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
- -
ZAP-IT: ZN-c3 + Carboplatin + Pembrolizumab in mTNBC
- First Posted Date
- 2024-04-08
- Last Posted Date
- 2024-12-18
- Lead Sponsor
- Filipa Lynce, MD
- Target Recruit Count
- 78
- Registration Number
- NCT06351332
- Locations
- 🇺🇸
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
A Study of MK-1084 Plus Pembrolizumab (MK-3475) in Participants With KRAS G12C Mutant, Metastatic Non-small Cell Lung Cancer (NSCLC) With Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥50% (MK-1084-004)
- Conditions
- Interventions
- First Posted Date
- 2024-04-03
- Last Posted Date
- 2024-12-18
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Target Recruit Count
- 600
- Registration Number
- NCT06345729
- Locations
- 🇺🇸
Beverly Hills Cancer Center ( Site 0116), Beverly Hills, California, United States
🇺🇸Orchard Healthcare Research Inc. ( Site 0115), Skokie, Illinois, United States
🇺🇸St. Vincent Frontier Cancer Center-Research ( Site 0105), Billings, Montana, United States
Study of BBO-8520 in Adult Subjects with KRASG12C Non-small Cell Lung and Colorectal Cancer
- First Posted Date
- 2024-04-02
- Last Posted Date
- 2024-10-30
- Target Recruit Count
- 229
- Registration Number
- NCT06343402
- Locations
- 🇺🇸
University of California - San Diego Moores Cancer Center, La Jolla, California, United States
🇺🇸UCLA Health - Santa Monica Cancer Care, Santa Monica, California, United States
🇺🇸Yale Cancer Center, New Haven, Connecticut, United States
Study of Suratadenoturev (OBP-301) in Combination With Pembrolizumab in Esophagogastric Adenocarcinoma
- Conditions
- Interventions
- First Posted Date
- 2024-04-01
- Last Posted Date
- 2024-05-07
- Lead Sponsor
- Weill Medical College of Cornell University
- Target Recruit Count
- 27
- Registration Number
- NCT06340711
- Locations
- 🇺🇸
Weill Cornell Medicine/NewYork-Presbyterian Hospital, New York, New York, United States
AMG 193 Alone or in Combination With Other Therapies in Subjects With Advanced Thoracic Tumors With Homozygous MTAP-deletion (Master Protocol)
- Conditions
- Interventions
- First Posted Date
- 2024-03-27
- Last Posted Date
- 2024-12-06
- Lead Sponsor
- Amgen
- Target Recruit Count
- 500
- Registration Number
- NCT06333951
- Locations
- 🇯🇵
Aichi Cancer Center, Nagoya-shi, Aichi, Japan
🇺🇸Virginia Cancer Specialists PC, Fairfax, Virginia, United States
🇺🇸Northwest Medical Specialties, PLLC, Tacoma, Washington, United States
A Study of DM919 Alone and in Combination With Pembrolizumab in Advanced Solid Tumors
- First Posted Date
- 2024-03-25
- Last Posted Date
- 2024-08-06
- Lead Sponsor
- D2M Biotherapeutics Inc.
- Target Recruit Count
- 160
- Registration Number
- NCT06328673
- Locations
- 🇺🇸
NEXT Oncology, San Antonio, Texas, United States
🇨🇳The Cancer Institute and Hospital, Chinese Academy of Medical Sciences(CAMS), Beijing, China
Personalized Vaccine Immunotherapy in Combination with Checkpoint Inhibitor for Treatment of Triple Negative Breast Cancer
- Conditions
- Anatomic Stage I Breast Cancer AJCC V8Anatomic Stage IA Breast Cancer AJCC V8Anatomic Stage IB Breast Cancer AJCC V8Anatomic Stage II Breast Cancer AJCC V8Anatomic Stage IIB Breast Cancer AJCC V8Anatomic Stage IIA Breast Cancer AJCC V8Metastatic Triple-Negative Breast CarcinomaPrognostic Stage IA Breast Cancer AJCC V8Prognostic Stage IB Breast Cancer AJCC V8Anatomic Stage III Breast Cancer AJCC V8
- Interventions
- First Posted Date
- 2024-03-21
- Last Posted Date
- 2024-11-05
- Lead Sponsor
- Emory University
- Target Recruit Count
- 18
- Registration Number
- NCT06324240
- Locations
- 🇺🇸
Grady Health System, Atlanta, Georgia, United States
🇺🇸Emory University Hospital Midtown, Atlanta, Georgia, United States
🇺🇸Emory University Hospital/Winship Cancer Institute, Atlanta, Georgia, United States
Study of Pembrolizumab Plus Chemotherapy With Lenvatinib for Malignant Pleural Mesothelioma
- Conditions
- Interventions
- First Posted Date
- 2024-03-19
- Last Posted Date
- 2024-03-19
- Lead Sponsor
- Hyogo Medical University
- Target Recruit Count
- 25
- Registration Number
- NCT06318286
- Locations
- 🇯🇵
Hyogo Medical University Hospital, Nishinomiya, Hyogo, Japan
Open-label, Single Center, Single-arm, Phase 2 Study of Neoadjuvant Pembrolizumab in Combination With Carboplatin and Paclitaxel in Patients With Stage 1 cT1b-T1cN0M0 Triple Negative Breast Cancer
- Conditions
- Interventions
- First Posted Date
- 2024-03-19
- Last Posted Date
- 2024-12-13
- Lead Sponsor
- M.D. Anderson Cancer Center
- Target Recruit Count
- 28
- Registration Number
- NCT06318897
- Locations
- 🇺🇸
MD Anderson Cancer Center, Houston, Texas, United States
A Study of Sacituzumab Tirumotecan (MK-2870) as a Single Agent and in Combination With Pembrolizumab (MK-3475) Versus Treatment of Physician's Choice in Participants With HR+/HER2- Unresectable Locally Advanced or Metastatic Breast Cancer (MK-2870-010)
- Conditions
- Interventions
- First Posted Date
- 2024-03-15
- Last Posted Date
- 2024-12-05
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Target Recruit Count
- 1200
- Registration Number
- NCT06312176
- Locations
- 🇩🇰
Vejle Sygehus ( Site 1183), Vejle, Syddanmark, Denmark
🇳🇱Isala, locatie Zwolle ( Site 1525), Zwolle, Overijssel, Netherlands
🇵🇹Unidade Local de Saude de Santa Maria - Hospital de Santa Maria ( Site 1661), Lisbon, Lisboa, Portugal
Drug Development Updates
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