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 ...

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
-

Pilot Study of Vigil™ + Pembrolizumab for Advanced Melanoma

First Posted Date
2015-10-14
Last Posted Date
2017-09-27
Lead Sponsor
Gradalis, Inc.
Target Recruit Count
2
Registration Number
NCT02574533
Locations
🇺🇸

Texas Oncology P.A., Texas Cancer Center, Abilene, Texas, United States

🇺🇸

Mary Crowley Medical Research Centers, Dallas, Texas, United States

🇺🇸

Cancer Care Northwest, Spokane, Washington, United States

GR-MD-02 Plus Pembrolizumab in Melanoma, Non-small Cell Lung Cancer, and Squamous Cell Head and Neck Cancer Patients

First Posted Date
2015-10-14
Last Posted Date
2023-06-05
Lead Sponsor
Providence Health & Services
Target Recruit Count
36
Registration Number
NCT02575404
Locations
🇺🇸

Providence Cancer Center, Portland, Oregon, United States

Intratumoral CAVATAK (CVA21) and Pembrolizumab in Patients With Advanced Melanoma (VLA-011 CAPRA)

Phase 1
Completed
Conditions
Interventions
First Posted Date
2015-10-01
Last Posted Date
2023-01-17
Lead Sponsor
Viralytics
Target Recruit Count
36
Registration Number
NCT02565992
Locations
🇺🇸

Gabrail Cancer Center Research, Canton, Ohio, United States

🇺🇸

John Wayne Cancer Institute, Santa Monica, California, United States

🇺🇸

Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey, United States

Study of Pembrolizumab Maintenance Following First-Line Platinum Based Chemotherapy in Patients With Metastatic Squamous - Non-Small Cell Lung Cancer (sNSCLC)

First Posted Date
2015-09-30
Last Posted Date
2022-01-04
Lead Sponsor
AIO-Studien-gGmbH
Target Recruit Count
41
Registration Number
NCT02564380
Locations
🇩🇪

LungenClinic Grosshansdorf, Großhansdorf, Germany

A Study of PEGylated Recombinant Human Hyaluronidase (PEGPH20) With Pembrolizumab in Participants With Selected Hyaluronan High Solid Tumors

Phase 1
Completed
Conditions
Interventions
First Posted Date
2015-09-30
Last Posted Date
2020-02-07
Lead Sponsor
Halozyme Therapeutics
Target Recruit Count
56
Registration Number
NCT02563548
Locations
🇺🇸

Virginia Cancer Specialists, PC, Fairfax, Virginia, United States

🇺🇸

Gabrail Cancer Center, Canton, Ohio, United States

🇺🇸

University of Chicago, Chicago, Illinois, United States

and more 24 locations

Trial of Pembrolizumab and Radiotherapy in Melanoma

Phase 2
Terminated
Conditions
Interventions
First Posted Date
2015-09-29
Last Posted Date
2020-04-09
Lead Sponsor
Royal Marsden NHS Foundation Trust
Target Recruit Count
234
Registration Number
NCT02562625
Locations
🇬🇧

Royal Marsden, London, United Kingdom

Pembrolizumab in Muscle Invasive/Metastatic Bladder Cancer

First Posted Date
2015-09-25
Last Posted Date
2021-04-19
Lead Sponsor
Royal Marsden NHS Foundation Trust
Target Recruit Count
34
Registration Number
NCT02560636
Locations
🇬🇧

NIHR Biomedical Research Centre at RM and ICR (https://www.cancerbrc.org/), Sutton, United Kingdom

PV-10 in Combination With Pembrolizumab for Treatment of Metastatic Melanoma

Phase 1
Active, not recruiting
Conditions
Interventions
First Posted Date
2015-09-23
Last Posted Date
2023-11-21
Lead Sponsor
Provectus Biopharmaceuticals, Inc.
Target Recruit Count
50
Registration Number
NCT02557321
Locations
🇺🇸

MD Anderson Cancer Center, Houston, Texas, United States

🇺🇸

Moffitt Cancer Center, Tampa, Florida, United States

🇺🇸

Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, United States

and more 2 locations

Pembro/Carbo/Taxol in Endometrial Cancer

First Posted Date
2015-09-15
Last Posted Date
2022-03-02
Lead Sponsor
Daniela Matei, MD
Target Recruit Count
46
Registration Number
NCT02549209
Locations
🇺🇸

University of Iowa Hospitals and Clinics, Iowa City, Iowa, United States

🇺🇸

Northwestern University, Robert H. Lurie Cancer Center, Chicago, Illinois, United States

🇺🇸

Indiana University Melvin and Bren Simon Cancer Center, Indianapolis, Indiana, United States

and more 3 locations
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