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

Retrospective Assessment of Adverse Events-related Healthcare Resource Utilization and Costs of Immune Checkpoint Inhibitor and Targeted Therapy for Adjuvant Treatment of Melanoma

Completed

Conditions: Melanoma

Interventions: Drug: Dabrafenib + trametinib
Drug: Nivolumab
Drug: Ipilimumab + nivolumab
Drug: Pembrolizumab

First Posted Date: 2023-02-06

Last Posted Date: 2023-02-06

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 618

Registration Number: NCT05714371

Locations: 🇺🇸
Novartis Pharmaceuticals, East Hanover, New Jersey, United States

NUC-3373 in Combination With Other Agents in Patients With Advanced Solid Tumours

Phase 1

Recruiting

Conditions: Advanced Cancer
Advanced Solid Tumor
Neoplasm Malignant
Metastatic Cancer
Melanoma
Classical Hodgkin Lymphoma
Non Small Cell Lung Cancer
Renal Cell Carcinoma
Urothelial Carcinoma
Head and Neck Squamous Cell Carcinoma

Interventions: Drug: Fosifloxuridine Nafalbenamide
Drug: Leucovorin
Drug: Pembrolizumab
Drug: Docetaxel

First Posted Date: 2023-02-06

Last Posted Date: 2023-06-23

Lead Sponsor: NuCana plc

Target Recruit Count: 91

Registration Number: NCT05714553

Locations: 🇬🇧
The Beatson West of Scotland Cancer Centre, Glasgow, United Kingdom
🇬🇧
Queen Elizabeth Hospital University Hospitals Birmingham NHS Foundation Trust, Birmingham, United Kingdom
🇬🇧
Guy's and St Thomas NHS Foundation Trust, London, United Kingdom

and more 1 locations

IMM60 and Pembrolizumab in Melanoma and NSCLC

Phase 1

Terminated

Conditions: Non-small Cell Lung Cancer
Melanoma

Interventions: Drug: IMM60
Drug: Pembrolizumab

First Posted Date: 2023-02-02

Last Posted Date: 2024-04-24

Lead Sponsor: iOx Therapeutics

Target Recruit Count: 1

Registration Number: NCT05709821

Locations: 🇺🇸
Rutgers, The State University of New Jersey - Robert Wood Johnson Medical School - The Cancer Institute of New Jersey (CINJ), New Brunswick, New Jersey, United States
🇺🇸
Next VA, Fairfax, Virginia, United States
🇪🇸
Hospital Xeral Álvaro Cunqueiro, Vigo, Pontevedra, Spain

and more 11 locations

Study of Navtemadlin Plus Pembrolizumab as Maintenance Therapy in Locally Advanced and Metastatic Non-Small Cell Lung Cancer

Phase 1

Withdrawn

Conditions: Non Small Cell Lung Cancer

Interventions: Drug: Navtemadlin
Drug: Navtemadlin Placebo
Drug: Pembrolizumab

First Posted Date: 2023-01-30

Last Posted Date: 2024-03-22

Lead Sponsor: Kartos Therapeutics, Inc.

Registration Number: NCT05705466

A Study of EBC-129 in Advanced Solid Tumours

Phase 1

Recruiting

Conditions: Advanced Solid Tumours

Interventions: Drug: EBC-129
Drug: Pembrolizumab

First Posted Date: 2023-01-27

Last Posted Date: 2025-01-03

Lead Sponsor: EDDC (Experimental Drug Development Centre), A*STAR Research Entities

Target Recruit Count: 84

Registration Number: NCT05701527

Locations: 🇺🇸
University of Colorado Hospital (UCH) - University of Colorado Cancer Center (UCCC) - Neuroendocrine Tumor Center, Aurora, Colorado, United States
🇺🇸
UT MD Anderson Cancer Center, Houston, Texas, United States
🇸🇬
National University Hospital - Medical Oncology, Singapore, South West, Singapore

and more 1 locations

Immunotherapy With Non-Ablative Radiation in Previously Untreated Patients With Stage IV NSCLC

Phase 2

Active, not recruiting

Conditions: NSCLC Stage IV

Interventions: Drug: Pembrolizumab
Radiation: Radiation
Drug: Chemotherapy

First Posted Date: 2023-01-20

Last Posted Date: 2024-10-14

Lead Sponsor: NYU Langone Health

Target Recruit Count: 14

Registration Number: NCT05691829

Locations: 🇺🇸
NYU Langone Health, New York, New York, United States

Pemetrexed-free vs. Pemetrexed-based Immunochemotherapy in Metastatic TTF-1 Negative Lung Adenocarcinoma

Phase 4

Recruiting

Conditions: Non-Small Cell Lung Cancer Metastatic

Interventions: Drug: Atezolizumab
Drug: Pembrolizumab
Drug: Nab paclitaxel
Drug: Cisplatin
Drug: Carboplatin
Drug: Pemetrexed

First Posted Date: 2023-01-19

Last Posted Date: 2024-10-26

Lead Sponsor: Nikolaj Frost MD

Target Recruit Count: 136

Registration Number: NCT05689671

Locations: 🇩🇪
LungenClinic Großhansdorf GmbH, Großhansdorf, Germany
🇩🇪
Universitätsmedizin Göttingen, Göttingen, Germany
🇩🇪
Asklepios Klinkum Hamburg, Hamburg, Germany

and more 28 locations

Phase III, Open-label, First-line Study of Dato-DXd in Combination With Durvalumab and Carboplatin for Advanced NSCLC Without Actionable Genomic Alterations

Phase 3

Active, not recruiting

Conditions: NSCLC

Interventions: Drug: Datopotamab deruxtecan
Drug: Durvalumab
Drug: Pembrolizumab
Drug: Carboplatin
Drug: Cisplatin
Drug: Pemetrexed
Drug: Paclitaxel

First Posted Date: 2023-01-18

Last Posted Date: 2024-12-02

Lead Sponsor: AstraZeneca

Target Recruit Count: 1350

Registration Number: NCT05687266

Locations: 🇻🇳
Research Site, Ho Chi Minh, Vietnam

A Phase II Study Evaluating the Efficacy and Safety of Pembrolizumab in Combination With Chemotherapy as Neoadjuvant Therapy for Triple-negative Breast Cancer

Phase 2

Recruiting

Conditions: Breast Cancer

Interventions: Drug: Pembrolizumab
Drug: Paclitaxel
Drug: Epirubicin
Drug: Cyclophosphamide

First Posted Date: 2023-01-12

Last Posted Date: 2023-01-12

Lead Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Target Recruit Count: 26

Registration Number: NCT05681728

Locations: 🇨🇳
National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, Beijing, China

A Phase II Study of Neoadjuvant Sacituzumab Govitecan and Pembrolizumab Therapy for Immunochemotherapy-resistant Early-stage Triple-negative Breast Cancer (TNBC)

Phase 2

Recruiting

Conditions: Breast Cancer

Interventions: Drug: Sacituzumab Govitecan
Drug: Pembrolizumab

First Posted Date: 2023-01-09

Last Posted Date: 2024-12-16

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 25

Registration Number: NCT05675579

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

Drug Development Updates

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