Pembrolizumab
- Generic Name
- Pembrolizumab
- Brand Names
- Keytruda
- Drug Type
- Biotech
- Chemical Formula
- -
- CAS Number
- 1374853-91-4
- Unique Ingredient Identifier
- DPT0O3T46P
- Background
Pembrolizumab is a highly selective IgG4-kappa humanized monoclonal antibody against PD-1 receptors. It was generated by grafting the variable sequences of a very high-affinity mouse antihuman PD-1 antibody onto a human IgG4-kappa isotype containing a stabilizing S228P Fc mutation. It contains 32 cysteine residues and the complete folded molecule includes 4 disulfide linkages as interchain bonds and 23 interchain bonds. It was developed by Merck & Co and first approved for the treatment of metastatic malignant melanoma by the FDA on September 4, 2014, becoming the first approved therapy against PD-1. In the time since its initial approval, pembrolizumab has been granted approval in the treatment of a wide variety of cancers.
- Indication
Pembrolizumab is indicated for the following conditions:
For all approved adult indications, pembrolizumab may be used for an additional 6 weeks at 400mg weekly.
- Associated Conditions
- Advanced Endometrial Cancer, Advanced Renal Cell Carcinoma, Hepatocellular Carcinoma, Locally Advanced Cutaneous Squamous Cell Carcinoma, Locally Advanced or Metastatic Urothelial Carcinoma (UC), Metastatic Adenocarcinoma of the Gastroesophageal Junction, Metastatic Cervical Cancer, Metastatic Esophageal 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 Triple Negative Breast Cancers, Metastatic Urothelial Carcinoma (UC), Metastatic cutaneous squamous cell carcinoma, Metastic Renal Cell Carcinoma, Non-Small Cell Lung Cancer (NSCLC), Nonsmall Cell Lung Cancer, Stage II, Persistent Cervical Cancer, Recurrent Cervical Cancer, Refractory Primary Mediastinal Large B-Cell Cell Lymphoma, Renal Cell Carcinoma (RCC), Resectable Non-small Cell Lung Cancer, Stage IB Non-small Cell Lung Cancer, Stage IIB Melanoma, Stage IIC Melanoma, Stage III Melanoma, Stage IIIA Non Small Cell Lung Cancer, Unresectable Melanoma, Advanced Microsatellite Instability High Endometrial Carcinoma, Advanced Mismatch Repair-deficient (dMMR) Endometrial Carcinoma, High risk, early Triple Negative Breast Cancer, High risk, in situ Non-Muscle Invasive Bladder Cancer (NMIBC) Refractory to BCG, Locally advanced Adenocarcinomas of the Gastroesophageal Junction, Locally advanced Esophageal Carcinoma, Locally advanced Urothelial Carcinoma, Metastatic HER2-positive Adenocarcinoma of the Stomach, Metastatic HER2-positive Adenocarcinomas of the Gastroesophageal Junction, Metastatic High Tumor Mutation Burden Solid Tumors, Metastatic Merkel Cell Carcinoma (MCC), Metastatic Microsatellite Instability High Colorectal Cancer, Metastatic Microsatellite Instability-High (MSI-H) Solid Tumors, Metastatic Mismatch Repair Deficient Colorectal Cancer, Metastatic Mismatch repair deficient (dMMR) solid tumors, Recurrent Cutaneous Squamous Cell Carcinoma, Recurrent Squamous Cell Carcinoma of the Head and Neck (SCCHN), Recurrent, locally advanced Adenocarcinomas of the Gastroesophageal Junction, Recurrent, locally advanced Merkel Cell Carcinoma, Refractory Classical Hodgkin's Lymphoma, Relapsed Classical Hodgkin's Lymphoma, Stage 3 Non-Small Cell Lung Carcinoma (NSCLC), Unresectable High Tumor Mutation Burden Solid Tumors, Unresectable Microsatellite Instability High Colorectal Cancer, Unresectable Microsatellite Instability-High (MSI-H) Solid Tumors, Unresectable Mismatch Repair Deficient Colorectal Cancer, Unresectable Mismatch repair deficient (dMMR) solid tumors, Unresectable, locally advanced HER2-positive Adenocarcinoma of the Stomach, Unresectable, locally advanced HER2-positive Adenocarcinomas of the Gastroesophageal Junction, Unresectable, locally recurrent Triple Negative Breast Cancer, Unresectable, recurrent Squamous Cell Carcinoma of the Head and Neck (SCCHN)
- Associated Therapies
- -
Pembrolizumab, Lenvatinib and IL-15 Superagonist N-803 in Combination With HER2 Targeting Autologous Dendritic Cell (AdHER2DC) Vaccine in Participants With Advanced or Metastatic Endometrial Cancer
- First Posted Date
- 2024-02-12
- Last Posted Date
- 2024-12-16
- Lead Sponsor
- National Cancer Institute (NCI)
- Target Recruit Count
- 60
- Registration Number
- NCT06253494
- Locations
- 🇺🇸
National Institutes of Health Clinical Center, Bethesda, Maryland, United States
Efficacy and Safety of Combination Therapy With Bojungikki-tang and Pembrolizumab Monotherapy in Patients With Advanced Non-small Cell Lung Cancer
