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

Phase 1 Study Evaluating the Safety and PK of ADU-1805 in Advanced Solid Tumors

Phase 1

Recruiting

Conditions: Refractory Cancer
Metastatic Solid Tumor
Solid Tumor, Adult

Interventions: Drug: ADU-1805
Drug: Pembrolizumab

First Posted Date: 2023-05-12

Last Posted Date: 2023-05-30

Lead Sponsor: Sairopa B.V.

Target Recruit Count: 90

Registration Number: NCT05856981

Locations: 🇺🇸
Gabrail Cancer & Research Center, Canton, Ohio, United States
🇲🇩
National Institute of Oncology, Chișinău, Moldova, Republic of
🇺🇸
Carolina BioOncology Institute - Cancer Research Clinic, Huntersville, North Carolina, United States

Study of MK-0472 in Participants With Advanced/Metastatic Solid Tumors (MK-0472-001)

Phase 1

Recruiting

Conditions: Metastatic Solid Tumors
Advanced Solid Tumors

Interventions: Drug: MK-0472
Drug: MK-1084
Biological: Pembrolizumab

First Posted Date: 2023-05-10

Last Posted Date: 2024-10-18

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 178

Registration Number: NCT05853367

Locations: 🇨🇦
Princess Margaret Cancer Centre ( Site 0101), Toronto, Ontario, Canada
🇺🇸
Northwestern Memorial Hospital ( Site 0002), Chicago, Illinois, United States
🇨🇦
Centre Hospitalier de l'Université de Montréal-Unit for Innovative Therapies ( Site 0100), Montréal, Quebec, Canada

and more 4 locations

Pembrolizumab in High-risk Thyroid Cancer

Phase 2

Not yet recruiting

Conditions: Differentiated Thyroid Cancer

Interventions: Drug: Pembrolizumab

First Posted Date: 2023-05-10

Last Posted Date: 2024-07-09

Lead Sponsor: Istituti Clinici Scientifici Maugeri SpA

Target Recruit Count: 25

Registration Number: NCT05852223

Locations: 🇮🇹
Istituti Clinici Scientifici Maugeri, Pavia, Lombardia, Italy

A Study of Tobemstomig + Nab-Paclitaxel Compared With Pembrolizumab + Nab-Paclitaxel in Participants With Previously Untreated, PD-L1-Positive, Locally-Advanced Unresectable or Metastatic Triple-Negative Breast Cancer

Phase 2

Active, not recruiting

Conditions: Breast Cancer

Interventions: Drug: Tobemstomig
Drug: Pembrolizumab
Drug: Nab-Paclitaxel

First Posted Date: 2023-05-10

Last Posted Date: 2025-01-06

Lead Sponsor: Hoffmann-La Roche

Target Recruit Count: 160

Registration Number: NCT05852691

Locations: 🇺🇸
Ellison Institute of Technology, Los Angeles, California, United States
🇦🇺
Fiona Stanley Hospital, Bull Creek, Western Australia, Australia
🇧🇷
Hospital Araujo Jorge, Goiania, Goiás, Brazil

and more 72 locations

A Study of CDX-1140, a CD40 Agonist, in Combination With Capecitabine and Oxaliplatin (CAPOX) and Keytruda in Subjects With Biliary Tract Carcinoma (BTC)

Phase 1

Recruiting

Conditions: Biliary Cancer
Bile Duct Cancer
Cancer of the Bile Duct

Interventions: Drug: oxaliplatin
Drug: capecitabine
Biological: Keytruda
Biological: CDX-1140

First Posted Date: 2023-05-09

Last Posted Date: 2024-12-11

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 60

Registration Number: NCT05849480

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

A Study of Efficacy and Safety of Pembrolizumab Plus Enfortumab Vedotin (EV) +/- Investigational Agents in First-Line Metastatic Urothelial Carcinoma (mUC) (MK-3475-04B/KEYMAKER-U04)

