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

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

Phase 2

Active, not 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: 2025-01-10

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 160

Registration Number: NCT06036836

Locations: 🇺🇸
Yale-New Haven Hospital-Yale Cancer Center ( Site 0643), New Haven, Connecticut, United States
🇺🇸
Dana-Farber Cancer Institute ( Site 0642), Boston, Massachusetts, United States
🇺🇸
Rutgers Cancer Institute of New Jersey ( Site 0635), New Brunswick, New Jersey, United States

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

Evaluating the Safety of Shortened Infusion Times for dIfferent Oncological Immunotherapie

Phase 4

Recruiting

Conditions: Oncology
Infusion Reaction

Interventions: Drug: Nivolumab
Drug: Ipilimumab
Drug: Durvalumab
Drug: Pembrolizumab
Drug: Trastuzumab
Drug: Atezolizumab
Drug: Bevacizumab

First Posted Date: 2023-09-11

Last Posted Date: 2024-03-07

Lead Sponsor: Isala

Target Recruit Count: 679

Registration Number: NCT06031233

Locations: 🇳🇱
Isala Hospital, Zwolle, Netherlands

Efficacy and Safety of Nab-paclitaxel-Lenvatinib-Pembrolizumab as Second-line Treatment in Advanced NSCLC Patients

Phase 2

Not yet recruiting

Conditions: Recurrent Non-Squamous Non-Small Cell Lung Cancer
Advanced Non-squamous Non-small-cell Lung Cancer
Metastatic Non-squamous Non Small Cell Lung Cancer

Interventions: Drug: pembrolizumab
Drug: lenvatinib
Drug: albumin-bound paclitaxel

First Posted Date: 2023-09-08

Last Posted Date: 2023-09-13

Lead Sponsor: Peking University First Hospital

Target Recruit Count: 28

Registration Number: NCT06028633

Locations: 🇨🇳
Peking University First Hospital Ethics Committee, Beijing, Beijing, China

Pembrolizumab/Lenvatinib with and Without Responder-derived FMT in Relapsed/Refractory Melanoma

Phase 2

Not yet recruiting

Conditions: PD-1 Refractory Advanced Melanoma

Interventions: Biological: Responder-Derived Fecal microbiota transplantation (R-FMT
Drug: Pembrolizumab
Drug: Lenvatinib

First Posted Date: 2023-09-08

Last Posted Date: 2024-12-24

Lead Sponsor: Diwakar Davar

Target Recruit Count: 56

Registration Number: NCT06030037

Locations: 🇺🇸
UPMC Hillman Cancer Center, Pittsburgh, Pennsylvania, United States

Phase II Trial of Trilaciclib, Pembrolizumab, Gemcitabine and Carboplatin in Metastatic Triple-Negative Breast Cancer

Phase 2

Recruiting

Conditions: Metastatic Triple-Negative Breast Cancer

Interventions: Drug: Trilaciclib
Drug: Pembrolizumab
Drug: Gemcitabine
Drug: Carboplatin

First Posted Date: 2023-09-07

Last Posted Date: 2024-07-18

Lead Sponsor: Wake Forest University Health Sciences

Target Recruit Count: 36

Registration Number: NCT06027268

Locations: 🇺🇸
Levine Cancer Institute, Charlotte, North Carolina, United States

Safety and Efficacy of VB10.16 and Pembrolizumab in Patients with Head-Neck Squamous Cell Carcinoma

Phase 1

Recruiting

Conditions: HPV Positive Oropharyngeal Squamous Cell Carcinoma
HNSCC

Interventions: Biological: VB10.16
Drug: Pembrolizumab

First Posted Date: 2023-08-30

Last Posted Date: 2024-12-17

Lead Sponsor: Nykode Therapeutics ASA

Target Recruit Count: 51

Registration Number: NCT06016920

Locations: 🇫🇷
CRLC Val d'Aurelle - Institut de Recherche en Cancerologie de Montpellier (IRCM), Montpellier, France
🇨🇿
Fakultni nemocnice Olomouc, Olomuoc, Olomouc, Czechia
🇫🇷
Hospices Civils De Lyon, Lyon, France

and more 14 locations

Regorafenib in Combination with Pembrolizumab or Pembrolizumab for MSI-H Colorectal Cancer

Phase 2

Recruiting

Conditions: MSI-H Colorectal Cancer

Interventions: Drug: Regorafenib
Drug: Pembrolizumab

First Posted Date: 2023-08-23

Last Posted Date: 2024-10-02

Lead Sponsor: Ibrahim Halil Sahin

Target Recruit Count: 154

Registration Number: NCT06006923

Locations: 🇺🇸
AdventHealth Orlando, Orlando, Florida, United States
🇺🇸
Northwestern University, Evanston, Illinois, United States
🇺🇸
UPMC Hillman Cancer Center, Pittsburgh, Pennsylvania, United States

and more 1 locations