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

Safety and Efficacy of NEO212 in Patients with Astrocytoma IDH-mutant, Glioblastoma IDH-wildtype or Brain Metastasis

Phase 1

Recruiting

Conditions: Glioblastoma, IDH-wildtype
Head and Neck Squamous Cell Carcinoma
Melanoma
Merkel Cell Carcinoma
Mismatch Repair Deficient Solid Malignant Tumor
Microsatellite Instability-High Colorectal Cancer
Colorectal Cancer
Microsatellite Instability-High Solid Malignant Tumor
Non-small Cell Lung Cancer
Renal Cell Carcinoma

Interventions: Drug: NEO212 Oral Capsule
Drug: FOLFIRI Protocol
Drug: Ipilimumab
Drug: Regorafenib
Drug: Pembrolizumab
Drug: Carboplatin
Drug: Paclitaxel
Drug: Bevacizumab
Drug: Nivolumab

First Posted Date: 2023-09-21

Last Posted Date: 2024-10-16

Lead Sponsor: Neonc Technologies, Inc.

Target Recruit Count: 134

Registration Number: NCT06047379

Locations: 🇺🇸
Precision NextGen Oncology, Beverly Hills, California, United States
🇺🇸
Northwest Medical Specialties, Tacoma, Washington, United States

Phase II Trial of Magrolimab and Cetuximab With Pembrolizumab or Docetaxel for Recurrent/Metastatic Head Neck Squamous Cell Carcinoma

Phase 2

Terminated

Conditions: Head Neck
Squamous Cell Carcinoma of Head and Neck

Interventions: Drug: Pembrolizumab
Drug: Magrolimab
Drug: cetuximab
Drug: Docetaxel

First Posted Date: 2023-09-21

Last Posted Date: 2024-10-23

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 57

Registration Number: NCT06046482

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

Pembrolizumab in First-Line Treatment of Advanced-Stage Classical Hodgkin Lymphoma

Phase 2

Not yet recruiting

Conditions: Hodgkin Lymphoma

First Posted Date: 2023-09-21

Last Posted Date: 2024-08-22

Lead Sponsor: University of Cologne

Target Recruit Count: 40

Registration Number: NCT06045195

Locations: 🇩🇪
1st Department of Medicine, Cologne University Hospital, Cologne, Germany

Enfortumab Vedotin With or Without Pembrolizumab in Rare Genitourinary Tumors (E-VIRTUE)

Phase 2

Not yet recruiting

Conditions: Squamous Cell Carcinoma of the Bladder
Testicular Germ Cell Tumors
Adenocarcinoma of the Bladder

Interventions: Drug: Enfortumab vedotin
Drug: Pembrolizumab

First Posted Date: 2023-09-18

Last Posted Date: 2024-12-20

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 68

Registration Number: NCT06041503

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

Study of Favezelimab Coformulated With Pembrolizumab (MK-4280A) in Participants With Selected Solid Tumors (MK-4280A-010)

Phase 2

Recruiting

Conditions: Cutaneous Squamous Cell Carcinoma
Endometrial Cancer
Solid Tumor

Interventions: Biological: favezelimab/pembrolizumab
Biological: pembrolizumab
Drug: lenvatinib

First Posted Date: 2023-09-14

Last Posted Date: 2024-11-19

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 160

Registration Number: NCT06036836

Locations: 🇨🇳
Taichung Veterans General Hospital-GYNECOLOGY ( Site 0033), Taichung, Taiwan
🇨🇳
National Cheng Kung University Hospital-Clinical Trial Center ( Site 0032), Tainan, Taiwan
🇨🇳
National Taiwan University Hospital ( Site 0031), Taipei, Taiwan

and more 41 locations

CLN-617 Alone and in Combination With Pembrolizumab in Patients With Advanced Solid Tumors

Phase 1

Recruiting

Conditions: Advanced Solid Tumor

Interventions: Drug: CLN-617
Drug: Pembrolizumab

First Posted Date: 2023-09-13

Last Posted Date: 2024-05-02

Lead Sponsor: Cullinan Therapeutics Inc.

Target Recruit Count: 86

Registration Number: NCT06035744

Locations: 🇺🇸
USC Norris Comprehensive Cancer Center, Los Angeles, California, United States
🇺🇸
University of Chicago, Chicago, Illinois, United States
🇺🇸
Fred Hutchinson Cancer Center, Seattle, Washington, United States

and more 3 locations