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
- -
A Study to Assess Efficacy and Safety of Pembrolizumab With or Without Sacituzumab Tirumotecan (MK- 2870) in Adult Participants With Resectable Non Small Cell Lung Cancer (NSCLC) Not Achieving Pathological Complete Response (pCR) (MK-2870-019)
- First Posted Date
- 2024-03-15
- Last Posted Date
- 2024-12-05
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Target Recruit Count
- 780
- Registration Number
- NCT06312137
- Locations
- 🇨🇳
Zhongshan Hospital of Fudan University ( Site 1325), Shangai, Shanghai, China
🇫🇷Groupe hospitalier Paris saint Joseph. ( Site 1807), Paris, Ile-de-France, France
🇫🇷Centre Jean Perrin - Centre Régional de Lutte contre le Cancer d'Auvergne-ONCOLOGY ( Site 1810), Clermont-Ferrand, Puy-de-Dome, France
Pembrolizumab, INCB081776, and Radiation Therapy for Head and Neck Squamous Cell Carcinoma
- Conditions
- Interventions
- First Posted Date
- 2024-03-13
- Last Posted Date
- 2024-08-23
- Lead Sponsor
- University of Wisconsin, Madison
- Target Recruit Count
- 12
- Registration Number
- NCT06308913
- Locations
- 🇺🇸
UW Carbone Cancer Center, Madison, Wisconsin, United States
A Clinical Study of V940 Treatment and Pembrolizumab in People With Bladder Cancer (V940-005/INTerpath-005)
- Conditions
- Interventions
- First Posted Date
- 2024-03-12
- Last Posted Date
- 2024-12-06
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Target Recruit Count
- 230
- Registration Number
- NCT06305767
- Locations
- 🇵🇪
Hospital Militar Central Luis Arias Schereiber ( Site 1700), Jesús María, Lima, Peru
🇵🇪Oncosalud ( Site 1701), Lima, Peru
🇨🇦Centre Hospitalier de l'Université de Montréal ( Site 0005), Montréal, Quebec, Canada
A Study of Adjuvant V940 and Pembrolizumab in Renal Cell Carcinoma (V940-004)
- Conditions
- Interventions
- First Posted Date
- 2024-03-12
- Last Posted Date
- 2024-12-19
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Target Recruit Count
- 272
- Registration Number
- NCT06307431
- Locations
- 🇫🇷
Gustave Roussy ( Site 0304), Villejuif, Ile-de-France, France
🇫🇷Hôpital Européen Georges Pompidou ( Site 0300), Paris, France
🇩🇪Klinikum Stuttgart - Katharinenhospital ( Site 0400), Stuttgart, Baden-Wurttemberg, Germany
INBRX-106 in Combination With Pembrolizumab in First-line PD-L1 CPS≥20 HNSCC
- Conditions
- Interventions
- First Posted Date
- 2024-03-06
- Last Posted Date
- 2024-11-18
- Lead Sponsor
- Inhibrx Biosciences, Inc
- Target Recruit Count
- 410
- Registration Number
- NCT06295731
- Locations
- 🇺🇸
Los Angeles Cancer Network (LACN), Los Angeles, California, United States
🇺🇸Sutter Health, Sacramento, California, United States
🇺🇸Sarcoma Oncology Center, Santa Monica, California, United States
A Study of (Neo)Adjuvant V940 and Pembrolizumab in Cutaneous Squamous Cell Carcinoma (V940-007)
- Conditions
- Interventions
- First Posted Date
- 2024-03-06
- Last Posted Date
- 2024-12-19
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Target Recruit Count
- 1012
- Registration Number
- NCT06295809
- Locations
- 🇺🇸
Hoag Memorial Hospital Presbyterian ( Site 1122), Newport Beach, California, United States
🇧🇷Clinica Amo - Rio Vermelho-INSTITUTO ETICA ( Site 1315), Salvador, Bahia, Brazil
🇧🇷Fundação Faculdade Regional de Medicina de São José do Rio Preto-Centro Integrado de Pesquisa ( Site, São José do Rio Preto, Sao Paulo, Brazil
Efficacy and Safety of Zanidatamab With Standard-of-care Therapy Against Standard-of-care Therapy for Advanced HER2-positive Biliary Tract Cancer
- Conditions
- Interventions
- First Posted Date
- 2024-02-28
- Last Posted Date
- 2024-12-05
- Lead Sponsor
- Jazz Pharmaceuticals
- Target Recruit Count
- 286
- Registration Number
- NCT06282575
- Locations
- 🇺🇸
The University of Kansas Cancer Center - Westwood, Westwood, Kansas, United States
🇺🇸Atlantic Health System/Morristown Medical Center, Morristown, New Jersey, United States
🇺🇸Laura and Isaac Perlmutter Cancer Center at NYU Langone - Ambulatory Care Center, New York, New York, United States
A Phase 1 Study of PLN-101095 in Adults With Advanced or Metastatic Solid Tumors
- First Posted Date
- 2024-02-21
- Last Posted Date
- 2024-06-12
- Lead Sponsor
- Pliant Therapeutics, Inc.
- Target Recruit Count
- 77
- Registration Number
- NCT06270706
- Locations
- 🇺🇸
South Texas Accelerated Research Therapeutics (START), Grand Rapids, Michigan, United States
🇺🇸NEXT Virginia, Fairfax, Virginia, United States
🇺🇸University of Texas MD Anderson Cancer Center, Houston, Texas, United States
Study of Pembrolizumab and Lenvatinib in Metastatic and Recurrent Cervix Cancer (LenPem Cervix)
- Conditions
- Interventions
- First Posted Date
- 2024-02-20
- Last Posted Date
- 2024-03-13
- Lead Sponsor
- University of Texas Southwestern Medical Center
- Target Recruit Count
- 30
- Registration Number
- NCT06266338
- Locations
- 🇺🇸
UT Southwestern Medical Center, Dallas, Texas, United States
VO and Nivolumab vs Physician's Choice in Advanced Melanoma That Progressed on Anti-PD-1 & Anti-CTLA-4 Drugs (IGNYTE-3)
- First Posted Date
- 2024-02-16
- Last Posted Date
- 2024-11-20
- Lead Sponsor
- Replimune Inc.
- Target Recruit Count
- 400
- Registration Number
- NCT06264180
- Locations
- 🇺🇸
Stony Brook University Cancer Center, Stony Brook, New York, United States
🇺🇸The Angeles Clinic and Research Institute, Los Angeles, California, United States
🇺🇸USC Norris Comprehensive Cancer Center, Los Angeles, California, United States
Drug Development Updates
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