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

APX005M in Combination With Systemic Pembrolizumab in Patients With Metastatic Melanoma

Phase 1

Active, not recruiting

Conditions: Melanoma

Interventions: Drug: APX005M
Drug: Pembrolizumab

First Posted Date: 2016-03-11

Last Posted Date: 2024-12-12

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 32

Registration Number: NCT02706353

Locations: 🇺🇸
University of Texas MD Anderson Cancer Center, Houston, Texas, United States

Pembrolizumab and GM-CSF in Biliary Cancer

Phase 2

Completed

Conditions: Biliary Cancer

Interventions: Drug: Pembrolizumab
Drug: Sargramostim

First Posted Date: 2016-03-09

Last Posted Date: 2022-01-25

Lead Sponsor: Robin Kate Kelley

Target Recruit Count: 42

Registration Number: NCT02703714

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

Efficacy Study of Pembrolizumab With Entinostat to Treat Metastatic Melanoma of the Eye

Phase 2

Completed

Conditions: Metastatic Uveal Melanoma

Interventions: Drug: Pembrolizumab
Drug: Entinostat

First Posted Date: 2016-03-03

Last Posted Date: 2023-12-08

Lead Sponsor: Vastra Gotaland Region

Target Recruit Count: 29

Registration Number: NCT02697630

Locations: 🇸🇪
Department of oncology, Sahlgrenska University Hospital, Gothenburg, Västra Götaland Region, Sweden

TAPUR: Testing the Use of Food and Drug Administration (FDA) Approved Drugs That Target a Specific Abnormality in a Tumor Gene in People With Advanced Stage Cancer

First Posted Date: 2016-02-26

Last Posted Date: 2024-11-11

Lead Sponsor: American Society of Clinical Oncology

Target Recruit Count: 3791

Registration Number: NCT02693535

Locations: 🇺🇸
University of Alabama at Birmingham Comprehensive Cancer Center, Birmingham, Alabama, United States
🇺🇸
Cancer Treatment Centers of America-Phoenix, Phoenix, Arizona, United States
🇺🇸
Sutter Auburn, Auburn, California, United States

and more 125 locations

A Study of Pembrolizumab in Patients With Malignant Peripheral Nerve Sheath Tumor (MPNST), Not Eligible for Curative Surgery

Phase 2

Terminated

Conditions: Malignant Peripheral Nerve Sheath Tumour (MPNST)

Interventions: Drug: Pembrolizumab

First Posted Date: 2016-02-24

Last Posted Date: 2021-06-23

Lead Sponsor: Oslo University Hospital

Target Recruit Count: 8

Registration Number: NCT02691026

Locations: 🇳🇴
Oslo university Hospital, Oslo, Norway

Pembrolizumab in Anaplastic/Undifferentiated Thyroid Cancer

Phase 2

Completed

Conditions: Anaplastic Thyroid Cancer

Interventions: Drug: Pembrolizumab

First Posted Date: 2016-02-23

Last Posted Date: 2022-02-10

Lead Sponsor: Saad A Khan

Target Recruit Count: 6

Registration Number: NCT02688608

Locations: 🇺🇸
UT Southwestern Medical Center, Dallas, Texas, United States

Phase II Trial of Sequential Consolidation With Pembrolizumab Followed by Nab-paclitaxel

Phase 2

Completed

Conditions: Non Small Cell Lung Cancer

Interventions: Drug: Pembrolizumab

First Posted Date: 2016-02-18

Last Posted Date: 2022-06-03

Lead Sponsor: UNC Lineberger Comprehensive Cancer Center

Target Recruit Count: 20

Registration Number: NCT02684461

Locations: 🇺🇸
Inova Schar Cancer Institute, Fairfax, Virginia, United States
🇺🇸
Rex Cancer Center, Raleigh, North Carolina, United States
🇺🇸
UT Southwestern Medical Center, Dallas, Texas, United States

and more 2 locations

Study of Pembrolizumab (MK-3475) vs. Brentuximab Vedotin in Participants With Relapsed or Refractory Classical Hodgkin Lymphoma (MK-3475-204/KEYNOTE-204)

Phase 3

Active, not recruiting

Conditions: Hodgkin Lymphoma

Interventions: Biological: brentuximab vedotin
Biological: pembrolizumab

First Posted Date: 2016-02-17

Last Posted Date: 2024-11-11

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 304

Registration Number: NCT02684292

Clinical Study of CMP-001 in Combination With Pembrolizumab or as a Monotherapy

Phase 1

Completed

Conditions: Melanoma

Interventions: Drug: CMP-001
Drug: Pembrolizumab

First Posted Date: 2016-02-11

Last Posted Date: 2023-01-11

Lead Sponsor: Regeneron Pharmaceuticals

Target Recruit Count: 199

Registration Number: NCT02680184

Locations: 🇺🇸
Georgetown, Washington, District of Columbia, United States
🇺🇸
University of Iowa Hospitals and Clinics, Iowa City, Iowa, United States
🇺🇸
Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States

and more 10 locations

Phase 1 Study of IMP321 (Eftilagimod Alpha) Adjuvant to Anti-PD-1 Therapy in Unresectable or Metastatic Melanoma

Phase 1

Completed

Conditions: Stage IV Melanoma
Stage III Melanoma

Interventions: Drug: IMP321 (eftilagimod alpha)
Drug: Pembrolizumab

First Posted Date: 2016-02-08

Last Posted Date: 2019-12-18

Lead Sponsor: Immutep Australia Pty. Ltd.

Target Recruit Count: 24

Registration Number: NCT02676869

Locations: 🇦🇺
Princess Alexandra Hospital, Brisbane, Queensland, Australia
🇦🇺
Fiona Stanley Hospital, Perth, Western Australia, Australia
🇦🇺
Ballarat Hospital, Ballarat, Victoria, Australia

and more 4 locations

Drug Development Updates

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