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

Pembrolizumab and Tazemetostat to Overcome Immune Tolerance Following ASCT or CAR T-cell Therapy in Patients With Aggressive B-Cell Non-Hodgkin's Lymphoma

Phase 2

Recruiting

Conditions: B-Cell Non-Hodgkin Lymphoma

Interventions: Procedure: Biospecimen Collection
Procedure: Computed Tomography
Procedure: Echocardiography
Biological: Pembrolizumab
Procedure: Positron Emission Tomography
Drug: Tazemetostat

First Posted Date: 2024-02-05

Last Posted Date: 2024-10-08

Lead Sponsor: Northwestern University

Target Recruit Count: 32

Registration Number: NCT06242834

Locations: 🇺🇸
Northwestern University, Chicago, Illinois, United States

TBio-4101 and Pembro wi/ or w/o Chemo in Recurrent/Metastatic HNSCC

Phase 1

Recruiting

Conditions: Squamous Cell Carcinoma of Head and Neck
Metastatic Squamous Cell Carcinoma

Interventions: Biological: TBio-4101
Drug: Pembrolizumab
Drug: Platinum based chemotherapy
Drug: Cyclophosphamide
Drug: Fludarabine
Drug: Aldesleukin

First Posted Date: 2024-02-01

Last Posted Date: 2024-11-29

Lead Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Target Recruit Count: 15

Registration Number: NCT06236425

Locations: 🇺🇸
Moffitt Cancer Center, Tampa, Florida, United States

Study to Evaluate Adverse Events, Optimal Dose, and Change in Disease Activity, With Livmoniplimab in Combination With Budigalimab Plus Chemotherapy Versus IV Infused Pembrolizumab Plus Chemotherapy in Adult Participants With Untreated Metastatic Non-Squamous Non-Small Cell Lung Cancer (NSCLC)

Phase 2

Recruiting

Conditions: Non-Small Cell Lung Cancer

Interventions: Drug: Livmoniplimab
Drug: Pembrolizumab
Drug: Pemetrexed
Drug: Budigalimab
Drug: Cisplatin
Drug: Carboplatin

First Posted Date: 2024-02-01

Last Posted Date: 2024-12-24

Lead Sponsor: AbbVie

Target Recruit Count: 840

Registration Number: NCT06236438

Locations: 🇺🇸
Memorial Hospital West /ID# 262221, Pembroke Pines, Florida, United States
🇺🇸
Bond Clinic /ID# 262611, Winter Haven, Florida, United States
🇺🇸
University Cancer & Blood Cent /ID# 261824, Athens, Georgia, United States

and more 26 locations

Dose Escalation and Expansion Study of BH3120 in Advanced or Metastatic Solid Tumors

Phase 1

Recruiting

Conditions: Advanced or Metastatic Solid Tumors

Interventions: Drug: BH3120
Drug: pembrolizumab

First Posted Date: 2024-01-31

Last Posted Date: 2024-02-02

Lead Sponsor: Hanmi Pharmaceutical Company Limited

Target Recruit Count: 191

Registration Number: NCT06234397

Locations: 🇺🇸
Carl & Edyth Lindner Center for Research & Education at The Christ Hospital and The Christ Hospital Cancer Center, Cincinnati, Ohio, United States
🇺🇸
Mary Crowley Cancer Research, Dallas, Texas, United States
🇺🇸
Mays Cancer Center at University of Texas Health San Antonio MD Anderson Cencer Center, San Antonio, Texas, United States

and more 5 locations

Study BT8009-230 in Participants With Locally Advanced or Metastatic Urothelial Cancer (Duravelo-2)

Phase 2

Recruiting

Conditions: Metastatic Urothelial Cancer

Interventions: Drug: BT8009
Drug: Gemcitabine + cisplatin Or carboplatin
Drug: Pembrolizumab
Drug: Avelumab

First Posted Date: 2024-01-26

Last Posted Date: 2025-01-08

Lead Sponsor: BicycleTx Limited

Target Recruit Count: 956

Registration Number: NCT06225596

Locations: 🇺🇸
University of Arkansas for Medical Sciences, Little Rock, Arkansas, United States
🇺🇸
Virginia K. Crosson Cancer Center at St. Jude Medical Center, Fullerton, California, United States
🇺🇸
University of California - Irvine Medical Center, Orange, California, United States

and more 147 locations

Targeting ODC as an Immunotherapeutic Target in STK11 (LKB1) Pathway-Deficient NSCLC (DFMO)

