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

To Access the Safety and Effects of Intravenous Administration of AMX-818 Alone and in Combination With Pembrolizumab in Adult Participants With Locally Advanced or Metastatic HER2-Expressing Cancers

Phase 1

Recruiting

Conditions: Locally Advanced or Metastatic HER2-Expressing Cancers

Interventions: Drug: AMX-818
Drug: pembrolizumab

First Posted Date: 2022-05-02

Last Posted Date: 2024-06-07

Lead Sponsor: Amunix, a Sanofi Company

Target Recruit Count: 645

Registration Number: NCT05356741

Locations: 🇵🇹
Investigational site number #200, Porto, Portugal
🇫🇷
Investigational site number #150, Toulouse, France
🇪🇸
Investigational site number #253, Pozuelo de Alarcón, Spain

and more 7 locations

Clinical Study of Fianlimab in Combination With Cemiplimab Versus Pembrolizumab in Adolescent and Adult Patients With Previously Untreated Unresectable Locally Advanced or Metastatic Melanoma

Phase 3

Recruiting

Conditions: Melanoma

Interventions: Drug: Fianlimab
Drug: Pembrolizumab
Drug: Cemiplimab
Drug: Placebo

First Posted Date: 2022-04-29

Last Posted Date: 2024-10-30

Lead Sponsor: Regeneron Pharmaceuticals

Target Recruit Count: 1535

Registration Number: NCT05352672

Locations: 🇺🇸
Atlantic Health System - Morristown Medical Center, Morristown, New Jersey, United States
🇦🇷
Fundacion Cenit para la Investigacion en Neurociencias, Buenos Aires, Argentina
🇦🇷
DIABAID - Instituto de Asistencia Integral en Diabetes, Buenos Aires, Argentina

and more 216 locations

Testing of Tazemetostat in Combination With Topotecan and Pembrolizumab in Patients With Recurrent Small Cell Lung Cancer

Phase 1

Suspended

Conditions: Platinum-Resistant Lung Small Cell Carcinoma
Limited Stage Lung Small Cell Carcinoma
Extensive Stage Lung Small Cell Carcinoma
Platinum-Sensitive Lung Small Cell Carcinoma
Recurrent Lung Small Cell Carcinoma

Interventions: Procedure: Biopsy
Procedure: Biospecimen Collection
Procedure: Computed Tomography
Biological: Pembrolizumab
Drug: Tazemetostat Hydrobromide
Drug: Topotecan Hydrochloride

First Posted Date: 2022-04-29

Last Posted Date: 2024-12-04

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 60

Registration Number: NCT05353439

Locations: 🇺🇸
Los Angeles General Medical Center, Los Angeles, California, United States
🇺🇸
USC Norris Oncology/Hematology-Newport Beach, Newport Beach, California, United States
🇺🇸
Northwestern University, Chicago, Illinois, United States

and more 10 locations

Personalized TCR-T: Study of Adoptively Transferred T-cell Receptor Gene-engineered T Cells (TCR-T)

Phase 1

Active, not recruiting

Conditions: Malignant Epithelial Neoplasms

Interventions: Biological: TCR-transduced T cells
Drug: CDX-1140
Drug: Pembrolizumab

First Posted Date: 2022-04-27

Last Posted Date: 2024-11-25

Lead Sponsor: Providence Health & Services

Target Recruit Count: 1

Registration Number: NCT05349890

Locations: 🇺🇸
Providence Portland Medical Center, Portland, Oregon, United States

A Study of Combination Therapies With or Without Pembrolizumab (MK-3475) and/or Chemotherapy in Participants With Advanced Esophageal Cancer (MK-3475-06A)

Phase 1

Active, not recruiting

Conditions: Esophageal Squamous Cell Carcinoma (ESCC)

Interventions: Biological: Pembrolizumab
Biological: Coformulation favezelimab/pembrolizumab
Biological: MK-4830
Drug: Irinotecan
Drug: Paclitaxel
Drug: Lenvatinib

First Posted Date: 2022-04-22

Last Posted Date: 2024-12-02

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 120

Registration Number: NCT05342636

Locations: 🇧🇷
ICESP - INSTITUTO DO CÂNCER DO ESTADO DE SÃO PAULO ( Site 2300), São Paulo, Sao Paulo, Brazil
🇫🇷
Hopital Claude Huriez - CHU de Lille ( Site 1100), Lille, Nord, France
🇫🇷
Centre Hospitalier Régional Universitaire de Brest - Hôpital Morvan ( Site 1104), Brest, Finistere, France

and more 43 locations

Pembrolizumab and Disitamab Vedotin in HER2-expressing Metastatic Colorectal Cancer

