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

Study of Safety and Tolerability of BCA101 Monotherapy and in Combination Therapy in Patients With EGFR-driven Advanced Solid Tumors

Phase 1

Recruiting

Conditions: Colorectal Cancer
Cutaneous Squamous Cell Carcinoma
Epithelial Ovarian Cancer
Head and Neck Squamous Cell Carcinoma
Squamous Cell Carcinoma of the Lung
Carcinoma, Squamous Cell
Squamous Cell Carcinoma of Head and Neck
EGFR Amplification
Squamous Cell Carcinoma of Anal Canal
Pancreas Cancer

Interventions: Drug: BCA101
Drug: Pembrolizumab

First Posted Date: 2020-06-12

Last Posted Date: 2024-11-07

Lead Sponsor: Bicara Therapeutics

Target Recruit Count: 292

Registration Number: NCT04429542

Locations: 🇺🇸
Levine Cancer Institute, Charlotte, North Carolina, United States
🇦🇺
Austin Hospital, Heidelberg, Victoria, Australia
🇺🇸
Moores Cancer Center UC San Diego Health, La Jolla, California, United States

and more 16 locations

Lenvatinib (E7080/MK-7902) in Combination With Pembrolizumab (MK-3475) vs. Standard Chemotherapy and Lenvatinib Monotherapy in Participants With Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma That Progressed After Platinum Therapy and Immunotherapy (MK-7902-009/E7080-G000-228/LEAP-009)

Phase 2

Active, not recruiting

Conditions: Squamous Cell Carcinoma of Head and Neck

Interventions: Drug: Lenvatinib
Drug: Docetaxel
Biological: Pembrolizumab
Drug: Capecitabine
Drug: Paclitaxel
Drug: Cetuximab

First Posted Date: 2020-06-11

Last Posted Date: 2024-12-10

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 408

Registration Number: NCT04428151

Locations: 🇺🇸
Rush University Medical Center ( Site 1560), Chicago, Illinois, United States
🇺🇸
Cleveland Clinic Main ( Site 1598), Cleveland, Ohio, United States
🇺🇸
Boston Medical Center ( Site 1605), Boston, Massachusetts, United States

and more 117 locations

Preoperative Lenvatinib Plus Pembrolizumab in Early-Stage Triple-Negative Breast Cancer (TNBC)

Phase 1

Recruiting

Conditions: Triple Negative Breast Cancer

Interventions: Drug: Lenvatinib
Drug: Pembrolizumab

First Posted Date: 2020-06-11

Last Posted Date: 2024-07-24

Lead Sponsor: University of Illinois at Chicago

Target Recruit Count: 12

Registration Number: NCT04427293

Locations: 🇺🇸
University of Illinois, Chicago, Illinois, United States

Study of GSK3359609 With Pembrolizumab and 5-fluorouracil (5-FU)-Platinum Chemotherapy in Participants With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

Phase 3

Terminated

Conditions: Neoplasms, Head and Neck

Interventions: Drug: Feladilimab
Drug: Pembrolizumab
Drug: Placebo
Drug: Platinum based chemotherapy
Drug: Fluorouracil (5FU)

First Posted Date: 2020-06-11

Last Posted Date: 2024-10-09

Lead Sponsor: GlaxoSmithKline

Target Recruit Count: 117

Registration Number: NCT04428333

Locations: 🇬🇧
GSK Investigational Site, Sutton, United Kingdom

Pembrolizumab, Ibrutinib and Rituximab in PCNSL

Phase 1

Recruiting

Conditions: Primary Central Nervous System Lymphoma
Refractory Cancer
Relapsed Cancer
Recurrent Cancer

Interventions: Drug: Ibrutinib
Drug: Pembrolizumab
Drug: Rituximab

First Posted Date: 2020-06-09

Last Posted Date: 2024-10-17

Lead Sponsor: Dana-Farber Cancer Institute

Target Recruit Count: 37

Registration Number: NCT04421560

Locations: 🇺🇸
Dana Farber Cancer Institute, Boston, Massachusetts, United States
🇺🇸
Columbia University Medical Center, New York, New York, United States

A Study of Dazostinag as Single Agent and Dazostinag in Combination With Pembrolizumab in Adults With Advanced or Metastatic Solid Tumors

Phase 1

Recruiting

Conditions: Solid Neoplasms

Interventions: Drug: Dazostinag
Drug: Pembrolizumab
Drug: Platinum
Drug: 5-fluorouracil

First Posted Date: 2020-06-09

Last Posted Date: 2024-12-20

Lead Sponsor: Takeda

Target Recruit Count: 374

Registration Number: NCT04420884

Locations: 🇺🇸
University of California San Diego Moores Cancer Center, La Jolla, California, United States
🇺🇸
Norris Comprehensive Cancer Center, Los Angeles, California, United States
🇺🇸
UCI Health - Chao Family Comprehensive Cancer Center, Orange, California, United States

and more 64 locations

Safety and Efficacy Study of SAR442720 in Combination With Other Agents in Advanced Malignancies

Phase 1

Terminated

Conditions: Metastatic Neoplasm

Interventions: Drug: SAR442720
Drug: Pembrolizumab
Drug: Adagrasib

First Posted Date: 2020-06-05

Last Posted Date: 2024-05-01

Lead Sponsor: Sanofi

Target Recruit Count: 65

Registration Number: NCT04418661

Locations: 🇺🇸
~University of Texas - MD Anderson Cancer Center Site Number : 8400001, Houston, Texas, United States
🇨🇱
Investigational Site Number : 1520002, Temuco, Chile
🇨🇳
Investigational Site Number : 1580001, Taipei, Taiwan

and more 18 locations

Combining Pembrolizumab and Metformin in Metastatic Head and Neck Cancer Patients

Phase 2

Active, not recruiting

Conditions: Head and Neck Squamous Cell Carcinoma

Interventions: Drug: Metformin Extended Release Oral Tablet
Drug: Pembrolizumab

First Posted Date: 2020-06-04

Last Posted Date: 2024-08-01

Lead Sponsor: Trisha Wise-Draper

Target Recruit Count: 20

Registration Number: NCT04414540

Locations: 🇺🇸
University of Cincinnati Medical Center, Cincinnati, Ohio, United States

Olaparib Monotherapy and Olaparib + Pembrolizumab Combination Therapy for Ovarian Cancer

Phase 2

Completed

Conditions: Ovarian Cancer

Interventions: Drug: Olaparib
Drug: Pembrolizumab

First Posted Date: 2020-06-04

Last Posted Date: 2023-07-06

Lead Sponsor: National Cancer Center Hospital East

Target Recruit Count: 30

Registration Number: NCT04417192

Locations: 🇯🇵
National Cancer Center Hospital East, Kashiwa, Chiba, Japan
🇯🇵
National Hospital Organization Shikoku Cancer Center, Matsuyama, Ehime, Japan
🇯🇵
Kurume University Hospital, Kurume, Fukuoka, Japan

Pembrolizumab and Radiotherapy for Patients With NK/T Cell Lymphoma

Phase 2

Recruiting

Conditions: Lymphoma, Extranodal NK-T-Cell

Interventions: Drug: Pembrolizumab
Radiation: Involved Field Radiation Therapy

First Posted Date: 2020-06-04

Last Posted Date: 2024-07-22

Lead Sponsor: International Extranodal Lymphoma Study Group (IELSG)

Target Recruit Count: 30

Registration Number: NCT04417166

Locations: 🇨🇳
Sun Yat-sen University Cancer Center, Guangzhou, China
🇨🇳
Shanghai Rui-Jin Hospital, Shanghai, China

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