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

A Study of (Neo)Adjuvant V940 and Pembrolizumab in Cutaneous Squamous Cell Carcinoma (V940-007).

Phase 2

Recruiting

Conditions: Carcinoma, Squamous Cell
Skin Neoplasms

Interventions: Procedure: Surgery
Biological: Pembrolizumab
Biological: V940

First Posted Date: 2024-03-06

Last Posted Date: 2024-12-30

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 1012

Registration Number: NCT06295809

Locations: 🇺🇸
Hoag Memorial Hospital Presbyterian ( Site 1122), Newport Beach, California, United States
🇧🇷
Clinica Amo - Rio Vermelho-INSTITUTO ETICA ( Site 1315), Salvador, Bahia, Brazil
🇧🇷
Fundação Faculdade Regional de Medicina de São José do Rio Preto-Centro Integrado de Pesquisa ( Site, São José do Rio Preto, Sao Paulo, Brazil

and more 102 locations

Efficacy and Safety of Zanidatamab With Standard-of-care Therapy Against Standard-of-care Therapy for Advanced HER2-positive Biliary Tract Cancer

Phase 3

Recruiting

Conditions: Biliary Tract Cancer
HER2 Gene Mutation

Interventions: Drug: Cisplatin
Drug: Zanidatamab
Drug: Gemcitabine
Drug: Pembrolizumab
Drug: Durvalumab

First Posted Date: 2024-02-28

Last Posted Date: 2024-12-05

Lead Sponsor: Jazz Pharmaceuticals

Target Recruit Count: 286

Registration Number: NCT06282575

Locations: 🇺🇸
The University of Kansas Cancer Center - Westwood, Westwood, Kansas, United States
🇺🇸
Atlantic Health System/Morristown Medical Center, Morristown, New Jersey, United States
🇺🇸
Laura and Isaac Perlmutter Cancer Center at NYU Langone - Ambulatory Care Center, New York, New York, United States

and more 101 locations

A Phase 1 Study of PLN-101095 in Adults With Advanced or Metastatic Solid Tumors

Phase 1

Recruiting

Conditions: Metastatic Solid Tumor

Interventions: Drug: PLN-101095
Drug: Pembrolizumab

First Posted Date: 2024-02-21

Last Posted Date: 2024-06-12

Lead Sponsor: Pliant Therapeutics, Inc.

Target Recruit Count: 77

Registration Number: NCT06270706

Locations: 🇺🇸
South Texas Accelerated Research Therapeutics (START), Grand Rapids, Michigan, United States
🇺🇸
NEXT Virginia, Fairfax, Virginia, United States
🇺🇸
University of Texas MD Anderson Cancer Center, Houston, Texas, United States

and more 2 locations

Study of Pembrolizumab and Lenvatinib in Metastatic and Recurrent Cervix Cancer (LenPem Cervix)

Phase 2

Recruiting

Conditions: Cervix Cancer
Cervical Cancer

Interventions: Drug: Pembrolizumab
Drug: Lenvatinib

First Posted Date: 2024-02-20

Last Posted Date: 2024-03-13

Lead Sponsor: University of Texas Southwestern Medical Center

Target Recruit Count: 30

Registration Number: NCT06266338

Locations: 🇺🇸
UT Southwestern Medical Center, Dallas, Texas, United States

VO and Nivolumab vs Physician's Choice in Advanced Melanoma That Progressed on Anti-PD-1 & Anti-CTLA-4 Drugs (IGNYTE-3)

Phase 3

Recruiting

Conditions: Advanced Melanoma

Interventions: Biological: Vusolimogene Oderparepvec
Biological: Nivolumab + Relatlimab
Biological: Nivolumab
Biological: Pembrolizumab
Drug: Single-agent chemotherapy

First Posted Date: 2024-02-16

Last Posted Date: 2024-12-24

Lead Sponsor: Replimune Inc.

