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

Phase II Study of Olaparib and Pembrolizumab in Advanced Melanoma With Homologous Recombination (HR) Mutation

Phase 2

Recruiting

Conditions: Metastatic Melanoma

Interventions: Drug: Olaparib
Drug: Pembrolizumab

First Posted Date: 2020-11-18

Last Posted Date: 2022-12-06

Lead Sponsor: California Pacific Medical Center Research Institute

Target Recruit Count: 41

Registration Number: NCT04633902

Locations: 🇺🇸
The University of Texas MD Anderson Cancer Center, Houston, Texas, United States
🇺🇸
California Pacific Medical Center Research Institute, San Francisco, California, United States

Substudy 03B: A Study of Immune and Targeted Combination Therapies in Participants With Second Line Plus (2L+) Renal Cell Carcinoma (MK-3475-03B)

Phase 1

Active, not recruiting

Conditions: Carcinoma, Renal Cell

Interventions: Biological: Favezelimab/Pembrolizumab
Biological: Pembrolizumab
Biological: Pembrolizumab/Quavonlimab
Drug: Belzutifan
Biological: MK-4830
Drug: Lenvatinib

First Posted Date: 2020-11-12

Last Posted Date: 2024-11-18

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 370

Registration Number: NCT04626518

Locations: 🇺🇸
UTSW Medical Center ( Site 3003), Dallas, Texas, United States
🇺🇸
University of Chicago ( Site 3013), Chicago, Illinois, United States
🇺🇸
Yale-New Haven Hospital-Yale Cancer Center ( Site 3011), New Haven, Connecticut, United States

and more 48 locations

Substudy 03A: A Study of Immune and Targeted Combination Therapies in Participants With First Line (1L) Renal Cell Carcinoma (MK-3475-03A)

Phase 1

Active, not recruiting

Conditions: Carcinoma, Renal Cell

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

First Posted Date: 2020-11-12

Last Posted Date: 2024-11-18

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 400

Registration Number: NCT04626479

Locations: 🇳🇱
Nederlands Kanker Instituut - Antoni van Leeuwenhoek (NKI-AVL)-medical oncology ( Site 2402), Amsterdam, Noord-Holland, Netherlands
🇨🇱
CIDO SpA-Oncology ( Site 2106), Temuco, Araucania, Chile
🇬🇧
The Christie NHS Foundation Trust ( Site 1400), Manchester, United Kingdom

and more 52 locations

Tazemetostat and Pembrolizumab in Patients With Pembrolizumab- or Nivolumab-Resistant, Recurrent or Metastatic Head and Neck Squamous-Cell Carcinoma

Phase 1

Terminated

Conditions: Head and Neck Squamous Cell Carcinoma

Interventions: Drug: Tazemetostat
Drug: Pembrolizumab

First Posted Date: 2020-11-10

Last Posted Date: 2024-02-21

Lead Sponsor: Washington University School of Medicine

Target Recruit Count: 13

Registration Number: NCT04624113

Locations: 🇺🇸
Washington University School of Medicine, Saint Louis, Missouri, United States

A Study of Tiragolumab in Combination With Atezolizumab Plus Pemetrexed and Carboplatin/Cisplatin Versus Pembrolizumab Plus Pemetrexed and Carboplatin/Cisplatin in Participants With Previously Untreated Advanced Non-Squamous Non-Small Cell Lung Cancer

Phase 2

Active, not recruiting

Conditions: Non-small Cell Lung Cancer (NSCLC)

Interventions: Drug: Tiragolumab
Drug: Atezolizumab
Drug: Pemetrexed
Drug: Tiragolumab Matching Placebo
Drug: Carboplatin
Drug: Cisplatin
Drug: Pembrolizumab

First Posted Date: 2020-11-06

Last Posted Date: 2024-12-11

Lead Sponsor: Hoffmann-La Roche

Target Recruit Count: 542

Registration Number: NCT04619797

Locations: 🇧🇪
Vitaz, Sint Niklaas, Belgium
🇫🇷
CHU Strasbourg - Nouvel Hopital Civil, Strasbourg, France
🇯🇵
The Cancer Institute Hospital of JFCR, Tokyo, Japan

and more 137 locations

In Situ Immunomodulation with CDX-301, Radiation Therapy, CDX-1140 and Poly-ICLC in Patients W/ Unresectable and Metastatic Solid Tumors

