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 Pembrolizumab With Maintenance Olaparib or Maintenance Pemetrexed in First-line (1L) Metastatic Nonsquamous Non-Small-Cell Lung Cancer (NSCLC) (MK-7339-006, KEYLYNK-006)

Phase 3

Active, not recruiting

Conditions: Carcinoma, Nonsquamous Non-small-cell Lung

Interventions: Biological: Pembrolizumab
Drug: Pemetrexed
Drug: Carboplatin
Drug: Cisplatin
Drug: Olaparib

First Posted Date: 2019-06-06

Last Posted Date: 2024-11-19

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 672

Registration Number: NCT03976323

Locations: 🇺🇸
Renovatio Clinical ( Site 0062), The Woodlands, Texas, United States
🇦🇺
Liverpool Hospital ( Site 1201), Liverpool, New South Wales, Australia
🇨🇦
Stronach Regional Cancer Centre ( Site 0101), Newmarket, Ontario, Canada

and more 175 locations

Efficacy and Safety of Pembrolizumab (MK-3475) With Lenvatinib (E7080/MK-7902) vs. Docetaxel in Participants With Metastatic Non-Small Cell Lung Cancer (NSCLC) and Progressive Disease (PD) After Platinum Doublet Chemotherapy and Immunotherapy (MK-7902-008/E7080-G000-316/LEAP-008)

Phase 3

Completed

Conditions: Metastatic Non-Small Cell Lung Cancer

Interventions: Biological: Pembrolizumab
Drug: Docetaxel
Drug: Lenvatinib

First Posted Date: 2019-06-06

Last Posted Date: 2024-11-18

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 422

Registration Number: NCT03976375

Locations: 🇺🇸
Harry & Jeanette Weinberg Cancer Institute ( Site 1626), Baltimore, Maryland, United States
🇺🇸
Massachusetts General Hospital ( Site 1622), Boston, Massachusetts, United States
🇫🇷
ICO Centre Paul Papin ( Site 0412), Angers, Maine-et-Loire, France

and more 140 locations

A Study of Pembrolizumab (MK-3475) With or Without Maintenance Olaparib in First-line Metastatic Squamous Non-small Cell Lung Cancer (NSCLC, MK-7339-008/KEYLYNK-008)

Phase 3

Active, not recruiting

Conditions: Carcinoma, Squamous Cell, Non-small-cell Lung

Interventions: Biological: Pembrolizumab
Drug: Carboplatin
Drug: Paclitaxel
Drug: Nab-paclitaxel
Drug: Placebo
Drug: Olaparib

First Posted Date: 2019-06-06

Last Posted Date: 2024-11-19

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 851

Registration Number: NCT03976362

Locations: 🇦🇷
Sanatorio Privado San Geronimo S.R.L ( Site 0510), Santa Fe, Argentina
🇺🇸
Thompson Cancer Survival Center ( Site 2812), Knoxville, Tennessee, United States
🇦🇹
Social Medical Center - Otto Wagner Hospital ( Site 1301), Vienna, Wien, Austria

and more 175 locations

Pembrolizumab and Oral Metronomic Cyclophosphamide in Patients With Chest Wall Breast Cancer

Phase 2

Recruiting

Conditions: Breast Cancer
Chest Wall Tumor

Interventions: Drug: Pembrolizumab

First Posted Date: 2019-06-03

Last Posted Date: 2024-11-19

Lead Sponsor: European Institute of Oncology

Target Recruit Count: 46

Registration Number: NCT03971045

Locations: 🇮🇹
Istituto Europeo di Oncologia, Milan, Italy

Pembrolizumab and Decitabine With or Without Venetoclax in Treating Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome That Is Newly-Diagnosed, Recurrent, or Refractory

Phase 1

Recruiting

Conditions: Acute Myeloid Leukemia
Myelodysplastic Syndrome
Recurrent Acute Myeloid Leukemia
Recurrent Myelodysplastic Syndrome
Refractory Acute Myeloid Leukemia
Refractory Myelodysplastic Syndrome

Interventions: Drug: Decitabine
Biological: Pembrolizumab
Drug: Venetoclax

First Posted Date: 2019-05-31

Last Posted Date: 2025-01-03

Lead Sponsor: City of Hope Medical Center

Target Recruit Count: 54

Registration Number: NCT03969446

Locations: 🇺🇸
City of Hope Medical Center, Duarte, California, United States

This Study Will Evaluate the Effect of Canakinumab or Pembrolizumab Given as Monotherapy or in Combination as Neo-adjuvant Treatment for Subjects With Early Stages NSCLC.

