent Cervical Carcinoma / Recurrent Endometrial Cancer / Recurrent Gynecological Cancer / Recurrent Ovarian Carcinoma / Recurrent Vaginal Cancer / Recurrent Vulvar Cancer / Recurrent, IV-B Cervical cancer1
1RecruitingTreatmentMuscle Invasive Bladder Cancer1
1RecruitingTreatmentMyelodysplastic Syndrome1
1RecruitingTreatmentRenal Cancers / Renal Cell Adenocarcinoma1
1RecruitingTreatmentSelected Advanced Solid Tumors2
1RecruitingTreatmentTNBC - Triple-Negative Breast Cancer / Triple Negative Breast Cancer (TNBC) / Triple Negative Breast Neoplasms / Triple-Negative Breast Carcinoma1
1RecruitingTreatmentTumors, Solid2
1RecruitingTreatmentUrinary Bladder Neoplasms1
1TerminatedTreatmentMultiple Myeloma (MM)1
1TerminatedTreatmentTumors, Solid1
1WithdrawnTreatmentResectable Squamous Cell Carcinoma of Oral Cavity / Squamous Cell Carcinoma Mouth / Squamous Cell Carcinoma, Head And Neck1
1WithdrawnTreatmentSolitary Bone Plasmacytoma1
1, 2Active Not RecruitingTreatmentAdvanced Malignancies / Clear Cell Renal Cell Carcinoma / Renal Cancers / Select Advanced Malignancies1
1, 2Active Not RecruitingTreatmentAdvanced Malignancy1
1, 2Active Not RecruitingTreatmentAdvanced Solid Tumors1
1, 2Active Not RecruitingTreatmentCancer of the Ovary1
1, 2Active Not RecruitingTreatmentFollicular Lymphoma (FL) / Lymphoma, Large B-Cell, Diffuse (DLBCL)1
1, 2Active Not RecruitingTreatmentGastric or Gastroesophageal Junction Adenocarcinoma1
1, 2Active Not RecruitingTreatmentLeukemia, Lymphocytic, Chronic, B-Cell / Malignant Lymphomas1
1, 2Active Not RecruitingTreatmentLung Cancer Non-Small Cell Cancer (NSCLC) / Lung Cancers1
1, 2CompletedTreatmentAdvanced Solid Tumors / Aggressive B-cell Lymphomas1
1, 2CompletedTreatmentCancer, Breast / Lung Cancer Non-Small Cell Cancer (NSCLC) / Malignant Neoplasm of Pancreas1
1, 2CompletedTreatmentCarcinoma NOS / Lung Cancer Non-Small Cell Cancer (NSCLC)1
1, 2CompletedTreatmentMelanoma1
1, 2CompletedTreatmentMetastatic Pancreatic Ductal Adenocarcinoma1
1, 2Not Yet RecruitingTreatmentAdenocarcinoma of the Pancreas / Colorectal Adenocarcinoma / Metastatic Colorectal Cancers / Pancreatic Cancer Metastatic1
1, 2Not Yet RecruitingTreatmentClinical Stage I HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC (American Joint Committee on Cancer) v8 / Clinical Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 / Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 / Human Papillomavirus Positive / Oropharyngeal Squamous Cell Carcinoma / P16 Positive Neoplastic Cells Present / Pathologic Stage I HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 / Pathologic Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 / Pathologic Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v81
1, 2Not Yet RecruitingTreatmentHypopharynx Squamous Cell Carcinoma / Larynx Squamous Cell Carcinoma / Metastatic squamous cell carcinoma / Oral Cavity Squamous Cell Carcinoma / Oropharynx Squamous Cell Carcinoma / Paranasal Sinus Squamous Cell Carcinoma / Squamous Cell Carcinoma (SCC) / Squamous Cell Carcinoma of the Head and Neck (SCCHN)1
1, 2Not Yet RecruitingTreatmentInfiltrating Bladder Urothelial Carcinoma1
