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 in Combination With Lenvatinib in Pts With Recurrent, Persistent, Metastatic or Locally Advanced Vulvar Cancer Not Amenable to Curative Surgery or Radiotherapy

Phase 2

Not yet recruiting

Conditions: Recurrent Vulvar Cancer
Persistent Vulvar Cancer
Metastatic Vulva Cancer
Locally Advanced Vulvar Cancer

Interventions: Drug: Pembrolizumab
Drug: Lenvatinib

First Posted Date: 2023-06-15

Last Posted Date: 2024-08-09

Lead Sponsor: AGO Research GmbH

Target Recruit Count: 42

Registration Number: NCT05903833

Clinical Study of Ivonescimab for First-line Treatment of Metastatic NSCLC Patients

Phase 3

Recruiting

Conditions: Non-Small Cell Lung Cancer

Interventions: Biological: Ivonescimab Injection
Biological: Pembrolizumab Injection

First Posted Date: 2023-06-12

Last Posted Date: 2025-01-07

Lead Sponsor: Summit Therapeutics

Target Recruit Count: 1080

Registration Number: NCT05899608

Locations: 🇨🇦
Summit Therapeutics Research Center, Regina, Saskatchewan, Canada
🇺🇸
MD Anderson Cancer Center, Houston, Texas, United States

Naptumomab Estafenatox in Combination With Pembrolizumab Preceded by Obinutuzumab in Patients With Urothelial Cancers

Phase 1

Withdrawn

Conditions: Urothelial Carcinoma

Interventions: Drug: Naptumomab Estafenatox
Drug: Pembrolizumab
Drug: Obinutuzumab

First Posted Date: 2023-06-08

Last Posted Date: 2024-04-12

Lead Sponsor: Weill Medical College of Cornell University

Registration Number: NCT05894447

Locations: 🇺🇸
Weill Cornell Medicine/NewYork-Presbyterian Hospital, New York, New York, United States

Study of TNG260 and an Anti-PD Antibody in STK11 Mutated Solid Tumors

Phase 1

Recruiting

Conditions: Carcinoma of Unknown Primary
Solid Tumors, Adult
Pancreatic Cancer
Cervical Cancer
Breast Cancer
Non Small Cell Lung Cancer
Endometrial Cancer

Interventions: Drug: TNG260
Drug: Pembrolizumab

First Posted Date: 2023-06-02

Last Posted Date: 2024-08-13

Lead Sponsor: Tango Therapeutics, Inc.

Target Recruit Count: 126

Registration Number: NCT05887492

Locations: 🇺🇸
NEXT Oncology Virginia, Fairfax, Virginia, United States
🇺🇸
UCLA Hematology/Oncology, Santa Monica, California, United States
🇺🇸
Florida Cancer Specialists, Sarasota, Florida, United States

and more 6 locations

LK101 Combined With PD-1 or PD-L1 Monoclonal Antibody in the Treatment of Lung Cancer

Phase 1

Recruiting

Conditions: Advanced Lung Carcinoma

Interventions: Drug: LK101 injection (personlized neoantigen pulsed DC vaccine )
Drug: Durvalumab
Drug: Pembrolizumab

First Posted Date: 2023-06-02

Last Posted Date: 2023-06-02

Lead Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Target Recruit Count: 40

Registration Number: NCT05886439

Locations: 🇨🇳
Cancer hospital Chinese Academy of Medical Sciences, Beijing, Beijing, China

Randomized Study of Neo-adjuvant and Adjuvant Pembrolizumab With and Without Targeted Blood Brain Barrier Opening Using Exablate MRI-guided Focused Ultrasound (Exablate MRgFUS) for Recurrent Glioblastoma

Phase 2

Withdrawn

Conditions: Recurrent Glioblastoma

Interventions: Drug: Pembrolizumab
Device: Exablate MRgFUS + neoadjuvant pembolizumab

First Posted Date: 2023-05-30

Last Posted Date: 2024-11-20

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 10

Registration Number: NCT05879120

Locations: 🇺🇸
M D Anderson Cancer Center, Houston, Texas, United States

Study of Front Line Pembrolizumab and Valemetostat in PD-L1 Positive, HPV-Negative Recurrent/Metastatic Squamous Cell Carcinoma (SCC) of the Head and Neck: The PANTHERAS

Phase 1

Not yet recruiting

Conditions: Squamous Non-small Cell Lung Cancer
Lung Cancer
Sinonasal Cancer
Head and Neck Squamous Cell Carcinoma
Head and Neck Cancer
Head and Neck Carcnimona

Interventions: Drug: pembrolizumab
Drug: valemetostat

First Posted Date: 2023-05-30

Last Posted Date: 2025-01-10

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 47

Registration Number: NCT05879484

Locations: 🇺🇸
National Institutes of Health Clinical Center, Bethesda, Maryland, United States

Testing Experimental Anti-cancer Drug SLC-391 with an Approved Immunotherapy Drug, Pembrolizumab, for Advanced Lung Cancers

Phase 1

Recruiting

Conditions: Lung Cancer, Nonsmall Cell
Lung Cancer Stage IV
Lung Cancer Metastatic

Interventions: Drug: SLC-391
Biological: pembrolizumab

First Posted Date: 2023-05-16

Last Posted Date: 2024-11-19

Lead Sponsor: SignalChem Lifesciences Corporation

Target Recruit Count: 92

Registration Number: NCT05860296

Locations: 🇨🇦
McGill University Health Centre, Montréal, Quebec, Canada
🇺🇸
Community Health Network, Indianapolis, Indiana, United States
🇺🇸
Horizon Verdi Oncology, Lafayette, Indiana, United States

and more 10 locations

A Phase 1 Study of ZL-1218 in Subjects With Advanced Solid Tumors

Phase 1

Active, not recruiting

Conditions: Malignant Solid Tumor

Interventions: Drug: ZL-1218
Drug: Pembrolizumab

First Posted Date: 2023-05-16

Last Posted Date: 2024-10-22

Lead Sponsor: Zai Lab (Hong Kong), Ltd.

Target Recruit Count: 60

Registration Number: NCT05859464

Locations: 🇺🇸
Zai Lab Site 2005, Irvine, California, United States
🇺🇸
Zai Lab Site 2007, Detroit, Michigan, United States
🇺🇸
Zai Lab Site 2001, Hackensack, New Jersey, United States

and more 12 locations

A Study of MQ710 With and Without Pembrolizumab in People With Solid Tumor Cancer

Phase 1

Active, not recruiting

Conditions: Cutaneous Squamous Cell Carcinoma
Basal Cell Carcinoma
BCC - Basal Cell Carcinoma
Melanoma
Merkel Cell Carcinoma
Metastatic Cancer
Refractory Cancer
BCC
Extramammary Paget Disease
Adnexal Carcinoma

Interventions: Biological: MQ719
Drug: Pembrolizumab

First Posted Date: 2023-05-15

Last Posted Date: 2024-07-25

Lead Sponsor: Memorial Sloan Kettering Cancer Center

Target Recruit Count: 5

Registration Number: NCT05859074

Locations: 🇺🇸
Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities), Commack, New York, United States
🇺🇸
Memorial Sloan Kettering Monmouth (Limited protocol activities), Middletown, New Jersey, United States
🇺🇸
Memorial Sloan Kettering Westchester (Limited Protocol Activities), Harrison, New York, United States

and more 4 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