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

Physician/Patient Choice of Either High-Dose Recombinant Interferon Alfa-2B or Ipilimumab, Versus Pembrolizumab in Treating Patients With Stage III-IV High Risk Melanoma That Has Been Removed by Surgery

Phase 3

Active, not recruiting

Conditions: Clinical Stage IV Cutaneous Melanoma AJCC v8
Metastatic Non-Cutaneous Melanoma
Recurrent Cutaneous Melanoma
Recurrent Mucosal Melanoma
Clinical Stage III Cutaneous Melanoma AJCC v8
Metastatic Cutaneous Melanoma
Metastatic Mucosal Melanoma
Recurrent Non-Cutaneous Melanoma
Non-Cutaneous Melanoma

Interventions: Procedure: Biospecimen Collection
Procedure: Computed Tomography
Biological: Ipilimumab
Biological: Pembrolizumab
Procedure: Magnetic Resonance Imaging
Procedure: Positron Emission Tomography
Other: Quality-of-Life Assessment
Biological: Recombinant Interferon Alfa-2b

First Posted Date: 2015-07-23

Last Posted Date: 2025-05-22

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 1301

Registration Number: NCT02506153

Locations: 🇺🇸
Kaiser Permanente-Irvine, Irvine, California, United States
🇺🇸
University of Alabama at Birmingham Cancer Center, Birmingham, Alabama, United States
🇺🇸
Cancer Center at Saint Joseph's, Phoenix, Arizona, United States

and more 575 locations

Study of Intratumoral G100 With Or Without Pembrolizumab or Rituximab In Participants With Follicular Non-Hodgkin's Lymphoma (MK-3475-174/IMDZ-G142)

Phase 1

Terminated

Conditions: Follicular Low Grade Non-Hodgkin's Lymphoma

Interventions: Drug: G100
Drug: Pembrolizumab
Drug: Rituximab

First Posted Date: 2015-07-17

Last Posted Date: 2020-09-09

Lead Sponsor: Immune Design, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Target Recruit Count: 52

Registration Number: NCT02501473

A Trial of Lenvatinib (E7080) Plus Pembrolizumab in Participants With Selected Solid Tumors

Phase 1

Completed

Conditions: Tumors

Interventions: Drug: Lenvatinib
Drug: Pembrolizumab

First Posted Date: 2015-07-17

Last Posted Date: 2023-07-20

Lead Sponsor: Eisai Inc.

Target Recruit Count: 357

Registration Number: NCT02501096

Locations: 🇺🇸
The University of Chicago, Chicago, Illinois, United States
🇺🇸
Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States
🇺🇸
Mass General Hospital, Boston, Massachusetts, United States

and more 49 locations

Testing the PD-1 Inhibitor Pembrolizumab as Maintenance Therapy After Initial Chemotherapy in Metastatic Bladder Cancer

Phase 2

Completed

Conditions: Bladder Cancer
Urothelial Carcinoma

Interventions: Other: Placebo
Drug: Pembrolizumab

First Posted Date: 2015-07-16

Last Posted Date: 2022-09-30

Lead Sponsor: Matthew Galsky

Target Recruit Count: 108

Registration Number: NCT02500121

Locations: 🇺🇸
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland, United States
🇺🇸
The John Theuer Cancer Center at Hackensack University Medical Center, Hackensack, New Jersey, United States
🇺🇸
Ohio State University Comprehensive Cancer Center, Columbus, Ohio, United States

and more 25 locations

Pembrolizumab in Subjects With Incurable Platinum-Refractory Germ Cell Tumors

Phase 2

Terminated

Conditions: Germ Cell Neoplasms
Testicular Neoplasms
Non Seminomatous Germ Cell Tumors
Mediastinal Neoplasms
Genital Neoplasms, Male
Genital Neoplasms, Female
Ovarian Neoplasms

Interventions: Drug: Pembrolizumab

First Posted Date: 2015-07-16

Last Posted Date: 2022-07-11

Lead Sponsor: Nasser Hanna, M.D.

