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 and Olaparib in Bile Duct Cancer

Phase 2

Active, not recruiting

Conditions: Cholangiocarcinoma

Interventions: Drug: Pembrolizumab
Drug: Olaparib

First Posted Date: 2020-03-12

Last Posted Date: 2024-12-17

Lead Sponsor: Georgetown University

Target Recruit Count: 14

Registration Number: NCT04306367

Locations: 🇺🇸
Lombardi Comprehensive Cancer Center, Georgetown University, Washington, District of Columbia, United States

Substudy 02B: Safety and Efficacy of Pembrolizumab in Combination With Investigational Agents or Pembrolizumab Alone in Participants With First Line (1L) Advanced Melanoma (MK-3475-02B/KEYMAKER-U02)

Phase 1

Recruiting

Conditions: Melanoma

Interventions: Biological: Pembrolizumab
Biological: Favezelimab/Pembrolizumab
Drug: ATRA
Biological: Pembrolizumab/Quavonlimab
Biological: Vibostolimab
Drug: Lenvatinib

First Posted Date: 2020-03-12

Last Posted Date: 2024-12-27

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 315

Registration Number: NCT04305054

Locations: 🇺🇸
University of Colorado, Anschutz Cancer Pavilion ( Site 2012), Aurora, Colorado, United States
🇺🇸
The Angeles Clinic and Research Institute ( Site 2009), Los Angeles, California, United States
🇺🇸
UCLA Hematology & Oncology ( Site 2004), Los Angeles, California, United States

and more 57 locations

Substudy 02C: Safety and Efficacy of Pembrolizumab in Combination With Investigational Agents or Pembrolizumab Alone in Participants With Stage III Melanoma Who Are Candidates for Neoadjuvant Therapy (MK-3475-02C/KEYMAKER-U02)

Phase 1

Active, not recruiting

Conditions: Melanoma

Interventions: Biological: Pembrolizumab
Biological: Favezelimab + Pembrolizumab
Biological: Vibostolimab
Drug: ATRA
Biological: Gebasaxturev
Biological: MK-4830

First Posted Date: 2020-03-10

Last Posted Date: 2024-11-19

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 90

Registration Number: NCT04303169

Locations: 🇮🇹
Istituto Europeo di Oncologia ( Site 3301), Milano, Italy
🇮🇹
Policlinico Le Scotte - A.O. Senese ( Site 3377), Siena, Italy
🇺🇸
The Angeles Clinic and Research Institute ( Site 3009), Los Angeles, California, United States

and more 26 locations

Study of Pembrolizumab and Single Agent Chemotherapy as First Line Treatment for Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer With Eastern Cooperative Oncology Group (ECOG) Performance Status of 2

Phase 1

Recruiting

Conditions: Non-small Cell Lung Cancer

Interventions: Drug: Pembrolizumab
Other: Pemetrexed (Chemotherapy)
Other: Nab-paclitaxel (Chemotherapy)

First Posted Date: 2020-03-05

Last Posted Date: 2024-05-10

Lead Sponsor: University of Rochester

Target Recruit Count: 28

Registration Number: NCT04297605

Locations: 🇺🇸
University of Rochester, Rochester, New York, United States

Safety Study of BJ-001, an IL-15 Fusion Protein, for Locally Advanced/Metastatic Solid Tumors

Phase 1

Active, not recruiting

Conditions: Locally Advanced/Metastatic Solid Tumors

Interventions: Drug: BJ-001
Drug: Pembrolizumab

First Posted Date: 2020-03-04

Last Posted Date: 2023-11-09

Lead Sponsor: BJ Bioscience, Inc.

