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 of Modakafusp Alfa (TAK-573) Given by Itself and Together With Pembrolizumab in Adults With Advanced or Metastatic Solid Tumors

Phase 1

Terminated

Conditions: Melanoma
Neoplasms

Interventions: Drug: Modakafusp Alfa
Drug: Pembrolizumab

First Posted Date: 2019-11-08

Last Posted Date: 2024-12-27

Lead Sponsor: Takeda

Target Recruit Count: 45

Registration Number: NCT04157517

Locations: 🇺🇸
University of California San Diego Moores Cancer Center, La Jolla, California, United States
🇺🇸
Norris Cotton Cancer Center Lebanon, Lebanon, New Hampshire, United States
🇺🇸
Morristown Medical Center, Morristown, New Jersey, United States

and more 14 locations

Pembrolizumab + Platinum Doublets Without Radiation for Programmed Death-ligand 1 (PD-L1) ≥50% Locally Advanced NSCLC

Phase 2

Conditions: Locally Advanced Non-small Cell Lung Cancer

Interventions: Drug: Pembrolizumab
Drug: Cis Platinum
Drug: Carboplatin
Drug: Pemetrexed
Drug: nab paclitaxel

First Posted Date: 2019-11-06

Last Posted Date: 2019-11-06

Lead Sponsor: Kobe Minimally Invasive Cancer Center

Target Recruit Count: 21

Registration Number: NCT04153734

A Study of Pembrolizumab in Combination With Cisplatin and Pemetrexed in Advanced Malignant Pleural Mesothelioma (MPM) (MK-3475-A17)

Phase 1

Completed

Conditions: Mesothelioma

Interventions: Drug: Pembrolizumab
Drug: Pemetrexed
Drug: Cisplatin

First Posted Date: 2019-11-06

Last Posted Date: 2024-03-22

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 19

Registration Number: NCT04153565

Locations: 🇯🇵
Kanagawa Cancer Center ( Site 0004), Yokohama, Kanagawa, Japan
🇯🇵
JOHAS Okayama Rosai Hospital ( Site 0002), Okayama, Japan
🇯🇵
Hyogo College of Medicine Hospital ( Site 0003), Nishinomiya, Hyogo, Japan

and more 1 locations

Efficacy, Safety, and Tolerability of Gebasaxturev (V937) Administered Intravenously or Intratumorally With Pembrolizumab (MK-3475) Versus Pembrolizumab Alone in Participants With Advanced/Metastatic Melanoma (V937-011)

Phase 2

Terminated

Conditions: Advanced/Metastatic Melanoma

Interventions: Biological: Gebasaxturev IV
Biological: Gebasaxturev ITu
Drug: Pembrolizumab

First Posted Date: 2019-11-05

Last Posted Date: 2024-08-06

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 85

Registration Number: NCT04152863

Locations: 🇩🇪
Universitaetsklinikum Regensburg ( Site 2007), Regensburg, Bayern, Germany
🇺🇸
Rutgers Cancer Institute of New Jersey ( Site 0002), New Brunswick, New Jersey, United States
🇺🇸
Providence Portland Medical Center [Portland, OR] ( Site 0005), Portland, Oregon, United States

and more 27 locations

1922GCCC: Pembro and Bavituximab for Squamous Cell Carcinoma of Head and Neck

Phase 2

Active, not recruiting

Conditions: Squamous Cell Carcinoma

Interventions: Drug: Bavituximab
Drug: Pembrolizumab

First Posted Date: 2019-11-05

Last Posted Date: 2023-09-05

Lead Sponsor: University of Maryland, Baltimore

Target Recruit Count: 7

Registration Number: NCT04150900

Locations: 🇺🇸
University of Maryland Medical Center, Baltimore, Maryland, United States

Oxaliplatin and Liposomal Irinotecan (Plus Trastuzumab for HER2-positive Disease) in Advanced Esophageal and Gastric Adenocarcinoma

Phase 2

Recruiting

Conditions: Esophageal Adenocarcinoma
Gastric Adenocarcinoma

Interventions: Drug: Nal-IRI
Drug: Oxaliplatin
Drug: 5-FU
Drug: Trastuzumab
Drug: Nivolumab
Drug: Pembrolizumab

First Posted Date: 2019-11-05

Last Posted Date: 2024-08-15

Lead Sponsor: University of Wisconsin, Madison

Target Recruit Count: 52

Registration Number: NCT04150640

Locations: 🇺🇸
University of Wisconsin Carbone Cancer Center, Madison, Wisconsin, United States

A Study of the CD73 Inhibitor LY3475070 Alone or in Combination With Pembrolizumab in Participants With Advanced Cancer

Phase 1

Completed

Conditions: Advanced Cancer

Interventions: Drug: LY3475070
Drug: Pembrolizumab

First Posted Date: 2019-11-04

Last Posted Date: 2024-04-05

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 52

Registration Number: NCT04148937

Locations: 🇬🇧
Beatson West of Scotland Cancer Center, Glasgow, Scotland, United Kingdom
🇬🇧
Royal Marsden NHS Trust, Sutton, United Kingdom
🇬🇧
Addenbrookes Hospital, Cambridge, Cambridgeshire, United Kingdom

and more 9 locations

A Study of ALKS 4230 (Nemvaleukin Alfa) With Pembrolizumab in Head and Neck Cancer

Phase 2

Completed

Conditions: Squamous Cell Carcinoma of Head and Neck

Interventions: Drug: Nemvaleukin Alfa
Drug: Pembrolizumab

First Posted Date: 2019-10-30

Last Posted Date: 2024-10-16

Lead Sponsor: Mural Oncology, Inc

Target Recruit Count: 14

Registration Number: NCT04144517

Locations: 🇺🇸
Mural Oncology Investigational Site, Austin, Texas, United States

Safety, PK and Efficacy of ONC-392 in Monotherapy and in Combination of Anti-PD-1 in Advanced Solid Tumors and NSCLC

Phase 1

Recruiting

Conditions: Metastatic Head and Neck Carcinoma
Metastatic Colorectal Cancer
Metastatic Prostate Cancer
Gastric Cancer
Non Small Cell Lung Cancer
Metastatic Melanoma
Ovarian Cancer
Salivary Gland Cancer
Urothelial Carcinoma
Advanced Solid Tumor

Interventions: Drug: ONC-392
Drug: Docetaxel
Drug: Pembrolizumab

First Posted Date: 2019-10-28

Last Posted Date: 2024-05-13

Lead Sponsor: OncoC4, Inc.

Target Recruit Count: 733

Registration Number: NCT04140526

Locations: 🇺🇸
Memorial Sloan Kettering Cancer Center, New York, New York, United States
🇺🇸
The Oncology Institute of Hope and Innovation, Downey, California, United States
🇺🇸
University of California at Davis, Davis, California, United States

and more 34 locations

Safety and Efficacy of Capmatinib (INC280) Plus Pembrolizumab vs Pembrolizumab Alone in NSCLC With PD-L1≥ 50%

Phase 2

Terminated

Conditions: Non-small Cell Lung Cancer (NSCLC)

Interventions: Drug: Capmatinib
Biological: Pembrolizumab

First Posted Date: 2019-10-25

Last Posted Date: 2024-10-09

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 76

Registration Number: NCT04139317

Locations: 🇹🇭
Novartis Investigative Site, Bangkok, Thailand

Drug Development Updates

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