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

RADVAX™ for Relapsed/Refractory Non-Hodgkin Lymphoma: A Phase II Trial of Pembrolizumab + Low Dose Radiotherapy

Phase 2

Recruiting

Conditions: Non Hodgkin Lymphoma

Interventions: Drug: Pembrolizumab

First Posted Date: 2021-04-01

Last Posted Date: 2024-01-12

Lead Sponsor: Abramson Cancer Center at Penn Medicine

Target Recruit Count: 40

Registration Number: NCT04827862

Locations: 🇺🇸
Abamson Cancer Center of the University of Pennsylvania, Philadelphia, Pennsylvania, United States

Safety and Oversight of the Individually Tailored Treatment Approach: A Novel Pilot Study

Not Applicable

Terminated

Conditions: Cancer

Interventions: Drug: Trametinib
Drug: Cobimetinib
Drug: Binimetinib
Drug: Alpelisib
Drug: Vemurafenib
Drug: Dabrafenib
Drug: Encorafenib
Drug: Palbociclib
Drug: Olaparib
Drug: Ribociclib
Drug: Abemaciclib
Drug: Talazoparib
Drug: Nivolumab
Drug: Atezolizumab
Drug: Pembrolizumab

First Posted Date: 2021-03-17

Last Posted Date: 2023-05-10

Lead Sponsor: Peter MacCallum Cancer Centre, Australia

Target Recruit Count: 3

Registration Number: NCT04801966

Locations: 🇦🇺
Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia

A Study of TransCon TLR7/8 Agonist With or Without Pembrolizumab in Patients With Advanced or Metastatic Solid Tumors

Phase 1

Active, not recruiting

Conditions: Locally Advanced Solid Tumor
Advanced Solid Tumor
Metastatic Solid Tumor
HPV-associated Cancers
Neoadjuvant Cutaneous Squamous Cell Carcinoma (cSCC)
Head and Neck Squamous Cell Carcinoma HNSCC
Neoadjuvant Melanoma

Interventions: Drug: TransCon TLR7/8 Agonist
Drug: Pembrolizumab

First Posted Date: 2021-03-16

Last Posted Date: 2024-10-30

Lead Sponsor: Ascendis Pharma Oncology Division A/S

Target Recruit Count: 188

Registration Number: NCT04799054

Locations: 🇦🇺
Ascendis Pharma Investigational Site, Frankston, Victoria, Australia
🇨🇳
Ascendis Investigational Site, Taipei City, Taiwan

Immunotherapy in MSI/dMMR Tumors in Perioperative Setting.

Phase 2

Active, not recruiting

Conditions: Localized Resectable Tumor
MSI/dMMR

Interventions: Drug: Pembrolizumab

First Posted Date: 2021-03-12

Last Posted Date: 2024-06-27

Lead Sponsor: Centre Leon Berard

Target Recruit Count: 240

Registration Number: NCT04795661

Locations: 🇫🇷
Groupe Hospitalier Diaconesses Croix Saint-Simon, Paris, France
🇫🇷
Centre Georges-Francois Leclerc, Dijon, France
🇫🇷
Institut Paoli Calmettes, Marseille, France

and more 14 locations

Lung Cancer Cryo-Activation as a Novel Approach to Augment Immunotherapy Efficacy (CRYOVATE)

Not Applicable

Completed

Conditions: Cryotherapy Effect
Non-small Cell Lung Cancer Metastatic

Interventions: Procedure: Cryo-activation
Drug: Pembrolizumab

First Posted Date: 2021-03-11

Last Posted Date: 2023-06-29

Lead Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)

Target Recruit Count: 15

Registration Number: NCT04793815

Locations: 🇨🇦
Centre hospitalier de l'Université de Montréal (CHUM), Montreal, Quebec, Canada

Study of Magrolimab and Pembrolizumab in Relapsed or Refractory Classic Hodgkin Lymphoma

Phase 2

Active, not recruiting

Conditions: Classic Hodgkin Lymphoma
Refractory Classic Hodgkin Lymphoma
Hodgkin Lymphoma
Relapsed Classical Hodgkin Lymphoma