Phase 1

Recruiting

Conditions: Lung Cancer
Non Small Cell Lung Cancer

Interventions: Drug: Pembrolizumab
Drug: Difluoromethylornithine

First Posted Date: 2024-01-23

Last Posted Date: 2024-12-06

Lead Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Target Recruit Count: 45

Registration Number: NCT06219174

Locations: 🇺🇸
Moffitt Cancer Center, Tampa, Florida, United States

LUNAR-2: TTFields With Pembrolizumab + Platinum-based Chemotherapy for Metastatic NSCLC

Phase 3

Recruiting

Conditions: Metastatic Non-small Cell Lung Cancer

Interventions: Device: NovoTTF-200T
Drug: Pembrolizumab
Drug: Platinum based chemotherapy

First Posted Date: 2024-01-22

Last Posted Date: 2024-11-22

Lead Sponsor: NovoCure GmbH

Target Recruit Count: 734

Registration Number: NCT06216301

Locations: 🇺🇸
St. Jude Herritage Medical Group, Fullerton, California, United States
🇺🇸
Edward Cancer Center, Naperville, Illinois, United States
🇪🇸
Hospital Universitario Arnau de Vilanova, Lleida, Spain

and more 27 locations

Allogeneic Gammadelta T Cells Combined With Interferon-α1b or PD-1 Monoclonal Antibody in Stage III-IV Amenable to Surgical Resection Melanoma

Early Phase 1

Not yet recruiting

Conditions: Melanoma

Interventions: Biological: Ex-vivo expanded allogeneic γδ T cells
Drug: Recombinant human interferon α1b
Drug: Pembrolizumab

First Posted Date: 2024-01-18

Last Posted Date: 2024-01-25

Lead Sponsor: Xijing Hospital

Target Recruit Count: 10

Registration Number: NCT06212388

BI-1910 as a Single Agent and in Combination With Pembrolizumab for the Treatment of Advanced Solid Tumors

Phase 1

Recruiting

Conditions: Solid Tumors
Non Small Cell Lung Cancer
Hepatocellular Carcinoma

Interventions: Drug: BI-1910
Drug: Pembrolizumab

First Posted Date: 2024-01-16

Last Posted Date: 2024-07-23

Lead Sponsor: BioInvent International AB

Target Recruit Count: 104

Registration Number: NCT06205706

Locations: 🇵🇱
Uniwersytecki Szpital Kliniczny, Poznań, Poland
🇵🇱
Instytut Centrum Zdrowia Matki Polki, Łódź, Poland
🇪🇸
Hospital Fundacion Jimenez Diaz, Madrid, Spain

and more 9 locations

Drug Screening Using IMD in Bladder Cancer

Early Phase 1

Not yet recruiting

Conditions: Muscle Invasive Bladder Urothelial Carcinoma

Interventions: Device: Implantable Micro-Device
Drug: Methotrexate
Drug: Carboplatin
Drug: Avelumab
Drug: Paclitaxel
Drug: Vinblastine
Drug: Gemcitabine/Cisplatin I
Drug: Methotrexate/Vinblastine/Doxorubicin/Cisplatin/Avelumab
Drug: Gemcitabine/Cisplatin II
Drug: Cisplatin
Drug: Nivolumab
Drug: Pembrolizumab
Drug: Gemcitabine/Carboplatin
Drug: Methotrexate/Vinblastine/Doxorubicin/Cisplatin
Drug: Gemcitabine/Cisplatin/Nivolumab
Drug: Erdafitinib
Drug: Paclitaxel/Docetaxel/Ifosfamide
Drug: Gemcitabine
Drug: Gemcitabine/Carboplatin/Nivolumab
Drug: Enfortumab
Drug: Sacituzumab

First Posted Date: 2024-01-12

Last Posted Date: 2024-01-12

Lead Sponsor: Brigham and Women's Hospital

Target Recruit Count: 18

Registration Number: NCT06204614

Locations: 🇺🇸
Brigham and Women's Hospital, Boston, Massachusetts, United States

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