Phase 1

Active, not recruiting

Conditions: Metastatic Urothelial Carcinoma
Urothelial Neoplasms

Interventions: Biological: Coformulated vibostolimab/pembrolizumab
Biological: Coformulated favezelimab/pembrolizumab
Combination Product: EV
Biological: Pembrolizumab

First Posted Date: 2023-05-06

Last Posted Date: 2024-11-21

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 390

Registration Number: NCT05845814

Locations: 🇨🇦
Princess Margaret Cancer Centre ( Site 3106), Toronto, Ontario, Canada
🇺🇸
Emory University School of Medicine ( Site 3043), Atlanta, Georgia, United States
🇨🇱
Bradfordhill-Clinical Area ( Site 3155), Santiago, Region M. De Santiago, Chile

and more 41 locations

IDO and PD-L1 Peptide Based Immune-Modulatory Therapeutic (IO102-IO103) in Combination With Pembrolizumab for BCG-Unresponsive or Intolerant, Non-Muscle Invasive Bladder Cancer

Phase 1

Recruiting

Conditions: Stage 0is Bladder Cancer AJCC v8
High Risk Non-Muscle Invasive Bladder Urothelial Carcinoma
Stage 0a Bladder Cancer AJCC v8
Stage I Bladder Cancer AJCC v8

Interventions: Biological: PD-L1/IDO Peptide Vaccine
Biological: Pembrolizumab

First Posted Date: 2023-05-06

Last Posted Date: 2024-12-18

Lead Sponsor: University of California, Davis

Target Recruit Count: 30

Registration Number: NCT05843448

Locations: 🇺🇸
University of California Davis Comprehensive Cancer Center, Sacramento, California, United States

Study of HRO761 Alone or in Combination in Cancer Patients With Specific DNA Alterations Called Microsatellite Instability or Mismatch Repair Deficiency.

Phase 1

Recruiting

Conditions: MSIhi or dMMR Advanced Unresectable or Metastatic Solid Tumors, Including Colorectal Cancers

Interventions: Drug: HRO761
Biological: pembrolizumab
Drug: irinotecan

First Posted Date: 2023-05-03

Last Posted Date: 2024-12-10

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 327

Registration Number: NCT05838768

Locations: 🇺🇸
University of California LA, Los Angeles, California, United States
🇬🇧
Novartis Investigative Site, Oxford, United Kingdom
🇺🇸
Columbia University Medical Ctr, New York, New York, United States

and more 4 locations

A Study to Learn About the Effectiveness of Cancer Medicines in Patients With Metastatic Non-small Cell Lung Cancer in Norway.

Recruiting

Conditions: Non-Small Cell Lung Cancer

Interventions: Drug: lorlatinib
Drug: crizotinib
Drug: brigatinib
Drug: ceritinib
Drug: alectinib
Drug: atezolizumab
Drug: bevacizumab
Drug: paclitaxel
Drug: carboplatin
Drug: docetaxel
Drug: erlotinib
Drug: gefitinib
Drug: afatinib
Drug: dacomitinib
Drug: osimertinib
Drug: pembrolizumab
Drug: nivolumab
Drug: entrectinib

First Posted Date: 2023-04-28

Last Posted Date: 2023-10-10

Lead Sponsor: Pfizer

Target Recruit Count: 20605

Registration Number: NCT05834348

Locations: 🇳🇴
Pfizer Norway, Oslo, Norway

Phase 1 Trial in Patients With Human Papillomavirus (HPV)-Associated Cancer

Phase 1

Recruiting

Conditions: HPV Associated Cancers

Interventions: Drug: TGN-S11
Drug: Pembrolizumab

First Posted Date: 2023-04-24

Last Posted Date: 2024-08-09

Lead Sponsor: Toragen, Inc.

Target Recruit Count: 55

Registration Number: NCT05826275

Locations: 🇺🇸
MD Anderson Cancer Center, Houston, Texas, United States
🇺🇸
UCSD Moores Cancer Center, La Jolla, California, United States
🇺🇸
City of Hope, Duarte, California, United States

and more 2 locations

Drug Development Updates

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