Interventions: Drug: Magrolimab
Drug: Pembrolizumab
Procedure: PET/CT

First Posted Date: 2021-03-09

Last Posted Date: 2024-06-21

Lead Sponsor: Stanford University

Target Recruit Count: 8

Registration Number: NCT04788043

Locations: 🇺🇸
Dana Farber Cancer Institute, Boston, Massachusetts, United States
🇺🇸
Stanford University, Stanford, California, United States

Tucatinib Together With Pembrolizumab and Trastuzumab

Phase 2

Recruiting

Conditions: Breast Cancer
HER2-positive Breast Cancer

Interventions: Drug: Tucatinib
Drug: Pembrolizumab
Drug: Trastuzumab
Drug: Capecitabine

First Posted Date: 2021-03-09

Last Posted Date: 2024-06-21

Lead Sponsor: Breast Cancer Trials, Australia and New Zealand

Target Recruit Count: 57

Registration Number: NCT04789096

Locations: 🇦🇺
Peter MacCallum Cancer Centre, Parkville, Victoria, Australia
🇦🇺
Macquarie University, Macquarie Park, New South Wales, Australia
🇦🇺
Nepean Cancer Care Centre, Kingswood, New South Wales, Australia

and more 12 locations

Phase 1a and Phase 2 Study for Safety, Preliminary Efficacy, PK and PD of ST-067

Phase 1

Recruiting

Conditions: Cancer
Squamous Cell Carcinoma of the Head and Neck
Non Small Cell Lung Cancer
Renal Cell Carcinoma
MSI-High
Solid Tumor
Carcinoma
Melanoma
Triple-negative Breast Cancer

Interventions: Biological: ST-067
Biological: Obinutuzumab 25 MG/1 ML Intravenous Solution [GAZYVA]
Biological: pembrolizumab

First Posted Date: 2021-03-08

Last Posted Date: 2024-11-15

Lead Sponsor: Simcha IL-18, Inc.

Target Recruit Count: 316

Registration Number: NCT04787042

Locations: 🇺🇸
HonorHealth Research Institute, Scottsdale, Arizona, United States
🇺🇸
Yale Cancer Center, New Haven, Connecticut, United States
🇺🇸
Moffitt Cancer Center, Tampa, Florida, United States

and more 3 locations

Lenvatinib and Pembrolizumab in People With Advanced Soft Tissue Sarcoma

Phase 2

Active, not recruiting

Conditions: Advanced Sarcoma

Interventions: Drug: Lenvatinib
Drug: Pembrolizumab

First Posted Date: 2021-03-05

Last Posted Date: 2024-06-06

Lead Sponsor: Memorial Sloan Kettering Cancer Center

Target Recruit Count: 52

Registration Number: NCT04784247

Locations: 🇺🇸
Memorial Sloan Kettering Bergen (Limited Protocol Activities), Montvale, New Jersey, United States
🇺🇸
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities), Basking Ridge, New Jersey, United States
🇺🇸
Memorial Sloan Kettering Monmouth (Limited Protocol Activities), Middletown, New Jersey, United States

and more 4 locations

Study of Lenvatinib (MK-7902/E7080) in Combination With Pembrolizumab (MK-3475) Versus Standard of Care in Participants With Metastatic Colorectal Cancer (MK-7902-017/E7080-G000-325/LEAP-017)

Phase 3

Completed

Conditions: Colorectal Neoplasms

Interventions: Drug: pembrolizumab
Drug: regorafenib
Drug: TAS-102 (trifluridine and tipiracil)
Drug: lenvatinib

First Posted Date: 2021-03-01

Last Posted Date: 2024-10-29

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 480

Registration Number: NCT04776148

Locations: 🇨🇦
NSHA-QEII Health Sciences Centre-Dickson Bldg-Dept. of Medical Oncology ( Site 0200), Halifax, Nova Scotia, Canada
🇯🇵
Shizuoka Cancer Center ( Site 1706), Nagaizumi, Shizuoka, Japan
🇩🇰
Herlev and Gentofte Hospital-Department of Oncology ( Site 0704), Copenhagen, Hovedstaden, Denmark

and more 92 locations

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