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

Study of Pembrolizumab (MK-3475) Compared to Platinum-Based Chemotherapies in Participants With Metastatic Non-Small Cell Lung Cancer (MK-3475-024/KEYNOTE-024)

Phase 3

Completed

Conditions: Non-Small Cell Lung Carcinoma

Interventions: Drug: Pembrolizumab
Drug: Paclitaxel
Drug: Carboplatin
Drug: Cisplatin
Drug: Gemcitabine
Drug: Pemetrexed

First Posted Date: 2014-05-20

Last Posted Date: 2022-06-13

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 305

Registration Number: NCT02142738

A Study of Abemaciclib (LY2835219) in Combination With Another Anti-cancer Drug in Participants With Lung Cancer (NSCLC)

Phase 1

Completed

Conditions: Carcinoma, Non-small Cell Lung

Interventions: Drug: Abemaciclib
Drug: LY3023414
Drug: Pemetrexed
Drug: Gemcitabine
Drug: Ramucirumab
Drug: Pembrolizumab

First Posted Date: 2014-03-06

Last Posted Date: 2020-09-11

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 142

Registration Number: NCT02079636

Locations: 🇺🇸
Highlands Oncology Group, Fayetteville, Arkansas, United States
🇺🇸
Indiana Cancer Pavilion, Indianapolis, Indiana, United States
🇺🇸
The West Clinic, Germantown, Tennessee, United States

and more 7 locations

Study of IDO Inhibitor in Combination With Checkpoint Inhibitors for Adult Patients With Metastatic Melanoma

Phase 1

Completed

Conditions: Metastatic Melanoma
Stage III Melanoma
Stage IV Melanoma

Interventions: Drug: Indoximod
Drug: Ipilimumab
Drug: Pembrolizumab
Drug: Nivolumab

First Posted Date: 2014-02-27

Last Posted Date: 2020-06-05

Lead Sponsor: NewLink Genetics Corporation

Target Recruit Count: 132

Registration Number: NCT02073123

Locations: 🇺🇸
Huntsman Cancer Institute, Salt Lake City, Utah, United States
🇺🇸
Penn State Hershey Cancer Institue, Hershey, Pennsylvania, United States
🇺🇸
Augusta University, Augusta, Georgia, United States

and more 3 locations

Immunotherapy Study for Patients With Stage IV Melanoma

Phase 2

Terminated

Conditions: Stage IV Melanoma
Metastatic Melanoma

Interventions: Drug: Nivolumab
Drug: HyperAcute®-Melanoma (HAM) Immunotherapy
Drug: Ipilimumab
Drug: Pembrolizumab

First Posted Date: 2014-02-04

Last Posted Date: 2023-04-18

Lead Sponsor: NewLink Genetics Corporation

Target Recruit Count: 47

Registration Number: NCT02054520

Locations: 🇺🇸
University of Tennessee Medical Center, Knoxville, Tennessee, United States
🇺🇸
University of Kansas Cancer Center, Westwood, Kansas, United States
🇺🇸
Oncology Specialists, Niles, Illinois, United States

and more 2 locations

A Study of DKN-01 in Combination With Paclitaxel or Pembrolizumab

Phase 1

Completed

Conditions: Esophageal Neoplasms
Adenocarcinoma of the Gastroesophageal Junction
Gastroesophageal Cancer
Squamous Cell Carcinoma
Gastric Adenocarcinoma

Interventions: Drug: DKN-01 150 mg
Drug: Paclitaxel
Drug: DKN-01 300 mg
Drug: Pembrolizumab

First Posted Date: 2013-12-17

Last Posted Date: 2023-11-01

Lead Sponsor: Leap Therapeutics, Inc.

Target Recruit Count: 151

Registration Number: NCT02013154

Locations: 🇺🇸
Dana Farber Cancer Institute, Boston, Massachusetts, United States
🇺🇸
Duke University, Durham, North Carolina, United States
🇺🇸
CTRC @ The University of Texas Health Science Center at San Antonio, San Antonio, Texas, United States

and more 7 locations

A Phase 1 Study of Pegilodecakin (LY3500518) in Participants With Advanced Solid Tumors

Phase 1

Completed

Conditions: Prostate Cancer
Pancreatic Carcinoma
Solid Tumors
Breast Cancer
Melanoma
Renal Cell Carcinoma
Non-small Cell Lung Carcinoma
Ovarian Cancer
Colorectal Carcinoma

Interventions: Drug: Gemcitabine/carboplatin
Drug: Pegilodecakin
Drug: nivolumab
Drug: Paclitaxel or Docetaxel and Carboplatin or Cisplatin
Drug: FOLFOX (Oxaliplatin/Leucovorin/5-Fluorouracil)
Drug: gemcitabine/nab-paclitaxel
Drug: Capecitabine
Drug: Pazopanib
Drug: Paclitaxel
Drug: Pembrolizumab

First Posted Date: 2013-12-12

Last Posted Date: 2024-11-15

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 353

Registration Number: NCT02009449

Locations: 🇺🇸
UCLA Medical Hematology & Oncology, Los Angeles, California, United States
🇺🇸
Memorial Sloan Kettering Cancer Center, New York, New York, United States
🇺🇸
Florida Cancer Specialists & Research Institute, Sarasota, Florida, United States

and more 7 locations