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

Longitudinal Immune-phenotyping of HCC Following MK-3475

Phase 1

Active, not recruiting

Conditions: Hepatocellular Carcinoma

Interventions: Drug: Pembrolizumab

First Posted Date: 2020-01-13

Last Posted Date: 2024-01-19

Lead Sponsor: National Cancer Centre, Singapore

Target Recruit Count: 8

Registration Number: NCT04224480

Locations: 🇸🇬
National Cancer Centre Singapore, Singapore, Singapore

Enfortumab Vedotin and Pembrolizumab vs. Chemotherapy Alone in Untreated Locally Advanced or Metastatic Urothelial Cancer

Phase 3

Active, not recruiting

Conditions: Urothelial Cancer

Interventions: Drug: Enfortumab vedotin
Drug: Cisplatin
Drug: Pembrolizumab
Drug: Carboplatin
Drug: Gemcitabine

First Posted Date: 2020-01-10

Last Posted Date: 2024-07-26

Lead Sponsor: Astellas Pharma Global Development, Inc.

Target Recruit Count: 1030

Registration Number: NCT04223856

Locations: 🇺🇸
Hillman Cancer Center / University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, United States
🇯🇵
Site JP81006, Kawasaki-shi, Japan
🇨🇳
Site CN86025, Hefei, China

and more 257 locations

A Study of Pralsetinib Versus Standard of Care for First-Line Treatment of Advanced Non-Small Cell Lung Cancer (NSCLC)

Phase 3

Active, not recruiting

Conditions: RET-fusion Non Small Cell Lung Cancer
Lung Neoplasm
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Disease
Carcinoma, Bronchogenic

Interventions: Drug: Pralsetinib
Drug: Carboplatin
Drug: Cisplatin
Drug: Pemetrexed
Drug: Pembrolizumab
Drug: Gemcitabine
Drug: Paclitaxel
Drug: Nab-Paclitaxel

First Posted Date: 2020-01-10

Last Posted Date: 2025-01-03

Lead Sponsor: Hoffmann-La Roche

Target Recruit Count: 223

Registration Number: NCT04222972

Locations: 🇦🇷
Hospital Britanico, Buenos Aires, Argentina
🇦🇺
Royal North Shore Hospital, St Leonards, New South Wales, Australia
🇧🇷
Hospital A. C. Camargo, Sao Paulo, São Paulo, Brazil

and more 64 locations

Study of Chemoradiotherapy With or Without Pembrolizumab (MK-3475) For The Treatment of Locally Advanced Cervical Cancer (MK-3475-A18/KEYNOTE-A18/ENGOT-cx11/GOG-3047)

Phase 3

Active, not recruiting

Conditions: Uterine Cervical Neoplasms

Interventions: Biological: Pembrolizumab
Drug: Placebo for pembrolizumab
Drug: Cisplatin
Radiation: External Beam Radiotherapy (EBRT)
Radiation: Brachytherapy

First Posted Date: 2020-01-09

Last Posted Date: 2024-11-26

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 980

Registration Number: NCT04221945

Locations: 🇧🇷
Hospital das Clinicas da UFMG ( Site 0172), Belo Horizonte, Minas Gerais, Brazil
🇦🇺
St John of God Subiaco Hospital ( Site 0969), Subiaco, Western Australia, Australia
🇬🇷
General Hospital of Patras. St Andrews ( Site 0473), Patras, Achaia, Greece

and more 173 locations

Pilot Study of Pembrolizumab Combined With Pemetrexed or Abemaciclib for High Grade Glioma

Early Phase 1

Withdrawn

Conditions: High Grade Glioma

Interventions: Drug: Pembrolizumab
Drug: Pemetrexed
Drug: Abemaciclib

First Posted Date: 2020-01-07

Last Posted Date: 2020-07-31

Lead Sponsor: Jose Carrillo

Registration Number: NCT04220892

Locations: 🇺🇸
John Wayne Cancer Institute, Santa Monica, California, United States

BLAST MRD AML-1: BLockade of PD-1 Added to Standard Therapy to Target Measurable Residual Disease in Acute Myeloid Leukemia 1- A Randomized Phase 2 Study of Anti-PD-1 Pembrolizumab in Combination With Intensive Chemotherapy as Frontline Therapy in Patients With Acute Myeloid Leukemia

Phase 2

Active, not recruiting

Conditions: Acute Myeloid Leukemia
Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
Acute Myeloid Leukemia Post Cytotoxic Therapy
Secondary Acute Myeloid Leukemia