Target Recruit Count: 400

Registration Number: NCT06264180

Locations: 🇺🇸
UC San Diego Moores Cancer Center, La Jolla, California, United States
🇺🇸
The Angeles Clinic and Research Institute, Los Angeles, California, United States
🇺🇸
USC Norris Comprehensive Cancer Center, Los Angeles, California, United States

and more 17 locations

Pembrolizumab, Lenvatinib and IL-15 Superagonist N-803 in Combination With HER2 Targeting Autologous Dendritic Cell (AdHER2DC) Vaccine in Participants With Advanced or Metastatic Endometrial Cancer

Phase 1

Suspended

Conditions: Endometrial Cancer
Cancer of Endometrium
Carcinoma of Endometrium
Endometrial Carcinoma

Interventions: Biological: AdHER2DC vaccine
Biological: Pembrolizumab
Drug: Lenvatinib
Biological: N-803
Device: PATHWAY HER2 (4B5) assay

First Posted Date: 2024-02-12

Last Posted Date: 2025-01-10

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 60

Registration Number: NCT06253494

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

Efficacy and Safety of Combination Therapy With Bojungikki-tang and Pembrolizumab Monotherapy in Patients With Advanced Non-small Cell Lung Cancer

Phase 2

Recruiting

Conditions: Non-small Cell Lung Cancer

Interventions: Drug: Bojungikki-tang(BJIKT)
Drug: Pembrolizumab

First Posted Date: 2024-02-08

Last Posted Date: 2024-10-01

Lead Sponsor: Korea Institute of Oriental Medicine

Target Recruit Count: 70

Registration Number: NCT06249854

Locations: 🇰🇷
The catholic university of Korea Seoul Saint. Mary's hospital, Seoul, Korea, Republic of
🇰🇷
Hallym University Medical Center, Anyang-si, Gyeonggi-do, Korea, Republic of
🇰🇷
Pusan National University Yangsan Hospital, Yangsan, Gyeongsangnam-do, Korea, Republic of

and more 4 locations

PET Dynamics to Response-Adapted Neoadjuvant Therapy in TNBC

Phase 2

Recruiting

Conditions: Triple Negative Breast Cancer

Interventions: Drug: Paclitaxel
Drug: Carboplatin
Drug: Pembrolizumab
Drug: Doxorubicin
Drug: Cyclophosphamide
Drug: Olaparib
Drug: Capecitabine

First Posted Date: 2024-02-07

Last Posted Date: 2024-05-08

Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Target Recruit Count: 30

Registration Number: NCT06245889

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

A Phase 2 Study of EIK1001 in Combo With Pembrolizumab and Chemotherapy in Patients With Stage 4 NSCLC

Phase 2

Recruiting

Conditions: NSCLC

Interventions: Drug: EIK1001
Drug: Pembrolizumab
Drug: Paclitaxel
Drug: Pemetrexed
Drug: Carboplatin

First Posted Date: 2024-02-07

Last Posted Date: 2024-11-21

Lead Sponsor: Eikon Therapeutics

Target Recruit Count: 70

Registration Number: NCT06246110

Locations: 🇺🇸
Tennessee Cancer Specialists, Knoxville, Tennessee, United States
🇺🇸
Southern Cancer Care, Daphne, Alabama, United States
🇺🇸
Ironwood Cancer and Research Center, Chandler, Arizona, United States

and more 31 locations

A Study of Pembrolizumab and Cryoablation in People with Breast Cancer

Phase 1

Recruiting

Conditions: Triple Negative Breast Cancer
Metastatic Triple-Negative Breast Carcinoma
Locally Advanced Triple-Negative Breast Carcinoma
Breast Cancer
Metastatic Breast Cancer
Breast Cancer Stage IV
Locally Advanced Breast Cancer
Triple Negative Breast Neoplasms

Interventions: Drug: Pembrolizumab
Device: Cryoablation

First Posted Date: 2024-02-07

Last Posted Date: 2024-10-02

Lead Sponsor: Memorial Sloan Kettering Cancer Center

Target Recruit Count: 30

Registration Number: NCT06246968

Locations: 🇺🇸
Memorial Sloan Kettering Cancer Center at Basking Ridge (Limited Protocol Activities), Basking Ridge, New Jersey, United States
🇺🇸
Memorial Sloan Kettering Bergen (Limited Protocol Activities), Montvale, New Jersey, United States
🇺🇸
Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities ), Commack, New York, United States

and more 4 locations

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