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
- -
Safety and Efficacy of VB10.16 and Pembrolizumab in Patients with Head-Neck Squamous Cell Carcinoma
- Conditions
- Interventions
- First Posted Date
- 2023-08-30
- Last Posted Date
- 2024-12-17
- Lead Sponsor
- Nykode Therapeutics ASA
- Target Recruit Count
- 51
- Registration Number
- NCT06016920
- Locations
- 🇫🇷
CRLC Val d'Aurelle - Institut de Recherche en Cancerologie de Montpellier (IRCM), Montpellier, France
🇨🇿Fakultni nemocnice Olomouc, Olomuoc, Olomouc, Czechia
🇫🇷Hospices Civils De Lyon, Lyon, France
Regorafenib in Combination with Pembrolizumab or Pembrolizumab for MSI-H Colorectal Cancer
- First Posted Date
- 2023-08-23
- Last Posted Date
- 2024-10-02
- Lead Sponsor
- Ibrahim Halil Sahin
- Target Recruit Count
- 154
- Registration Number
- NCT06006923
- Locations
- 🇺🇸
AdventHealth Orlando, Orlando, Florida, United States
🇺🇸Northwestern University, Evanston, Illinois, United States
🇺🇸UPMC Hillman Cancer Center, Pittsburgh, Pennsylvania, United States
A Study to Investigate the Efficacy of Durvalumab Plus Tremelimumab in Combination With Chemotherapy Compared With Pembrolizumab in Combination With Chemotherapy in Metastatic Non-Small Cell Lung Cancer (NSCLC) Patients
- Conditions
- Interventions
- First Posted Date
- 2023-08-23
- Last Posted Date
- 2024-12-11
- Lead Sponsor
- AstraZeneca
- Target Recruit Count
- 280
- Registration Number
- NCT06008093
- Locations
- 🇺🇸
Research Site, Milwaukee, Wisconsin, United States
A Randomized Trial of Maintenance Systemic Therapy After Radiation for Oligometastatic Renal Cell Carcinoma (ASTROs)
- Conditions
- Interventions
- First Posted Date
- 2023-08-22
- Last Posted Date
- 2024-06-26
- Lead Sponsor
- M.D. Anderson Cancer Center
- Target Recruit Count
- 144
- Registration Number
- NCT06004336
- Locations
- 🇺🇸
M D Anderson Cancer Center, Houston, Texas, United States
A Study to Evaluate the Safety, Pharmacokinetics, and Anti-Tumor Activity of RO7589831 as Monotherapy and in Combination With Pembrolizumab in Participants With Advanced Solid Tumors
- First Posted Date
- 2023-08-22
- Last Posted Date
- 2024-12-06
- Lead Sponsor
- Hoffmann-La Roche
- Target Recruit Count
- 295
- Registration Number
- NCT06004245
- Locations
- 🇺🇸
City of Hope, Duarte, California, United States
🇺🇸City of Hope at Irvine Lennar, Irvine, California, United States
🇺🇸Norton Cancer Institute - MDC, Louisville, Kentucky, United States
Perioperative Gemcitabine, Cisplatin, and Pembrolizumab in Potentially Resectable Biliary Tract Cancers
- Conditions
- Interventions
- First Posted Date
- 2023-08-21
- Last Posted Date
- 2024-07-25
- Target Recruit Count
- 27
- Registration Number
- NCT06001658
- Locations
- 🇺🇸
SKCCC Johns Hopkins, Baltimore, Maryland, United States
The Effect of Combined Cryotherapy and Immunotherapy on Systemic T Cell Changes and Clinical Outcomes in Metastatic Non-small Cell Lung Cancer
- Conditions
- Interventions
- First Posted Date
- 2023-08-21
- Last Posted Date
- 2023-08-21
- Lead Sponsor
- Lithuanian University of Health Sciences
- Target Recruit Count
- 120
- Registration Number
- NCT06000358
- Locations
- 🇱🇹
Lithuanian University of Health Sciences, Kaunas, Lithuania
GEN-001 Plus Pembrolizumab for Patients With Advanced Refractory Biliary Tract Cancer
- Conditions
- Interventions
- First Posted Date
- 2023-08-21
- Last Posted Date
- 2024-03-21
- Lead Sponsor
- Genome & Company
- Target Recruit Count
- 148
- Registration Number
- NCT05998447
- Locations
- 🇰🇷
Severance Hospital, Seoul, Korea, Republic of
🇰🇷Seoul National University Hospital, Seoul, Korea, Republic of
🇰🇷Samsung Medical Center., Seoul, Korea, Republic of
Phase II Trial of Immunotherapeutic HPV Vaccine PRGN-2009 With Pembrolizumab Before Standard Treatment in Subjects With Newly Diagnosed HPV-Associated Oropharyngeal Cancer
- Conditions
- Interventions
- First Posted Date
- 2023-08-18
- Last Posted Date
- 2024-11-25
- Lead Sponsor
- National Cancer Institute (NCI)
- Target Recruit Count
- 29
- Registration Number
- NCT05996523
- Locations
- 🇺🇸
National Institutes of Health Clinical Center, Bethesda, Maryland, United States
IDE196 (Darovasertib) in Combination With Crizotinib as First-line Therapy in Metastatic Uveal Melanoma
- Conditions
- Interventions
- First Posted Date
- 2023-08-14
- Last Posted Date
- 2024-12-09
- Lead Sponsor
- IDEAYA Biosciences
- Target Recruit Count
- 420
- Registration Number
- NCT05987332
- Locations
- 🇺🇸
Honor Health, Scottsdale, Arizona, United States
🇺🇸Moores Cancer Center, La Jolla, California, United States
🇺🇸UCLA Medical Center, Los Angeles, California, United States
Drug Development Updates
Stay informed with timely notifications on clinical trials, regulatory changes, and research advancements related to this medication.