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

Immunotherapy With or Without Radiation Therapy for Metastatic Urothelial Cancer

Phase 2

Terminated

Conditions: Metastatic Urothelial Carcinoma
Platinum-Resistant Urothelial Carcinoma
Stage IV Bladder Cancer AJCC v8

Interventions: Procedure: Biospecimen Collection
Procedure: Bone Scan
Procedure: Computed Tomography
Procedure: Magnetic Resonance Imaging
Biological: Pembrolizumab
Procedure: Positron Emission Tomography
Other: Questionnaire Administration
Radiation: Stereotactic Body Radiation Therapy

First Posted Date: 2021-06-23

Last Posted Date: 2024-11-27

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 1

Registration Number: NCT04936230

Locations: 🇺🇸
Springfield Memorial Hospital, Springfield, Illinois, United States
🇺🇸
Marshfield Medical Center - Minocqua, Minocqua, Wisconsin, United States
🇺🇸
Littleton Adventist Hospital, Littleton, Colorado, United States

and more 80 locations

NeoVax + CDX-301 and Nivolumab or Pembrolizumab in Melanoma

Phase 1

Recruiting

Conditions: Metastatic Melanoma
Melanoma

Interventions: Drug: CDX-301
Biological: NEOVAX
Drug: Nivolumab
Drug: Pembrolizumab

First Posted Date: 2021-06-18

Last Posted Date: 2024-03-27

Lead Sponsor: Dana-Farber Cancer Institute

Target Recruit Count: 30

Registration Number: NCT04930783

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

Sitravatinib Plus Pembrolizumab in Patients With Advanced Treatment-Naïve PD-L1+ Non-Squamous NSCLC

Phase 2

Terminated

Conditions: Lung Neoplasms
Metastatic Lung Non-Small Cell Carcinoma
Sitravatinib
Carcinoma, Non-Small-Cell Lung
PD-L1 Gene Mutation
Advanced Treatment-Naïve PD-L1
Lung Diseases
Stage IV Lung Non-Small Cell Cancer AJCC v7
Pembrolizumab

Interventions: Drug: Sitravatinib
Drug: Pembrolizumab

First Posted Date: 2021-06-14

Last Posted Date: 2024-01-30

Lead Sponsor: Sarah Goldberg

Target Recruit Count: 9

Registration Number: NCT04925986

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

Efficacy and Safety of Pembrolizumab Plus Investigational Agents in Combination With Chemotherapy as First-Line Treatment in Extensive-Stage Small Cell Lung Cancer (ES-SCLC) (MK-3475-B99/ KEYNOTE-B99)

Phase 2

Active, not recruiting

Conditions: Small Cell Lung Cancer

Interventions: Biological: Pembrolizumab
Drug: Lenvatinib
Biological: MK-4830
Biological: Boserolimab
Drug: Etoposide
Drug: Cisplatin
Drug: Carboplatin

First Posted Date: 2021-06-11

Last Posted Date: 2024-11-19

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 120

Registration Number: NCT04924101

Locations: 🇺🇸
UPMC Hillman Cancer Center ( Site 0127), Pittsburgh, Pennsylvania, United States
🇺🇸
MFSMC-HJWCI-Oncology Research ( Site 0128), Baltimore, Maryland, United States
🇺🇸
Cleveland Clinic-Taussig Cancer Center ( Site 0116), Cleveland, Ohio, United States

and more 46 locations

Pembrolizumab (MK-3475) Plus Gemcitabine/Cisplatin Versus Placebo Plus Gemcitabine/Cisplatin for First-Line Advanced and/or Unresectable Biliary Tract Carcinoma (BTC) (MK-3475-966/KEYNOTE-966)-China Extension Study

Phase 3

Active, not recruiting

Conditions: Biliary Tract Carcinoma

Interventions: Biological: Pembrolizumab
Drug: Gemcitabine
Drug: Placebo
Drug: Cisplatin

First Posted Date: 2021-06-11

Last Posted Date: 2024-03-26

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 158

Registration Number: NCT04924062

Locations: 🇨🇳
Anhui Provincial Hospital ( Site 0140), Hefei, Anhui, China
🇨🇳
Beijing Cancer Hospital ( Site 0138), Beijing, Beijing, China
🇨🇳
Peking Union Medical College Hospital ( Site 0150), Beijing, Beijing, China

and more 19 locations

DPX-Survivac and Pembrolizumab With and Without Intermittent Low-Dose Cyclophosphamide, in Subjects With Relapsed/Refractory Diffuse Large B-Cell Lymphoma

Phase 2

Recruiting

Conditions: Relapsed Diffuse Large B-cell Lymphoma
Refractory Diffuse Large B-cell Lymphoma

Interventions: Drug: DPX-Survivac
Drug: Pembrolizumab
Drug: CPA

First Posted Date: 2021-06-10

Last Posted Date: 2023-04-07

Lead Sponsor: ImmunoVaccine Technologies, Inc. (IMV Inc.)

Target Recruit Count: 102

Registration Number: NCT04920617

Locations: 🇺🇸
Boca Raton Regional Hospital, Boca Raton, Florida, United States
🇺🇸
BRCR Medical Center Inc., Plantation, Florida, United States
🇺🇸
Blood and Marrow Transplant Group of Georgia, Atlanta, Georgia, United States

and more 46 locations

A Study of SAR444245 Combined With Other Anticancer Therapies for the Treatment of Participants With Lung Cancer or Mesothelioma (Pegathor Lung 202)

Phase 2

Terminated

Conditions: Pleural Mesothelioma
Non-small Cell Lung Cancer

Interventions: Drug: THOR-707
Drug: Pembrolizumab

First Posted Date: 2021-06-07

Last Posted Date: 2024-10-23

Lead Sponsor: Sanofi

Target Recruit Count: 106

Registration Number: NCT04914897

Locations: 🇮🇹
Investigational Site Number : 3800005, Aviano (PN), Friuli-Venezia Giulia, Italy
🇮🇹
Investigational Site Number : 3800001, Rozzano, Milano, Italy
🇰🇷
Investigational Site Number : 4100001, Seoul, Seoul-teukbyeolsi, Korea, Republic of

and more 32 locations

REduced Frequency ImmuNE Checkpoint Inhibition in Cancers

Phase 2

Recruiting

Conditions: Renal Cell Carcinoma
Melanoma

Interventions: Drug: Nivolumab
Drug: Pembrolizumab

First Posted Date: 2021-06-04

Last Posted Date: 2022-09-21

Lead Sponsor: University College, London

Target Recruit Count: 160

Registration Number: NCT04913025

Locations: 🇬🇧
Addenbrooke's Hospital, Cambridge, Cambridgeshire, United Kingdom
🇬🇧
The Christie, Manchester, United Kingdom
🇬🇧
Castle Hill Hospital, Hull, United Kingdom