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

Pembrolizumab in Ultramutated and Hypermutated Endometrial Cancer

Phase 2

Active, not recruiting

Conditions: Recurrent Endometrial Cancer

Interventions: Drug: Pembrolizumab

First Posted Date: 2016-09-14

Last Posted Date: 2024-04-08

Lead Sponsor: Yale University

Target Recruit Count: 25

Registration Number: NCT02899793

Locations: 🇺🇸
Yale New Haven Hospital, New Haven, Connecticut, United States

Palbociclib and Pembrolizumab in Central Nervous System Metastases

Phase 2

Recruiting

Conditions: Metastatic Malignant Neoplasm to Brain
Recurrent Brain Metastases
Progressive Brain Metastases

Interventions: Drug: Palbociclib
Drug: Pembrolizumab

First Posted Date: 2016-09-12

Last Posted Date: 2024-11-21

Lead Sponsor: Massachusetts General Hospital

Target Recruit Count: 45

Registration Number: NCT02896335

Locations: 🇺🇸
Massachusetts General Hospital, Boston, Massachusetts, United States
🇺🇸
Dana Farber Cancer Institute, Boston, Massachusetts, United States

Pembrolizumab in HNSCC With Residual Disease After Radiation

Phase 2

Terminated

Conditions: Head and Neck Squamous Cell Carcinoma

Interventions: Drug: Pembrolizumab

First Posted Date: 2016-09-08

Last Posted Date: 2023-12-28

Lead Sponsor: Yale University

Target Recruit Count: 9

Registration Number: NCT02892201

Locations: 🇺🇸
Yale Cancer Center, New Haven, Connecticut, United States
🇺🇸
University of Texas Southwestern Medical Center (UTSW), Dallas, Texas, United States

Pembrolizumab In Central Nervous System Metastases

Phase 2

Active, not recruiting

Conditions: Brain Metastases

Interventions: Drug: Pembrolizumab
Radiation: MRI
Radiation: PET/CT
Procedure: Stereotactic Radiosurgery

First Posted Date: 2016-09-01

Last Posted Date: 2024-03-12

Lead Sponsor: Massachusetts General Hospital

Target Recruit Count: 101

Registration Number: NCT02886585

Locations: 🇺🇸
Dana Farber Cancer Institute, Boston, Massachusetts, United States
🇺🇸
Priscilla Brastianos, Boston, Massachusetts, United States

Study of Pembrolizumab as First Line Therapy in Patients With Unresectable Squamous Cell Carcinoma of the Skin

Phase 2

Completed

Conditions: Carcinoma, Squamous Cell

Interventions: Drug: Pembrolizumab

First Posted Date: 2016-08-30

Last Posted Date: 2021-01-13

Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Target Recruit Count: 57

Registration Number: NCT02883556

Locations: 🇫🇷
Hôpital Avicenne, Bobigny, France

Pembrolizumab in Treating Patients With High Risk Oral Intraepithelial Neoplasia

Phase 2

Active, not recruiting

Conditions: Oral Cavity Carcinoma
Oral Intraepithelial Neoplasia

Interventions: Other: Laboratory Biomarker Analysis
Other: Patient Observation
Biological: Pembrolizumab

First Posted Date: 2016-08-29

Last Posted Date: 2024-10-04

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 15

Registration Number: NCT02882282

Locations: 🇺🇸
M D Anderson Cancer Center, Houston, Texas, United States

RADVAX™: A Trial of Combined Pembrolizumab and Hypofractionated Radiation in Patients With Advanced Urothelial Cancer Who Have Progressed on Anti-PD-1/PD-L1 Monotherapy

Phase 1

Withdrawn

Conditions: Urothelial Cancer

Interventions: Drug: PEMBROLIZUMAB
Radiation: hypofractionated radiation

First Posted Date: 2016-08-26

Last Posted Date: 2019-04-23

Lead Sponsor: Abramson Cancer Center at Penn Medicine

Registration Number: NCT02880345

Locations: 🇺🇸
Abramson Cancer Center of the University of Pennsylvania, Philadelphia, Pennsylvania, United States

A Study of ARRY-382 in Combination With Pembrolizumab for the Treatment of Patients With Advanced Solid Tumors

Phase 1

Terminated

Conditions: Advanced Solid Tumors

Interventions: Drug: ARRY-382
Drug: Pembrolizumab

First Posted Date: 2016-08-26

Last Posted Date: 2022-06-16

Lead Sponsor: Pfizer

Target Recruit Count: 82

Registration Number: NCT02880371

Locations: 🇺🇸
Ronald Reagan UCLA Medical Center, Los Angeles, California, United States
🇺🇸
UCLA Hematology/Oncology - Santa Monica, Santa Monica, California, United States
🇺🇸
UCLA Hematology/Oncology, Los Angeles, California, United States

and more 27 locations

Pembrolizumab in Advanced/Metastatic Acral Lentiginous Melanoma

Phase 2

Completed

Conditions: Acral Lentiginous Melanoma

Interventions: Drug: pembrolizumab

First Posted Date: 2016-08-23

Last Posted Date: 2023-03-07

Lead Sponsor: Chinese University of Hong Kong

Target Recruit Count: 9

Registration Number: NCT02875132

Locations: 🇭🇰
Department of Clinical Oncology, Prince of Wales Hospital, Hong Kong, Hong Kong

BGB324 in Combination With Pembrolizumab or Dabrafenib/Trametinib in Metastatic Melanoma

Phase 1

Completed

Conditions: Melanoma

Interventions: Drug: BGB324+pembrolizumab
Drug: BGB324+dabrafenib and trametinib
Drug: dabrafenib and trametinib
Drug: pembrolizumab

First Posted Date: 2016-08-19

Last Posted Date: 2024-06-20

Lead Sponsor: Haukeland University Hospital

Target Recruit Count: 74

Registration Number: NCT02872259

Locations: 🇳🇴
St. Olavs Hospital, Trondheim, Norway
🇳🇴
Oslo University Hospital, Radiumhospitalet, Oslo, Norway
🇳🇴
Haukeland University Hospital, Bergen, Norway

and more 2 locations

Drug Development Updates

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