Phase 2

Not yet recruiting

Conditions: Colorectal Neoplasms

Interventions: Drug: Pembrolizumab
Drug: Disitamab vedotin

First Posted Date: 2022-04-19

Last Posted Date: 2022-04-20

Lead Sponsor: Shanghai Zhongshan Hospital

Target Recruit Count: 30

Registration Number: NCT05333809

A Study in Patients With Advanced Cancers

Phase 1

Recruiting

Conditions: Advanced Cancer
Advanced Solid Tumor
Oncology
Cancer

Interventions: Drug: BIO-106
Drug: Pembrolizumab

First Posted Date: 2022-04-11

Last Posted Date: 2022-07-19

Lead Sponsor: BiOneCure Therapeutics Inc.

Target Recruit Count: 332

Registration Number: NCT05320588

Locations: 🇺🇸
NEXT Oncology Austin, Austin, Texas, United States
🇺🇸
University of Texas MD Anderson Cancer Center, Houston, Texas, United States
🇺🇸
NEXT Oncology Virginia, Fairfax, Virginia, United States

A Study to Evaluate Safety, Efficacy of FF-10832 in Combo With Pembrolizumab in Urothelial & Non-small Cell Lung Cancer

Phase 2

Recruiting

Conditions: Advanced Non Small Cell Lung Cancer
Advanced Urothelial Carcinoma

Interventions: Drug: Pembrolizumab
Drug: FF-10832

First Posted Date: 2022-04-08

Last Posted Date: 2024-07-24

Lead Sponsor: Fujifilm Pharmaceuticals U.S.A., Inc.

Target Recruit Count: 120

Registration Number: NCT05318573

Locations: 🇺🇸
TriHealth Cancer Institute; Good Samaritan Hospital, Cincinnati, Ohio, United States
🇺🇸
Sharp Memorial Hospital (Oncology Clinical Research), San Diego, California, United States
🇺🇸
Comprehensive Cancer Centers of Nevada - Southern Hills, Las Vegas, Nevada, United States

and more 18 locations

A Study to Evaluate Investigational Agents With or Without Pembrolizumab (MK-3475) in Participants With Advanced Esophageal Cancer Previously Exposed to Programmed Cell Death 1 Protein (PD-1)/ Programmed Cell Death Ligand 1 (PD-L1) Treatment (MK-3475-06B)

Phase 1

Recruiting

Conditions: Esophageal Squamous Cell Carcinoma

Interventions: Drug: Paclitaxel
Biological: Sacituzumab tirumotecan
Drug: Irinotecan
Biological: MK-4830
Drug: Antihistamine
Drug: H2 Receptor Antagonist
Biological: Pembrolizumab
Drug: Lenvatinib
Drug: Acetaminophen (or equivalent)
Drug: Dexamethasone (or equivalent)

First Posted Date: 2022-04-08

Last Posted Date: 2024-12-27

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 200

Registration Number: NCT05319730

Locations: 🇺🇸
University of Arizona Cancer Center-University of Arizona Cancer Center ( Site 4927), Tucson, Arizona, United States
🇺🇸
Hematology-Oncology Associates of Central NY, P.C. ( Site 4925), East Syracuse, New York, United States
🇧🇷
Liga Norte Riograndense Contra o Câncer ( Site 4303), Natal, Rio Grande Do Norte, Brazil

and more 50 locations

Blood-brain Barrier (BBB) Disruption Using Exablate Focused Ultrasound With Standard of Care Treatment of NSCLC Brain Mets

Phase 3

Recruiting

Conditions: Brain Tumor

Interventions: Device: Blood Brain Barrier Disruption - Oncology
Drug: Pembrolizumab

First Posted Date: 2022-04-08

Last Posted Date: 2024-03-13

Lead Sponsor: InSightec

Target Recruit Count: 20

Registration Number: NCT05317858

Locations: 🇰🇷
Seoul National University Hospital, Seoul, Korea, Republic of
🇰🇷
Severance Hospital, Yonsei University Health System, Soeul, Korea, Republic of
🇺🇸
St. Joseph's Hospital and Medical Center, Phoenix, Arizona, United States

and more 5 locations

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