Phase 2

Terminated

Conditions: Non-small Cell Lung Cancer

Interventions: Drug: Canakinumab
Drug: Pembrolizumab

First Posted Date: 2019-05-30

Last Posted Date: 2024-06-20

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 88

Registration Number: NCT03968419

Locations: 🇺🇸
University of Kansas Medical Center Neurology Dept., Kansas City, Kansas, United States
🇺🇸
Methodist Hospital / Methodist Cancer Center, Houston, Texas, United States
🇺🇸
UCLA Oncology Hematology, La Jolla, California, United States

and more 2 locations

Cabozantinib and Pembrolizumab for Advanced Metastatic Melanoma

Phase 1

Recruiting

Conditions: Advanced Metastatic Melanoma

Interventions: Drug: Cabozantinib
Drug: Pembrolizumab

First Posted Date: 2019-05-21

Last Posted Date: 2024-06-14

Lead Sponsor: Yousef Zakharia

Target Recruit Count: 62

Registration Number: NCT03957551

Locations: 🇺🇸
University of Iowa Hospitals and Clinics, Iowa City, Iowa, United States

Tesetaxel Plus 3 Different PD-(L)1 Inhibitors in Patients With Triple-Negative MBC and Tesetaxel Monotherapy in Patients With HER2-Negative MBC

Phase 2

Terminated

Conditions: Breast Cancer

Interventions: Drug: Tesetaxel
Drug: Nivolumab
Drug: Atezolizumab
Drug: Pembrolizumab

First Posted Date: 2019-05-16

Last Posted Date: 2021-07-30

Lead Sponsor: Odonate Therapeutics, Inc.

Target Recruit Count: 294

Registration Number: NCT03952325

Locations: 🇺🇸
West Cancer Center, Germantown, Tennessee, United States
🇸🇬
National Cancer Centre Singapore, Singapore, Singapore
🇺🇸
Sarah Cannon Research Institute - Florida Cancer Specialists, Fort Myers, Florida, United States

and more 8 locations

Androgen Deprivation Therapy (ADT) and Pembrolizumab for Advanced Stage Androgen Receptor-positive Salivary Gland Carcinoma

Phase 2

Recruiting

Conditions: Salivary Gland Carcinoma

Interventions: Drug: Goserelin Acetate
Drug: Pembrolizumab

First Posted Date: 2019-05-08

Last Posted Date: 2024-10-11

Lead Sponsor: Manish Patel

Target Recruit Count: 20

Registration Number: NCT03942653

Locations: 🇺🇸
University of Illinois Cancer Center, Chicago, Illinois, United States
🇺🇸
University of Iowa Hospitals and Clinics, Iowa City, Iowa, United States
🇺🇸
University of Michigan Health System, Ann Arbor, Michigan, United States

and more 4 locations

Safety of SNK01 in Subjects With Pathologically Confirmed Metastatic and/or Unresectable Cancer Refractory to Conventional Therapy

Phase 1

Completed

Conditions: Refractory Cancer
Metastatic Cancer
Recurrent Cancer
Unresectable Carcinoma
Solid Tumor, Adult
Advanced Cancer
Advanced Solid Tumor

Interventions: Biological: SNK01
Drug: Avelumab
Drug: Pembrolizumab

First Posted Date: 2019-05-07

Last Posted Date: 2023-11-13

Lead Sponsor: NKGen Biotech, Inc.

Target Recruit Count: 27

Registration Number: NCT03941262

Locations: 🇺🇸
Sarcoma Oncology Research Center, Santa Monica, California, United States

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