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

Neoadjuvant PD-1 Blockade in Resectable Merkel Cell Carcinoma

Phase 2

Recruiting

Conditions: Merkel Cell Carcinoma

Interventions: Drug: Pembrolizumab

First Posted Date: 2022-08-10

Last Posted Date: 2024-12-27

Lead Sponsor: Abramson Cancer Center at Penn Medicine

Target Recruit Count: 15

Registration Number: NCT05496036

Locations: 🇺🇸
Penn Medicine, Philadelphia, Pennsylvania, United States

Pembrolizumab, Belantamab and Dexamethasone in Refractory Multiple Myeloma.

Phase 1

Withdrawn

Conditions: Multiple Myeloma, Refractory

Interventions: Drug: Pembrolizumab
Drug: Belantamab mafodotin
Drug: Dexamethasone

First Posted Date: 2022-08-09

Last Posted Date: 2023-01-27

Lead Sponsor: Hackensack Meridian Health

Registration Number: NCT05493618

Locations: 🇺🇸
Lombardi Comprehensive Cancer Center, Georgetown University, Washington, District of Columbia, United States
🇺🇸
Jersey Shore Medical Center, Neptune, New Jersey, United States
🇺🇸
John Theurer Cancer Center, Hackensack Meridian Health, Hackensack, New Jersey, United States

Reinvigorating TNBC Response to Immunotherapy With Combination Myeloid Inhibition and Radiation

Phase 2

Recruiting

Conditions: Breast Cancer
TNBC - Triple-Negative Breast Cancer

Interventions: Drug: Pembrolizumab
Radiation: Radiation Therapy
Drug: Axatilimab

First Posted Date: 2022-08-08

Last Posted Date: 2024-03-25

Lead Sponsor: Stephen Shiao

Target Recruit Count: 35

Registration Number: NCT05491226

Locations: 🇺🇸
Cedars-Sinai Medical Center, Los Angeles, California, United States

A Safety and Antitumor Activity Trial of Immunoradiotherapy Combinations as a Treatment Option for Subjects With Metastatic Solid Tumors

Phase 1

Active, not recruiting

Conditions: Non-CNS Tumor

Interventions: Biological: GEN1042
Radiation: Radiotherapy
Drug: Pembrolizumab

First Posted Date: 2022-08-08

Last Posted Date: 2025-01-07

Lead Sponsor: Genmab

Target Recruit Count: 88

Registration Number: NCT05491317

Locations: 🇫🇷
Institut Bergonie, Bordeaux, France
🇫🇷
Centre Leon Berard, Lyon, France
🇫🇷
Institut Gustave Roussy, Villejuif, France

START: Safety and Anti-Tumor Activity of PeptiCRAd-1 in Treatment of Cancer

Phase 1

Recruiting

Conditions: Melanoma (Skin)
Triple-Negative Breast Cancer
Non-Small Cell Lung Cancer
Synovial Sarcoma
Myxoid Liposarcoma
Colorectal Cancer
Osteosarcoma
Sarcoma

Interventions: Drug: PeptiCRAd-1
Drug: Cyclophosphamide
Drug: Pembrolizumab

First Posted Date: 2022-08-08

Last Posted Date: 2024-12-27

Lead Sponsor: Valo Therapeutics Oy

Target Recruit Count: 15

Registration Number: NCT05492682

Locations: 🇩🇪
Krankenhaus Nordwest, Frankfurt, Germany
🇩🇪
National Center for Tumor Diseases, Heidelberg, Germany
🇩🇪
Universitätsklinikum Tübingen, Tübingen, Germany

Immunotherapy Combined With Radiotherapy for Metastatic Sarcoma

Early Phase 1

Recruiting

Conditions: Sarcoma, Soft Tissue

Interventions: Drug: Pembrolizumab
Radiation: Radiation therapy

First Posted Date: 2022-08-04

Last Posted Date: 2024-08-09

Lead Sponsor: University of California, Irvine

Target Recruit Count: 12

Registration Number: NCT05488366

Locations: 🇺🇸
Chao Family Comprehensive Cancer Center, University of California, Irvine, Orange, California, United States