1, 2Not Yet RecruitingTreatmentNeoplasms, Head and Neck1
1, 2Not Yet RecruitingTreatmentRecurrent Non-Small Cell Lung Carcinoma / Stage IV Lung Cancer / Stage IVA Lung Cancer / Stage IVB Lung Cancer1
1, 2Not Yet RecruitingTreatmentTriple Negative Breast Cancer (TNBC)1
1, 2RecruitingTreatmentAdvanced Kidney Cancer / Clear Cell Renal Cell Carcinoma / Renal Cancers1
1, 2RecruitingTreatmentAdvanced Solid Tumors & Metastatic Squamous Cell Carcinoma of the Head and Neck / Metastatic Squamous Cell Carcinoma of the Head and Neck1
1, 2RecruitingTreatmentBRCA1 Gene Mutation / Brca2 Gene Mutation / Ovarian Serous Adenocarcinoma / Recurrent Fallopian Tube Carcinoma / Recurrent Ovarian Carcinoma / Recurrent Primary Peritoneal Carcinoma1
1, 2RecruitingTreatmentBladder Cancers / Cancer, Breast / Cutaneous T-Cell Lymphoma (CTCL) / Head and Neck Squamous Cell Carcinoma (HNSCC) / Melanoma / Neuroendocrine Carcinoma of the Skin / Prostate Cancer / Renal Cancers / Sarcomas1
1, 2RecruitingTreatmentBladder Cancers / Transitional Cell Carcinoma1
1, 2RecruitingTreatmentBreast / Lung Cancer Small Cell Lung Cancer (SCLC) / Malignant Neoplasm of Stomach / Ovarian1
1, 2RecruitingTreatmentCancer of Pancreas / Cancer of the Pancreas / Malignant Neoplasm of Pancreas / Neoplasms, Pancreatic1
1, 2RecruitingTreatmentCancer of the Ovary / Cancer, Breast / Colorectal Cancers / Lung Cancers / Prostate Cancer / Triple Negative Breast Cancer (TNBC)1
1, 2RecruitingTreatmentCancer of the Ovary / Cervical Cancers / Colorectal Cancers / Endometrial Cancers / Gynecologic Cancers / Large Intestine Cancer / Malignant Neoplasm of Colon / Ovarian Cancer, Epithelial / Platinum-resistant Ovarian Cancer / Rectal Carcinoma / Small Intestine Cancer / Uterine Cancers / Vaginal Cancers / Vulvar Cancers1
1, 2RecruitingTreatmentCancer of the Ovary / Fallopian Tube Cancer / Malignant Neoplasms of Female Genital Organs / Primary Peritoneal Carcinoma1
1, 2RecruitingTreatmentCancer, Advanced1
1, 2RecruitingTreatmentCancer, Breast1
1, 2RecruitingTreatmentCancer, Breast / Luminal B / Triple Negative Breast Cancer (TNBC)1
1, 2RecruitingTreatmentCarcinoma NOS / Pancreatic Adenocarcinoma Metastatic1
1, 2RecruitingTreatmentCarcinoma, Bronchogenic / Lung Cancer Non-Small Cell Cancer (NSCLC) / Neoplasm, Bronchial / Neoplasms / Neoplasms, Lung / Respiratory Tract Neoplasms / Thoracic Neoplasms1
1, 2RecruitingTreatmentCarcinoma, Colorectal / Colorectal Adenocarcinoma / Colorectal Cancers / Metastatic Disease / Microsatellite-Stable (MSS) Tumor / Neoplasms, Colorectal / Refractory Cancer1
1, 2RecruitingTreatmentClear Cell Renal Cell Carcinoma / Renal Papillary Cell Carcinoma1
1, 2RecruitingTreatmentEsophageal Cancers1
1, 2RecruitingTreatmentFollicular Lymphoma (FL) / Lymphoma, Large B-Cell, Diffuse (DLBCL) / Non-Hodgkin's Lymphoma (NHL)1
1, 2RecruitingTreatmentFolliculotropic Mycosis Fungoides / Recurrent Cutaneous T-Cell Non-Hodgkin Lymphoma / Recurrent Mature T- and NK-Cell Non-Hodgkin Lymphoma / Recurrent Mycosis Fungoides / Refractory Cutaneous T-Cell Non-Hodgkin Lymphoma / Refractory Peripheral T-Cell Lymphoma, Not Otherwise Specified / Refractory, advanced Mycosis fungoides / Sezary Syndrome1
