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

Efficacy and Safety of Eribulin in the Treatment of Advanced Breast Cancer

Conditions: Breast Cancer

Interventions: Drug: Eribulin
Drug: Pembrolizumab
Drug: Trastuzumab
Drug: Camerlizumab
Drug: pertuzumab
Drug: Pyrotinib

First Posted Date: 2020-12-24

Last Posted Date: 2020-12-24

Lead Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Target Recruit Count: 80

Registration Number: NCT04683445

Locations: 🇨🇳
Sun Yat Sen Memorial Hospital，Sun Yat sen University, Guangzhou, Guangdong, China

A Study of Radiation Therapy With Pembrolizumab and Olaparib or Other Radiosensitizers in Women Who Have Triple-Negative or Hormone-Receptor Positive/Her2 Negative Breast Cancer

Phase 2

Recruiting

Conditions: TNBC - Triple-Negative Breast Cancer
Breast Cancer
Metastatic Breast Cancer
Triple Negative Breast Cancer

Interventions: Drug: Pembrolizumab
Radiation: Radiation
Drug: Olaparib

First Posted Date: 2020-12-24

Last Posted Date: 2024-10-07

Lead Sponsor: Memorial Sloan Kettering Cancer Center

Target Recruit Count: 34

Registration Number: NCT04683679

Locations: 🇺🇸
Memorial Sloan Kettering 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 Monmouth (Limited Protocol Activities), Middletown, New Jersey, United States

and more 4 locations

To Examine the Effects of Axitinib Dose Reduction and Interruption for Adverse Event Management Among Patients Receiving Axitinib in for the Treatment of Advanced Renal Cell Carcinoma

Completed

Conditions: Renal Cell Carcinoma

First Posted Date: 2020-12-24

Last Posted Date: 2025-01-03

Lead Sponsor: Pfizer

Target Recruit Count: 481

Registration Number: NCT04682587

Locations: 🇺🇸
Pfizer, New York, New York, United States

Evorpacept (ALX148) in Combination With Pembrolizumab and Chemotherapy in Patients With Advanced Head and Neck Squamous Cell Carcinoma (ASPEN-04)

Phase 2

Active, not recruiting

Conditions: Head and Neck Cancer
Head and Neck Squamous Cell Carcinoma

Interventions: Drug: pembrolizumab
Drug: evorpacept
Drug: Cisplatin/Carboplatin; 5FU

First Posted Date: 2020-12-19

Last Posted Date: 2024-07-22

Lead Sponsor: ALX Oncology Inc.

Target Recruit Count: 172

Registration Number: NCT04675333

Locations: 🇺🇸
University of Miami, Sylvester Comprehensive Cancer Center, Miami, Florida, United States
🇺🇸
Vanderbilt - Ingram Cancer Center, Nashville, Tennessee, United States
🇺🇸
Oregon Health & Science University/ Knight Cancer Institute, Portland, Oregon, United States

and more 41 locations

Evorpacept (ALX148) in Combination With Pembrolizumab in Patients With Advanced Head and Neck Squamous Cell Carcinoma (ASPEN-03)

Phase 2

Active, not recruiting

Conditions: Head and Neck Squamous Cell Carcinoma
Head and Neck Cancer

Interventions: Drug: evorpacept
Drug: pembrolizumab

First Posted Date: 2020-12-19

Last Posted Date: 2024-07-22

Lead Sponsor: ALX Oncology Inc.

Target Recruit Count: 189

Registration Number: NCT04675294

Locations: 🇺🇸
The Ohio State University, Columbus, Ohio, United States
🇺🇸
Rutgers Cancer Institute of New Jersey, Newark, New Jersey, United States
🇧🇪
Cliniques Universitaires Saint-Luc, Brussels, Belgium

and more 49 locations

A Dose Escalation/Expansion Study of ERAS-601 in Patients With Advanced or Metastatic Solid Tumors

Phase 1

Active, not recruiting

Conditions: Advanced or Metastatic Solid Tumors

Interventions: Drug: ERAS-601
Drug: Cetuximab
Drug: Pembrolizumab

First Posted Date: 2020-12-17

Last Posted Date: 2024-08-27

Lead Sponsor: Erasca, Inc.

