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
- -
Study of HRO761 Alone or in Combination in Cancer Patients With Specific DNA Alterations Called Microsatellite Instability or Mismatch Repair Deficiency.
- Conditions
- Interventions
- First Posted Date
- 2023-05-03
- Last Posted Date
- 2024-12-10
- Lead Sponsor
- Novartis Pharmaceuticals
- Target Recruit Count
- 327
- Registration Number
- NCT05838768
- Locations
- 🇺🇸
University of California LA, Los Angeles, California, United States
🇬🇧Novartis Investigative Site, Oxford, United Kingdom
🇺🇸Columbia University Medical Ctr, New York, New York, United States
A Study to Learn About the Effectiveness of Cancer Medicines in Patients With Metastatic Non-small Cell Lung Cancer in Norway.
- Conditions
- Interventions
- First Posted Date
- 2023-04-28
- Last Posted Date
- 2023-10-10
- Lead Sponsor
- Pfizer
- Target Recruit Count
- 20605
- Registration Number
- NCT05834348
- Locations
- 🇳🇴
Pfizer Norway, Oslo, Norway
Phase 1 Trial in Patients With Human Papillomavirus (HPV)-Associated Cancer
- First Posted Date
- 2023-04-24
- Last Posted Date
- 2024-08-09
- Lead Sponsor
- Toragen, Inc.
- Target Recruit Count
- 55
- Registration Number
- NCT05826275
- Locations
- 🇺🇸
MD Anderson Cancer Center, Houston, Texas, United States
🇺🇸UCSD Moores Cancer Center, La Jolla, California, United States
🇺🇸City of Hope, Duarte, California, United States
A Study to Evaluate the Safety and Therapeutic Activity of GI-102 As a Single Agent and in Combination with Conventional Anti-cancer Drugs, Pembrolizumab or Trastuzumab Deruxtecan(T-DXd) in Patients with Advanced Solid Tumors (KEYNOTE-G08)
- Conditions
- Interventions
- First Posted Date
- 2023-04-24
- Last Posted Date
- 2024-11-25
- Lead Sponsor
- GI Innovation, Inc.
- Target Recruit Count
- 358
- Registration Number
- NCT05824975
- Locations
- 🇺🇸
Mayo Clinic in Arizona, Scottsdale, Arizona, United States
🇺🇸Mayo Clinic in Florida, Jacksonville, Florida, United States
🇺🇸Mayo Clinic in Minnesota, Rochester, Minnesota, United States
The Effect of Prebiotic Inulin on Patients Affected by R/M HNSCC Treated With Immune Checkpoint Inhibitors
- Conditions
- Interventions
- First Posted Date
- 2023-04-20
- Last Posted Date
- 2023-04-20
- Lead Sponsor
- Fondazione del Piemonte per l'Oncologia
- Target Recruit Count
- 40
- Registration Number
- NCT05821751
- Locations
- 🇮🇹
Fondazione del Piemonte per l'Oncologia-IRCCS Candiolo, Candiolo, Turin, Italy
A Study of SKB264 for the Treatment of Participants With Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC)
- Conditions
- Interventions
- First Posted Date
- 2023-04-18
- Last Posted Date
- 2024-07-31
- Lead Sponsor
- Klus Pharma Inc.
- Target Recruit Count
- 278
- Registration Number
- NCT05816252
- Locations
- 🇦🇺
St Vincent's Hospital - Kinghorn Cancer Centre, Darlinghurst, New South Wales, Australia
🇨🇳Beijing Cancer Hospital, Beijing, Beijing, China
🇨🇳The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, Shaanxi, China
Pembrolizumab and Radiotherapy for Oligometastatic Head and Neck Cancer
- Conditions
- Interventions
- First Posted Date
- 2023-04-18
- Last Posted Date
- 2024-02-22
- Target Recruit Count
- 200
- Registration Number
- NCT05815927
Activity and Safety of Danvatirsen and Pembrolizumab in HNSCC
- First Posted Date
- 2023-04-18
- Last Posted Date
- 2024-05-31
- Lead Sponsor
- Flamingo Therapeutics NV
- Target Recruit Count
- 81
- Registration Number
- NCT05814666
- Locations
- 🇺🇸
University of Illinois Cancer Center, Chicago, Illinois, United States
🇺🇸Mary Bird Perkins Cancer Center, Baton Rouge, Louisiana, United States
🇺🇸Morristown Medical Center, Morristown, New Jersey, United States
Pembrolizumab vs. Observation in People With Triple-negative Breast Cancer Who Had a Pathologic Complete Response After Chemotherapy Plus Pembrolizumab
- Conditions
- Interventions
- First Posted Date
- 2023-04-14
- Last Posted Date
- 2024-12-27
- Lead Sponsor
- Alliance for Clinical Trials in Oncology
- Target Recruit Count
- 1295
- Registration Number
- NCT05812807
- Locations
- 🇺🇸
Stamford Hospital/Bennett Cancer Center, Stamford, Connecticut, United States
🇺🇸Memorial Regional Hospital/Joe DiMaggio Children's Hospital, Hollywood, Florida, United States
🇺🇸Health Central, Ocoee, Florida, United States
Phase II Study Evaluating the Efficacy and Safety of Ociperlimab in Combination With Tislelizumab and Chemotherapy as First-line Treatment for Participants With Advanced Triple Negative Breast Cancer
- First Posted Date
- 2023-04-12
- Last Posted Date
- 2023-07-24
- Lead Sponsor
- Novartis Pharmaceuticals
- Registration Number
- NCT05809895
Drug Development Updates
Stay informed with timely notifications on clinical trials, regulatory changes, and research advancements related to this medication.