1, 2RecruitingTreatmentGastrooesophageal Cancer / Head and Neck Carcinoma / HNSCC (Head and Neck Squamous Cell Cancer / HNSCC (Head and Neck Squamous Cell Cancer) / Lung Cancer Non-Small Cell Cancer (NSCLC) / Malignant Neoplasm of Stomach / Melanoma / NSCLC (Non-small Cell Lung Carcinoma) / Selected Advanced Solid Tumors / Solid Tumors and Hematologic Malignancy / Triple Negative Breast Cancer (TNBC) / Tumors, Solid / UC (Urothelial Cancer) / Urothelial Cancer1
1, 2RecruitingTreatmentGlioblastomas1
1, 2RecruitingTreatmentHead and Neck Carcinoma1
1, 2RecruitingTreatmentHead and Neck Carcinoma / Human Papilloma Virus (HPV)1
1, 2RecruitingTreatmentHead and Neck Squamous Cell Carcinoma (HNSCC) / Lung Cancers / Malignant Neoplasm of Esophagus1
1, 2RecruitingTreatmentHead and Neck Squamous Cell Carcinoma (HNSCC) / Metastatic squamous cell carcinoma1
1, 2RecruitingTreatmentLung Cancer Non-Small Cell Cancer (NSCLC)1
1, 2RecruitingTreatmentLung Cancer Non-Small Cell Cancer (NSCLC) / Metastatic Non-Small Cell Lung Cancer1
1, 2RecruitingTreatmentMalignant Melanoma1
1, 2RecruitingTreatmentMetastatic Colorectal Cancers1
1, 2RecruitingTreatmentMetastatic Head and Neck Squamous Cell Carcinoma / Recurrent Head and Neck Squamous Cell Carcinoma1
1, 2RecruitingTreatmentNeoplasms Pancreas1
1, 2RecruitingTreatmentNeoplasms, Breast2
1, 2RecruitingTreatmentT-Cell Lymphomas1
1, 2RecruitingTreatmentUrothelial Cancer1
1, 2SuspendedTreatmentCancers / Cervical Cancers / Head and Neck Carcinoma1
2Active Not RecruitingTreatmentAdenocarcinoma of the Pancreas1
2Active Not RecruitingTreatmentAdvanced Colorectal Cancer1
2Active Not RecruitingTreatmentCancer of Kidney / Cancer of the Breast / Cancer of the Kidney / Cancer of the Ovary / Cancer of the Pancreas / Cancer, Breast / Carcinoma, Colorectal / Colorectal Cancers / Gastrooesophageal Cancer / Lung Cancer Non-Small Cell Cancer (NSCLC) / Malignant Neoplasm of Pancreas / Renal Cancers1
2Active Not RecruitingTreatmentCancer of the Ovary1
2Active Not RecruitingTreatmentCancer, Breast1
2Active Not RecruitingTreatmentCancers / Human Immunodeficiency Virus (HIV)1
2Active Not RecruitingTreatmentColorectal Cancers1
2Active Not RecruitingTreatmentDurvalumab + Tremelimumab Combination Treatment, Pulmonary Sarcomatoid Carcinoma / Durvalumab + Tremelimumab Combination Treatment, Pulmonary Sarcomatoid Carcinoma, NSCLC1
2Active Not RecruitingTreatmentEsophageal Cancers1
2Active Not RecruitingTreatmentGlioblastomas1
2Active Not RecruitingTreatmentLeukemia Acute Myeloid Leukemia (AML) / Myelodysplastic Syndromes1
2Active Not RecruitingTreatmentLung Cancer Non-Small Cell Cancer (NSCLC)1
2Active Not RecruitingTreatmentLymphoma, Large B-Cell, Diffuse (DLBCL)1
2Active Not RecruitingTreatmentMesothelioma / Pleural Mesotheliomas1
2Active Not RecruitingTreatmentMultiple Myeloma (MM)1
2Active Not RecruitingTreatmentRecurrent or Metastatic PD-L1-positive Squamous Cell Carcinoma of the Head and Neck / Recurrent or Metastatic PD-L1-positive Squamous Cell Carcinoma of the Head and Neck (SCCHN)1
2Active Not RecruitingTreatmentRecurrent/Metastatic Squamous Cell Carcinoma of Head & Neck1
