MedPath

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 of TAK-676 With Pembrolizumab After Radiation Therapy to Treat a Number of Cancers

Phase 1
Completed
Conditions
Squamous Cell Carcinoma of Head and Neck
Carcinoma, Non-Small-Cell Lung
Triple Negative Breast Neoplasms
Interventions
Drug: Pembrolizumab
Drug: TAK-676
Radiation: Image-guided radiation therapy
First Posted Date
2021-05-10
Last Posted Date
2024-06-11
Lead Sponsor
Takeda
Target Recruit Count
34
Registration Number
NCT04879849
Locations
🇺🇸

Cedars Sinai Medical Center, Duarte, California, United States

🇺🇸

University of Chicago, Chicago, Illinois, United States

🇺🇸

Providence Portland Medical Center, Portland, Oregon, United States

and more 2 locations

Neoadjuvant Lenvatinib Plus Pembrolizumab in Merkel Cell Carcinoma

Phase 2
Active, not recruiting
Conditions
Merkel Cell Carcinoma
Neuroendocrine Carcinoma of the Skin
Trabecular Carcinoma of the Skin
Interventions
First Posted Date
2021-05-03
Last Posted Date
2024-11-07
Lead Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Target Recruit Count
26
Registration Number
NCT04869137
Locations
🇺🇸

Moffitt Cancer Center, Tampa, Florida, United States

Pembrolizumab and Lenvatinib in Advanced Cervical Cancer

Phase 2
Recruiting
Conditions
Metastatic Cervical Cancer
Cervical Cancer
Interventions
First Posted Date
2021-04-29
Last Posted Date
2024-08-23
Lead Sponsor
Georgetown University
Target Recruit Count
35
Registration Number
NCT04865887
Locations
🇺🇸

Georgia Cancer Center at Augusta University, Augusta, Georgia, United States

🇺🇸

John Theurer Cancer Center at Hackensack UMC, Hackensack, New Jersey, United States

🇺🇸

Medstar Washington Hospital Center, Washington, District of Columbia, United States

and more 1 locations

Pembrolizumab (MK-3475) Plus Lenvatinib (E7080/MK-7902) Versus Chemotherapy for Endometrial Carcinoma (ENGOT-en9 / MK-7902-001) - China Extension Study

Phase 3
Active, not recruiting
Conditions
Endometrial Neoplasms
Interventions
First Posted Date
2021-04-29
Last Posted Date
2024-10-18
Lead Sponsor
Merck Sharp & Dohme LLC
Target Recruit Count
130
Registration Number
NCT04865289
Locations
🇨🇳

Fudan University Shanghai Cancer Center ( Site 2500), Shanghai, Shanghai, China

🇨🇳

Women s Hospital School of Medicine Zhejiang University ( Site 2511), Hangzhou, Zhejiang, China

🇨🇳

Anhui Cancer Hospital-Gynecological Oncology ( Site 2509), Hefei, Anhui, China

and more 19 locations

Open-label, Uncontrolled, Non-Interventional, Retrospective Study to Evaluate Molecular Determinants of Outcome to the Immune Checkpoint Inhibitors (Anti-PD-1/Anti-PD-L1 Monoclonal Antibodies) Treatment for Solid Tumors

Conditions
Melanoma
Lung Cancer
First Posted Date
2021-04-26
Last Posted Date
2021-04-26
Lead Sponsor
Asylia Diagnostics BV
Target Recruit Count
400
Registration Number
NCT04860076
Locations
🇧🇪

Universitair Ziekenhuis Antwerpen, Edegem, Belgium

First Line Weekly Chemo/Immunotherapy for Metastatic Head/Neck Squamous Cell Carcinoma Patients

Phase 2
Recruiting
Conditions
Head Neck Cancer
Oropharynx Squamous Cell Carcinoma
Oral Cavity Squamous Cell Carcinoma
Hypopharynx Squamous Cell Carcinoma
Larynx Squamous Cell Carcinoma
Metastatic Squamous Cell Carcinoma
Interventions
First Posted Date
2021-04-26
Last Posted Date
2024-05-17
Lead Sponsor
Wake Forest University Health Sciences
Target Recruit Count
35
Registration Number
NCT04858269
Locations
🇺🇸

Wake Forest Baptist Health Sciences, Winston-Salem, North Carolina, United States

A Study of Sargramostim Plus Pembrolizumab with or Without Pemetrexed in Patients with Advance Non-small Cell Lung Cancer After Completion of Chemoimmunotherapy

Phase 2
Terminated
Conditions
Advanced Lung Non-Small Cell Carcinoma
Non-Small Cell Carcinoma of Lung, TNM Stage 4
Interventions
Drug: Granulocyte-Macrophage Colony-Stimulating Factor
Drug: Pembrolizumab
Drug: pemetrexed
Drug: Paclitaxel
Drug: Carboplatin
First Posted Date
2021-04-23
Last Posted Date
2025-01-01
Lead Sponsor
Tufts Medical Center
Target Recruit Count
5
Registration Number
NCT04856176
Locations
🇺🇸

Tufts Medical Center, Boston, Massachusetts, United States

A Study to Evaluate the Safety and Efficacy of Selinexor With or Without Pembrolizumab Versus Standard of Care in Previously Treated Metastatic Colorectal Cancer With RAS Mutations

Phase 2
Terminated
Conditions
Metastatic Colorectal Cancer
Interventions
First Posted Date
2021-04-22
Last Posted Date
2023-11-03
Lead Sponsor
Karyopharm Therapeutics Inc
Target Recruit Count
13
Registration Number
NCT04854434
Locations
🇺🇸

Christiana Care Health Services, Christiana Hospital, Newark, Delaware, United States

🇺🇸

BRCR Global, Plantation, Florida, United States

🇺🇸

Valkyrie Clinical Trials, Los Angeles, California, United States

Study of Magrolimab Combination Therapy in Patients With Head and Neck Squamous Cell Carcinoma

Phase 2
Terminated
Conditions
Head and Neck Squamous Cell Carcinoma
Interventions
First Posted Date
2021-04-22
Last Posted Date
2024-10-15
Lead Sponsor
Gilead Sciences
Target Recruit Count
193
Registration Number
NCT04854499
Locations
🇺🇸

UCLA Hematology/Oncology, Los Angeles, California, United States

🇺🇸

Memorial Healthcare System, Hollywood, Florida, United States

🇧🇪

Algemeen Ziekenhuis Klina, Brasschaat, Belgium

and more 84 locations

Pembrolizumab and Lenvatinib in Advanced/Metastatic Neuroendocrine Prostate Cancer

Phase 2
Recruiting
Conditions
Neuroendocrine Tumors
Prostate Cancer Metastatic
Interventions
First Posted Date
2021-04-19
Last Posted Date
2024-08-14
Lead Sponsor
University of Michigan Rogel Cancer Center
Target Recruit Count
50
Registration Number
NCT04848337
Locations
🇺🇸

City of Hope, Duarte, California, United States

🇺🇸

Winship Cancer Instituted of Emory University, Atlanta, Georgia, United States

🇺🇸

Oregon health, Portland, Oregon, United States

and more 2 locations
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