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 With Chemotherapy in Front Line Advanced Ovarian, Primary Peritoneal and Fallopian Tube Cancer

Phase 2

Recruiting

Conditions: Ovarian Cancer

Interventions: Drug: Pembrolizumab
Drug: Paclitaxel
Drug: Carboplatin

First Posted Date: 2018-01-25

Last Posted Date: 2023-03-24

Lead Sponsor: National Cancer Institute, Naples

Target Recruit Count: 72

Registration Number: NCT03410784

Locations: 🇮🇹
Ospedale Generale Regionale "F. Miulli ", Acquaviva delle Fonti, Italy
🇮🇹
Policlinico Universitario Gemelli Università Cattolica del Sacro Cuore, Roma, Italy
🇮🇹
Fondazione del Piemonte per l'Oncologia, Candiolo, Italy

and more 10 locations

Apatinib With Pembrolizumab in Previously Treated Advanced Malignancies

Phase 1

Terminated

Conditions: Advanced Malignancies
MSI-H or dMMR Solid Tumors
Urothelial Carcinoma
Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma

Interventions: Drug: Apatinib
Drug: Pembrolizumab

First Posted Date: 2018-01-23

Last Posted Date: 2020-07-15

Lead Sponsor: University of Utah

Target Recruit Count: 5

Registration Number: NCT03407976

Locations: 🇺🇸
Huntsman Cancer Institute, Salt Lake City, Utah, United States

Safety and Efficacy of Pembrolizumab (MK-3475) in Children and Young Adults With Classical Hodgkin Lymphoma (MK-3475-667/KEYNOTE-667)

Phase 2

Active, not recruiting

Conditions: Hodgkin Lymphoma

Interventions: Biological: pembrolizumab
Drug: doxorubicin
Drug: vinblastine
Drug: dacarbazine
Drug: cyclophosphamide
Drug: bleomycin
Drug: vincristine
Radiation: Radiotherapy (RT)
Drug: prednisone/prednisolone
Drug: etoposide

First Posted Date: 2018-01-23

Last Posted Date: 2024-11-20

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 340

Registration Number: NCT03407144

Locations: 🇺🇸
University of Chicago ( Site 0066), Chicago, Illinois, United States
🇺🇸
Cohen Children's Medical Center of New York ( Site 0052), New Hyde Park, New York, United States
🇺🇸
Columbia University/Herbert Irving Cancer Center ( Site 0063), New York, New York, United States

and more 90 locations

Study Testing The Safety and Efficacy of Adjuvant Temozolomide Plus TTFields (Optune®) Plus Pembrolizumab in Patients With Newly Diagnosed Glioblastoma (2-THE-TOP)

Phase 2

Active, not recruiting

Conditions: Glioblastoma
Glioblastoma, WHO Grade IV

Interventions: Drug: Temozolomide (TMZ)
Device: Optune System
Drug: Pembrolizumab

First Posted Date: 2018-01-23

Last Posted Date: 2024-10-23

Lead Sponsor: University of Florida

Target Recruit Count: 40

Registration Number: NCT03405792

Locations: 🇺🇸
University of Florida Health, Gainesville, Florida, United States

Study of Pembrolizumab Following TACE in Primary Liver Carcinoma

Phase 1

Active, not recruiting

Conditions: Primary Liver Carcinoma

Interventions: Drug: Pembrolizumab
Combination Product: Trans-arterial chemoembolization

First Posted Date: 2018-01-12

Last Posted Date: 2023-02-15

Lead Sponsor: Imperial College London

Target Recruit Count: 26

Registration Number: NCT03397654

Locations: 🇬🇧
Imperial College Healthcare NHS Trust, London, United Kingdom

Study of Boserolimab (MK-5890) as Monotherapy and in Combination With Pembrolizumab (MK-3475) in Adults With Advanced Solid Tumors (MK-5890-001)

Phase 1

Completed

Conditions: Solid Tumor
Pharmacokinetics
Carcinoma, Non-Small-Cell Lung
Triple Negative Breast Neoplasms

Interventions: Drug: Boserolimab
Biological: Pembrolizumab
Drug: Nab-paclitaxel
Drug: Pemetrexed
Drug: Carboplatin

First Posted Date: 2018-01-11

Last Posted Date: 2024-10-10

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 184

Registration Number: NCT03396445

Locations: 🇺🇸
Florida Cancer Specialists ( Site 0002), Sarasota, Florida, United States
🇮🇱
Soroka Medical Center-Oncology ( Site 0012), Be'er Sheva, Israel
🇺🇸
The West Clinic, P.C. ( Site 0021), Germantown, Tennessee, United States

and more 15 locations

Study of LYC-55716 With Pembrolizumab in Adult Subjects With Non-Small Cell Lung Cancer

Phase 1

Conditions: Non-small Cell Lung Cancer

Interventions: Drug: LYC-55716
Drug: Pembrolizumab

First Posted Date: 2018-01-11

Last Posted Date: 2019-09-25

Lead Sponsor: Lycera Corp.

Target Recruit Count: 17

Registration Number: NCT03396497

Locations: 🇺🇸
Lycera Investigational Site, Seattle, Washington, United States

Study of Pembrolizumab and Concurrent Radiation in Patients With Previously Treated Carcinoma of Unknown Primary

Phase 2

Terminated

Conditions: Carcinoma, Unspecified Site

Interventions: Drug: Pembrolizumab
Radiation: External Beam Radiation Therapy

First Posted Date: 2018-01-11

Last Posted Date: 2024-04-18

Lead Sponsor: Hoosier Cancer Research Network

Target Recruit Count: 14

Registration Number: NCT03396471

Locations: 🇺🇸
Mayo Clinic, Rochester, Minnesota, United States
🇺🇸
MD Anderson Cancer Center, Houston, Texas, United States

Study of Pembrolizumab Plus Fulvestrant in Hormone Receptor Positive, HER-2 Negative Advanced/Metastatic Breast Cancer Patients

Phase 2

Active, not recruiting

Conditions: Breast Cancer

Interventions: Drug: Pembrolizumab
Drug: Fulvestrant

First Posted Date: 2018-01-09

Last Posted Date: 2023-07-05

Lead Sponsor: Nancy Chan, MD

Target Recruit Count: 47

Registration Number: NCT03393845

Locations: 🇺🇸
Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey, United States
🇺🇸
Michigan State University, Breslin Cancer Center, Lansing, Michigan, United States
🇺🇸
New York University Clinical Cancer Center, New York, New York, United States

and more 2 locations

A Study of Erdafitinib Compared With Vinflunine or Docetaxel or Pembrolizumab in Participants With Advanced Urothelial Cancer and Selected Fibroblast Growth Factor Receptor (FGFR) Gene Aberrations

Phase 3

Active, not recruiting

Conditions: Urothelial Cancer

Interventions: Drug: Erdafitinib
Drug: Vinflunine
Drug: Pembrolizumab
Device: Fibroblast Growth Factor Receptor inhibitor Clinical Trial Assay (FGFRi CTA)
Drug: Docetaxel

First Posted Date: 2018-01-04

Last Posted Date: 2024-12-05

Lead Sponsor: Janssen Research & Development, LLC

Target Recruit Count: 629

Registration Number: NCT03390504

Locations: 🇨🇦
Saskatchewan Cancer Agency (SCA) - Allan Blair Cancer Centre, Regina, Saskatchewan, Canada
🇺🇸
University of Miami Sylvester Cancer Center, Miami, Florida, United States
🇺🇸
Oncology Hematology Care, Cincinnati, Ohio, United States

and more 343 locations

Drug Development Updates

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