Phase 1

Recruiting

Conditions: Unresectable Melanoma
Cutaneous Squamous Cell Carcinoma
Merkel Cell Carcinoma
Soft Tissue Sarcoma
Bone Sarcoma
Sarcoma,Soft Tissue
Anatomic Stage IV Breast Cancer AJCC V8
Metastatic Breast Carcinoma
Prognostic Stage IV Breast Cancer AJCC V8
Unresectable Breast Carcinoma

Interventions: Biological: Anti-CD40 Agonist Monoclonal Antibody CDX-1140
Drug: Poly ICLC
Radiation: Radiation Therapy
Biological: Recombinant Flt3 Ligand
Drug: Pembrolizumab
Drug: Tocilizumab

First Posted Date: 2020-11-04

Last Posted Date: 2024-12-16

Lead Sponsor: University of Southern California

Target Recruit Count: 18

Registration Number: NCT04616248

Locations: 🇺🇸
Los Angeles General Medical Center, Los Angeles, California, United States
🇺🇸
USC/Norris Comprehensive Cancer Center, Los Angeles, California, United States

Phase 2 Trial of Adagrasib Monotherapy and in Combination With Pembrolizumab and a Phase 3 Trial of Adagrasib in Combination in Patients With a KRAS G12C Mutation KRYSTAL-7

Phase 2

Recruiting

Conditions: Advanced Non-Small Cell Lung Cancer
Metastatic Non-Small Cell Lung Cancer

Interventions: Drug: Adagrasib
Drug: Pembrolizumab

First Posted Date: 2020-11-03

Last Posted Date: 2025-01-08

Lead Sponsor: Mirati Therapeutics Inc.

Target Recruit Count: 806

Registration Number: NCT04613596

Locations: 🇺🇸
USOR - Texas Oncology - Dallas Fort Worth (DFW) - South Austin, Austin, Texas, United States
🇺🇸
USOR - Texas Oncology - Dallas Fort Worth (DFW) - Odessa West Texas Cancer Center, Odessa, Texas, United States
🇦🇺
Canberra Hospital, Garran, Australia

and more 521 locations

Pilot Trial of SP-2577 Plus Pembrolizumab in Select Gynecologic Cancers

Phase 1

Withdrawn

Conditions: SCCOHT
Ovarian Endometrioid Adenocarcinoma
Endometrial Cancer
Ovarian Clear Cell Tumor

Interventions: Drug: SP-2577
Drug: Pembrolizumab

First Posted Date: 2020-11-02

Last Posted Date: 2022-03-02

Lead Sponsor: HonorHealth Research Institute

Registration Number: NCT04611139

Locations: 🇺🇸
HonorHealth Research Institute, Scottsdale, Arizona, United States

Brentuximab Vedotin With Pembrolizumab in Metastatic Solid Tumors

Phase 2

Recruiting

Conditions: Non-small Cell Lung Cancer
Melanoma
Squamous Cell Carcinoma of the Head and Neck

Interventions: Drug: brentuximab vedotin
Drug: pembrolizumab

First Posted Date: 2020-10-30

Last Posted Date: 2024-11-13

Lead Sponsor: Seagen Inc.

Target Recruit Count: 140

Registration Number: NCT04609566

Locations: 🇺🇸
Arizona Oncology Associates, PC - HOPE, Tucson, Arizona, United States
🇺🇸
Highlands Oncology Group, Springdale, Arkansas, United States
🇺🇸
cCARE - Northern, Fresno, California, United States

and more 31 locations

Study of SNX281 in Subjects With Advanced Solid Tumors and Lymphoma

Phase 1

Terminated

Conditions: Advanced Solid Tumor
Advanced Lymphoma

Interventions: Drug: SNX281
Drug: pembrolizumab

First Posted Date: 2020-10-30

Last Posted Date: 2024-01-30

Lead Sponsor: Stingthera, Inc.

Target Recruit Count: 27

Registration Number: NCT04609579

Locations: 🇺🇸
Sarah Cannon Research Institute at HealthONE, Denver, Colorado, United States
🇺🇸
Tennessee Oncology, Nashville, Tennessee, United States
🇺🇸
Florida Cancer Specialists, Sarasota, Florida, United States

and more 1 locations

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