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 Preliminary Efficacy of BNT314 with or Without an Immune Checkpoint Inhibitor in Cancer Patients with Malignant Solid Tumors

Phase 1

Recruiting

Conditions: Advanced Malignant Solid Tumor

Interventions: Biological: BNT314
Biological: Pembrolizumab

First Posted Date: 2023-11-29

Last Posted Date: 2024-11-27

Lead Sponsor: BioNTech SE

Target Recruit Count: 360

Registration Number: NCT06150183

Locations: 🇺🇸
Cleveland Clinic, Cleveland, Ohio, United States
🇧🇪
GZA Ziekenhuizen, Antwerpen, Belgium
🇧🇪
CHU de Liège, Liege, Belgium

and more 11 locations

Multi-classifier System for Stratifying Stage III Papillary Renal Cell Carcinoma of Receiving Adjuvant Therapy

Phase 3

Not yet recruiting

Conditions: Papillary Renal Cell Carcinoma

Interventions: Drug: Pembrolizumab
Drug: Placebo

First Posted Date: 2023-11-27

Last Posted Date: 2023-11-29

Lead Sponsor: First Affiliated Hospital, Sun Yat-Sen University

Target Recruit Count: 468

Registration Number: NCT06146777

A Study of Tetrathiomolybdate (TM) Plus Capecitabine

Phase 1

Recruiting

Conditions: Residual Disease
Triple Negative Breast Cancer

Interventions: Drug: Tetrathiomolybdate
Drug: Capecitabine
Drug: Pembrolizumab

First Posted Date: 2023-11-18

Last Posted Date: 2024-11-27

Lead Sponsor: Dartmouth-Hitchcock Medical Center

Target Recruit Count: 204

Registration Number: NCT06134375

Locations: 🇺🇸
Dartmouth Hitchcock Medical Center, Lebanon, New Hampshire, United States

A Study of AMG 355 Alone and in Combination With Pembrolizumab in Participants With Advanced Solid Tumors

Phase 1

Recruiting

Conditions: Advanced Solid Tumors

Interventions: Drug: AMG 355
Drug: Pembrolizumab

First Posted Date: 2023-11-14

Last Posted Date: 2024-11-07

Lead Sponsor: Amgen

Target Recruit Count: 515

Registration Number: NCT06131398

Locations: 🇺🇸
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
🇨🇭
Kantonsspital Sankt Gallen, St. Gallen, Switzerland
🇺🇸
City of Hope National Medical Center, Duarte, California, United States

and more 20 locations

A Study of Pembrolizumab With Trastuzumab and Chemotherapy in People With Esophagogastric Cancer

Phase 2

Recruiting

Conditions: Gastric Adenocarcinoma
HER2 Gene Mutation
Esophageal Cancer

Interventions: Drug: Pembrolizumab
Drug: Trastuzumab
Drug: Oxaliplatin
Drug: Capecitabine

First Posted Date: 2023-11-08

Last Posted Date: 2024-10-23

Lead Sponsor: Memorial Sloan Kettering Cancer Center

Target Recruit Count: 25

Registration Number: NCT06123338

Locations: 🇺🇸
Johns Hopkins University (Data Collection Only), Baltimore, Maryland, United States
🇺🇸
Massachusetts General Hospital (Data Collection Only), Boston, Massachusetts, United States
🇺🇸
Memorial Sloan Kettering Bergen (Limited Protocol Activities), Montvale, New Jersey, United States

and more 6 locations

A Study of First-Line Olomorasib (LY3537982) and Pembrolizumab With or Without Chemotherapy in Patients With Advanced KRAS G12C-Mutant Non-small Cell Lung Cancer

Phase 3

Recruiting

Conditions: Carcinoma, Non-Small-Cell Lung
Neoplasm Metastasis

Interventions: Drug: LY3537982
Drug: Pembrolizumab
Drug: Placebo
Drug: Cisplatin
Drug: Carboplatin
Drug: Pemetrexed

First Posted Date: 2023-11-07

Last Posted Date: 2024-11-13

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 1016

Registration Number: NCT06119581

Locations: 🇺🇸
Cedars-Sinai Medical Center, Los Angeles, California, United States
🇺🇸
Highlands Oncology Group, Springdale, Arkansas, United States
🇦🇹
Ordensklinikum Linz GmbH Elisabethinen, Linz, Oberösterreich, Austria

and more 361 locations