Interventions: Procedure: Biospecimen Collection
Procedure: Bone Marrow Aspiration
Procedure: Bone Marrow Biopsy
Procedure: Computed Tomography
Drug: Cytarabine
Drug: Daunorubicin Hydrochloride
Procedure: Echocardiography
Procedure: Hematopoietic Cell Transplantation
Drug: Idarubicin Hydrochloride
Procedure: Multigated Acquisition Scan
Biological: Pembrolizumab
Procedure: Punch Biopsy

First Posted Date: 2020-01-02

Last Posted Date: 2024-12-04

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 50

Registration Number: NCT04214249

Locations: 🇺🇸
University of Alabama at Birmingham Cancer Center, Birmingham, Alabama, United States
🇺🇸
UC Irvine Health/Chao Family Comprehensive Cancer Center, Orange, California, United States
🇺🇸
Wake Forest Baptist Health - Wilkes Medical Center, Wilkesboro, North Carolina, United States

and more 7 locations

Testing the Addition of the Immunotherapy Drug, Pembrolizumab, to the Usual Radiation Treatment for Newly Diagnosed Early Stage High Intermediate Risk Endometrial Cancer

Phase 3

Active, not recruiting

Conditions: Stage I Uterine Corpus Cancer AJCC v8
Stage II Uterine Corpus Cancer AJCC v8
Endometrial Endometrioid Adenocarcinoma

Interventions: Procedure: Biospecimen Collection
Radiation: Brachytherapy
Procedure: Computed Tomography
Radiation: External Beam Radiation Therapy
Procedure: Magnetic Resonance Imaging
Biological: Pembrolizumab
Other: Quality-of-Life Assessment
Other: Questionnaire Administration
Procedure: X-Ray Imaging

First Posted Date: 2019-12-30

Last Posted Date: 2024-12-04

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 168

Registration Number: NCT04214067

Locations: 🇺🇸
Springfield Memorial Hospital, Springfield, Illinois, United States
🇺🇸
Marshfield Medical Center - Minocqua, Minocqua, Wisconsin, United States
🇺🇸
University of Alabama at Birmingham Cancer Center, Birmingham, Alabama, United States

and more 277 locations

Pembrolizumab in Pre Neoplastic High Grade HPV-related Vulvar and Cervical Lesions

Phase 2

Recruiting

Conditions: Cervical, Vaginal and Vulval Inflammatory Diseases

Interventions: Drug: Pembrolizumab

First Posted Date: 2019-12-26

Last Posted Date: 2021-08-27

Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Target Recruit Count: 45

Registration Number: NCT04211103

Locations: 🇮🇹
Ospedale "degli Infermi", Faenza, Italy
🇮🇹
Ospedale Santa Maria delle Croci, Ravenna, Italy
🇮🇹
Istituti fisioterapici Ospitalieri - Istituto Tumori Regina Elena, Rome, Italy

and more 6 locations

Study of Pembrolizumab (MK-3475) Versus Placebo in Participants With Esophageal Carcinoma Who Are Receiving Chemotherapy and Radiation Therapy (MK-3475-975/KEYNOTE-975)

Phase 3

Active, not recruiting

Conditions: Esophageal Squamous Cell Carcinoma (ESCC)
Gastroesophageal Junction Carcinoma (GEJC)
Esophageal Adenocarcinoma (EAC)

Interventions: Biological: pembrolizumab
Drug: placebo
Drug: cisplatin
Drug: 5-FU
Radiation: radiotherapy
Drug: leucovorin
Drug: levoleucovorin
Drug: oxaliplatin

First Posted Date: 2019-12-24

Last Posted Date: 2024-11-15

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 703

Registration Number: NCT04210115

Locations: 🇺🇸
Greater Baltimore Medical Center ( Site 0031), Baltimore, Maryland, United States
🇺🇸
Allegheny Health Network ( Site 0042), Pittsburgh, Pennsylvania, United States
🇧🇷
ONCOSITE - Centro de Pesquisa Clinica em Oncologia ( Site 0088), Ijui, Rio Grande Do Sul, Brazil

and more 167 locations

Paclitaxel, Pembrolizumab and Olaparib in Previously Treated Advanced Gastric Adenocarcinoma

Phase 2

Recruiting

Conditions: Advanced Gastric Adenocarcinoma

Interventions: Drug: Paclitaxel
Drug: Olaparib
Drug: Pembrolizumab

First Posted Date: 2019-12-24

Last Posted Date: 2024-05-31

Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Target Recruit Count: 36

Registration Number: NCT04209686

Locations: 🇺🇸
Sidney Kimmel Comprehensive Cancer Center, Baltimore, Maryland, United States

Drug Development Updates

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