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

Neoadjuvant Pembrolizumab and IO102-103 for Squamous Cell Carcinoma of the Head and Neck (SCCHN).

Phase 2

Recruiting

Conditions: Head and Neck Squamous Cell Carcinoma

Interventions: Drug: Pembrolizumab
Drug: IO102-103

First Posted Date: 2023-08-07

Last Posted Date: 2024-02-13

Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Target Recruit Count: 15

Registration Number: NCT05977907

Locations: 🇺🇸
Northwestern Memorial Hospital, Chicago, Illinois, United States
🇺🇸
Providence Cancer Institute, Portland, Oregon, United States
🇺🇸
Johns Hopkins University, Baltimore, Maryland, United States

and more 2 locations

Lenvatinib, Pembrolizumab, and Tumor Treating Fields (TTFields) for Second-line Treatment of Glioblastoma

Phase 1

Withdrawn

Conditions: GBM

Interventions: Drug: Lenvatinib
Drug: Pembrolizumab
Device: Tumor Treating Fields (TTFields)

First Posted Date: 2023-08-03

Last Posted Date: 2024-12-04

Lead Sponsor: Tel Aviv Medical Center

Target Recruit Count: 47

Registration Number: NCT05973903

A Single-Arm Study of Pembrolizumab With Gemcitabine and Cisplatin as Perioperative Therapy for Potentially Resectable Intrahepatic Cholangiocarcinoma

Phase 2

Recruiting

Conditions: Cholangiocarcinoma

Interventions: Drug: Pembrolizumab
Drug: Gemcitabine
Drug: Cisplatin

First Posted Date: 2023-08-01

Last Posted Date: 2024-03-21

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 24

Registration Number: NCT05967182

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

Neoadjuvant Pembrolizumab and Axitinib in Renal Cell Carcinoma with Inferior Vena Cava Tumor Thrombus

Phase 2

Recruiting

Conditions: Kidney Cancer
Renal Cancer
Inferior Vena Cava Thrombosis
Renal Cell Carcinoma

Interventions: Drug: Axitinib
Drug: Pembrolizumab

First Posted Date: 2023-08-01

Last Posted Date: 2024-10-23

Lead Sponsor: University of Colorado, Denver

Target Recruit Count: 17

Registration Number: NCT05969496

Locations: 🇺🇸
University of Colorado Cancer Center, Aurora, Colorado, United States

Propranolol and Pembrolizumab in Advanced Soft Tissue Sarcoma Patients

Phase 2

Recruiting

Conditions: Soft Tissue Sarcoma Adult
Undifferentiated Pleomorphic Sarcoma
Angiosarcoma

Interventions: Drug: Propranolol
Drug: Pembrolizumab

First Posted Date: 2023-07-27

Last Posted Date: 2023-07-27

Lead Sponsor: Niels Junker

Target Recruit Count: 80

Registration Number: NCT05961761

Locations: 🇳🇴
Oslo University Hospital, Oslo, Norway
🇩🇰
Herlev Gentofte Hospital, Herlev, Denmark
🇩🇰
Aarhus University Hospital, Aarhus, Denmark

and more 1 locations

Pembrolizumab and Mogamulizumab in Advanced-stage, Relapsed/Refractory Cutaneous T-cell Lymphomas

Phase 2

Recruiting

Conditions: Cutaneous T Cell Lymphoma
Fungoides Mycosis Sezary Syndrome

Interventions: Drug: Pembrolizumab
Drug: Mogamulizumab

First Posted Date: 2023-07-21

Last Posted Date: 2024-01-12

Lead Sponsor: University of Michigan Rogel Cancer Center

Target Recruit Count: 23

Registration Number: NCT05956041

Locations: 🇺🇸
University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan, United States

Phase 2 Futibatinib in Combination With PD-1 Antibody Based Standard of Care in Solid Tumors

Phase 2

Recruiting

Conditions: Esophageal Squamous Cell Cancer
Locally Advanced Unresectable or Metastatic Solid Tumors Including Esophageal Cancer
Siewert Type 1 GEJ Cancer
Pancreatic Cancer
Esophageal Adenocarcinoma

Interventions: Drug: Futibatinib
Drug: Pembrolizumab
Drug: Cisplatin
Drug: 5-FU
Drug: Oxaliplatin
Drug: Leucovorin
Drug: Irinotecan
Drug: Levoleucovorin

First Posted Date: 2023-07-14

Last Posted Date: 2025-01-07

Lead Sponsor: Taiho Oncology, Inc.