Target Recruit Count: 92

Registration Number: NCT04294576

Locations: 🇺🇸
Northwest Medical Specialities, Tacoma, Washington, United States
🇺🇸
Greenville Hospital System University Medical Center (ITOR), Greenville, South Carolina, United States
🇺🇸
Mount Sinai, New York, New York, United States

and more 2 locations

Pembrolizumab Plus Lenvatinib In Second Line and Third Line Malignant Pleural mesotheLioma Patients

Phase 2

Active, not recruiting

Conditions: Mesotheliomas Pleural

Interventions: Drug: Pembrolizumab
Drug: Lenvatinib

First Posted Date: 2020-02-27

Last Posted Date: 2024-11-05

Lead Sponsor: The Netherlands Cancer Institute

Target Recruit Count: 58

Registration Number: NCT04287829

Locations: 🇳🇱
Antoni van Leeuwenhoekziekenhuis (NKI-AVL), Amsterdam, Noord-Holland, Netherlands

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

Phase 2

Active, not recruiting

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

Interventions: Drug: Azacitidine
Procedure: Biopsy
Procedure: Biospecimen Collection
Procedure: Bone Marrow Aspiration
Procedure: Bone Marrow Biopsy
Procedure: Echocardiography
Procedure: Multigated Acquisition Scan
Drug: Venetoclax
Biological: Pembrolizumab

First Posted Date: 2020-02-26

Last Posted Date: 2024-12-27

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 76

Registration Number: NCT04284787

Locations: 🇺🇸
The University of Kansas Cancer Center - Olathe, Olathe, Kansas, United States
🇺🇸
Smilow Cancer Hospital Care Center at Greenwich, Greenwich, Connecticut, United States
🇺🇸
Smilow Cancer Hospital Care Center at Saint Francis, Hartford, Connecticut, United States

and more 26 locations

A Phase Ib Combination Study of Rituximab, TinostamustinEAnd CHeckpoint Inhibition With Pembrolizumab in Relapsed/Refractory DLBCL

Phase 1

Withdrawn

Conditions: Relapsed or Refractory Diffuse Large B-cell Lymphoma

Interventions: Drug: Tinostamustinein
Drug: Pembrolizumab
Drug: Rituximab

First Posted Date: 2020-02-21

Last Posted Date: 2020-02-21

Lead Sponsor: Royal Marsden NHS Foundation Trust

Registration Number: NCT04279938

Locations: 🇬🇧
The Royal Marsden NHS Foundation Trust, Sutton, Surrey, United Kingdom

A Safety Study of Oral Venetoclax in Combination With Intravenous Pembrolizumab in Adult Participants With Previously Untreated Non-Small Cell Lung Cancer (NSCLC) With High Programmed Cell Death Ligand-1 (PD-L1) Expression

Phase 1

Terminated

Conditions: Non Small Cell Lung Cancer
Cancer

Interventions: Drug: Venetoclax
Drug: Pembrolizumab

First Posted Date: 2020-02-18

Last Posted Date: 2021-02-11

Lead Sponsor: AbbVie

Target Recruit Count: 2

Registration Number: NCT04274907

Locations: 🇺🇸
Arizona Oncology Associates, PC-HOPE (Rudasill) /ID# 216984, Tucson, Arizona, United States
🇺🇸
St Jude Hospital dba St Joseph /ID# 212360, Santa Rosa, California, United States
🇺🇸
Icri /Id# 217071, Whittier, California, United States

and more 36 locations

Pembrolizumab in MarginalzoneLymphoma a MULTICENTER OPEN LABEL SINGLE-ARM PHASE II STUDY

Not Applicable

Terminated

Conditions: Marginal Zone Lymphoma

Interventions: Drug: Rituximab
Drug: Pembrolizumab

First Posted Date: 2020-02-13

Last Posted Date: 2024-12-27

Lead Sponsor: University of Ulm

Target Recruit Count: 22

Registration Number: NCT04268277

Locations: 🇩🇪
Universitätsklinikum Ulm; Klinik für Innere Medizin Innere Medizin III, Ulm, Baden- Württemberg, Germany
🇩🇪
Charité Universitätsmedizin Berlin; Hämatologie - Onkologie - Tumorimmunologie, Berlin, Germany
🇩🇪
Klinikum Chemnitz gGmbH, Klinik für Innere Medizin III, Chemnitz, Germany

and more 9 locations

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