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

Biomarkers to Predict the Response to Pembrolizumab in Chinese NSCLC Patients

Completed

Conditions: NSCLC Stage IV

Interventions: Drug: Pembrolizumab

First Posted Date: 2019-09-03

Last Posted Date: 2020-09-02

Lead Sponsor: Kiang Wu Hospital

Target Recruit Count: 37

Registration Number: NCT04076228

Locations: 🇨🇳
Kiang Wu Hospital, Macao, China

Binimetinib Encorafenib Pembrolizumab +/- Stereotactic Radiosurgery in BRAFV600 Melanoma With Brain Metastasis

Phase 2

Active, not recruiting

Conditions: BRAF V600 Mutation
Malignant Melanoma
Brain Metastases

Interventions: Radiation: Stereotaxic radiosurgery (SRS)
Drug: Binimetinib Oral Tablet
Drug: Pembrolizumab
Drug: Encorafenib Oral Capsule

First Posted Date: 2019-08-29

Last Posted Date: 2024-06-03

Lead Sponsor: UNICANCER

Target Recruit Count: 10

Registration Number: NCT04074096

Locations: 🇫🇷
APHP - Hôpital Avicenne, Bobigny, France
🇫🇷
CHU de Caen, Caen, France
🇫🇷
CHU de Bordeaux - Hôpital Saint André, Bordeaux, France

and more 18 locations

Talimogene Laherparepvec With Pembrolizumab in Melanoma Following Progression on Prior Anti-PD-1 Based Therapy (MASTERKEY-115) (Mk-3475-A07/KEYNOTE-A07).

Phase 2

Completed

Conditions: Melanoma

Interventions: Drug: Talimogene laherparepvec
Drug: Pembrolizumab

First Posted Date: 2019-08-28

Last Posted Date: 2025-01-07

Lead Sponsor: Amgen

Target Recruit Count: 72

Registration Number: NCT04068181

Locations: 🇺🇸
New York Oncology Hematology, PC, Albany, New York, United States
🇺🇸
United States Oncology Regulatory Affairs Corporate Office, The Woodlands, Texas, United States
🇺🇸
Cleveland Clinic, Cleveland, Ohio, United States

and more 43 locations

GB1275 Monotherapy and in Combination With an Anti-PD1 Antibody in Patients With Specified Advanced Solid Tumors or in Combination With Standard of Care in Patients With Metastatic Pancreatic Adenocarcinoma

Phase 1

Terminated

Conditions: Pancreatic Adenocarcinoma
Esophageal Adenocarcinoma
Gastroesophageal Junction Adenocarcinoma
Triple Negative Breast Cancer
Castration-resistant Prostate Cancer
Microsatellite Stable Colorectal Cancer
Non-small Cell Lung Cancer
Esophageal Squamous Cell Carcinoma
Gastric Adenocarcinoma
Small-cell Lung Cancer

Interventions: Drug: GB1275
Drug: nab-paclitaxel and gemcitabine
Drug: pembrolizumab

First Posted Date: 2019-08-19

Last Posted Date: 2022-08-18

Lead Sponsor: GB006, Inc., a wholly owned subsidiary of Gossamer Bio, Inc.

Target Recruit Count: 61

Registration Number: NCT04060342

Locations: 🇺🇸
Memorial Sloan Kettering Cancer Center, New York, New York, United States
🇺🇸
Duke University Medical Center, Durham, North Carolina, United States
🇺🇸
South Texas Accelerated Research Therapeutics, LLC, San Antonio, Texas, United States

and more 5 locations

AMD3100 Plus Pembrolizumab in Immune Checkpoint Blockade Refractory Head and Neck Squamous Cell Carcinoma

