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

A Study to Evaluate the Safety, Pharmacokinetics, and Activity of RO7502175 as a Single Agent and in Combination With Checkpoint Inhibitor in Participants With Locally Advanced or Metastatic Solid Tumors

Phase 1

Recruiting

Conditions: Locally Advanced or Metastatic Solid Tumors
NSCLC
HNSCC
Melanoma
TNBC
Esophageal Cancer
Gastric Cancer
Cervical Cancer
Colorectal Cancer
Urothelial Carcinoma

Interventions: Drug: RO7502175
Drug: Atezolizumab
Drug: Pembrolizumab

First Posted Date: 2022-10-14

Last Posted Date: 2024-11-22

Lead Sponsor: Genentech, Inc.

Target Recruit Count: 450

Registration Number: NCT05581004

Locations: 🇪🇸
Hospital Universitario 12 De Octubre, Madrid, Spain
🇪🇸
Hospital Universitario Virgen de la Victoria, Malaga, Spain
🇪🇸
Hospital Clinico Universitario de Valencia, Valencia, Spain

and more 30 locations

Pembrolizumab as First-line Treatment for Advanced NSCLC Complicated With COPD

Phase 2

Recruiting

Conditions: NSCLC With COPD

Interventions: Drug: Pembrolizumab

First Posted Date: 2022-10-13

Last Posted Date: 2022-10-13

Lead Sponsor: Tianjin Chest Hospital

Target Recruit Count: 30

Registration Number: NCT05578222

Locations: 🇨🇳
Tianjin Chest Hospital, Tianjin, China

A Study of ANV419 Alone or in Combination with Approved Treatment in Patients with Cutaneous Melanoma (OMNIA-1).

Phase 1

Completed

Conditions: Melanoma (Skin)
Cutaneous Melanoma
Adult Disease
Advanced Solid Tumor
Metastatic Melanoma

Interventions: Drug: ANV419
Drug: Ipilimumab
Drug: Pembrolizumab

First Posted Date: 2022-10-13

Last Posted Date: 2024-11-27

Lead Sponsor: Anaveon AG

Target Recruit Count: 29

Registration Number: NCT05578872

Locations: 🇺🇸
University of Alabama at Birmingham, Birmingham, Alabama, United States
🇺🇸
University of California San Diego, La Jolla, California, United States
🇺🇸
University of California San Francisco, San Francisco, California, United States

and more 22 locations

Efficacy and Safety of Neoadjuvant Pembrolizumab in III-IVA Resectable Oral Squamous Cell Carcinoma

Recruiting

Conditions: Oral Cavity Squamous Cell Carcinoma

Interventions: Drug: Pembrolizumab

First Posted Date: 2022-10-13

Last Posted Date: 2023-02-03

Lead Sponsor: Nanfang Hospital, Southern Medical University

Target Recruit Count: 47

Registration Number: NCT05578170

Locations: 🇨🇳
Liuxiqiang, Guangzhou, Guangdong, China

A Study of TBio-4101 (TIL) and Pembrolizumab in Patients With Advanced Solid Tumors

Phase 1

Recruiting

Conditions: Breast Cancer
Colorectal Cancer
Cutaneous Melanoma
Uveal Melanoma
Non-Small Cell Lung Cancer
Head and Neck Squamous Cell Carcinoma

Interventions: Biological: TBio-4101
Drug: Pembrolizumab

First Posted Date: 2022-10-12

Last Posted Date: 2025-01-08

Lead Sponsor: Turnstone Biologics, Corp.

Target Recruit Count: 60

Registration Number: NCT05576077

Locations: 🇺🇸
Providence Cancer Institute, Portland, Oregon, United States
🇺🇸
University of California Irvine, Irvine, California, United States
🇺🇸
Memorial Healthcare System, Hollywood, Florida, United States

and more 10 locations

A Safety, Tolerability and Efficacy Study of NC410 Plus Pembrolizumab in Participants with Advanced Unresectable or Metastatic Solid Tumors

Phase 1

Active, not recruiting

Conditions: Ovarian Cancer
Colo-rectal Cancer
Advanced or Metastatic Solid Tumors
Lung Cancer
Microsatellite Instability High
Microsatellite Stable
Endometrial Cancer
Cervical Cancer
Esophageal Cancer
Microsatellite Instability Low

Interventions: Drug: NC410
Drug: pembrolizumab

First Posted Date: 2022-10-10

Last Posted Date: 2024-12-16

Lead Sponsor: NextCure, Inc.

Target Recruit Count: 97

Registration Number: NCT05572684

Locations: 🇺🇸
Arizona Oncology Associates, Tucson, Arizona, United States
🇺🇸
Rocky Mountain Cancer Centers, Aurora, Colorado, United States
🇺🇸
St. Elizabeth Edgewood Hospital, Edgewood, Kentucky, United States

and more 14 locations

SX-682 With Pembrolizumab for the Treatment of Metastatic or Recurrent Stage IIIC or IV Non-Small Cell Lung Cancer

Phase 2

Recruiting

Conditions: Metastatic Lung Non-Small Cell Carcinoma
Recurrent Lung Non-Small Cell Carcinoma
Stage IIIC Lung Cancer AJCC v8
Stage IV Lung Cancer AJCC v8

Interventions: Procedure: Biopsy
Procedure: Biospecimen Collection
Procedure: Computed Tomography
Drug: CXCR1/2 Inhibitor SX-682
Procedure: Magnetic Resonance Imaging
Biological: Pembrolizumab
Procedure: Positron Emission Tomography

First Posted Date: 2022-10-07

Last Posted Date: 2024-11-27

Lead Sponsor: University of Washington

Target Recruit Count: 30

Registration Number: NCT05570825

Locations: 🇺🇸
Fred Hutch/University of Washington Cancer Consortium, Seattle, Washington, United States

CISH Inactivated TILs in the Treatment of NSCLC

Phase 1

Not yet recruiting

Conditions: Metastatic Non Small Cell Lung Cancer
Stage IV Non-small Cell Lung Cancer
Squamous Cell Lung Cancer
Carcinoma, Non-Small-Cell Lung
Adenocarcinoma of Lung
Large Cell Lung Cancer

Interventions: Drug: Fludarabine
Drug: Cyclophosphamide
Biological: CISH Inactivated TIL
Drug: Aldesleukin
Drug: Pembrolizumab

First Posted Date: 2022-10-04

Last Posted Date: 2022-12-09

Lead Sponsor: Intima Bioscience, Inc.

Target Recruit Count: 70

Registration Number: NCT05566223

Locations: 🇺🇸
Masonic Cancer Center, University of Minnesota, Minneapolis, Minnesota, United States
🇺🇸
City of Hope Comprehensive Cancer Center, Duarte, California, United States