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 in the First Line Therapy for R/M HNSCC in China

Conditions: Head and Neck Squamous Cell Carcinoma

First Posted Date: 2021-02-05

Last Posted Date: 2022-02-07

Lead Sponsor: Shi Yuankai

Target Recruit Count: 30

Registration Number: NCT04740996

Locations: 🇨🇳
Cancer Institute/Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China

Coformulation of Pembrolizumab/Vibostolimab (MK-7684A) Versus Pembrolizumab (MK-3475) Monotherapy for Programmed Cell Death 1 Ligand 1 (PD-L1) Positive Metastatic Non-Small Cell Lung Cancer (MK-7684A-003, KEYVIBE-003)

Phase 3

Active, not recruiting

Conditions: Lung Neoplasms
Non-Small-Cell Lung Carcinoma

Interventions: Biological: Pembrolizumab/Vibostolimab
Biological: Pembrolizumab

First Posted Date: 2021-02-04

Last Posted Date: 2024-11-08

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 1264

Registration Number: NCT04738487

Locations: 🇺🇸
Boca Raton Regional Hospital ( Site 0004), Boca Raton, Florida, United States
🇺🇸
Illinois Cancer Care ( Site 0026), Peoria, Illinois, United States
🇺🇸
Mercy Research - David C. Pratt Cancer Center ( Site 0025), Saint Louis, Missouri, United States

and more 185 locations

A Study of Pembrolizumab (MK-3475) in Combination With Belzutifan (MK-6482) and Lenvatinib (MK-7902), or Pembrolizumab/Quavonlimab (MK-1308A) in Combination With Lenvatinib, Versus Pembrolizumab and Lenvatinib, for Treatment of Advanced Clear Cell Renal Cell Carcinoma (MK-6482-012)

Phase 3

Active, not recruiting

Conditions: Carcinoma, Renal Cell

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

First Posted Date: 2021-02-03

Last Posted Date: 2024-11-18

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 1653

Registration Number: NCT04736706

Locations: 🇺🇸
Hartford Hospital ( Site 0024), Hartford, Connecticut, United States
🇺🇸
Cedars Sinai Medical Center ( Site 0027), Los Angeles, California, United States
🇺🇸
New England Cancer Specialists ( Site 0082), Scarborough, Maine, United States

and more 259 locations

Study Evaluating Effectiveness and Safety of Zimberelimab and Domvanalimab in Lung Cancer

Phase 2

Active, not recruiting

Conditions: Squamous Non Small Cell Lung Cancer
Non Small Cell Lung Cancer
Nonsquamous Non Small Cell Lung Cancer
Lung Cancer

Interventions: Drug: Domvanalimab
Drug: Carboplatin
Drug: Pembrolizumab
Drug: Zimberelimab
Drug: Paclitaxel
Drug: Pemetrexed

First Posted Date: 2021-02-03

Last Posted Date: 2025-01-01

Lead Sponsor: Arcus Biosciences, Inc.

Target Recruit Count: 169

Registration Number: NCT04736173

Locations: 🇺🇸
City of Hope-Duarte, Duarte, California, United States
🇺🇸
City of Hope - Huntington Beach (Including Long Beach Elm), Huntington Beach, California, United States
🇺🇸
City Of Hope, Irvine, California, United States

and more 108 locations

Fecal Microbiota Transplant and Re-introduction of Anti-PD-1 Therapy (Pembrolizumab or Nivolumab) for the Treatment of Metastatic Colorectal Cancer in Anti-PD-1 Non-responders

Phase 2

Active, not recruiting

Conditions: Metastatic Small Intestinal Adenocarcinoma
Stage IV Colorectal Cancer AJCC v8
Stage IV Small Intestinal Adenocarcinoma AJCC v8
Stage IVB Colorectal Cancer AJCC v8
Metastatic Colorectal Adenocarcinoma
Stage IVC Colorectal Cancer AJCC v8
Stage IVA Colorectal Cancer AJCC v8

Interventions: Procedure: Biopsy
Procedure: Fecal Microbiota Transplantation
Drug: Fecal Microbiota Transplantation Capsule
Drug: Metronidazole
Drug: Neomycin
Biological: Nivolumab
Biological: Pembrolizumab
Other: Questionnaire Administration
Drug: Vancomycin