Phase 2

Withdrawn

Conditions: Head and Neck Cancer

Interventions: Drug: AMD3100
Drug: Pembrolizumab

First Posted Date: 2019-08-15

Last Posted Date: 2020-09-07

Lead Sponsor: Massachusetts General Hospital

Registration Number: NCT04058145

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

Phase 1b/II Trial of Pembrolizumab Plus IMRT in Stage III/IV Carcinoma of Anus

Phase 1

Conditions: Anal Cancer Stage III B
Anal Cancer Stage III A

Interventions: Drug: Pembrolizumab

First Posted Date: 2019-08-06

Last Posted Date: 2021-05-28

Lead Sponsor: Cardiff University

Target Recruit Count: 50

Registration Number: NCT04046133

Locations: 🇳🇴
Oslo University Hospital, Oslo, Norway
🇬🇧
Aberdeen Royal Informary, Aberdeen, Scotland, United Kingdom
🇬🇧
Mount Vernon Cancer Centre, Northwood, United Kingdom

DS8201a and Pembrolizumab in Participants With Locally Advanced/Metastatic Breast or Non-Small Cell Lung Cancer

Phase 1

Recruiting

Conditions: Breast Cancer
Non-small Cell Lung Carcinoma

Interventions: Drug: Trastuzumab deruxtecan (DS-8201a)
Drug: Pembrolizumab

First Posted Date: 2019-08-02

Last Posted Date: 2024-11-12

Lead Sponsor: Daiichi Sankyo

Target Recruit Count: 115

Registration Number: NCT04042701

Locations: 🇺🇸
Moffitt Cancer Center, Tampa, Florida, United States
🇺🇸
Univ. of Cali. San Francisco Medical Center, San Francisco, California, United States
🇺🇸
Yale Cancer Center, New Haven, Connecticut, United States

and more 28 locations

Neoadjuvant Therapy of Pembrolizumab + Ramucirumab for PD-L1 Positive Stage IB-IIIA Lung Cancer (EAST ENERGY)

Phase 2

Recruiting

Conditions: Non-small Cell Lung Cancer Stage IB
Non-small Cell Lung Cancer Stage ⅢA
Non-small Cell Lung Cancer Stage II

Interventions: Drug: Pembrolizumab
Drug: Ramucirumab
Procedure: Surgery

First Posted Date: 2019-07-31

Last Posted Date: 2022-04-06

Lead Sponsor: Masahiro Tsuboi

Target Recruit Count: 24

Registration Number: NCT04040361

Locations: 🇯🇵
National Cancer Center Hospital East, Kashiwa, Chiba, Japan
🇯🇵
Tokyo Medical University Hospita, Shinjuku-Ku, Tokyo, Japan

Addition of SNS-301 to Checkpoint Inhibitor Treatment in Metastatic/Recurrent SCCHN

Phase 1

Terminated

Conditions: Squamous Cell Carcinoma of the Head and Neck

Interventions: Drug: SNS-301
Drug: Pembrolizumab

First Posted Date: 2019-07-26

Last Posted Date: 2023-03-24

Lead Sponsor: Sensei Biotherapeutics, Inc.

Target Recruit Count: 25

Registration Number: NCT04034225

Locations: 🇺🇸
Alliance for Multispeciality Research, Kansas City, Missouri, United States
🇺🇸
Christiana Care, Newark, Delaware, United States
🇺🇸
Georgetown University, Washington, District of Columbia, United States

and more 7 locations

A Study of Ladiratuzumab Vedotin in Advanced Solid Tumors

Phase 2

Terminated

Conditions: Melanoma
Small Cell Lung Cancer
Non-small Cell Lung Cancer, Non-squamous
Prostate Cancer
Non-small Cell Lung Cancer, Squamous
Esophageal Squamous Cell Carcinoma
Head and Neck Squamous Cell Carcinoma
Gastric Adenocarcinoma
Gastroesophageal Junction Adenocarcinoma

Interventions: Drug: ladiratuzumab vedotin
Drug: pembrolizumab

First Posted Date: 2019-07-25

Last Posted Date: 2024-04-17

Lead Sponsor: Seagen Inc.

Target Recruit Count: 205

Registration Number: NCT04032704

Locations: 🇺🇸
FirstHealth of the Carolinas, Pinehurst, North Carolina, United States
🇺🇸
Adventist Health White Memorial, Los Angeles, California, United States
🇺🇸
Northwestern University, Chicago, Illinois, United States

and more 63 locations

Drug Development Updates

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