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 and Brentuximab Vedotin in Subjects With Relapsed/Refractory T-cell Lymphoma

Phase 2

Recruiting

Conditions: T-Cell Lymphoma

Interventions: Drug: Brentuximab vedotin
Drug: Pembrolizumab

First Posted Date: 2022-04-06

Last Posted Date: 2024-06-05

Lead Sponsor: Yale University

Target Recruit Count: 43

Registration Number: NCT05313243

Locations: 🇺🇸
Yale Smilow Cancer Hospital, New Haven, Connecticut, United States

A Study of IMU-131 (HER-Vaxx) in Combination with Chemotherapy or Pembrolizumab in Patients with Metastatic HER2/neu Over-Expressing Gastric Cancer (nextHERIZON)

Phase 2

Completed

Conditions: Gastric Cancer
Stomach Adenocarcinoma
Stomach Cancer
Gastric Adenocarcinoma
Cancer of Stomach
Gastroesophageal Junction Adenocarcinoma

Interventions: Biological: IMU-131
Drug: Ramucirumab plus Paclitaxel
Biological: Pembrolizumab

First Posted Date: 2022-04-05

Last Posted Date: 2024-10-24

Lead Sponsor: Imugene Limited

Target Recruit Count: 7

Registration Number: NCT05311176

Locations: 🇨🇳
National Taiwan University Hospital, Taipei, Taiwan
🇨🇳
Kaohsiung Medical University Hospital, Kaohsiung City, Taiwan
🇨🇳
National Cheng Kung University Hospital, Tainan City, Taiwan

and more 4 locations

Lenvatinib Plus Pembrolizumab In Patients With Immune Checkpoint Inhibitor Naïve Metastatic Uveal Melanoma

Phase 2

Active, not recruiting

Conditions: Melanoma, Uveal

Interventions: Drug: Pembrolizumab
Drug: Lenvatinib

First Posted Date: 2022-04-04

Last Posted Date: 2024-12-05

Lead Sponsor: Providence Health & Services

Target Recruit Count: 6

Registration Number: NCT05308901

Locations: 🇺🇸
Providence Portland Medical Center, Portland, Oregon, United States

Overcoming Primary Resistance to Immunotherapy in Metastatic Melanoma

Phase 2

Not yet recruiting

Conditions: Immunotherapy
BRAF V600E
Malignant Melanoma Stage IV
Metastatic Melanoma
Malignant Melanoma

Interventions: Drug: Pembrolizumab
Drug: Encorafenib
Drug: Binimetinib

First Posted Date: 2022-03-31

Last Posted Date: 2023-06-05

Lead Sponsor: Dr. Ronnie Shapira

Target Recruit Count: 12

Registration Number: NCT05304546

Neoadjuvant Pembrolizumab Plus Chemotherapy for Resectable Locally Advanced Esophageal Squamous Cell Carcinoma

Phase 2

Completed

Conditions: Esophageal Squamous Cell Carcinoma

Interventions: Drug: Pembrolizumab
Drug: Carboplatin or Cisplatin
Drug: Docetaxel

First Posted Date: 2022-03-31

Last Posted Date: 2023-10-10

Lead Sponsor: Peking Union Medical College Hospital

Target Recruit Count: 28

Registration Number: NCT05302011

Locations: 🇨🇳
Peking Union Medical College Hospital, Beijing, Beijing, China

Pembrolizumab and Lenvatinib in Clear Cell Ovarian Cancer

Phase 2

Recruiting

Conditions: Ovarian Clear Cell Carcinoma
Gynecologic Cancer

Interventions: Drug: Lenvatinib
Drug: Pembrolizumab

First Posted Date: 2022-03-25

Last Posted Date: 2024-01-26

Lead Sponsor: Elizabeth K. Lee MD

Target Recruit Count: 31

Registration Number: NCT05296512

Locations: 🇺🇸
University of Chicago Medicine, Chicago, Illinois, United States
🇺🇸
Dana Farber Cancer Institute, Boston, Massachusetts, United States
🇺🇸
Mayo Clinic Comprehensive Cancer Center, Rochester, Minnesota, United States

A Study of Pembrolizumab (MK-3475) Plus Platinum and Gemcitabine as First Line Treatment of Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma (PIPER)

Phase 2

Recruiting

Conditions: Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma

Interventions: Drug: Pembrolizumab
Drug: Cisplatin
Drug: Carboplatin
Drug: Gemcitabine

First Posted Date: 2022-03-18

Last Posted Date: 2024-10-14

Lead Sponsor: University of Malaya

Target Recruit Count: 63

Registration Number: NCT05286619

Locations: 🇲🇾
University Malaya Medical Centre, Kuala Lumpur, Malaysia

Pembrolizumab Plus Chemo in Neoadjuvant Treatment of Esophageal Squamous Cell Carcinoma (Eastern Cooperative Thoracic Oncology Projects 2004, ECTOP-2004)

Phase 2

Recruiting

Conditions: Esophageal Squamous Cell Carcinoma

Interventions: Drug: Pembrolizumab
Drug: Paclitaxel
Drug: Cisplatin

First Posted Date: 2022-03-15

Last Posted Date: 2023-07-13

Lead Sponsor: Fudan University

Target Recruit Count: 128

Registration Number: NCT05281003

Locations: 🇨🇳
Fudan University Cancer Center, Shanghai, Shanghai, China
🇨🇳
Fudan University Shanghai Cancer Center, Shanghai, Shanghai, China

A Pilot Study to Assess Changes in Tumor Biology Following Second-line Treatment With Pembrolizumab Plus Lenvatinib in Patients With Advanced Pancreatic Ductal Adenocarcinoma

Phase 1

Active, not recruiting

Conditions: Tumor
Adenocarcinoma

Interventions: Drug: Pembrolizumab
Drug: lenvatinib

First Posted Date: 2022-03-10

Last Posted Date: 2024-10-22

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 14

Registration Number: NCT05273554

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

A Phase 2 Open Label Study of BA3021 in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck

Phase 2

Recruiting

Conditions: Metastatic Cancer
Head and Neck Cancer
Squamous Cell Carcinoma of Head and Neck
Metastatic Squamous Cell Carcinoma of the Head and Neck
Recurrent Squamous Cell Carcinoma of the Head and Neck

Interventions: Biological: Ozuriftamab Vedotin
Biological: Cetuximab
Biological: Pembrolizumab
Biological: Evalstotug (BA3071)

First Posted Date: 2022-03-09

Last Posted Date: 2023-09-29

Lead Sponsor: BioAtla, Inc.

Target Recruit Count: 80

Registration Number: NCT05271604

Locations: 🇺🇸
USC Norris Comprehensive Cancer Center, Los Angeles, California, United States
🇺🇸
Christiana Care Helen Graham Cancer Center, Newark, Delaware, United States
🇺🇸
Northwestern University, Chicago, Illinois, United States

and more 5 locations

Drug Development Updates

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