Target Recruit Count: 12

Registration Number: NCT02499952

Locations: 🇺🇸
Indiana University Melvin and Bren Simon Cancer Center, Indianapolis, Indiana, United States
🇺🇸
University of Pennsylvania, Philadelphia, Pennsylvania, United States

Pembrolizumab, Standard Chemotherapy, Tumor Infiltrating Lymphocytes, and High- or Low-Dose Aldesleukin in Treating Patients With Metastatic Melanoma

Phase 2

Completed

Conditions: Stage IIIC Cutaneous Melanoma AJCC v7
Metastatic Melanoma
Stage IV Cutaneous Melanoma AJCC v6 and v7
Stage IIIB Cutaneous Melanoma AJCC v7

Interventions: Biological: Aldesleukin
Drug: Cyclophosphamide
Drug: Fludarabine Phosphate
Other: Laboratory Biomarker Analysis
Biological: Pembrolizumab
Other: Quality-of-Life Assessment
Biological: Therapeutic Tumor Infiltrating Lymphocytes

First Posted Date: 2015-07-16

Last Posted Date: 2025-01-15

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 18

Registration Number: NCT02500576

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

Trial of pIL-12/MK-3475 in Metastatic Melanoma

Phase 2

Completed

Conditions: Melanoma

Interventions: Drug: Pembrolizumab
Drug: pIL-12

First Posted Date: 2015-07-09

Last Posted Date: 2021-01-06

Lead Sponsor: University of California, San Francisco

Target Recruit Count: 24

Registration Number: NCT02493361

Locations: 🇺🇸
University of San Francisco, California, San Francisco, California, United States
🇺🇸
Huntsman Cancer Institute, University of Utah, Salt Lake City, Utah, United States

Pembrolizumab After SBRT Versus Pembrolizumab Alone in Advanced NSCLC

Phase 2

Completed

Conditions: Non-Small Cell Lung Cancer

Interventions: Drug: pembrolizumab
Radiation: Stereotactic Body Radiation Therapy

First Posted Date: 2015-07-08

Last Posted Date: 2020-08-17

Lead Sponsor: The Netherlands Cancer Institute

Target Recruit Count: 92

Registration Number: NCT02492568

Locations: 🇳🇱
Antoni van Leeuwenhoek (NKI-AVL), Amsterdam, Noord-Holland, Netherlands

A Study of BBI503 in Combination With Selected Anti-Cancer Therapeutics in Adult Patients With Advanced Cancer

Phase 1

Completed

Conditions: Cancer

Interventions: Drug: BBI503
Drug: Pembrolizumab
Drug: Sunitinib
Drug: Capecitabine
Drug: Doxorubicin
Drug: Nivolumab
Drug: Paclitaxel

First Posted Date: 2015-06-26

Last Posted Date: 2023-11-14

Lead Sponsor: Sumitomo Pharma America, Inc.

Target Recruit Count: 165

Registration Number: NCT02483247

Locations: 🇺🇸
Indiana University Health Goshen, Goshen, Indiana, United States
🇺🇸
Louisiana State Univesity, New Orleans, Louisiana, United States
🇨🇦
Ottawa Hospital Research Institute, Ottawa, Ontario, Canada

and more 5 locations

A Study of BBI608 Administered in Combination With Immune Checkpoint Inhibitors in Adult Patients With Advanced Cancers

Phase 1

Completed

Conditions: Cancer

Interventions: Drug: BBI608
Drug: Nivolumab
Drug: Ipilimumab
Drug: Pembrolizumab

First Posted Date: 2015-06-10

Last Posted Date: 2023-11-14

Lead Sponsor: Sumitomo Pharma America, Inc.

Target Recruit Count: 104

Registration Number: NCT02467361

Locations: 🇺🇸
Massachusetts General Hospital Cancer Center, Boston, Massachusetts, United States
🇺🇸
Emory University Winship Cancer Institute, Atlanta, Georgia, United States
🇺🇸
University of Colorado Cancer Center, Denver, Colorado, United States

and more 5 locations

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