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
- -
Chemotherapy Combined With Immunotherapy Versus Immunotherapy Alone for Older Adults With Stage IIIB-IV Lung Cancer, The ACHIEVE Trial
- Conditions
- Interventions
- First Posted Date
- 2023-10-24
- Last Posted Date
- 2024-12-20
- Lead Sponsor
- National Cancer Institute (NCI)
- Target Recruit Count
- 304
- Registration Number
- NCT06096844
- Locations
- 🇺🇸
Highlands Oncology Group - Fayetteville, Fayetteville, Arkansas, United States
🇺🇸Highlands Oncology Group - Rogers, Rogers, Arkansas, United States
🇺🇸Highlands Oncology Group, Springdale, Arkansas, United States
Phase II Investigation of Pembrolizumab in Combination With Bevacizumab and Oral Cyclophosphamide in Patients With High Grade Ovarian Cancer and Surgically Documented Minimal Residual Disease After Frontline Therapy
- Conditions
- Interventions
- First Posted Date
- 2023-10-16
- Last Posted Date
- 2024-12-12
- Lead Sponsor
- M.D. Anderson Cancer Center
- Target Recruit Count
- 20
- Registration Number
- NCT06083844
- Locations
- 🇺🇸
MD Anderson Cancer Center, Houston, Texas, United States
NeoAdj. Therapy Comparing Sacituzumab Govitecan (SG) vs. SG+Pembrolizumab in Low-risk, Triple-neg. EBC (ADAPT-TN-III)
- Conditions
- Interventions
- First Posted Date
- 2023-10-13
- Last Posted Date
- 2024-11-13
- Lead Sponsor
- West German Study Group
- Target Recruit Count
- 348
- Registration Number
- NCT06081244
- Locations
- 🇩🇪
Kliniken Essen-Mitte, Klinik für Senologie/Interdisziplinäres Brustzentrum, Essen, NRW, Germany
🇩🇪Ev. Krankenhaus Bethesda Brustzentrum Niederrhein, Mönchengladbach, NRW, Germany
A Study of V940 Plus Pembrolizumab (MK-3475) Versus Placebo Plus Pembrolizumab in Participants With Non-small Cell Lung Cancer (V940-002)
- Conditions
- Interventions
- First Posted Date
- 2023-10-11
- Last Posted Date
- 2024-12-06
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Target Recruit Count
- 868
- Registration Number
- NCT06077760
- Locations
- 🇺🇸
AdventHealth Orlando-AdventHealth Medical Group Hematology & Oncology at Orlandoc ( Site 0013), Orlando, Florida, United States
🇺🇸Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital ( Site 0012), Marietta, Georgia, United States
🇺🇸The University of Louisville, James Graham Brown Cancer Center ( Site 0037), Louisville, Kentucky, United States
Study of Radiotherapy and Pembrolizumab in People with Adrenocortical Carcinoma
- Conditions
- Interventions
- First Posted Date
- 2023-10-04
- Last Posted Date
- 2024-10-14
- Lead Sponsor
- Memorial Sloan Kettering Cancer Center
- Target Recruit Count
- 12
- Registration Number
- NCT06066333
- Locations
- 🇺🇸
Memorial Sloan Kettering Westchester (All Protocol Activities), Harrison, New York, United States
🇺🇸Memorial Sloan Kettering Suffolk-Commack, Commack, New York, United States
🇺🇸Memorial Sloan Kettering Basking Ridge (All Protocol Activities), Basking Ridge, New Jersey, United States
A Safety Trial of GEN1042 in Japanese Subjects With Malignant Solid Tumors
- Conditions
- Interventions
- First Posted Date
- 2023-09-28
- Last Posted Date
- 2024-12-20
- Lead Sponsor
- Genmab
- Target Recruit Count
- 42
- Registration Number
- NCT06057038
- Locations
- 🇯🇵
National Cancer Center East, Kashiwa, Japan
🇯🇵National Cancer Center Hospital, Tokyo, Japan
Study of ALE.C04 in Patients With Head and Neck Cancer
- Conditions
- Interventions
- First Posted Date
- 2023-09-26
- Last Posted Date
- 2024-07-09
- Lead Sponsor
- Alentis Therapeutics AG
- Target Recruit Count
- 220
- Registration Number
- NCT06054477
- Locations
- 🇫🇷
Centre Hospitalier Universitaire (CHU) de Bordeaux - Hospitalier Saint-Andre, Bordeaux, France
🇫🇷Oncopole Claudius Regaud, Iuct-Oncopole, Toulouse, France
🇪🇸Vall d'Hebron Institute of Oncology, Barcelona, Spain
Neoadjuvant Sacituzumab Govitecan Plus Pembrolizumab in Resectable Non-Small Cell Lung Cancer
- First Posted Date
- 2023-09-26
- Last Posted Date
- 2024-02-29
- Lead Sponsor
- Chinese University of Hong Kong
- Target Recruit Count
- 37
- Registration Number
- NCT06055465
- Locations
- 🇭🇰
Department of Oncology, Princess Margaret Hospital, Hong Kong, Hong Kong
🇭🇰Department of Clinical Oncology, Prince of Wales Hospital, Hong Kong, Hong Kong
🇭🇰Department of Clinical Oncology, Queen Elizabeth Hospital, Hong Kong, Hong Kong
Pulsed Dose Chemotherapy Plus Pembrolizumab in Recurrent/Metastatic HNSCC
- Conditions
- Interventions
- First Posted Date
- 2023-09-25
- Last Posted Date
- 2024-02-07
- Lead Sponsor
- Dan Zandberg
- Target Recruit Count
- 15
- Registration Number
- NCT06052839
- Locations
- 🇺🇸
UPMC Hillman Cancer Center, Pittsburgh, Pennsylvania, United States
Sacituzumab Tirumotecan (MK-2870) as Monotherapy and in Combination With Pembrolizumab in Participants With Advanced Solid Tumors (MK-2870-008)
- First Posted Date
- 2023-09-22
- Last Posted Date
- 2024-12-02
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Target Recruit Count
- 36
- Registration Number
- NCT06049212
- Locations
- 🇯🇵
National Hospital Organization Shikoku Cancer Center ( Site 0008), Matsuyama, Ehime, Japan
🇯🇵Aichi Cancer Center Hospital ( Site 0006), Nagoya, Aichi, Japan
🇯🇵National Cancer Center Hospital East ( Site 0002), Kashiwa, Chiba, Japan
Drug Development Updates
Stay informed with timely notifications on clinical trials, regulatory changes, and research advancements related to this medication.