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
- -
The Addition of Pembrolizumab to Postoperative Radiotherapy in Cutaneous Squamous Cell Cancer of the Head and Neck
- Conditions
- Interventions
- First Posted Date
- 2017-02-20
- Last Posted Date
- 2022-06-30
- Lead Sponsor
- Case Comprehensive Cancer Center
- Target Recruit Count
- 18
- Registration Number
- NCT03057613
- Locations
- 🇺🇸
University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center, Cleveland, Ohio, United States
🇺🇸Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center, Cleveland, Ohio, United States
Safety, Tolerability, and Efficacy of Doxorubicin and Pembrolizumab for Sarcoma
- Conditions
- Interventions
- First Posted Date
- 2017-02-16
- Last Posted Date
- 2023-11-18
- Lead Sponsor
- Wake Forest University Health Sciences
- Target Recruit Count
- 30
- Registration Number
- NCT03056001
- Locations
- 🇺🇸
Levine Cancer Institute, Charlotte, North Carolina, United States
Adjuvant Pembrolizumab in N2 Positive Non-small Cell Lung Cancer Patients
- First Posted Date
- 2017-02-15
- Last Posted Date
- 2017-02-15
- Lead Sponsor
- Samsung Medical Center
- Target Recruit Count
- 37
- Registration Number
- NCT03053856
- Locations
- 🇰🇷
Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea, Republic of
A Randomized Phase II Study Of Eribulin Mesylate With or Without Pembrolizumab For Metastatic Hormone Receptor Positive Breast Cancer
- First Posted Date
- 2017-02-14
- Last Posted Date
- 2024-03-06
- Lead Sponsor
- Dana-Farber Cancer Institute
- Target Recruit Count
- 90
- Registration Number
- NCT03051659
- Locations
- 🇺🇸
Massachusetts General Hospital, Boston, Massachusetts, United States
🇺🇸Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States
🇺🇸Dana-Farber Cancer Institute, Boston, Massachusetts, United States
Phase II PEMBROLIZUMAB + PALLIATIVE RADIOTHERAPY IN BC
- Conditions
- Interventions
- First Posted Date
- 2017-02-14
- Last Posted Date
- 2021-04-27
- Lead Sponsor
- Dana-Farber Cancer Institute
- Target Recruit Count
- 8
- Registration Number
- NCT03051672
- Locations
- 🇺🇸
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
Study of Pembrolizumab With Lanreotide Depot for Gastroenteropancreatic Neuroendocrine Tumors
- Conditions
- Interventions
- First Posted Date
- 2017-02-06
- Last Posted Date
- 2023-06-29
- Lead Sponsor
- Duke University
- Target Recruit Count
- 22
- Registration Number
- NCT03043664
- Locations
- 🇺🇸
Duke University Medical Center, Durham, North Carolina, United States
🇺🇸Lexington Medical Center, Columbia, South Carolina, United States
Study of Pembrolizumab (MK-3475) or Placebo With Chemoradiation in Participants With Locally Advanced Head and Neck Squamous Cell Carcinoma (MK-3475-412/KEYNOTE-412)
- Conditions
- Interventions
- First Posted Date
- 2017-02-02
- Last Posted Date
- 2024-02-26
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Target Recruit Count
- 804
- Registration Number
- NCT03040999
- Locations
- 🇺🇸
UCLA Medical Center ( Site 0273), Los Angeles, California, United States
🇵🇱Szpital Morski im. PCK. Szpitale Pomorskie Sp. Z o.o ( Site 1007), Gdynia, Poland
🇵🇱Centrum Onkologii-Instytut im. Marii Sklodowskiej-Curie ( Site 1000), Warszawa, Poland
Study of Pembrolizumab (MK-3475) Plus Chemotherapy vs Placebo Plus Chemotherapy as Neoadjuvant Therapy and Pembrolizumab vs Placebo as Adjuvant Therapy in Participants With Triple Negative Breast Cancer (TNBC) (MK-3475-522/KEYNOTE-522)
- Conditions
- Interventions
- First Posted Date
- 2017-01-30
- Last Posted Date
- 2024-11-11
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Target Recruit Count
- 1174
- Registration Number
- NCT03036488
- Locations
- 🇦🇺
Royal Adelaide Hospital ( Site 2008), Adelaide, South Australia, Australia
🇺🇸Cedars Sinai Medical Center ( Site 0091), Los Angeles, California, United States
🇺🇸The University of Chicago Medical Center ( Site 0047), Chicago, Illinois, United States
Dendritic Cell Therapy, Cryosurgery, and Pembrolizumab in Treating Patients with Non-Hodgkin Lymphoma
- Conditions
- Indolent Non-Hodgkin LymphomaRecurrent Diffuse Large B-Cell LymphomaRecurrent Follicular LymphomaSmall Lymphocytic LymphomaRecurrent Mantle Cell LymphomaRecurrent Primary Mediastinal (Thymic) Large B-Cell LymphomaAggressive Non-Hodgkin LymphomaRecurrent Marginal Zone LymphomaRecurrent T-Cell Non-Hodgkin LymphomaRecurrent Non-Hodgkin Lymphoma
- Interventions
- First Posted Date
- 2017-01-30
- Last Posted Date
- 2024-12-09
- Lead Sponsor
- Mayo Clinic
- Target Recruit Count
- 11
- Registration Number
- NCT03035331
- Locations
- 🇺🇸
Mayo Clinic in Rochester, Rochester, Minnesota, United States
A Study Of Pembrolizumab In Combination With Trastuzumab-DM1
- First Posted Date
- 2017-01-26
- Last Posted Date
- 2024-12-19
- Lead Sponsor
- Dana-Farber Cancer Institute
- Target Recruit Count
- 20
- Registration Number
- NCT03032107
- Locations
- 🇺🇸
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
🇺🇸Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States
Drug Development Updates
Stay informed with timely notifications on clinical trials, regulatory changes, and research advancements related to this medication.