Novel Neoadjuvant and Adjuvant Strategy for Germline BRCA 1/2 Mutated Triple Negative Breast Cancer

Phase 2

Recruiting

Conditions: Triple Negative Breast Neoplasms
Triple Negative Breast Cancer
Breast Neoplasms
Breast Cancer
BRCA1 Mutation
BRCA2 Mutation
BRCA Mutation
BRCA-Associated Breast Carcinoma

Interventions: Drug: Pembrolizumab
Drug: Paclitaxel
Drug: Carboplatin
Drug: Olaparib
Procedure: Definitive Surgery

First Posted Date: 2022-08-03

Last Posted Date: 2024-02-13

Lead Sponsor: Okayama University

Target Recruit Count: 23

Registration Number: NCT05485766

Locations: 🇯🇵
St. Luke's International Hospital, Tokyo, Japan
🇯🇵
Aichi Cancer Center, Nagoya, Japan
🇯🇵
Okayama University Hospital, Okayama, Japan

Study of Vorasidenib and Pembrolizumab Combination in Recurrent or Progressive IDH-1 Mutant Glioma

Phase 1

Recruiting

Conditions: Astrocytoma

Interventions: Drug: Vorasidenib
Drug: Pembrolizumab

First Posted Date: 2022-08-02

Last Posted Date: 2024-11-25

Lead Sponsor: Institut de Recherches Internationales Servier

Target Recruit Count: 72

Registration Number: NCT05484622

Locations: 🇺🇸
Northwestern University (Site: 840123), Chicago, Illinois, United States
🇺🇸
University of Alabama at Birmingham, Birmingham, Alabama, United States
🇺🇸
Mayo Clinic Florida, Cleveland, Ohio, United States

and more 13 locations

Dose Escalation and Expansion Study of WTX-124 As Monotherapy and in Combination with Pembrolizumab (pembro) in Patients with Selected Advanced or Metastatic Solid Tumors

Phase 1

Recruiting

Conditions: Metastatic Solid Tumor
Advanced Solid Tumor

Interventions: Drug: WTX-124
Drug: pembrolizumab

First Posted Date: 2022-07-29

Last Posted Date: 2024-12-27

Lead Sponsor: Werewolf Therapeutics, Inc.

Target Recruit Count: 150

Registration Number: NCT05479812

Locations: 🇺🇸
HonorHealth, Scottsdale, Arizona, United States
🇺🇸
Emory Winship Cancer Institute, Atlanta, Georgia, United States
🇺🇸
Northwestern University, Chicago, Illinois, United States

and more 5 locations

A Study to Investigate the Safety, Tolerability, and Preliminary Anti-tumor Activity of Bemcentinib in Combination With Pembrolizumab Plus Pemetrexed and Carboplatin in Adult Participants With Untreated Non-squamous Non-small Cell Lung Cancer

Phase 1

Recruiting

Conditions: Carcinoma, Non-Small-Cell Lung

Interventions: Drug: Bemcentinib
Drug: Pembrolizumab
Drug: Pemetrexed
Drug: Carboplatin

First Posted Date: 2022-07-21

Last Posted Date: 2023-10-10

Lead Sponsor: BerGenBio ASA

Target Recruit Count: 64

Registration Number: NCT05469178

Locations: 🇺🇸
Tennessee Oncology PLLC, Nashville, Tennessee, United States
🇺🇸
Mount Sinai Comprehensive Cancer Center, Miami Beach, Florida, United States
🇺🇸
Marlene and Stewart Greenebaum Comprehensive Cancer Center, University of Maryland, Baltimore, Maryland, United States

and more 2 locations

Drug Development Updates

Stay informed with timely notifications on clinical trials, regulatory changes, and research advancements related to this medication.

Home Terms & Conditions Privacy Policy