First Posted Date: 2021-01-28

Last Posted Date: 2024-12-12

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 15

Registration Number: NCT04729322

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

Pembrolizumab And Lenvatinib In Leptomeningeal Metastases

Phase 2

Terminated

Conditions: Solid Tumor
Solid Tumor, Adult
Leptomeningeal Metastasis

Interventions: Drug: Pembrolizumab
Drug: Lenvatinib

First Posted Date: 2021-01-28

Last Posted Date: 2024-03-15

Lead Sponsor: Massachusetts General Hospital

Target Recruit Count: 10

Registration Number: NCT04729348

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

JAB-3312 Based Combination Therapy in Adult Patients With Advanced Solid Tumors

Phase 1

Recruiting

Conditions: Solid Tumor
NSCLC

Interventions: Drug: JAB-3312
Drug: Binimetinib
Drug: Pembrolizumab
Drug: Sotorasib
Drug: Osimertinib

First Posted Date: 2021-01-22

Last Posted Date: 2023-05-18

Lead Sponsor: Jacobio Pharmaceuticals Co., Ltd.

Target Recruit Count: 200

Registration Number: NCT04720976

Locations: 🇺🇸
Research Site, Salt Lake City, Utah, United States

Study of SAR444881 Administered Alone and in Combination With Other Therapeutics in Participants With Advanced Solid Tumors

Phase 1

Recruiting

Conditions: Neoplasm
Cancer

Interventions: Drug: SAR444881
Drug: Pembrolizumab
Drug: Cetuximab
Drug: Carboplatin
Drug: Pemetrexed

First Posted Date: 2021-01-22

Last Posted Date: 2024-12-27

Lead Sponsor: Sanofi

Target Recruit Count: 456

Registration Number: NCT04717375

Locations: 🇺🇸
University of Colorado- Site Number : 8400012, Aurora, Colorado, United States
🇺🇸
Mayo Clinic Hospital- Site Number : 8400003, Phoenix, Arizona, United States
🇺🇸
City of Hope Comprehensive Cancer Center- Site Number : 8400002, Duarte, California, United States

and more 15 locations

Safety and Efficacy Study of Pemetrexed + Platinum Chemotherapy + Pembrolizumab (MK-3475) With or Without Lenvatinib (MK-7902/E7080) as First-line Intervention in Adults With Metastatic Nonsquamous Non-small Cell Lung Cancer (MK-7902-006/E7080-G000-315/LEAP-006)-China Extension Study

Phase 3

Completed

Conditions: Nonsquamous Non-small Cell Lung Cancer

Interventions: Biological: Pembrolizumab
Drug: Carboplatin
Drug: Cisplatin
Drug: Pemetrexed
Drug: Placebo matching lenvatinib
Drug: Lenvatinib

First Posted Date: 2021-01-20

Last Posted Date: 2024-10-04

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 201

Registration Number: NCT04716933

Locations: 🇨🇳
Fujian Provincial Cancer Hospital ( Site 0102), Fuzhou, Fujian, China
🇨🇳
Cancer Hospital Affiliated to Xinjiang Medical University ( Site 0110), Urumuqi, Xinjiang, China
🇨🇳
The First Affiliated Hospital of Wenzhou Medical University ( Site 0124), Wen Zhou, Zhejiang, China

and more 16 locations

Combination of Pembrolizumab and Lenvatinib, in Pre-treated Thymic CArcinoma paTIents

Phase 2

Active, not recruiting

Conditions: Metastatic Thymic Carcinoma
Thymoma Type B3

Interventions: Drug: Pembrolizumab
Drug: Lenvatinib 10 mg

First Posted Date: 2021-01-15

Last Posted Date: 2024-08-09

Lead Sponsor: MedSIR

Target Recruit Count: 43

Registration Number: NCT04710628

Locations: 🇫🇷
Institut Bergonié, Bordeaux, France
🇫🇷
Centre Oscar Lambert, Lille, France
🇫🇷
Hôpitaux Universitaires de Marseille - Hôpital Nord, Marseille, France

and more 10 locations

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