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 First-in-human Study to Learn How Safe the Study Drug BAY2965501 is, Find the Best Dose (Single Drug & Combination), How it Affects the Body, What Maximum Amount Can be Given, How it Moves Into, Through and Out of the Body, How it Acts on Different Tumors in Participants With Advanced Solid Tumors

Phase 1

Recruiting

Conditions: Advanced Solid Tumors

Interventions: Drug: BAY2965501
Drug: Pembrolizumab
Drug: Platinum-based Chemotherapy

First Posted Date: 2022-11-14

Last Posted Date: 2024-12-13

Lead Sponsor: Bayer

Target Recruit Count: 284

Registration Number: NCT05614102

Locations: 🇺🇸
Sarah Cannon Research Institute at HealthONE, Denver, Colorado, United States
🇺🇸
UF Health Cancer Center, Gainesville, Florida, United States
🇺🇸
UPMC Hillman Cancer Center, Pittsburgh, Pennsylvania, United States

and more 23 locations

Treatment Patterns and Outcomes of Targeted Therapy and Immunotherapy Among BRAF-Positive Melanoma Patients Treated in the Adjuvant Setting and Among BRAF-Positive Metastatic Melanoma Patients With Low Tumor Burden

Completed

Conditions: Metastatic Melanoma

Interventions: Drug: Nivolumab
Drug: Pembrolizumab
Combination Product: Dabrafenib+Trametinib
Combination Product: Ipilimumab+Nivolumab
Combination Product: Vemurafenib+Cobimetinib
Combination Product: Encorafenib+Binimetinib

First Posted Date: 2022-11-09

Last Posted Date: 2023-04-06

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 1975

Registration Number: NCT05611229

Locations: 🇺🇸
Novartis Investigative Site, East Hanover, New Jersey, United States

A Trial to See if the Combination of Fianlimab With Cemiplimab Works Better Than Pembrolizumab for Preventing or Delaying Melanoma From Coming Back After it Has Been Removed With Surgery

Phase 3

Recruiting

Conditions: Melanoma

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

First Posted Date: 2022-11-08

Last Posted Date: 2024-11-19

Lead Sponsor: Regeneron Pharmaceuticals

Target Recruit Count: 1530

Registration Number: NCT05608291

Locations: 🇺🇸
UCSF Medical Center, Investigational Pharmacy, San Francisco, California, United States
🇺🇸
University of Pittsburgh Medical Center (UPMC) Hillman Cancer Center, Pittsburgh, Pennsylvania, United States
🇺🇸
Cancer Center IDS UVA Cancer Center IDS Pharmacy, Charlottesville, Virginia, United States

and more 204 locations

Electroporation and Immunotherapy in Metastatic Colorectal Cancer

Phase 2

Terminated

Conditions: Metastatic Colorectal Cancer

Interventions: Device: Irreversible electroporation
Device: Calcium electroporation
Drug: Pembrolizumab

First Posted Date: 2022-11-08

Last Posted Date: 2024-06-03

Lead Sponsor: Ismail Gögenur

Target Recruit Count: 4

Registration Number: NCT05609656

Locations: 🇩🇰
Zealand University Hospital, Køge, Denmark

Study of Pembrolizumab (MK-3475) Monotherapy Versus Sacituzumab Govitecan in Combination With Pembrolizumab for Participants With Metastatic Non-small Cell Lung Cancer (NSCLC) With Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥50% (MK-3475-D46)

Phase 3

Recruiting

Conditions: Carcinoma, Non-Small-Cell Lung

Interventions: Biological: Sacituzumab Govitecan
Biological: Pembrolizumab

First Posted Date: 2022-11-08

Last Posted Date: 2024-11-18

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 614

Registration Number: NCT05609968

Locations: 🇺🇸
Houston Methodist Hospital ( Site 0419), Houston, Texas, United States
🇷🇴
Cardiomed SRL Cluj-Napoca ( Site 0217), Cluj-Napoca, Cluj, Romania
🇺🇸
Infirmary Cancer Care ( Site 0418), Mobile, Alabama, United States

and more 163 locations

Phase 1 Clinical Trial of Lenvatinib, Pembrolizumab and Hypofractionated Pelvic Radiation Therapy for pMMR Recurrent/Unresectable Endometrial Carcinoma

Phase 1

Recruiting

Conditions: Recurrent Endometrial Carcinoma
Unresectable Endometrial Carcinoma

Interventions: Drug: Lenvatinib
Drug: Pembrolizumab
Radiation: Hypofractionated External Beam Radiation Therapy

First Posted Date: 2022-11-03

Last Posted Date: 2024-03-28

Lead Sponsor: Aaron Wolfson

Target Recruit Count: 18

Registration Number: NCT05603910

Locations: 🇺🇸
University of Miami, Miami, Florida, United States

Study of DF9001 in Patients With Advanced Solid Tumors

Phase 1

Recruiting

Conditions: Solid Tumor, Adult

Interventions: Drug: DF9001
Drug: pembrolizumab
Drug: KEYTRUDA®

First Posted Date: 2022-10-28

Last Posted Date: 2024-05-16

Lead Sponsor: Dragonfly Therapeutics

Target Recruit Count: 242

Registration Number: NCT05597839

Locations: 🇺🇸
Rutgers, New Brunswick, New Jersey, United States
🇺🇸
University of Cincinnati, Cincinnati, Ohio, United States
🇺🇸
UMPC Hillman Cancer Center, Pittsburgh, Pennsylvania, United States

and more 14 locations

Pembrolizumab for Advanced NSCLC and PS 2-3

Phase 2

Recruiting

Conditions: Non-Small Cell Lung Cancer (NSCLC)

Interventions: Drug: Pembrolizumab

First Posted Date: 2022-10-21

Last Posted Date: 2024-06-05

Lead Sponsor: Icahn School of Medicine at Mount Sinai

Target Recruit Count: 45

Registration Number: NCT05589818

Locations: 🇺🇸
Mount Sinai Hospital, New York, New York, United States

Preoperative Pembrolizumab Plus Bevacizumab Combined With Chemotherapy in Patients With pMMR/MSS Locally Advanced Colorectal Cancer

Phase 2

Not yet recruiting

Conditions: Locally Advanced Colorectal Cancer

Interventions: Drug: Capecitabine
Drug: Oxaliplatin
Drug: Bevacizumab
Drug: Pembrolizumab

First Posted Date: 2022-10-19

Last Posted Date: 2022-10-19

Lead Sponsor: Shanghai Changzheng Hospital

Target Recruit Count: 12

Registration Number: NCT05585814

Phase II Study of Peptide Receptor Radionuclide Therapy in Combination With Immunotherapy for Patients With Merkel Cell Cancer

Phase 2

Suspended

Conditions: Merkel Cell Carcinoma

Interventions: Drug: Pembrolizumab
Drug: Lutetium Lu 177 dotatate

First Posted Date: 2022-10-18

Last Posted Date: 2024-06-27

Lead Sponsor: Weill Medical College of Cornell University

Target Recruit Count: 18

Registration Number: NCT05583708

Locations: 🇺🇸
Weill Cornell Medicine/NewYork-Presbyterian Hospital, New York, New York, United States
🇺🇸
University of Iowa Hospitals and Clinics, Iowa City, Iowa, United States

Drug Development Updates

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