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 Study Evaluating Whether Pembrolizumab Alone or in Combination With CMP-001 Improves Efficacy of Treatment in Patients With Operable Melanoma

Phase 2

Suspended

Conditions: Clinical Stage III Cutaneous Melanoma AJCC v8
Melanoma of Unknown Primary
Pathologic Stage IIIB Cutaneous Melanoma AJCC v8
Pathologic Stage IIIC Cutaneous Melanoma AJCC v8
Pathologic Stage IIID Cutaneous Melanoma AJCC v8
Recurrent Cutaneous Melanoma

Interventions: Procedure: Biopsy
Procedure: Biospecimen Collection
Procedure: Computed Tomography
Biological: Pembrolizumab
Procedure: Positron Emission Tomography
Procedure: Surgical Procedure
Drug: VLP-encapsulated TLR9 Agonist CMP-001

First Posted Date: 2021-01-14

Last Posted Date: 2024-12-27

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 60

Registration Number: NCT04708418

Locations: 🇺🇸
Springfield Memorial Hospital, Springfield, Illinois, United States
🇺🇸
Marshfield Medical Center - Minocqua, Minocqua, Wisconsin, United States
🇺🇸
Anchorage Associates in Radiation Medicine, Anchorage, Alaska, United States

and more 185 locations

Pembrolizumab Plus Lenvatinib for First-line Advanced/Metastatic Non-clear Cell Renal Cell Carcinoma (1L nccRCC) (MK-3475-B61)

Phase 2

Active, not recruiting

Conditions: Renal Cell Carcinoma

Interventions: Biological: Pembrolizumab
Drug: Lenvatinib

First Posted Date: 2021-01-11

Last Posted Date: 2024-11-28

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 152

Registration Number: NCT04704219

Locations: 🇺🇸
Comprehensive Cancer Centers of Nevada ( Site 0010), Las Vegas, Nevada, United States
🇺🇦
Chernihiv Medical Center of Modern Oncology ( Site 0509), Chernihiv, Chernihivska Oblast, Ukraine
🇷🇺
Russian Scientific Center of Radiology-Russian Scientific Center of Radiology ( Site 0602), Moscow, Moskva, Russian Federation

and more 53 locations

Cryoablation With Pembrolizumab Or Avelumab In Urothelial Carcinoma

Phase 2

Recruiting

Conditions: Metastatic Urothelial Carcinoma
Bladder Cancer

Interventions: Drug: Pembrolizumab
Procedure: Cryoablation
Drug: Avelumab

First Posted Date: 2021-01-08

Last Posted Date: 2024-04-16

Lead Sponsor: Massachusetts General Hospital

Target Recruit Count: 30

Registration Number: NCT04701918

Locations: 🇺🇸
Massachusetts General Hospital Cancer Center, Boston, Massachusetts, United States
🇺🇸
Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States

Substudy 02D: Safety and Efficacy of Pembrolizumab in Combination With Investigational Agents or Pembrolizumab Alone in Participants With Melanoma Brain Metastasis (MK-3475-02D/KEYMAKER-U02)

Phase 1

Active, not recruiting

Conditions: Melanoma

Interventions: Biological: Pembrolizumab
Biological: Pembrolizumab/Quavonlimab
Drug: Lenvatinib

First Posted Date: 2021-01-07

Last Posted Date: 2024-11-19

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 300

Registration Number: NCT04700072

Locations: 🇺🇸
The Angeles Clinic and Research Institute ( Site 4009), Los Angeles, California, United States
🇺🇸
UCLA Hematology & Oncology ( Site 4004), Los Angeles, California, United States
🇺🇸
Martha Morehouse Tower ( Site 4020), Columbus, Ohio, United States

and more 33 locations

The Study of NC318 Alone or in Combination With Pembrolizumab in Patients With Advanced Non-small Cell Lung Cancer

Phase 2

Recruiting

Conditions: Advanced Non-small Cell Lung Cancer

Interventions: Drug: NC318 400 mg
Drug: NC318 800 mg
Drug: Pembrolizumab

First Posted Date: 2021-01-07

Last Posted Date: 2024-05-24

Lead Sponsor: Yale University

Target Recruit Count: 159

Registration Number: NCT04699123

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

Perioperative Enfortumab Vedotin (EV) Plus Pembrolizumab (MK-3475) Versus Neoadjuvant Chemotherapy for Cisplatin-Eligible Muscle Invasive Bladder Cancer (MIBC) (MK-3475-B15/ KEYNOTE-B15 / EV-304)

Phase 3

Active, not recruiting

Conditions: Bladder Cancer

Interventions: Biological: Pembrolizumab
Biological: Enfortumab vedotin (EV)
Drug: Gemcitabine
Procedure: RC + PLND
Drug: Cisplatin

First Posted Date: 2021-01-07

Last Posted Date: 2024-12-24

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 808

Registration Number: NCT04700124

Locations: 🇯🇵
Gifu University Hospital ( Site 1513), Gifu, Japan
🇷🇺
Volgograd Regional Uronephrological Center ( Site 0870), Volzhsky, Volgogradskaya Oblast, Russian Federation
🇺🇦
Municipal Non-profit Enterprise of Kharkiv Regional Council RCSDRPP ( Site 0965), Kharkiv, Kharkivska Oblast, Ukraine

and more 185 locations

Regorafenib Plus Pembrolizumab in Patients With Advanced or Spreading Liver Cancer Who Have Been Previously Treated With PD-1/PD-L1 Immune Checkpoint Inhibitors

Phase 2

Completed

Conditions: Hepatocellular Carcinoma

Interventions: Drug: Pembrolizumab
Drug: Regorafenib (Stivarga, BAY73-4506)

First Posted Date: 2021-01-06

Last Posted Date: 2024-05-01

Lead Sponsor: Bayer

Target Recruit Count: 95

Registration Number: NCT04696055

Locations: 🇺🇸
City of Hope National Medical Center, Duarte, California, United States
🇩🇪
Eberhard-Karls-Universität Tübingen, Tübingen, Baden-Württemberg, Germany
🇫🇷
Hôpital de la Croix Rousse, Lyon, France

and more 36 locations

Intralesional Influenza Vaccine for the Treatment of Stage I-IV Melanoma

Phase 1

Recruiting

Conditions: Clinical Stage I Cutaneous Melanoma AJCC V8
Clinical Stage IA Cutaneous Melanoma AJCC V8
Clinical Stage IB Cutaneous Melanoma AJCC V8
Clinical Stage II Cutaneous Melanoma AJCC V8
Clinical Stage IIA Cutaneous Melanoma AJCC V8
Clinical Stage IIB Cutaneous Melanoma AJCC V8
Clinical Stage IIC Cutaneous Melanoma AJCC V8
Clinical Stage IV Cutaneous Melanoma AJCC V8
Metastatic Melanoma