2Active Not RecruitingTreatmentUrinary Bladder Neoplasms1
2CompletedTreatmentMetastatic Pancreatic Ductal Adenocarcinoma1
2Enrolling by InvitationTreatmentCancer of the Ovary / Cancer, Breast / Cervical Cancers / Endometrial Cancers / Fallopian Tube Cancer / Primary Peritoneal Carcinoma / Triple Negative Breast Cancer (TNBC) / Uterine Cancers1
2Enrolling by InvitationTreatmentColorectal Cancers / Malignant Neoplasm of Colon / Malignant Neoplasms of Digestive Organs1
2Not Yet RecruitingTreatmentAdenocarcinoma of the Pancreas1
2Not Yet RecruitingTreatmentAdvanced Gastric Cancer1
2Not Yet RecruitingTreatmentAnatomic Stage IV Breast Cancer AJCC v8 / Estrogen Receptor Negative / HER2/Neu Negative / Metastatic Triple-Negative Breast Carcinoma / Progesterone Receptor Negative / Prognostic Stage IV Breast Cancer AJCC v81
2Not Yet RecruitingTreatmentBladder Cancers2
2Not Yet RecruitingTreatmentBladder Urothelial Carcinoma / Stage IV Bladder Cancer AJCC v8 / Stage IVA Bladder Cancer AJCC v8 / Stage IVB Bladder Cancer AJCC v81
2Not Yet RecruitingTreatmentColorectal Cancers / Hepatic Metastases1
2Not Yet RecruitingTreatmentHepatocellular,Carcinoma / Intermediate Stage of Hepatocellular Carcinoma1
2Not Yet RecruitingTreatmentHuman Papilloma Virus (HPV) / Malignant Neoplasms of Digestive Organs / Malignant Neoplasms of Female Genital Organs / Malignant Neoplasms of Male Genital Organs1
2Not Yet RecruitingTreatmentLocally Advanced Head and Neck Squamous Cell Carcinoma1
2Not Yet RecruitingTreatmentMalignant Lymphomas1
2Not Yet RecruitingTreatmentMalignant Neoplasm of Esophagus1
2Not Yet RecruitingTreatmentMalignant Neoplasm of Pancreas / Pancreatic Ductal Adenocarcinoma1
2Not Yet RecruitingTreatmentMetastatic Pancreas Cancer1
2Not Yet RecruitingTreatmentNSCLC Stage IIIB / NSCLC Stage IV1
2Not Yet RecruitingTreatmentNon-Squamous Non-Small Cell Lung Cancer / Squamous Non-Small Cell Lung Cancer1
2Not Yet RecruitingTreatmentRenal Cell Adenocarcinoma1
2Not Yet RecruitingTreatmentStage III Non-small-Cell Lung Cancer1
2RecruitingOtherMesothelioma1
2RecruitingTreatmentAdenocarcinoma Of Esophagus / Adenocarcinomas of the Gastroesophageal Junction1
2RecruitingTreatmentAdenocarcinoma of the Bladder / Metastatic Bladder Cancer / Non-Transitional Cell Carcinoma of the Urothelial Tract / Small Cell of the Bladder / Squamous Cell Carcinoma of the Bladder1
2RecruitingTreatmentAdenocarcinoma of the Gastro-oesophageal Junction / Adenocarcinoma of the Oesophagus / Adenocarcinoma of the Stomach1
2RecruitingTreatmentAdenocarcinomas / Lung Cancer Non-Small Cell Cancer (NSCLC) / Squamous Cell Carcinoma (SCC)1
2RecruitingTreatmentAdvanced Rare Tumours1
2RecruitingTreatmentAdvanced and/or Metastatic Sarcoma1
2RecruitingTreatmentBile Duct Carcinoma / Biliary Tract Neoplasms / Cholangiocarcinomas / Hapatocellular Carcinoma / Hepatocellular,Carcinoma / Liver Cancer / Liver Cell Caricinoma / Neoplasms, Hepatic1
2RecruitingTreatmentBiliary Tract Cancer / Hepatocellular,Carcinoma1
2RecruitingTreatmentBiliary Tract Neoplasms1
2RecruitingTreatmentBladder Cancers / Carcinoma in Situ of Bladder1
2RecruitingTreatmentCancer, Breast / Estrogen Receptor Positive Tumor / Hormone Antagonist / Menopause1
