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 Evaluating the Safety, Activity, and Pharmacokinetics of Divarasib in Combination With Other Anti-Cancer Therapies in Participants With Previously Untreated Advanced or Metastatic Non-Small Cell Lung Cancer With a KRAS G12C Mutation

Phase 1

Recruiting

Conditions: Non-Small Cell Lung Cancer

Interventions: Drug: Divarasib
Drug: Pembrolizumab
Drug: Carboplatin
Drug: Cisplatin
Drug: Pemetrexed

First Posted Date: 2023-03-29

Last Posted Date: 2024-12-31

Lead Sponsor: Hoffmann-La Roche

Target Recruit Count: 240

Registration Number: NCT05789082

Locations: 🇰🇷
Pusan National University Hospital, Busan, Korea, Republic of
🇰🇷
Seoul National University Hospital, Seoul, Korea, Republic of
🇰🇷
Asan Medical Center, Seoul, Korea, Republic of

and more 54 locations

A Study of PARG Inhibitor IDE161 in Participants with Advanced Solid Tumors

Phase 1

Recruiting

Conditions: Advanced or Metastatic Solid Tumors
Pancreas Cancer
Prostate Cancer
Breast Cancer
Ovarian Cancer
Endometrial Cancer
Colorectal Cancer
Head and Neck Cancers

Interventions: Drug: IDE-161
Drug: Pembrolizumab

First Posted Date: 2023-03-28

Last Posted Date: 2024-10-28

Lead Sponsor: IDEAYA Biosciences

Target Recruit Count: 216

Registration Number: NCT05787587

Locations: 🇺🇸
The Angeles Clinic, Los Angeles, California, United States
🇺🇸
California Pacific Medical Center, San Francisco, California, United States
🇺🇸
Sarah Cannon Research Institute, Nashville, Tennessee, United States

and more 17 locations

DCSZ11 as a Monotherapy and in Combination in Patients With Advanced or Metastatic Solid Tumors

Phase 1

Recruiting

Conditions: Advanced or Metastatic Solid Tumors

Interventions: Drug: DCSZ11
Drug: Pembrolizumab

First Posted Date: 2023-03-27

Last Posted Date: 2024-11-22

Lead Sponsor: DynamiCure Biotechnology

Target Recruit Count: 257

Registration Number: NCT05785754

Locations: 🇺🇸
University of Miami, Miami, Florida, United States
🇦🇺
Liverpool Hospital, Liverpool, Australia
🇺🇸
University of Alabama, Birmingham, Alabama, United States

and more 29 locations

POTENT - Tepotinib in Combination with Pembrolizumab in NSCLC

Phase 1

Recruiting

Conditions: Advanced Cancer
Non Small Cell Lung Cancer

Interventions: Drug: Tepotinib
Drug: Pembrolizumab

First Posted Date: 2023-03-23

Last Posted Date: 2024-10-01

Lead Sponsor: Institute of Cancer Research, United Kingdom

Target Recruit Count: 38

Registration Number: NCT05782361

Locations: 🇬🇧
DDU, Royal Marsden Hospital NHS Foundation Trust, Sutton, Surrey, United Kingdom
🇬🇧
University College London Hospitals NHS Foundation Trust, London, United Kingdom
🇬🇧
Lung Unit, Royal Marsden Hospital NHS Foundation Trust, London, United Kingdom

and more 1 locations

Study of Aerosolized Antibiotics and Pembrolizumab in Advanced Non-small Cell Lung Cancer

Phase 1

Recruiting

Conditions: Advanced Non Small Cell Lung Cancer

Interventions: Drug: aerosolized aztreonam
Drug: aerosolized vancomycin
Drug: pembrolizumab

First Posted Date: 2023-03-21

Last Posted Date: 2024-12-20

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 20

Registration Number: NCT05777603

Locations: 🇺🇸
National Institutes of Health Clinical Center, Bethesda, Maryland, United States

A Study of Tobemstomig Plus Platinum-Based Chemotherapy vs Pembrolizumab Plus Platinum-Based Chemotherapy in Participants With Previously Untreated Non-Small Cell Lung Cancer

Phase 2

Active, not recruiting

Conditions: Non-small Cell Lung Cancer

Interventions: Drug: Tobemstomig
Drug: Pembrolizumab
Drug: Paclitaxel
Drug: Pemetrexed
Drug: Carboplatin

First Posted Date: 2023-03-20

Last Posted Date: 2024-11-20

Lead Sponsor: Hoffmann-La Roche

Target Recruit Count: 180

Registration Number: NCT05775289

Locations: 🇲🇽
ONCARE Viaducto Napoles, Ciudad de México, Mexico CITY (federal District), Mexico
🇪🇸
Hospital Son Llatzer, Palma de Mallorca, Islas Baleares, Spain
🇦🇺
Monash Health, Clayton, Victoria, Australia

and more 50 locations

Pembrolizumab and Enfortumab Vedotin With Pembrolizumab Prior to and After Radical Nephroureterectomy for High-Risk Upper Tract Urothelial Cancer

Phase 2

Recruiting

Conditions: Renal Pelvis and Ureter Urothelial Carcinoma

Interventions: Procedure: Biopsy
Procedure: Biospecimen Collection
Drug: Enfortumab Vedotin
Procedure: MR Urography
Procedure: Nephroureterectomy
Biological: Pembrolizumab

First Posted Date: 2023-03-20

Last Posted Date: 2024-12-24

Lead Sponsor: Jonsson Comprehensive Cancer Center

Target Recruit Count: 21

Registration Number: NCT05775471

Locations: 🇺🇸
UCLA / Jonsson Comprehensive Cancer Center, Los Angeles, California, United States

Pembrolizumab Plus 177Lu-PSMA-617 in Patients With Castration Resistant Prostate Cancer

Phase 2

Recruiting

Conditions: Castrate Resistant Prostate Cancer
Metastatic Castration-resistant Prostate Cancer
Prostate Cancer
Prostate Carcinoma

Interventions: Drug: Pembrolizumab
Drug: 177Lu-PSMA-617

First Posted Date: 2023-03-13

Last Posted Date: 2024-12-06

Lead Sponsor: University of California, San Francisco

Target Recruit Count: 48

Registration Number: NCT05766371

Locations: 🇺🇸
University of California, San Francisco, San Francisco, California, United States

Rigosertib Plus Pembrolizumab in Treating Patients With Unresectable/Metastatic Melanoma Refractory to PD-1 Inhibitors

Phase 2

Suspended

Conditions: Clinical Stage III Cutaneous Melanoma AJCC v8
Refractory Melanoma
Metastatic Melanoma
Unresectable Melanoma
Clinical Stage IV Cutaneous Melanoma AJCC v8

Interventions: Drug: Rigosertib
Biological: Pembrolizumab
Procedure: Magnetic Resonance Imaging
Procedure: Biospecimen Collection
Procedure: Biopsy