Target Recruit Count: 66

Registration Number: NCT05945823

Locations: 🇺🇸
University of California Los Angeles UCLA - Cancer Care - Santa Monica, Santa Monica, California, United States
🇺🇸
Rocky Mountain Cancer Centers Midtown, Denver, Colorado, United States
🇺🇸
Mount Sinai Comprehensive Cancer Center, Miami Beach, Florida, United States

and more 19 locations

Pembro Plus CAR T-cell Therapy in R/R in PMBCL

Phase 2

Recruiting

Conditions: Primary Mediastinal Large B-cell Lymphoma (PMBCL)
Primary Mediastinal Large B Cell Lymphoma
Primary Mediastinal Large B-Cell Lymphoma Refractory
Primary Mediastinal Large B-Cell Lymphoma Recurrent
Epstein-Barr Virus Positive Diffuse Large B-Cell Lymphoma
T-Cell/Histiocyte-Rich Large B-Cell Lymphoma

Interventions: Drug: Pembrolizumab
Drug: Lymphodepletion Chemotherapy
Drug: Chimeric Antigen Receptor (CAR) Therapy Infusion
Procedure: Leukapheresis

First Posted Date: 2023-07-07

Last Posted Date: 2024-12-18

Lead Sponsor: Jennifer Crombie, MD

Target Recruit Count: 35

Registration Number: NCT05934448

Locations: 🇺🇸
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
🇺🇸
Memorial Sloan Kettering Cancer Center, New York, New York, United States

A Clinical Study of V940 Plus Pembrolizumab in People With High-Risk Melanoma (V940-001)

Phase 3

Active, not recruiting

Conditions: Melanoma

Interventions: Biological: Pembrolizumab
Biological: V940
Other: Placebo

First Posted Date: 2023-07-06

Last Posted Date: 2024-11-18

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 1089

Registration Number: NCT05933577

Locations: 🇨🇳
Chang Gung Memorial Hospital at Kaohsiung (Site 4000), Kaohsiung, Taiwan
🇨🇳
National Cheng Kung University Hospital-Clinical Trial Center ( Site 4004), Tainan, Taiwan
🇨🇳
National Taiwan University Hospital (Site 4001), Taipei, Taiwan

and more 162 locations

Shorter Chemo-Immunotherapy Without Anthracycline Drugs for Early-Stage Triple Negative Breast Cancer

Phase 3

Recruiting

Conditions: Anatomic Stage II Breast Cancer AJCC v8
Anatomic Stage IIIA Breast Cancer AJCC v8
Anatomic Stage I Breast Cancer AJCC v8
Anatomic Stage IIIB Breast Cancer AJCC v8
Early Stage Triple-Negative Breast Carcinoma

Interventions: Procedure: Biospecimen Collection
Drug: Carboplatin
Drug: Cyclophosphamide
Drug: Docetaxel
Biological: Pembrolizumab
Drug: Doxorubicin
Other: Quality-of-Life Assessment
Drug: Paclitaxel
Other: Questionnaire Administration
Procedure: Surgical Procedure

First Posted Date: 2023-07-03

Last Posted Date: 2024-10-31

Lead Sponsor: SWOG Cancer Research Network

Target Recruit Count: 2400

Registration Number: NCT05929768

Locations: 🇺🇸
Northwestern Medicine Cancer Center Warrenville, Warrenville, Illinois, United States
🇺🇸
Cedars Sinai Medical Center, Los Angeles, California, United States
🇺🇸
Cancer Center of Kansas-Independence, Independence, Kansas, United States

and more 427 locations

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