2RecruitingTreatmentCancers / Rare Diseases1
2RecruitingTreatmentCastration-Resistant Prostate Cancer (CRPC)1
2RecruitingTreatmentCholangiocarcinoma Non-resectable / Cholangiocarcinomas / Gall Bladder Carcinoma / Gallbladder Carcinoma Non-Resectable1
2RecruitingTreatmentDysgerminoma / Germ Cell Tumors / Germinomatous Germ Cell Tumor / Nonseminomatous Germ Cell Tumor / Pineal Germ Cell Tumor / Seminoma1
2RecruitingTreatmentEndometrial Cancers / Endometrial Carcinoma / Endometrial Carcinosarcoma / Recurrent Endometrial Cancer / Recurrent Endometrial Carcinoma1
2RecruitingTreatmentEsophageal Cancers1
2RecruitingTreatmentEsophageal Cancers / Laryngeal Cancer / Lip Cancer / Oral Cancers / Oropharynx Cancers / Squamous Cell Carcinoma (SCC)1
2RecruitingTreatmentEstrogen Receptor Positive and HER2 Negative Breast Cancer / Microsatellite Stable Colorectal Carcinoma / Platinum Resistant Epithelial Ovarian Cancer Type II1
2RecruitingTreatmentGerm Cell Tumors1
2RecruitingTreatmentHepatocellular,Carcinoma1
2RecruitingTreatmentHuman Papillomavirus Infections / Stage I Oral Cavity Squamous Cell Carcinoma / Stage I Oropharyngeal Squamous Cell Carcinoma / Stage II Oral Cavity Squamous Cell Carcinoma / Stage II Oropharyngeal Squamous Cell Carcinoma / Stage III Oral Cavity Squamous Cell Carcinoma / Stage III Oropharyngeal Squamous Cell Carcinoma / Stage IVA Oral Cavity Squamous Cell Carcinoma / Stage IVA Oropharyngeal Squamous Cell Carcinoma / Stage IVB Oral Cavity Squamous Cell Carcinoma / Stage IVB Oropharyngeal Squamous Cell Carcinoma / Stage IVC Oropharyngeal Squamous Cell Carcinoma1
2RecruitingTreatmentLarge Cell Lung Carcinoma Metastatic / Lung Cancer Non-Small Cell Cancer (NSCLC) / Metastatic Lung Adenocarcinoma / Metastatic Lung Cancer1
2RecruitingTreatmentLung Cancer Metastatic1
2RecruitingTreatmentLung Cancer Non-Small Cell Cancer (NSCLC)7
2RecruitingTreatmentLung Cancer Small Cell Lung Cancer (SCLC)1
2RecruitingTreatmentMalignant Gliomas / Recurrent Glioblastoma1
2RecruitingTreatmentMalignant Neoplasm of Digestive Organs Intestinal Tract Primary / Malignant Neoplasm of Respiratory and Intrathoracic Organ Carcinoma1
2RecruitingTreatmentMalignant Neoplasm of Female Genital Organ1
2RecruitingTreatmentMalignant Solid Neoplasms1
2RecruitingTreatmentMesothelioma1
2RecruitingTreatmentMetastatic Adult Soft Tissue Sarcoma / Recurrent Adult Soft Tissue Sarcoma1
2RecruitingTreatmentMetastatic Breast Cancer (MBC)1
2RecruitingTreatmentMetastatic Colorectal Cancers3
2RecruitingTreatmentMetastatic Non-Small Cell Lung Cancer1
2RecruitingTreatmentMicrosatellite Stable / Recurrent Colorectal Carcinoma / Recurrent Non-Small Cell Lung Carcinoma / Stage IV Colorectal Cancer AJCC v7 / Stage IV Non-Small Cell Lung Cancer / Stage IV Non-Small Cell Lung Cancer AJCC v7 / Stage IVA Colorectal Cancer / Stage IVA Colorectal Cancer AJCC v7 / Stage IVB Colorectal Cancer / Stage IVB Colorectal Cancer AJCC v71
2RecruitingTreatmentMuscle-invasive Bladder Cancer1
2RecruitingTreatmentNSCLC, Stage I1
2RecruitingTreatmentNeuroendocrine Neoplasm of Lung / Neuroendocrine Tumors1
2RecruitingTreatmentOropharyngeal Squamous Cell Carcinoma1
