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

Anti-PD(L)1 and SBRT in the Treatment of Advanced, Platinum-Refractory Urothelial Carcinoma

Phase 2

Terminated

Conditions: Urothelial Carcinoma

Interventions: Drug: Pembrolizumab
Radiation: SBRT

First Posted Date: 2017-09-19

Last Posted Date: 2021-12-15

Lead Sponsor: University of Michigan Rogel Cancer Center

Target Recruit Count: 6

Registration Number: NCT03287050

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

Augmentation of the Graft vs. Leukemia Effect Via Checkpoint Blockade With Pembrolizumab

Phase 1

Terminated

Conditions: Myelodysplastic Syndromes
Acute Lymphoblastic Leukemia
Acute Myeloid Leukemia

Interventions: Drug: Pembrolizumab

First Posted Date: 2017-09-18

Last Posted Date: 2022-11-04

Lead Sponsor: University of Michigan Rogel Cancer Center

Target Recruit Count: 16

Registration Number: NCT03286114

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

Combination of Pembrolizumab With TGR-1202 in Patients With Relapsed/Refractory CLL and B-cell NHL

Phase 1

Active, not recruiting

Conditions: CLL
B-cell Non Hodgkin Lymphoma

Interventions: Drug: TGR-1202
Drug: Pembrolizumab

First Posted Date: 2017-09-14

Last Posted Date: 2024-01-29

Lead Sponsor: University of Chicago

Target Recruit Count: 20

Registration Number: NCT03283137

Locations: 🇺🇸
Yale University, New Haven, Connecticut, United States
🇺🇸
Memorial Sloan Kettering Cancer Center, New York, New York, United States
🇺🇸
University of Chicago, Chicago, Illinois, United States

Study of Pembrolizumab (MK-3475) in Combination With Romidepsin

Phase 1

Active, not recruiting

Conditions: Recurrent Anaplastic Large Cell Lymphoma
Refractory Anaplastic Large Cell Lymphoma
Refractory Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma
Refractory Mycosis Fungoides
Refractory Peripheral T-Cell Lymphoma, Not Otherwise Specified
Recurrent Angioimmunoblastic T-Cell Lymphoma
Recurrent Mature T- and NK-Cell Non-Hodgkin Lymphoma
Recurrent Primary Cutaneous T-Cell Non-Hodgkin Lymphoma
Refractory Primary Cutaneous T-Cell Non-Hodgkin Lymphoma
Recurrent Mycosis Fungoides

Interventions: Biological: Pembrolizumab
Drug: Romidepsin

First Posted Date: 2017-09-12

Last Posted Date: 2024-12-12

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 39

Registration Number: NCT03278782

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

Phase II Trial of Pembrolizumab in Recurrent or Residual High Grade Meningioma

Phase 2

Active, not recruiting

Conditions: High Grade Meningioma

Interventions: Drug: Pembrolizumab

First Posted Date: 2017-09-12

Last Posted Date: 2024-04-16

Lead Sponsor: Massachusetts General Hospital

Target Recruit Count: 26

Registration Number: NCT03279692

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

INCAGN01876 in Combination With Immune Therapies in Subjects With Advanced or Metastatic Malignancies

Phase 1

Terminated

Conditions: Advanced Malignancies
Metastatic Cancer

Interventions: Drug: INCAGN01876
Drug: Epacadostat
Drug: Pembrolizumab

First Posted Date: 2017-09-11

Last Posted Date: 2021-07-22

Lead Sponsor: Incyte Biosciences International Sàrl

Target Recruit Count: 10

Registration Number: NCT03277352

Locations: 🇺🇸
The Angeles Clinic and Research Institute, Los Angeles, California, United States
🇺🇸
Hackensack University Medical Center, Hackensack, New Jersey, United States

Imiquimod and Pembrolizumab in Treating Patients With Stage IIIB-IV Melanoma

Early Phase 1

Active, not recruiting

Conditions: Metastatic Melanoma
Stage IIIB Cutaneous Melanoma AJCC V7
Stage IIIC Cutaneous Melanoma AJCC V7
Stage IV Cutaneous Melanoma AJCC V6 and V7

Interventions: Drug: Imiquimod
Procedure: Biopsy
Biological: Pembrolizumab
Procedure: Computed Tomography
Procedure: Positron Emission Tomography
Procedure: Magnetic Resonance Imaging

First Posted Date: 2017-09-08

Last Posted Date: 2024-07-30

Lead Sponsor: Mayo Clinic

Target Recruit Count: 7

Registration Number: NCT03276832

Locations: 🇺🇸
Mayo Clinic in Florida, Jacksonville, Florida, United States

Pembrolizumab in Combination With Doxorubicin in Advanced, Recurrent or Metastatic Endometrial Cancer

Phase 2

Completed

Conditions: Endometrial Neoplasms

Interventions: Drug: Pembrolizumab

First Posted Date: 2017-09-08

Last Posted Date: 2021-10-05

Lead Sponsor: Vall d'Hebron Institute of Oncology

Target Recruit Count: 48

Registration Number: NCT03276013

Locations: 🇪🇸
CUN - Madrid, Madrid, Spain
🇪🇸
Hospital Universitario Reina Sofía- Córdoba, Córdoba, Spain
🇪🇸
Hospital Vall d'Hebron, Barcelona, Spain

and more 4 locations

A Study of Cobimetinib Plus Atezolizumab Versus Pembrolizumab in Participants With Previously Untreated Advanced BRAFv600 Wild-Type Melanoma

Phase 3

Terminated

Conditions: Advanced BRAFV600 Wild-type Melanoma

Interventions: Drug: Cobimetinib
Drug: Pembrolizumab
Drug: Atezolizumab

First Posted Date: 2017-09-06

Last Posted Date: 2022-09-21

Lead Sponsor: Hoffmann-La Roche

Target Recruit Count: 446

Registration Number: NCT03273153

Locations: 🇺🇸
USC Norris Cancer Center; USC Oncology Hematology Newport Beach, Newport Beach, California, United States
🇺🇸
Florida Cancer Specialists, West Palm Beach, Florida, United States
🇺🇸
Northwestern University, Chicago, Illinois, United States

and more 118 locations

Azacitidine and Pembrolizumab in Pancreatic Cancer

Phase 2

Active, not recruiting

Conditions: Pancreas Cancer

Interventions: Drug: Pembrolizumab
Drug: Azacitidine

First Posted Date: 2017-08-29

Last Posted Date: 2023-07-05

Lead Sponsor: Ruth A. White, MD, PhD.

Target Recruit Count: 36

Registration Number: NCT03264404

Locations: 🇺🇸
Columbia University Irving Medical Center, New York, New York, United States

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