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 Followed by Chemotherapy for the Treatment of Patients With Classical Hodgkin Lymphoma
- Conditions
- Interventions
- First Posted Date
- 2023-12-11
- Last Posted Date
- 2024-03-08
- Lead Sponsor
- Northwestern University
- Target Recruit Count
- 30
- Registration Number
- NCT06164275
- Locations
- 🇺🇸
Stanford Cancer Center, Stanford, California, United States
🇺🇸Northwestern University, Chicago, Illinois, United States
🇺🇸Cadence Health - CDH, Warrenville, Illinois, United States
Study of RAS(ON) Inhibitor Combinations in Patients with Advanced RAS-mutated NSCLC
- First Posted Date
- 2023-12-08
- Last Posted Date
- 2024-12-05
- Lead Sponsor
- Revolution Medicines, Inc.
- Target Recruit Count
- 484
- Registration Number
- NCT06162221
- Locations
- 🇺🇸
Cancer Specialists of North Florida, St Augustine, Florida, United States
🇺🇸Hillman Cancer Center, Pittsburgh, Pennsylvania, United States
🇩🇪Thoraxklinik Heidelberg gGmbH - Universitätsklinikum Heidelberg, Heidelberg, Germany
Pembrolizumab + N-803 Alone or in Combination With PD-L1 t-haNK Cells for Resectable Head and Neck Squamous Cell Carcinoma
- First Posted Date
- 2023-12-08
- Last Posted Date
- 2024-12-20
- Lead Sponsor
- National Cancer Institute (NCI)
- Target Recruit Count
- 40
- Registration Number
- NCT06161545
- Locations
- 🇺🇸
National Institutes of Health Clinical Center, Bethesda, Maryland, United States
T Cells and Pembrolizumab for Recurrent and Newly Diagnosed Glioblastoma
- Conditions
- Interventions
- First Posted Date
- 2023-12-06
- Last Posted Date
- 2024-05-31
- Lead Sponsor
- Queensland Institute of Medical Research
- Target Recruit Count
- 58
- Registration Number
- NCT06157541
- Locations
- 🇦🇺
Princess Alexandra Hospital, Woolloongabba, Queensland, Australia
🇦🇺Newro Foundation, Bowen Hills, Queensland, Australia
🇦🇺Royal Brisbane and Women's Hospital, Herston, Queensland, Australia
Beamion LUNG-2: A Study to Test Whether Zongertinib (BI 1810631) Helps People With Advanced Non-small Cell Lung Cancer With HER2 Mutations Compared With Standard Treatment
- Conditions
- Interventions
- First Posted Date
- 2023-11-30
- Last Posted Date
- 2024-12-11
- Lead Sponsor
- Boehringer Ingelheim
- Target Recruit Count
- 270
- Registration Number
- NCT06151574
- Locations
- 🇵🇹
Hospital CUF Porto, Porto, Portugal
🇺🇸Scripps Cancer Center Torrey Pines, La Jolla, California, United States
🇺🇸Valkyrie Clinical Trials, Los Angeles, California, United States
Safety and Preliminary Efficacy of BNT314 with or Without an Immune Checkpoint Inhibitor in Cancer Patients with Malignant Solid Tumors
- Conditions
- Interventions
- First Posted Date
- 2023-11-29
- Last Posted Date
- 2024-11-27
- Lead Sponsor
- BioNTech SE
- Target Recruit Count
- 360
- Registration Number
- NCT06150183
- Locations
- 🇺🇸
Cleveland Clinic, Cleveland, Ohio, United States
🇧🇪GZA Ziekenhuizen, Antwerpen, Belgium
🇧🇪CHU de Liège, Liege, Belgium
Multi-classifier System for Stratifying Stage III Papillary Renal Cell Carcinoma of Receiving Adjuvant Therapy
- Conditions
- Interventions
- First Posted Date
- 2023-11-27
- Last Posted Date
- 2023-11-29
- Target Recruit Count
- 468
- Registration Number
- NCT06146777
A Study of Tetrathiomolybdate (TM) Plus Capecitabine
- Conditions
- Interventions
- First Posted Date
- 2023-11-18
- Last Posted Date
- 2024-11-27
- Lead Sponsor
- Dartmouth-Hitchcock Medical Center
- Target Recruit Count
- 204
- Registration Number
- NCT06134375
- Locations
- 🇺🇸
Dartmouth Hitchcock Medical Center, Lebanon, New Hampshire, United States
A Study of AMG 355 Alone and in Combination With Pembrolizumab in Participants With Advanced Solid Tumors
- First Posted Date
- 2023-11-14
- Last Posted Date
- 2024-11-07
- Lead Sponsor
- Amgen
- Target Recruit Count
- 515
- Registration Number
- NCT06131398
- Locations
- 🇺🇸
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
🇨🇭Kantonsspital Sankt Gallen, St. Gallen, Switzerland
🇺🇸City of Hope National Medical Center, Duarte, California, United States
A Study of Pembrolizumab With Trastuzumab and Chemotherapy in People With Esophagogastric Cancer
- Conditions
- Interventions
- First Posted Date
- 2023-11-08
- Last Posted Date
- 2024-10-23
- Lead Sponsor
- Memorial Sloan Kettering Cancer Center
- Target Recruit Count
- 25
- Registration Number
- NCT06123338
- Locations
- 🇺🇸
Johns Hopkins University (Data Collection Only), Baltimore, Maryland, United States
🇺🇸Massachusetts General Hospital (Data Collection Only), Boston, Massachusetts, United States
🇺🇸Memorial Sloan Kettering Bergen (Limited Protocol Activities), Montvale, New Jersey, United States
Drug Development Updates
Stay informed with timely notifications on clinical trials, regulatory changes, and research advancements related to this medication.