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: -

Clinical Trials

Trial Combining Pembrolizumab and Cesium 131 Brachytherapy With Salvage Surgery in HNSCC

Phase 1

Active, not recruiting

Conditions: HNSCC

Interventions: Device: Cesium-131
Drug: Pembrolizumab

First Posted Date: 2020-04-09

Last Posted Date: 2024-03-29

Lead Sponsor: University of Cincinnati

Target Recruit Count: 50

Registration Number: NCT04340258

Locations: 🇺🇸
Thomas Jefferson, Philadelphia, Pennsylvania, United States
🇺🇸
University of Cincinnati Medical Center, Cincinnati, Ohio, United States

Cryoablation in Combination (or Not) With Pembrolizumab and Pemetrexed-carboplatin in 1st-line Treatment for Patients With Metastatic Lung Adenocarcinoma

Phase 3

Recruiting

Conditions: Cryotherapy Effect
Lung Adenocarcinoma

Interventions: Device: Cryoablation
Drug: Pembrolizumab
Drug: Pemetrexed
Drug: Carboplatin

First Posted Date: 2020-04-09

Last Posted Date: 2024-11-19

Lead Sponsor: Institut Bergonié

Target Recruit Count: 214

Registration Number: NCT04339218

Locations: 🇫🇷
Institut Bergonié, Bordeaux, Gironde, France

Study of SRF617 in Patients With Advanced Solid Tumors

Phase 1

Completed

Conditions: Advanced Solid Tumor

Interventions: Drug: SRF617
Drug: Gemcitabine
Drug: Pembrolizumab
Drug: Albumin-Bound Paclitaxel

First Posted Date: 2020-04-07

Last Posted Date: 2024-06-04

Lead Sponsor: Coherus Biosciences, Inc.

Target Recruit Count: 85

Registration Number: NCT04336098

Locations: 🇺🇸
University of Washington, Seattle, Washington, United States
🇺🇸
The Angeles Clinic and Research Institute, Los Angeles, California, United States
🇺🇸
City of Hope, Duarte, California, United States

and more 7 locations

A Study of Pembrolizumab Plus Local Chemotherapy Using Isolated Limb Infusion (ILI) for Patients With Sarcoma in the Arm or Leg

Phase 2

Recruiting

Conditions: Sarcoma
Myxofibrosarcoma
Undifferentiated Pleomorphic Sarcoma
Alveolar Soft Part Sarcoma

Interventions: Procedure: Isolated Limb Infusion
Drug: Pembrolizumab
Drug: infusion of melphalan and dactinomycin

First Posted Date: 2020-04-03

Last Posted Date: 2024-07-11

Lead Sponsor: Memorial Sloan Kettering Cancer Center

Target Recruit Count: 30

Registration Number: NCT04332874

Locations: 🇺🇸
Memorial Sloan Kettering Bergen (Limited Protocol Activities), Montvale, New Jersey, United States
🇺🇸
Memorial Sloan Kettering Nassau (Limited Protocol Activities), Uniondale, New York, United States
🇺🇸
Memorial Sloan Kettering Cancer Center @ Suffolk - Commack (Limited Protocol Activities), Commack, New York, United States

and more 4 locations

Neoadjuvant-Adjuvant Pembrolizumab in Resectable Advanced Basal Cell Carcinoma of H&N

Phase 1

Active, not recruiting

Conditions: Basal Cell Carcinoma of the Head and Neck

Interventions: Drug: Pembrolizumab
Other: Tissue collection

First Posted Date: 2020-03-26

Last Posted Date: 2024-01-18

Lead Sponsor: Brian Gastman

Target Recruit Count: 13

Registration Number: NCT04323202

Locations: 🇺🇸
Cleveland Clinic, Case Comprehensive Cancer Center, Cleveland, Ohio, United States

Intermittent Checkpoint Inhibitor Therapy In Patients With Advanced Urothelial Carcinoma

Phase 2

Completed

Conditions: Urothelial Carcinoma

Interventions: Drug: Pembrolizumab
Drug: Atezolizumab
Drug: Durvalumab
Drug: Nivolumab
Drug: Avelumab

First Posted Date: 2020-03-26

Last Posted Date: 2024-01-08

Lead Sponsor: Case Comprehensive Cancer Center

Target Recruit Count: 4

Registration Number: NCT04322643

Locations: 🇺🇸
Cleveland Clinic, Case Comprehensive Cancer Center, Cleveland, Ohio, United States

Pembrolizumab and Hypofractionated Radiation Therapy for the Treatment of Mucosal Melanoma

Phase 2

Recruiting

Conditions: Mucosal Melanoma of the Head and Neck

Interventions: Drug: Pembrolizumab
Radiation: Hypofractionated radiation therapy

First Posted Date: 2020-03-24

Last Posted Date: 2024-12-20

Lead Sponsor: Washington University School of Medicine

Target Recruit Count: 16

Registration Number: NCT04318717

Locations: 🇺🇸
Washington University School of Medicine, Saint Louis, Missouri, United States

Adjuvant Pembrolizumab vs Observation Following Curative Resection for Stage I Non-small Cell Lung Cancer (NSCLC) With Primary Tumors Between 1-4 cm

Phase 2

Recruiting

Conditions: NSCLC, Stage I

Interventions: Drug: Pembrolizumab

First Posted Date: 2020-03-23

Last Posted Date: 2024-11-13

Lead Sponsor: Greg Durm, MD

Target Recruit Count: 244

Registration Number: NCT04317534

Locations: 🇺🇸
Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey, United States
🇺🇸
Penn State Cancer Institute, Hershey, Pennsylvania, United States
🇺🇸
Ohio State University Comprehensive Cancer Center, Columbus, Ohio, United States

and more 10 locations

A Study of Pembrolizumab (MK-3475) in Participants With Relapsed or Refractory Primary Mediastinal Large B-cell Lymphoma (rrPMBCL) (MK-3475-A33/KEYNOTE-A33)

Phase 1

Completed

Conditions: Lymphoma, B-Cell

Interventions: Drug: Pembrolizumab

First Posted Date: 2020-03-20

Last Posted Date: 2024-05-13

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 7

Registration Number: NCT04317066

Locations: 🇯🇵
Okayama University Hospital ( Site 0004), Okayama, Japan
🇯🇵
Kindai University Hospital ( Site 0001), Osakasayama, Osaka, Japan
🇯🇵
National Hospital Organization Disaster Medical Center ( Site 0007), Tachikawa, Tokyo, Japan

and more 6 locations

Substudy 02A: Safety and Efficacy of Pembrolizumab in Combination With Investigational Agents in Participants With Programmed Cell-death 1 (PD-1) Refractory Melanoma (MK-3475-02A/KEYMAKER-U02)

Phase 1

Active, not recruiting

Conditions: Melanoma

Interventions: Biological: Pembrolizumab
Drug: ATRA
Biological: Quavonlimab
Biological: Vibostolimab
Drug: Lenvatinib

First Posted Date: 2020-03-12

Last Posted Date: 2024-11-19

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 200

Registration Number: NCT04305041

Locations: 🇮🇱
Chaim Sheba Medical Center ( Site 1701), Ramat Gan, Israel
🇫🇷
A.P.H. Paris, Hopital Saint Louis ( Site 1107), Paris, France
🇫🇷
Hopital Saint Andre ( Site 1108), Bordeaux, Gironde, France

and more 32 locations

Drug Development Updates

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