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

Pembrolizumab, IRX-2, and Chemotherapy in Triple Negative Breast Cancer

Phase 2

Active, not recruiting

Conditions: Breast Cancer
Breast Neoplasms

Interventions: Drug: Pembrolizumab
Drug: IRX 2

First Posted Date: 2020-05-04

Last Posted Date: 2024-06-21

Lead Sponsor: Providence Health & Services

Target Recruit Count: 12

Registration Number: NCT04373031

Locations: 🇺🇸
Providence Portland Medical Center, Portland, Oregon, United States

RTX-240 Monotherapy and in Combination With Pembrolizumab

Phase 1

Terminated

Conditions: Solid Tumor, AML Adult

Interventions: Drug: RTX-240
Drug: Pembrolizumab

First Posted Date: 2020-05-04

Last Posted Date: 2022-12-13

Lead Sponsor: Rubius Therapeutics

Target Recruit Count: 69

Registration Number: NCT04372706

Locations: 🇺🇸
Virginia Cancer Specialists, Fairfax, Virginia, United States
🇺🇸
Sylvester Comprehensive Cancer Center/UMHC, Miami, Florida, United States
🇺🇸
University of California San Diego, La Jolla, California, United States

and more 8 locations

Study of Relacorilant in Combination With Pembrolizumab for Patients With Adrenocortical Carcinoma Which Produces Too Much Stress Hormone (Cortisol)

Phase 1

Completed

Conditions: Adrenocortical Carcinoma

Interventions: Drug: Relacorilant
Drug: Pembrolizumab

First Posted Date: 2020-05-04

Last Posted Date: 2024-02-23

Lead Sponsor: Corcept Therapeutics

Target Recruit Count: 15

Registration Number: NCT04373265

Locations: 🇺🇸
Site #183, The University of Texas M.D. Anderson Cancer Center, Houston, Texas, United States
🇺🇸
Site #030 Mayo Clinic, Rochester, Minnesota, United States
🇺🇸
Site #150, Stanford Cancer Center, Stanford, California, United States

and more 3 locations

Pembrolizumab With or Without Axitinib for Treatment of Locally Advanced or Metastatic Clear Cell Kidney Cancer in Patients Undergoing Surgery

Phase 2

Recruiting

Conditions: Recurrent Clear Cell Renal Cell Carcinoma
Stage III Renal Cell Cancer AJCC v8
Clear Cell Renal Cell Carcinoma
Metastatic Clear Cell Renal Cell Carcinoma
Stage IV Renal Cell Cancer AJCC v8

Interventions: Drug: Axitinib (VEGF-TKI)
Procedure: Cytoreductive Nephrectomy (CN)
Procedure: Metastasectomy (MET)
Biological: Pembrolizumab

First Posted Date: 2020-05-01

Last Posted Date: 2024-10-04

Lead Sponsor: University of California, San Francisco

Target Recruit Count: 84

Registration Number: NCT04370509

Locations: 🇺🇸
University of California, San Francisco, San Francisco, California, United States

HPV-16 Vaccination and Pembrolizumab Plus Cisplatin for "Intermediate Risk" HPV-16-associated Head and Neck Squamous Cell Carcinoma

Phase 2

Active, not recruiting

Conditions: HPV-Related Squamous Cell Carcinoma
Head and Neck Squamous Cell Carcinoma

Interventions: Radiation: IMRT (Intensity Modulated Radiotherapy)
Drug: Pembrolizumab
Drug: Cisplatin
Biological: ISA101b

First Posted Date: 2020-04-30

Last Posted Date: 2024-10-04

Lead Sponsor: Dan Zandberg

Target Recruit Count: 18

Registration Number: NCT04369937

Locations: 🇺🇸
UPMC Hillman Cancer Center, Pittsburgh, Pennsylvania, United States

Study of Dara-Pembro for Multiple Myeloma Patients

Phase 2

Withdrawn

Conditions: Multiple Myeloma

Interventions: Drug: Pembrolizumab

First Posted Date: 2020-04-24

Last Posted Date: 2022-04-26

Lead Sponsor: Wake Forest University Health Sciences

Registration Number: NCT04361851

Lurbinectedin (PM01183) Combined With Pembrolizumab in Small Cell Lung Cancer.

