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
- -
Pembrolizumab Plus CA-4948 for the Treatment of Patients With Progressive Metastatic Urothelial Cancer Despite Prior Immunotherapy
- Conditions
- Unresectable Urothelial CarcinomaMetastatic Urothelial Carcinoma
- Interventions
- Procedure: BiopsyProcedure: Biospecimen CollectionProcedure: Computed TomographyBiological: EmavusertibProcedure: Magnetic Resonance ImagingBiological: PembrolizumabProcedure: Positron Emission Tomography
- First Posted Date
- 2024-06-03
- Last Posted Date
- 2024-12-19
- Lead Sponsor
- National Cancer Institute (NCI)
- Target Recruit Count
- 25
- Registration Number
- NCT06439836
Pharmacokinetic Similarity Between ABP 234 and Keytruda® (Pembrolizumab)
- Conditions
- Early-stage Non-squamous Non-small Cell Lung Cancer (NSCLC)
- Interventions
- Drug: ABP 234Drug: Pembrolizumab
- First Posted Date
- 2024-05-28
- Last Posted Date
- 2025-01-09
- Lead Sponsor
- Amgen
- Target Recruit Count
- 154
- Registration Number
- NCT06430866
- Locations
- 🇧🇬
University Multiprofile Hospital for Active Treatment Sofiamed, Sofia, Bulgaria
🇨🇱Centro de Investigaciones Clinicas Vina del Mar Ltda., Vina del Mar, Region De Valparaiso, Chile
🇨🇱Clinica Santa Maria, Santiago, Region Metropolitana, Chile
Measuring if Immunotherapy Plus Chemotherapy is Better Than Chemotherapy Alone for Patients With Aggressive Poorly Differentiated Sarcomas
- Conditions
- Unresectable Undifferentiated Pleomorphic SarcomaMetastatic Undifferentiated Pleomorphic SarcomaStage III Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8Stage IV Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8
- Interventions
- Procedure: Biospecimen CollectionProcedure: Diagnostic ImagingDrug: DoxorubicinProcedure: EchocardiographyProcedure: Multigated Acquisition ScanBiological: Pembrolizumab
- First Posted Date
- 2024-05-21
- Last Posted Date
- 2025-01-09
- Lead Sponsor
- National Cancer Institute (NCI)
- Target Recruit Count
- 180
- Registration Number
- NCT06422806
- Locations
- 🇺🇸
Siteman Cancer Center-South County, Saint Louis, Missouri, United States
🇺🇸Billings Clinic Cancer Center, Billings, Montana, United States
🇺🇸Bozeman Health Deaconess Hospital, Bozeman, Montana, United States
Pembrolizumab With or Without Maintenance Sacituzumab Tirumotecan (Sac-TMT; MK-2870) in Metastatic Squamous Non-small Cell Lung Cancer (NSCLC) [MK-2870-023]
- Conditions
- Non-small Cell Lung CancerNSCLC
- Interventions
- Biological: PembrolizumabBiological: sac-TMT
- First Posted Date
- 2024-05-20
- Last Posted Date
- 2024-12-27
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Target Recruit Count
- 851
- Registration Number
- NCT06422143
- Locations
- 🇨🇦
Grand River Hospital ( Site 0153), Kitchener, Ontario, Canada
🇨🇦McGill University Health Centre ( Site 0103), Montréal, Quebec, Canada
🇨🇳Army Medical Center of People's Liberation Army-respiratory ( Site 2426), Chongqing, Chongqing, China
ACE2016 in Adult Subjects With Locally Advanced or Metastatic Solid Tumors Expressing Epidermal Growth Factor Receptor (EGFR)
- Conditions
- Locally Advanced Solid TumorMetastatic Solid Tumor
- Interventions
- First Posted Date
- 2024-05-16
- Last Posted Date
- 2024-12-05
- Lead Sponsor
- Acepodia Biotech, Inc.
- Target Recruit Count
- 30
- Registration Number
- NCT06415487
- Locations
- 🇺🇸
University of California San Diego, San Diego, California, United States
🇺🇸Texas Oncology, Dallas, Texas, United States
🇨🇳Taipei Veterans General Hospital, Taipei City, Beitou District, Taiwan
Neoadjuvant Pembrolizumab, Carboplatin and Paclitaxel in Triple-negative Breast Cancer
- Conditions
- Triple Negative Breast Cancer
- Interventions
- First Posted Date
- 2024-05-09
- Last Posted Date
- 2024-05-09
- Lead Sponsor
- Tel Aviv Medical Center
- Target Recruit Count
- 25
- Registration Number
- NCT06407310
A Study of Pembrolizumab in Combination With Investigational Agents in Pediatric and Young Adult Participants With Hematologic Malignancies or Solid Tumors (MK-9999-01B/LIGHTBEAM-U01)
- Conditions
- Neoplasm Metastasis
- Interventions
- Biological: Favezelimab/PembrolizumabBiological: PembrolizumabBiological: Pembrolizumab/VibostolimabBiological: FavezelimabBiological: Vibostolimab
- First Posted Date
- 2024-05-01
- Last Posted Date
- 2024-12-10
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Target Recruit Count
- 80
- Registration Number
- NCT06395090
- Locations
- 🇺🇸
Children's Mercy Hospital ( Site 2024), Kansas City, Missouri, United States
🇺🇸Children's Hospital of Philadelphia (CHOP) ( Site 2021), Philadelphia, Pennsylvania, United States
🇨🇳National Taiwan University Hospital ( Site 2983), Taipei, Taiwan
Sacituzumab Tirumotecan (MK-2870) Plus Pembrolizumab Versus TPC in TNBC Who Did Not Achieve pCR (MK-2870-012)
- Conditions
- Triple-Negative Breast Cancer
- Interventions
- First Posted Date
- 2024-05-01
- Last Posted Date
- 2024-12-27
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Target Recruit Count
- 1530
- Registration Number
- NCT06393374
- Locations
- 🇺🇸
Infirmary Cancer Care ( Site 0001), Mobile, Alabama, United States
🇺🇸Ironwood Cancer & Research Centers-Research ( Site 0054), Chandler, Arizona, United States
🇺🇸Cancer Blood and Specialty Clinic-Research ( Site 0008), Los Alamitos, California, United States
Trial to Assess the Safety and Preliminary Efficacy of GEN1055 on Malignant Solid Tumors as Monotherapy and as Combination Therapy
- Conditions
- Malignant Solid Tumor
- Interventions
- First Posted Date
- 2024-04-30
- Last Posted Date
- 2025-01-07
- Lead Sponsor
- Genmab
- Target Recruit Count
- 270
- Registration Number
- NCT06391775
- Locations
- 🇺🇸
Yale-New Haven Hospital, New Haven, Connecticut, United States
🇪🇸Hospital Universtari Val D´Hebron, Barcelona, Spain
🇪🇸Start Madrid Ciocc Hm Sanchinarro, Madrid, Spain
Phase II Study of Moderate-dose Hypofractionated RT Combined With Pembrolizumab for HCC With Diffuse Tumor Thrombosis
- Conditions
- Hepatocellular CarcinomaRadiotherapyPembrolizumabTumor Thrombosis
- Interventions
- Radiation: Moderate-dose Hypofractionated Intensity-modulated RadiotherapyDrug: Pembrolizumab
- First Posted Date
- 2024-04-29
- Last Posted Date
- 2024-04-29
- Lead Sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Target Recruit Count
- 30
- Registration Number
- NCT06389422
- Locations
- 🇨🇳
National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciecnces and Peking Union Medical College, Beijing, Beijing, China
Drug Development Updates
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