Pembrolizumab
- Generic Name
- Pembrolizumab
- Brand Names
- Keytruda
- Drug Type
- Biotech
- 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)
A Study to Compare the Efficacy of Nivolumab and Relatlimab Plus Chemotherapy vs Pembrolizumab Plus Chemotherapy for Stage IV/Recurrent Non-squamous Non-small Cell Lung Cancer With PD-L1 Expression ≥ 1%
- Conditions
- Non-small Cell Lung Cancer
- Interventions
- First Posted Date
- 2024-08-20
- Last Posted Date
- 2025-05-09
- Lead Sponsor
- Bristol-Myers Squibb
- Target Recruit Count
- 1000
- Registration Number
- NCT06561386
- Locations
- 🇮🇹
Local Institution - 0222, Ravenna, Italy
🇺🇸Local Institution - 0368, Tucson, Arizona, United States
🇺🇸Local Institution - 0112, Los Angeles, California, United States
LUNAR-4: Effect of Tumor Treating Fields (TTFields) (150 kHz) Concurrent With Pembrolizumab for Treatment of Metastatic Non-small Cell Lung Cancer (NSCLC)
- Conditions
- Non-Small Cell Lung Cancer (NSCLC)
- Interventions
- Device: NovoTTF-200T
- First Posted Date
- 2024-08-19
- Last Posted Date
- 2025-04-02
- Lead Sponsor
- NovoCure GmbH
- Target Recruit Count
- 69
- Registration Number
- NCT06558799
- Locations
- 🇫🇷
Montpellier University Hospital, Montpellier, France
🇪🇸Clínica Universidad de Navarra, Madrid, Madrid, Spain
🇪🇸Clínica Universidad de Navarra, Pamplona, Spain
OPTIMUS PRIME: Safety and Feasibility of OPTune GIO® Integrated With MRI-gUided Laser Ablation Surgery and Pembrolizumab for Recurrent GlIoblastoMa, A randomizEd Trial
- Conditions
- Recurrent Glioblastoma
- Interventions
- First Posted Date
- 2024-08-16
- Last Posted Date
- 2025-03-05
- Lead Sponsor
- University of Florida
- Target Recruit Count
- 20
- Registration Number
- NCT06558214
- Locations
- 🇺🇸
UF Health Shands Hospital, Gainesville, Florida, United States
Reduction in the Number of Chemotherapy Cycles in Combination With Pembrolizumab in First-line Treatment of PD-L1-positive Recurrent or Metastatic Head and Neck Squamous Cell Carcinomas
- Conditions
- Squamous Cell Carcinoma of Head and Neck
- Interventions
- First Posted Date
- 2024-08-16
- Last Posted Date
- 2025-05-01
- Lead Sponsor
- Institut Claudius Regaud
- Target Recruit Count
- 86
- Registration Number
- NCT06557889
- Locations
- 🇫🇷
IUCT-O, Toulouse, France
🇫🇷CHU Poitiers, Poitiers, France
🇫🇷Chu Bordeaux - Hopital Saint André, Bordeaux, France
EF-41/KEYNOTE D58: Phase 3 Study of Optune Concomitant With Temozolomide Plus Pembrolizumab in Newly Diagnosed Glioblastoma
- Conditions
- Glioblastoma
- Interventions
- First Posted Date
- 2024-08-16
- Last Posted Date
- 2025-05-16
- Lead Sponsor
- NovoCure GmbH
- Target Recruit Count
- 741
- Registration Number
- NCT06556563
- Locations
- 🇬🇧
Addenbrooke's Hospital (Cambridge University Hospitals NHS Foundation Trust), Cambridge, United Kingdom
🇺🇸University of Southern California, Los Angeles, California, United States
🇺🇸Tufts Medical Center, Boston, Massachusetts, United States
A Study of GSK5764227 in Participants With Advanced Solid Tumors
- Conditions
- Neoplasms
- Interventions
- First Posted Date
- 2024-08-13
- Last Posted Date
- 2025-03-18
- Lead Sponsor
- GlaxoSmithKline
- Target Recruit Count
- 281
- Registration Number
- NCT06551142
- Locations
- 🇬🇧
GSK Investigational Site, Edinburgh, United Kingdom
Assessment of PK Similarity of FYB206 in Comparison With Keytruda in Resected Stage II or III Melanoma Patients
- Conditions
- Melanoma Stage IIIMelanoma, Stage II
- Interventions
- First Posted Date
- 2024-08-13
- Last Posted Date
- 2025-04-30
- Lead Sponsor
- Formycon AG
- Target Recruit Count
- 94
- Registration Number
- NCT06551064
- Locations
- 🇺🇦
Formycon Investigative Site, Kyiv, Ukraine
Ixovex-1 Single Agent and Combination Therapy
- Conditions
- Solid TumorHead and Neck Cancer
- Interventions
- First Posted Date
- 2024-08-12
- Last Posted Date
- 2025-01-30
- Lead Sponsor
- Psivac Ltd
- Target Recruit Count
- 18
- Registration Number
- NCT06549946
- Locations
- 🇬🇧
The Royal Marsden, London, United Kingdom
Study of XB010 in Subjects With Solid Tumors
- Conditions
- Locally Advanced or Metastatic Solid TumorsEsophageal Squamous Cell CancerHead and Neck Squamous Cell CancerNSCLC (Non-small Cell Lung Cancer)Hormone-receptor-positive Breast CancerTriple Negative Breast Cancer (TNBC)
- Interventions
- First Posted Date
- 2024-08-09
- Last Posted Date
- 2025-03-14
- Lead Sponsor
- Exelixis
- Target Recruit Count
- 396
- Registration Number
- NCT06545331
- Locations
- 🇺🇸
Exelixis Clinical Site #7, Dallas, Texas, United States
🇺🇸Exelixis Clinical Site #8, Houston, Texas, United States
🇺🇸Exelixis Clinical Site #4, Duarte, California, United States
A Trial to Evaluate Intravesical Nadofaragene Firadenovec Alone or in Combination With Chemotherapy or Immunotherapy in Participants With High-grade BCG Unresponsive Non-muscle Invasive Bladder Cancer
- Conditions
- Non-muscle Invasive Bladder Cancer With Carcinoma in Situ
- Interventions
- First Posted Date
- 2024-08-09
- Last Posted Date
- 2025-05-06
- Lead Sponsor
- Ferring Pharmaceuticals
- Target Recruit Count
- 150
- Registration Number
- NCT06545955
- Locations
- 🇺🇸
Ferring Investigational Site, Myrtle Beach, South Carolina, United States
Drug Development Updates
Stay informed with timely notifications on clinical trials, regulatory changes, and research advancements related to this medication.