2RecruitingTreatmentOvarian Clear Cell Carcinoma1
2RecruitingTreatmentPeritoneal Mesotheliomas / Pleural Mesotheliomas1
2RecruitingTreatmentPlatinum Refractory Extensive-Stage Small Cell Lung Carcinoma1
2RecruitingTreatmentProstate Cancer1
2RecruitingTreatmentRectal Carcinoma1
2RecruitingTreatmentRecurrent Small Cell Lung Carcinoma1
2RecruitingTreatmentRecurrent Squamous Cell Lung Carcinoma / Stage IV Squamous Cell Lung Carcinoma AJCC v71
2RecruitingTreatmentSquamous Cell Carcinoma of Esophagus1
2RecruitingTreatmentSquamous Cell Carcinoma of the Head and Neck (SCCHN)1
2RecruitingTreatmentUrothelial Cancer1
2SuspendedTreatmentEstrogen Receptor Negative / Estrogen Receptor Positive / HER2/Neu Negative / Recurrent Breast Carcinoma / Stage IV Breast Cancer1
2SuspendedTreatmentMalignant Neoplasm of Pancreas1
2TerminatedTreatmentMultiple Myeloma (MM)1
2WithdrawnTreatmentAdvanced Lung Cancer / Malignant Neoplasm of Respiratory and Intrathoracic Organ Carcinoma / Recurrent Nonsmall Cell Lung Cancer1
2WithdrawnTreatmentBladder Cancers1
2WithdrawnTreatmentCastration Levels of Testosterone / Hormone-Resistant Prostate Cancer / Microsatellite Instability1
2WithdrawnTreatmentEBV Related Non-Hodgkin's Lymphoma / Primary Central Nervous System Lymphoma (PCNSL) / Primary Testicular Lymphoma1
2WithdrawnTreatmentLung Cancer Non-Small Cell Cancer (NSCLC)2
2WithdrawnTreatmentLymphoma, Large B-Cell, Diffuse (DLBCL)1
2, 3Active Not RecruitingTreatmentRecurrent Squamous Cell Lung Carcinoma / Stage IV Squamous Cell Lung Carcinoma / Stage IV Squamous Cell Lung Carcinoma AJCC v71
2, 3RecruitingTreatmentRecurrent Squamous Cell Lung Carcinoma / Stage IV Squamous Cell Lung Carcinoma / Stage IV Squamous Cell Lung Carcinoma AJCC v71
2, 3SuspendedTreatmentHead and Neck Squamous Cell Carcinoma (HNSCC) / Squamous Cell Carcinoma of Unknown Primary Origin / Stage III Hypopharyngeal Squamous Cell Carcinoma AJCC v7 / Stage III Laryngeal Squamous Cell Carcinoma AJCC v6 and v7 / Stage III Oral Cavity Squamous Cell Carcinoma AJCC v6 and v7 / Stage III Oropharyngeal Squamous Cell Carcinoma AJCC v7 / Stage IVA Hypopharyngeal Squamous Cell Carcinoma AJCC v7 / Stage IVA Laryngeal Squamous Cell Carcinoma AJCC v7 / Stage IVA Oral Cavity Squamous Cell Carcinoma AJCC v6 and v7 / Stage IVA Oropharyngeal Squamous Cell Carcinoma AJCC v7 / Stage IVB Hypopharyngeal Squamous Cell Carcinoma AJCC v7 / Stage IVB Laryngeal Squamous Cell Carcinoma AJCC v7 / Stage IVB Oral Cavity Squamous Cell Carcinoma AJCC v6 and v7 / Stage IVB Oropharyngeal Squamous Cell Carcinoma AJCC v71
3Active Not RecruitingTreatmentLocally Advanced or Metastatic EGFR T790M+ NSCLC1
3Active Not RecruitingTreatmentLung Cancer Non-Small Cell Cancer (NSCLC)2
3Active Not RecruitingTreatmentLung Cancer Non-Small Cell Cancer (NSCLC) / Non-Small-Cell Lung Carcinoma NSCLC1
3Active Not RecruitingTreatmentNon Small Cell Lung Carcinoma (NSCLC) / Non Small Cell Lung Carcinoma NSCLC1
3Active Not RecruitingTreatmentRecurrent or Metastatic PD-L1-positive or -Negative Squamous Cell Carcinoma of the Head and Neck (SCCHN) / Recurrent or Metastatic PD-L1-positive or -Negative Squamous Cell Carcinoma of the Head and Neck SCCHN1
