Pembrolizumab

Generic Name: Pembrolizumab

Brand Names: Keytruda

Drug Type: Biotech

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)

Clinical Trials

Ph1b/2 Dose-Escalation Study of Entinostat With Pembrolizumab in Non-small Cell Lung Cancer (NSCLC) With Expansion Cohorts in NSCLC, Melanoma, and Colorectal Cancer (CRC)

Phase 1

Completed

Conditions: Non-Small Cell Lung Cancer
Melanoma
Mismatch Repair-Proficient Colorectal Cancer

Interventions: Drug: entinostat
Drug: pembrolizumab

First Posted Date: 2015-05-07

Last Posted Date: 2025-03-20

Lead Sponsor: Syndax Pharmaceuticals

Target Recruit Count: 191

Registration Number: NCT02437136

Locations: 🇺🇸
Dana Farber Cancer Institution, Boston, Massachusetts, United States
🇺🇸
The University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States
🇺🇸
Memorial Sloan Kettering Cancer Center, New York, New York, United States

and more 8 locations

Assess the Efficacy of Pembrolizumab Plus Radiotherapy or Ablation in Metastatic Colorectal Cancer Patients

Phase 2

Active, not recruiting

Conditions: Metastatic Colorectal Cancer

Interventions: Drug: Pembrolizumab
Radiation: Radiotherapy
Procedure: Radiofrequency ablation

First Posted Date: 2015-05-07

Last Posted Date: 2024-04-09

Lead Sponsor: Memorial Sloan Kettering Cancer Center

Target Recruit Count: 34

Registration Number: NCT02437071

Locations: 🇺🇸
Memorial Sloan Kettering Cancer Center, New York, New York, United States

A Tissue Collection Study of Pembrolizumab (MK-3475) in Subjects With Resectable Advanced Melanoma

Phase 1

Completed

Conditions: Malignant Melanoma

Interventions: Drug: pembrolizumab

First Posted Date: 2015-05-05

Last Posted Date: 2022-06-16

Lead Sponsor: Abramson Cancer Center at Penn Medicine

Target Recruit Count: 33

Registration Number: NCT02434354

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

Vaccine Therapy and Pembrolizumab in Treating Patients With Solid Tumors That Have Failed Prior Therapy

Phase 1

Active, not recruiting

Conditions: Non-Small Cell Lung Carcinoma
Unresectable Solid Neoplasm
Bladder Carcinoma
Rectal Carcinoma
Triple-Negative Breast Carcinoma
Adult Solid Neoplasm
Colon Carcinoma
Pancreatic Carcinoma
Progesterone Receptor Negative
TP53 Gene Mutation

Interventions: Other: Laboratory Biomarker Analysis
Biological: Modified Vaccinia Virus Ankara Vaccine Expressing p53
Biological: Pembrolizumab

First Posted Date: 2015-05-04

Last Posted Date: 2025-03-20

Lead Sponsor: City of Hope Medical Center

Target Recruit Count: 11

Registration Number: NCT02432963

Locations: 🇺🇸
City of Hope Medical Center, Duarte, California, United States

MK-3475 and Gemcitabine in Non-Small Cell Lung Cancer (NSCLC)

Phase 1

Active, not recruiting

Conditions: Carcinoma, Non-Small-Cell Lung

Interventions: Drug: MK-3475
Drug: Gemcitabine

First Posted Date: 2015-04-21

Last Posted Date: 2023-10-26

Lead Sponsor: Providence Health & Services

Target Recruit Count: 16

Registration Number: NCT02422381

Locations: 🇺🇸
Providence Oncology & Hematology Care Clinic - Westside, Portland, Oregon, United States
🇺🇸
Providence Oncology & Hematology Care Clinic - Eastside, Portland, Oregon, United States

Phase IB Study to Evaluate the Safety of Selinexor (KPT-330) in Combination With Multiple Standard Chemotherapy or Immunotherapy Agents in Patients With Advanced Malignancies

Phase 1

Active, not recruiting

Conditions: Advanced Malignant Solid Neoplasm
Clinical Stage III Cutaneous Melanoma AJCC V8
Clinical Stage IV Cutaneous Melanoma AJCC V8
Fallopian Tube Carcinoma
Metastatic Lung Non-Small Cell Carcinoma
Metastatic Malignant Solid Neoplasm
Metastatic Melanoma
Metastatic Renal Cell Carcinoma
Ovarian Carcinoma
Pathologic Stage III Cutaneous Melanoma AJCC V8

Interventions: Drug: Carboplatin
Drug: Eribulin
Drug: Fluorouracil
Drug: Paclitaxel
Drug: Cyclophosphamide
Drug: Capecitabine
Biological: Pembrolizumab
Drug: Olaparib
Biological: Nivolumab
Biological: Ipilimumab
Drug: Selinexor
Drug: Doxorubicin
Drug: Topotecan
Drug: Pemetrexed
Drug: Irinotecan Hydrochloride
Drug: Oxaliplatin
Drug: Leucovorin Calcium

First Posted Date: 2015-04-17

Last Posted Date: 2024-05-21

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 221

Registration Number: NCT02419495

Locations: 🇺🇸
MD Anderson in The Woodlands, Conroe, Texas, United States
🇺🇸
M D Anderson Cancer Center, Houston, Texas, United States
🇺🇸
MD Anderson West Houston, Houston, Texas, United States

and more 2 locations

Malignant Pleural Disease Treated With Autologous T Cells Genetically Engineered to Target the Cancer-Cell Surface Antigen Mesothelin

Phase 1

Active, not recruiting

Conditions: Malignant Pleural Disease
Lung Cancer
Metastases
Mesothelioma
Breast Cancer

Interventions: Genetic: iCasp9M28z T cell infusions
Drug: pembrolizumab
Drug: cyclophosphamide

First Posted Date: 2015-04-10

Last Posted Date: 2025-05-18

Lead Sponsor: Memorial Sloan Kettering Cancer Center

Target Recruit Count: 113

Registration Number: NCT02414269

Locations: 🇺🇸
Memorial Sloan Kettering Basking Ridge (Consent and Follow-Up), Basking Ridge, New Jersey, United States
🇺🇸
Memorial Sloan Kettering Monmouth (Consent and Follow-Up), Middletown, New Jersey, United States
🇺🇸
Memorial Sloan Kettering Bergen (Consent and Follow-Up), Montvale, New Jersey, United States

and more 3 locations

Pembrolizumab in Treating Patients With Stage IV Metastatic or Recurrent Inflammatory Breast Cancer or Triple-Negative Breast Cancer Who Have Achieved Clinical Response or Stable Disease to Prior Chemotherapy

Phase 2

Active, not recruiting

Conditions: Edema
Progesterone Receptor Negative
Estrogen Receptor Negative
Peau d'Orange
HER2/Neu Negative
Stage IV Inflammatory Breast Carcinoma
Erythema
Recurrent Inflammatory Breast Carcinoma
Triple-Negative Breast Carcinoma