Phase 1

Active, not recruiting

Conditions: Small Cell Lung Carcinoma

Interventions: Drug: Lurbinectedin
Drug: Pembrolizumab

First Posted Date: 2020-04-24

Last Posted Date: 2024-08-19

Lead Sponsor: Antonio Calles Blanco

Target Recruit Count: 28

Registration Number: NCT04358237

Locations: 🇪🇸
Hospital Vall D´Hebrón, Barcelona, Spain
🇪🇸
ICO - Instituto Catalán de Oncología, Barcelona, Spain
🇪🇸
START - Phase I Unit - HN San Chinarro, Madrid, Spain

and more 2 locations

Safety and Feasibility of PD-1 Blockade in the Treatment of dMMR or MSI-H Rectal Cancer

Phase 1

Completed

Conditions: Rectal Neoplasms

Interventions: Drug: Pembrolizumab
Radiation: External beam radiation
Drug: Capecitabine

First Posted Date: 2020-04-22

Last Posted Date: 2024-05-29

Lead Sponsor: Case Comprehensive Cancer Center

Target Recruit Count: 6

Registration Number: NCT04357587

Locations: 🇺🇸
Cleveland Clinic, Case Comprehensive Cancer Center, Cleveland, Ohio, United States

Dendritic Cell Vaccines Against Her2/Her3 and Pembrolizumab for the Treatment of Brain Metastasis From Triple Negative Breast Cancer or HER2+ Breast Cancer

Phase 2

Recruiting

Conditions: Metastatic Triple-Negative Breast Carcinoma
Anatomic Stage IV Breast Cancer AJCC v8
Metastatic Malignant Neoplasm in the Brain
Prognostic Stage IV Breast Cancer AJCC v8

Interventions: Biological: Anti-HER2/HER3 Dendritic Cell Vaccine
Biological: Pembrolizumab

First Posted Date: 2020-04-16

Last Posted Date: 2024-06-24

Lead Sponsor: Roswell Park Cancer Institute

Target Recruit Count: 23

Registration Number: NCT04348747

Locations: 🇺🇸
Moffitt Cancer Center, Tampa, Florida, United States
🇺🇸
Roswell Park Cancer Institute, Buffalo, New York, United States
🇺🇸
University of Virginia Comprehensive Cancer Center, Charlottesville, Virginia, United States

Phase 1a/1b Study of TPST-1495 as a Single Agent and in Combination With Pembrolizumab in Subjects With Solid Tumors

Phase 1

Active, not recruiting

Conditions: Endometrial Cancer
Gastric Adenocarcinoma
Solid Tumor
Colorectal Cancer
Squamous Cell Carcinoma of Head and Neck
Non Small Cell Lung Cancer
Urothelial Carcinoma
Solid Tumors With PIK3Ca Mutation
Gastroesophageal Junction Adenocarcinoma

Interventions: Drug: TPST-1495 once daily or on intermittent schedule
Drug: TPST-1495 twice daily
Drug: Pembrolizumab

First Posted Date: 2020-04-14

Last Posted Date: 2024-10-16

Lead Sponsor: Tempest Therapeutics

Target Recruit Count: 175

Registration Number: NCT04344795

Locations: 🇺🇸
University of Colorado, Aurora, Colorado, United States
🇺🇸
Baystate Gynecologic Oncology, Springfield, Massachusetts, United States
🇺🇸
University of Michigan Rogel Cancer Center, Ann Arbor, Michigan, United States

and more 8 locations

Drug Development Updates

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