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)

Clinical Trials

Study of the Combination of Acalabrutinib (ACP-196) and Pembrolizumab in Advanced Head and Neck Squamous Cell Carcinoma

Phase 2

Completed

Conditions: Squamous Cell Carcinoma of the Head and Neck

Interventions: Drug: pembrolizumab
Drug: Acalabrutinib

First Posted Date: 2015-05-27

Last Posted Date: 2019-09-12

Lead Sponsor: Acerta Pharma BV

Target Recruit Count: 78

Registration Number: NCT02454179

Locations: 🇺🇸
Oregon Health and Science University, Portland, Oregon, United States

Study of Pembrolizumab (MK-3475) in Participants With Relapsed or Refractory Classical Hodgkin Lymphoma (MK-3475-087/KEYNOTE-087)

Phase 2

Completed

Conditions: Hodgkin Lymphoma

Interventions: Biological: pembrolizumab

First Posted Date: 2015-05-25

Last Posted Date: 2024-10-29

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 211

Registration Number: NCT02453594

A Study of the Combination of Necitumumab (LY3012211) and Pembrolizumab (MK3475) in Participants With NSCLC

Phase 1

Completed

Conditions: Stage IV Non-Small Cell Lung Cancer

Interventions: Drug: Necitumumab
Drug: Pembrolizumab

First Posted Date: 2015-05-22

Last Posted Date: 2020-10-05

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 71

Registration Number: NCT02451930

Locations: 🇺🇸
Tennessee Oncology PLLC, Nashville, Tennessee, United States
🇯🇵
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician, Sunto-Gun, Japan
🇪🇸
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Valencia, Spain

and more 1 locations

Pembrolizumab Alone and In Combination With Acalabrutinib (ACP-196) in Subjects With Advanced Non-small Cell Lung Cancer

Phase 2

Completed

Conditions: Carcinoma, Non-Small-Cell Lung

Interventions: Drug: Pembrolizumab
Drug: Acalabrutinib

First Posted Date: 2015-05-19

Last Posted Date: 2019-09-12

Lead Sponsor: Acerta Pharma BV

Target Recruit Count: 74

Registration Number: NCT02448303

Locations: 🇺🇸
Western Regional Medical Center/Cancer Treatment Center of America, Goodyear, Arizona, United States

Rituximab and Pembrolizumab With or Without Lenalidomide in Treating Patients With Relapsed Follicular Lymphoma and Diffuse Large B-Cell Lymphoma

Phase 2

Active, not recruiting

Conditions: Recurrent Grade 3a Follicular Lymphoma
Recurrent Diffuse Large B-Cell Lymphoma
Recurrent Grade 2 Follicular Lymphoma
Recurrent Grade 1 Follicular Lymphoma

Interventions: Other: Laboratory Biomarker Analysis
Biological: Pembrolizumab
Drug: Lenalidomide
Biological: Rituximab

First Posted Date: 2015-05-18

Last Posted Date: 2025-05-01

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 53

Registration Number: NCT02446457

Locations: 🇺🇸
M D Anderson Cancer Center, Houston, Texas, United States

Pembrolizumab and Stereotactic Body Radiation Therapy or Non-Stereotactic Wide-Field Radiation Therapy in Treating Patients With Non-small Cell Lung Cancer

Phase 1

Active, not recruiting

Conditions: Metastatic Lung Non-Small Cell Carcinoma
Malignant Solid Neoplasm
Stage IV Lung Non-Small Cell Cancer AJCC v7

Interventions: Radiation: 3-Dimensional Conformal Radiation Therapy
Radiation: Intensity-Modulated Radiation Therapy
Other: Laboratory Biomarker Analysis
Biological: Pembrolizumab
Radiation: Proton Beam Radiation Therapy
Radiation: Stereotactic Body Radiation Therapy
Radiation: Radiation Therapy

First Posted Date: 2015-05-14

Last Posted Date: 2025-02-24

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 126

Registration Number: NCT02444741

Locations: 🇺🇸
M D Anderson Cancer Center, Houston, Texas, United States

A Study of Ramucirumab Plus Pembrolizumab in Participants With Gastric or GEJ Adenocarcinoma, NSCLC, Transitional Cell Carcinoma of the Urothelium, or Biliary Tract Cancer

Phase 1

Completed

Conditions: Gastric Adenocarcinoma
Biliary Tract Cancer
Carcinoma, Transitional Cell
Non-small Cell Lung Cancer
Adenocarcinoma of the Gastroesophageal Junction

Interventions: Drug: Ramucirumab
Drug: Pembrolizumab

First Posted Date: 2015-05-13

Last Posted Date: 2024-07-31

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 175

Registration Number: NCT02443324

Locations: 🇬🇧
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Sutton, United Kingdom
🇺🇸
Florida Cancer Specialists, Fort Myers, Florida, United States
🇺🇸
Tennessee Oncology PLLC, Nashville, Tennessee, United States

and more 4 locations

Dose Dense Paclitaxel With Pembrolizumab (MK-3475) in Platinum Resistant Ovarian Cancer

Phase 2

Completed

Conditions: Ovarian Cancer

Interventions: Drug: Pembrolizumab
Drug: Paclitaxel

First Posted Date: 2015-05-12

Last Posted Date: 2022-10-07

Lead Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Target Recruit Count: 42

Registration Number: NCT02440425

Locations: 🇺🇸
VCU Massey Cancer Center, Richmond, Virginia, United States
🇺🇸
H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida, United States
🇺🇸
Duke University, Durham, North Carolina, United States

A Study of Combination Therapies With Viagenpumatucel-L (HS-110) in Patients With Non-Small Cell Lung Cancer

Phase 1

Completed

Conditions: Non-small Cell Lung Cancer

Interventions: Biological: Viagenpumatucel-L
Drug: Nivolumab
Drug: Pembrolizumab
Drug: Pemetrexed

First Posted Date: 2015-05-08

Last Posted Date: 2023-09-21

Lead Sponsor: Heat Biologics

Target Recruit Count: 121

Registration Number: NCT02439450

Locations: 🇺🇸
UC San Diego, La Jolla, California, United States
🇺🇸
Horizon Oncology Research, Lafayette, Indiana, United States
🇺🇸
Ashland-Bellefonte Cancer Center, Ashland, Kentucky, United States

and more 13 locations

Pembrolizumab and Docetaxel or Gemcitabine Hydrochloride in Treating Patients Urothelial Cancer

Phase 1

Completed

Conditions: Recurrent Bladder Carcinoma
Stage IV Bladder Urothelial Carcinoma
Stage IV Urethral Cancer
Urethral Urothelial Carcinoma
Metastatic Urothelial Carcinoma of the Renal Pelvis and Ureter
Regional Urothelial Carcinoma of the Renal Pelvis and Ureter
Stage III Bladder Urothelial Carcinoma
Recurrent Urothelial Carcinoma of the Renal Pelvis and Ureter
Stage III Urethral Cancer

Interventions: Drug: Pembrolizumab
Drug: Docetaxel
Drug: Gemcitabine Hydrochloride

First Posted Date: 2015-05-07

Last Posted Date: 2022-10-18

Lead Sponsor: University of California, Davis

Target Recruit Count: 32

Registration Number: NCT02437370

Locations: 🇺🇸
University of California Davis Comprehensive Cancer Center, Sacramento, California, United States

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