Target Recruit Count: 200

Registration Number: NCT04670679

Locations: 🇺🇸
University of Pennsylvania, Philadelphia, Pennsylvania, United States
🇺🇸
The University of Texas MD Anderson Cancer Center, Houston, Texas, United States
🇺🇸
Washington University, Saint Louis, Missouri, United States

and more 12 locations

Testing What Happens When an Immunotherapy Drug (Pembrolizumab) is Given by Itself Compared to the Usual Treatment of Chemotherapy With Radiation After Surgery for Recurrent Head and Neck Squamous Cell Carcinoma

Phase 2

Recruiting

Conditions: Recurrent Hypopharyngeal Squamous Cell Carcinoma
Recurrent Oral Cavity Squamous Cell Carcinoma
Recurrent Laryngeal Squamous Cell Carcinoma
Recurrent Oropharyngeal Squamous Cell Carcinoma
Recurrent Head and Neck Squamous Cell Carcinoma

Interventions: Drug: Carboplatin
Drug: Cisplatin
Procedure: Computed Tomography
Biological: Pembrolizumab
Radiation: Intensity-Modulated Radiation Therapy
Procedure: Magnetic Resonance Imaging
Radiation: Proton Beam Radiation Therapy

First Posted Date: 2020-12-17

Last Posted Date: 2025-01-10

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 188

Registration Number: NCT04671667

Locations: 🇺🇸
University of Alabama at Birmingham Cancer Center, Birmingham, Alabama, United States
🇺🇸
University of Arkansas for Medical Sciences, Little Rock, Arkansas, United States
🇺🇸
Kaiser Permanente-Anaheim, Anaheim, California, United States

and more 143 locations

A Study of Pembrolizumab and Olaparib for People with Metastatic Pancreatic Ductal Adenocarcinoma and Homologous Recombination Deficiency or Exceptional Treatment Response to Platinum-Based Therapy

Phase 2

Active, not recruiting

Conditions: Metastatic Pancreatic Ductal Adenocarcinoma
Homologous Recombination Deficiency (HRD)

Interventions: Drug: Pembrolizumab
Drug: Olaparib

First Posted Date: 2020-12-14

Last Posted Date: 2024-10-14

Lead Sponsor: Memorial Sloan Kettering Cancer Center

Target Recruit Count: 63

Registration Number: NCT04666740

Locations: 🇺🇸
Memorial Sloan Kettering Monmouth (All protocol activities), Middletown, New Jersey, United States
🇺🇸
Memorial Sloan Kettering Bergen (All protocol activities), Montvale, New Jersey, United States
🇺🇸
Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (All protocol activities), Commack, New York, United States

and more 4 locations

Efficacy and Safety of Lenvatinib (E7080/MK-7902) Plus Pembrolizumab (MK-3475) Plus Chemotherapy in Participants With Advanced/Metastatic Gastroesophageal Adenocarcinoma (MK-7902-015/E7080-G000-321/LEAP-015)

Phase 3

Active, not recruiting

Conditions: Advanced/Metastatic Gastroesophageal Adenocarcinoma

Interventions: Biological: Pembrolizumab
Biological: Lenvatinib
Drug: Capecitabine
Drug: Leucovorin (or Levoleucovorin)
Drug: Oxaliplatin
Drug: 5-FU

First Posted Date: 2020-12-10

Last Posted Date: 2024-11-18

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 890

Registration Number: NCT04662710

Locations: 🇺🇸
UCLA Hematology/Oncology - Santa Monica ( Site 0003), Los Angeles, California, United States
🇦🇺
Nepean Hospital ( Site 2305), Kingswood, New South Wales, Australia
🇺🇸
Mount Sinai Hospital ( Site 0051), New York, New York, United States

and more 174 locations

Stereotactic Radiosurgery and Immunotherapy (Pembrolizumab) for the Treatment of Recurrent Meningioma

Phase 2

Recruiting

Conditions: Grade II Meningioma, Adult
Recurrent Meningioma
Grade I Meningioma, Adult
Grade III Meningioma, Adult

Interventions: Drug: Pembrolizumab
Procedure: Stereotactic Radiosurgery

First Posted Date: 2020-12-09

Last Posted Date: 2024-03-07

Lead Sponsor: Nancy Ann Oberheim Bush, MD

Target Recruit Count: 37

Registration Number: NCT04659811

Locations: 🇺🇸
University of California, San Francisco, San Francisco, California, United States

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