- Conditions
- Interventions
- First Posted Date
- 2024-02-08
- Last Posted Date
- 2024-10-01
- Lead Sponsor
- Korea Institute of Oriental Medicine
- Target Recruit Count
- 70
- Registration Number
- NCT06249854
- Locations
- 🇰🇷
The catholic university of Korea Seoul Saint. Mary's hospital, Seoul, Korea, Republic of
🇰🇷Hallym University Medical Center, Anyang-si, Gyeonggi-do, Korea, Republic of
🇰🇷Pusan National University Yangsan Hospital, Yangsan, Gyeongsangnam-do, Korea, Republic of
PET Dynamics to Response-Adapted Neoadjuvant Therapy in TNBC
- Conditions
- Interventions
- First Posted Date
- 2024-02-07
- Last Posted Date
- 2024-05-08
- Target Recruit Count
- 30
- Registration Number
- NCT06245889
- Locations
- 🇺🇸
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland, United States
A Phase 2 Study of EIK1001 in Combo With Pembrolizumab and Chemotherapy in Patients With Stage 4 NSCLC
- Conditions
- Interventions
- First Posted Date
- 2024-02-07
- Last Posted Date
- 2024-11-21
- Lead Sponsor
- Eikon Therapeutics
- Target Recruit Count
- 70
- Registration Number
- NCT06246110
- Locations
- 🇺🇸
Tennessee Cancer Specialists, Knoxville, Tennessee, United States
🇺🇸Southern Cancer Care, Daphne, Alabama, United States
🇺🇸Ironwood Cancer and Research Center, Chandler, Arizona, United States
A Study of Pembrolizumab and Cryoablation in People with Breast Cancer
- Conditions
- Interventions
- First Posted Date
- 2024-02-07
- Last Posted Date
- 2024-10-02
- Lead Sponsor
- Memorial Sloan Kettering Cancer Center
- Target Recruit Count
- 30
- Registration Number
- NCT06246968
- Locations
- 🇺🇸
Memorial Sloan Kettering Cancer Center at Basking Ridge (Limited Protocol Activities), Basking Ridge, New Jersey, United States
🇺🇸Memorial Sloan Kettering Bergen (Limited Protocol Activities), Montvale, New Jersey, United States
🇺🇸Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities ), Commack, New York, United States
Pembrolizumab and Tazemetostat to Overcome Immune Tolerance Following ASCT or CAR T-cell Therapy in Patients With Aggressive B-Cell Non-Hodgkin's Lymphoma
- First Posted Date
- 2024-02-05
- Last Posted Date
- 2024-10-08
- Lead Sponsor
- Northwestern University
- Target Recruit Count
- 32
- Registration Number
- NCT06242834
- Locations
- 🇺🇸
Northwestern University, Chicago, Illinois, United States
Study to Evaluate Adverse Events, Optimal Dose, and Change in Disease Activity, With Livmoniplimab in Combination With Budigalimab Plus Chemotherapy Versus IV Infused Pembrolizumab Plus Chemotherapy in Adult Participants With Untreated Metastatic Non-Squamous Non-Small Cell Lung Cancer (NSCLC)
- Conditions
- Interventions
- First Posted Date
- 2024-02-01
- Last Posted Date
- 2024-11-28
- Lead Sponsor
- AbbVie
- Target Recruit Count
- 840
- Registration Number
- NCT06236438
- Locations
- 🇺🇸
University of Kansas Medical Center /ID# 263196, Westwood, Kansas, United States
🇺🇸Memorial Hospital West /ID# 262221, Pembroke Pines, Florida, United States
🇺🇸Bond Clinic /ID# 262611, Winter Haven, Florida, United States
TBio-4101 and Pembro wi/ or w/o Chemo in Recurrent/Metastatic HNSCC
- First Posted Date
- 2024-02-01
- Last Posted Date
- 2024-11-29
- Target Recruit Count
- 15
- Registration Number
- NCT06236425
- Locations
- 🇺🇸
Moffitt Cancer Center, Tampa, Florida, United States
Dose Escalation and Expansion Study of BH3120 in Advanced or Metastatic Solid Tumors
- Conditions
- Interventions
- First Posted Date
- 2024-01-31
- Last Posted Date
- 2024-02-02
- Lead Sponsor
- Hanmi Pharmaceutical Company Limited
- Target Recruit Count
- 191
- Registration Number
- NCT06234397
- Locations
- 🇺🇸
Carl & Edyth Lindner Center for Research & Education at The Christ Hospital and The Christ Hospital Cancer Center, Cincinnati, Ohio, United States
🇺🇸Mary Crowley Cancer Research, Dallas, Texas, United States
🇺🇸Mays Cancer Center at University of Texas Health San Antonio MD Anderson Cencer Center, San Antonio, Texas, United States
Study BT8009-230 in Participants With Locally Advanced or Metastatic Urothelial Cancer (Duravelo-2)
- Conditions
- Interventions
- First Posted Date
- 2024-01-26
- Last Posted Date
- 2024-12-20
- Lead Sponsor
- BicycleTx Limited
- Target Recruit Count
- 956
- Registration Number
- NCT06225596
- Locations
- 🇫🇷
Service d'Oncologie Medicale - CHRU Besancon, Besançon, France
🇫🇷Institut Bergonie, Bordeaux Cedex, France
🇫🇷CHU Bordeaux - Hopital Saint-Andre, Bordeaux, France
Drug Development Updates
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