Pembrolizumab

Generic Name: Pembrolizumab

Brand Names: Keytruda

Drug Type: Biotech

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)

Clinical Trials

MRI and PET to Assess Pembrolizumab Response

Early Phase 1

Terminated

Conditions: Malignant Melanoma, Metastatic

Interventions: Drug: Pembrolizumab
Drug: FLT PET

First Posted Date: 2015-10-29

Last Posted Date: 2022-12-30

Lead Sponsor: Columbia University

Target Recruit Count: 6

Registration Number: NCT02591654

Locations: 🇺🇸
Columbia University Irving Medical Center / NewYork-Presbyterian Hospital, New York, New York, United States

Study of Pembrolizumab in Subjects With Advanced Gastric or Gastroesophageal Junction Adenocarcinoma Who Progressed After First-Line Therapy With Platinum and Fluoropyrimidine: Integration of Molecular Subtypes Through Integrative Genomic Analysis

Phase 2

Completed

Conditions: Gastroesophageal Junction Adenocarcinoma
Gastric Adenocarcinoma

Interventions: Drug: pembrolizumab

First Posted Date: 2015-10-28

Last Posted Date: 2023-05-09

Lead Sponsor: Samsung Medical Center

Target Recruit Count: 80

Registration Number: NCT02589496

Locations: 🇰🇷
Samsung Medical Center, Seoul, Korea, Korea, Republic of

Dose-escalation Study of Birinapant and Pembrolizumab in Solid Tumors

Phase 1

Terminated

Conditions: Solid Tumors

Interventions: Drug: Birinapant
Drug: Pembrolizumab

First Posted Date: 2015-10-27

Last Posted Date: 2021-01-14

Lead Sponsor: Medivir

Target Recruit Count: 34

Registration Number: NCT02587962

Locations: 🇺🇸
Banner MD Anderson Cancer Center, Gilbert, Arizona, United States
🇺🇸
The Sidney Kimmel Comprehensive Cancer Center at John Hopkins, Baltimore, Maryland, United States
🇺🇸
UCLA Dept of Medicine-Hematology/Oncology, Santa Monica, California, United States

and more 6 locations

Pembrolizumab and Palliative Radiotherapy in Lung

Phase 1

Completed

Conditions: Thoracic Tumours

Interventions: Drug: Pembrolizumab
Radiation: Radiotherapy

First Posted Date: 2015-10-27

Last Posted Date: 2024-05-14

Lead Sponsor: Royal Marsden NHS Foundation Trust

Target Recruit Count: 24

Registration Number: NCT02587455

Locations: 🇬🇧
NIHR Biomedical Research Centre at RM and ICR (https://www.cancerbrc.org/), Sutton, United Kingdom

Trial of Chemoradiation and Pembrolizumab in Patients With Rectal Cancer

Phase 2

Withdrawn

Conditions: Rectal Cancer
Rectal Neoplasm

Interventions: Drug: Pembrolizumab
Drug: Capecitabine
Radiation: Radiation Therapy

First Posted Date: 2015-10-26

Last Posted Date: 2017-01-20

Lead Sponsor: Osama Rahma, MD

Registration Number: NCT02586610

Pembrolizumab in Combination With CRT for LA-SCCHN

Phase 1

Active, not recruiting

Conditions: Oropharynx Cancer
Hypopharynx Cancer
Larynx Cancer
Laryngeal Cancer
Head and Neck Cancer
Squamous Cell Carcinoma
Oral Cavity Cancer

Interventions: Drug: pembrolizumab (MK-3475)
Drug: Cisplatin
Radiation: Radiation

First Posted Date: 2015-10-26

Last Posted Date: 2024-07-19

Lead Sponsor: Sanford Health

Target Recruit Count: 59

Registration Number: NCT02586207

Locations: 🇺🇸
UCSD Moores Cancer Center, La Jolla, California, United States
🇺🇸
Sanford-Bismarck Medical Center, Bismarck, North Dakota, United States
🇺🇸
Sanford-Roger Maris Cancer Center, Fargo, North Dakota, United States

and more 1 locations

Pembrolizumab in Untreated Extensive SCLC

Phase 2

Completed

Conditions: Small Cell Lung Cancer (SCLC)

Interventions: Drug: Pembrolizumab
Drug: cis/carboplatin and etoposide

First Posted Date: 2015-10-20

Last Posted Date: 2023-12-11

Lead Sponsor: European Organisation for Research and Treatment of Cancer - EORTC

Target Recruit Count: 125

Registration Number: NCT02580994

Locations: 🇮🇹
Ospedale S. Luigi Gonzaga - Universita Di Torino, Orbassano, Italy
🇫🇷
Centre Hospitalier d'Avignon - Hopital Duffaut, Avignon, France
🇫🇷
Centre Hopitalier Intercommunal De Creteil, Créteil, France

and more 15 locations

Study of Pemetrexed+Platinum Chemotherapy With or Without Pembrolizumab (MK-3475) in Participants With First Line Metastatic Nonsquamous Non-small Cell Lung Cancer (MK-3475-189/KEYNOTE-189)

Phase 3

Completed

Conditions: Non-Small-Cell Lung Carcinoma

Interventions: Biological: Pembrolizumab 200 mg
Drug: Cisplatin
Drug: Carboplatin
Drug: Pemetrexed
Dietary Supplement: Folic acid 350-1000 μg
Dietary Supplement: Vitamin B12 1000 μg
Drug: Dexamethasone 4 mg
Drug: Saline solution

First Posted Date: 2015-10-19

Last Posted Date: 2024-07-09

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 616

Registration Number: NCT02578680

MK-3475 in Combination With Docetaxel vs Docetaxel Alone in Non-Small Cell Lung Cancer Patients

Phase 2

Completed

Conditions: Carcinoma, Non-Small-Cell Lung

Interventions: Drug: MK-3475
Drug: Docetaxel

First Posted Date: 2015-10-14

Last Posted Date: 2021-01-06

Lead Sponsor: Instituto Nacional de Cancerologia de Mexico

Target Recruit Count: 78

Registration Number: NCT02574598

Locations: 🇲🇽
National Cancer Institute of Mexico, Mexico city, Distrito Federal, Mexico

Pilot Study of Vigil™ + Pembrolizumab for Advanced Melanoma

Phase 1

Completed

Conditions: Melanoma Recurrent
Malignant Melanoma
Melanoma

Interventions: Biological: Vigil
Drug: Pembrolizumab

First Posted Date: 2015-10-14

Last Posted Date: 2017-09-27

Lead Sponsor: Gradalis, Inc.

Target Recruit Count: 2

Registration Number: NCT02574533

Locations: 🇺🇸
Texas Oncology P.A., Texas Cancer Center, Abilene, Texas, United States
🇺🇸
Mary Crowley Medical Research Centers, Dallas, Texas, United States
🇺🇸
Cancer Care Northwest, Spokane, Washington, United States

Drug Development Updates

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