3Active Not RecruitingTreatmentSquamous Cell Carcinoma of the Head and Neck (SCCHN)1
3RecruitingTreatmentAdvanced Solid Malignancies1
3RecruitingTreatmentBladder Cancers / Urothelial Cancer1
3RecruitingTreatmentHepatocellular,Carcinoma1
3RecruitingTreatmentLung Cancer Non-Small Cell Cancer (NSCLC)3
3RecruitingTreatmentNon Small Cell Lung Carcinoma (NSCLC) / Non Small Cell Lung Carcinoma NSCLC1
3RecruitingTreatmentNon-muscle-invasive Bladder Cancer1
3RecruitingTreatmentRenal Cell Adenocarcinoma1
3RecruitingTreatmentSmall Cell Lung Carcinoma Extensive Disease1
3RecruitingTreatmentStage II Non-Small Cell Lung Cancer AJCC v7 / Stage IIA Non-small Cell Lung Cancer / Stage IIA Non-Small Cell Lung Carcinoma AJCC v7 / Stage IIB Non-small Cell Lung Cancer / Stage IIB Non-Small Cell Lung Carcinoma AJCC v7 / Stage III Non-Small Cell Lung Cancer AJCC v7 / Stage IIIA Non-Small Cell Lung Cancer / Stage IIIA Non-Small Cell Lung Cancer AJCC v7 / Stage IIIb Non-small Cell Lung Cancer / Stage IIIB Non-Small Cell Lung Cancer AJCC v71
Not AvailableActive Not RecruitingTreatmentMetastatic Breast Cancer (MBC)1

Pharmacoeconomics

Manufacturers
Not Available
Packagers
Not Available
Dosage forms
FormRouteStrength
Injection, solutionIntravenous120 mg/2.4mL
Injection, solutionIntravenous500 mg/10mL
SolutionIntravenous50 mg
Prices
Not Available
Patents
Not Available

Properties

State
Liquid
Experimental Properties
Not Available

Taxonomy

Description
Not Available
Kingdom
Organic Compounds
Super Class
Organic Acids
Class
Carboxylic Acids and Derivatives
Sub Class
Amino Acids, Peptides, and Analogues
Direct Parent
Peptides
Alternative Parents
Not Available
Substituents
Not Available
Molecular Framework
Not Available
External Descriptors
Not Available

Targets

Kind
Protein
Organism
Human
Pharmacological action
Yes
Actions
Binder
General Function
Not Available
Specific Function
Involved in the costimulatory signal, essential for T-cell proliferation and production of IL10 and IFNG, in an IL2-dependent and a PDCD1-independent manner. Interaction with PDCD1 inhibits T-cell ...
Gene Name
CD274
Uniprot ID
Q9NZQ7
Uniprot Name
Programmed cell death 1 ligand 1
Molecular Weight
33275.095 Da
References
  1. Bellmunt J, Powles T, Vogelzang NJ: A review on the evolution of PD-1/PD-L1 immunotherapy for bladder cancer: The future is now. Cancer Treat Rev. 2017 Mar;54:58-67. doi: 10.1016/j.ctrv.2017.01.007. Epub 2017 Feb 2. [PubMed:28214651]
Kind
Protein
Organism
Human
Pharmacological action
Yes
Actions
Binder
General Function
Virus receptor activity
Specific Function
Involved in the costimulatory signal essential for T-lymphocyte activation. T-cell proliferation and cytokine production is induced by the binding of CD28, binding to CTLA-4 has opposite effects an...
Gene Name
CD80
Uniprot ID
P33681
Uniprot Name
T-lymphocyte activation antigen CD80
Molecular Weight
33047.625 Da
References
  1. Reichert JM: Antibodies to watch in 2017. MAbs. 2017 Feb/Mar;9(2):167-181. doi: 10.1080/19420862.2016.1269580. Epub 2016 Dec 14. [PubMed:27960628]

Drug created on October 20, 2016 14:41 / Updated on September 21, 2018 20:42