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

Targeting PD-1 Therapy Resistance With Focused High or High and Low Dose Radiation in SCCHN

Phase 2

Active, not recruiting

Conditions: Head and Neck Cancer

Interventions: Drug: Pembrolizumab
Radiation: Radiation

First Posted Date: 2017-03-21

Last Posted Date: 2024-01-10

Lead Sponsor: Dana-Farber Cancer Institute

Target Recruit Count: 18

Registration Number: NCT03085719

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

A Study of Epacadostat in Combination With Pembrolizumab and Chemotherapy in Participants With Advanced or Metastatic Solid Tumors (ECHO-207/KEYNOTE-723)

Phase 1

Completed

Conditions: Solid Tumor

Interventions: Drug: Epacadostat
Drug: Pembrolizumab
Drug: Oxaliplatin
Drug: Gemcitabine
Drug: Pemetrexed
Drug: Cyclophosphamide
Drug: nab-Paclitaxel
Drug: Carboplatin
Drug: Paclitaxel
Drug: Leucovorin
Drug: 5-Fluorouracil
Drug: Cisplatin
Drug: Investigator's choice of platinum agent

First Posted Date: 2017-03-21

Last Posted Date: 2022-09-23

Lead Sponsor: Incyte Corporation

Target Recruit Count: 70

Registration Number: NCT03085914

Locations: 🇺🇸
The Angeles Clinic and Research Institute, Los Angeles, California, United States
🇺🇸
MD Anderson Cancer Center, Houston, Texas, United States
🇺🇸
Mayo Clinic Arizona, Phoenix, Arizona, United States

and more 12 locations

Phase 1B Study Evaluating Alternative Routes of Administration of CMP-001 in Combination With Pembrolizumab in Participants With Advanced Melanoma

Phase 1

Completed

Conditions: Malignant Melanoma

Interventions: Drug: CMP-001
Drug: Pembrolizumab

First Posted Date: 2017-03-21

Last Posted Date: 2022-08-03

Lead Sponsor: Regeneron Pharmaceuticals

Target Recruit Count: 30

Registration Number: NCT03084640

Locations: 🇺🇸
University of Colorado, Aurora, Colorado, United States
🇺🇸
University of California, Los Angeles, Los Angeles, California, United States
🇺🇸
University of Iowa Hospitals and Clinics, Iowa City, Iowa, United States

and more 1 locations

Phase II Trial of Continuation Therapy in Advanced NSCLC

Phase 2

Completed

Conditions: Non-Small-Cell Lung Cancer

Interventions: Drug: Pembrolizumab

First Posted Date: 2017-03-20

Last Posted Date: 2023-08-24

Lead Sponsor: Greg Durm, MD

Target Recruit Count: 35

Registration Number: NCT03083808

Locations: 🇺🇸
University of Illinois Cancer Center, Chicago, Illinois, United States
🇺🇸
University of Iowa Hospital Clinics, Iowa City, Iowa, United States
🇺🇸
University of Minnesota Medcical Center, Minneapolis, Minnesota, United States

and more 2 locations

Pembrolizumab in Recurrent or Metastatic Medullary Thyroid Cancer

Phase 2

Completed

Conditions: Medullary Thyroid Cancer (MTC)

Interventions: Drug: Pembrolizumab

First Posted Date: 2017-03-07

Last Posted Date: 2021-02-11

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 17

Registration Number: NCT03072160

Locations: 🇺🇸
National Institutes of Health Clinical Center, Bethesda, Maryland, United States

Safety and Efficacy of IMCgp100 Versus Investigator Choice in Advanced Uveal Melanoma

Phase 2

Active, not recruiting

Conditions: Uveal Melanoma

Interventions: Biological: IMCgp100
Drug: Dacarbazine
Biological: Ipilimumab
Biological: Pembrolizumab

First Posted Date: 2017-03-03

Last Posted Date: 2024-12-03

Lead Sponsor: Immunocore Ltd

Target Recruit Count: 378

Registration Number: NCT03070392

Locations: 🇺🇸
Portland Providence Medical Center, Portland, Oregon, United States
🇺🇸
UCLA Medical Center, Los Angeles, California, United States
🇺🇸
The Angeles Clinic and Research Institute, Los Angeles, California, United States

and more 53 locations

A Study of Talimogene Laherparepvec (T-VEC) in Combination With Pembrolizumab in Patients With Metastatic and/or Locally Advanced Sarcoma

Phase 2

Active, not recruiting

Conditions: Sarcoma
Epithelioid Sarcoma
Cutaneous Angiosarcoma

Interventions: Drug: Talimogene Laherparepvec (T-VEC)
Drug: Pembrolizumab

First Posted Date: 2017-03-03

Last Posted Date: 2024-07-30

Lead Sponsor: Memorial Sloan Kettering Cancer Center

Target Recruit Count: 41

Registration Number: NCT03069378

Locations: 🇺🇸
Memorial Sloan Kettering Cancer Center, New York, New York, United States
🇺🇸
MD Anderson Cancer Center (Data Analysis Only), Houston, Texas, United States
🇺🇸
Enable Medicine (Specimen Analysis Only), Menlo Park, California, United States

and more 2 locations

Pembrolizumab, Radiotherapy, and Chemotherapy in Neoadjuvant Treatment of Malignant Esophago-gastric Diseases (PROCEED)

Phase 2

Completed

Conditions: Locally Advanced Esophageal and Gastric Cancers (EGC)

Interventions: Drug: Pembrolizumab

First Posted Date: 2017-02-27

Last Posted Date: 2024-03-13

Lead Sponsor: Duke University

Target Recruit Count: 35

Registration Number: NCT03064490

Locations: 🇺🇸
Duke Cancer Center, Durham, North Carolina, United States

PD-1 Inhibition in Advanced Myeloproliferative Neoplasms

Phase 2

Completed

Conditions: Primary Myelofibrosis
Chronic Phase Myelofibrosis
Post-essential Thrombocythemia Myelofibrosis
Polycythemia Vera

Interventions: Drug: Pembrolizumab

First Posted Date: 2017-02-27

Last Posted Date: 2021-06-21

Lead Sponsor: John Mascarenhas

Target Recruit Count: 10

Registration Number: NCT03065400

Locations: 🇺🇸
Icahn School of Medicine at Mount Sinai, New York, New York, United States
🇺🇸
Harvard Medical School Massachusetts General Hospital, Boston, Massachusetts, United States
🇺🇸
Montefiore Medical Center Division of Hematology, Department of Oncology, Bronx, New York, United States

Study of Pembrolizumab (MK-3475) or Placebo Given With Best Supportive Care in Asian Participants With Previously Treated Advanced Hepatocellular Carcinoma (MK-3475-394/KEYNOTE-394)

Phase 3

Completed

Conditions: Carcinoma, Hepatocellular

Interventions: Drug: placebo
Biological: pembrolizumab
Other: best supportive care (BSC)

First Posted Date: 2017-02-23

Last Posted Date: 2024-11-05

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 453

Registration Number: NCT03062358

Locations: 🇨🇳
Beijing Cancer Hospital ( Site 0010), Beijing, China
🇨🇳
Zhongshan Hospital Fudan University ( Site 0012), Shanghai, China
🇨🇳
Renji Hosp,Shanghai Jiao Tong University School of Medicine ( Site 0017), Shanghai, China

and more 38 locations

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