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

Efineptakin Alfa and Pembrolizumab for the Treatment of Recurrent Glioblastoma

Phase 2

Recruiting

Conditions: High Grade Astrocytic Tumor
Recurrent Glioblastoma, IDH-Wildtype
Recurrent Gliosarcoma

Interventions: Procedure: Biospecimen Collection
Biological: Efineptakin alfa
Biological: Pembrolizumab
Procedure: Biopsy

First Posted Date: 2022-07-20

Last Posted Date: 2024-12-04

Lead Sponsor: Mayo Clinic

Target Recruit Count: 44

Registration Number: NCT05465954

Locations: 🇺🇸
Mayo Clinic, Rochester, Minnesota, United States

Safety and Efficacy of Anti-CD47, ALX148 in Combination with Liposomal Doxorubicin and Pembrolizumab in Recurrent Platinum-resistant Ovarian Cancer

Phase 2

Recruiting

Conditions: Ovarian Cancer

Interventions: Drug: Pembrolizumab
Drug: ALX148
Drug: Doxorubicin

First Posted Date: 2022-07-20

Last Posted Date: 2024-12-12

Lead Sponsor: Alexander B Olawaiye, MD

Target Recruit Count: 31

Registration Number: NCT05467670

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

Surgical Pembro +/- Olaparib w TMZ for rGBM

Phase 2

Recruiting

Conditions: Recurrent Glioblastoma
Glioblastoma

Interventions: Drug: Pembrolizumab
Drug: Olaparib
Drug: Temozolomide

First Posted Date: 2022-07-19

Last Posted Date: 2024-01-29

Lead Sponsor: L. Nicolas Gonzalez Castro, MD, PhD

Target Recruit Count: 78

Registration Number: NCT05463848

Locations: 🇺🇸
Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States
🇺🇸
Massachusetts General Hospital, Boston, Massachusetts, United States
🇺🇸
Dana-Farber Cancer Institute, Boston, Massachusetts, United States

Anti-PD-1 Antibody Combined With Autologous DC and NK Cells in the Treatment of Digestive Carcinoma

Phase 2

Not yet recruiting

Conditions: Gastrointestinal Tumours
NK-Cell
PD-1 Antibody
DC-Cell

Interventions: Drug: Pembrolizumab
Drug: Nivolumab
Drug: Sintilimab
Drug: Toripalimab
Drug: Camrelizumab
Drug: Tislelizumab
Biological: NK-Cell or DC-Cell

First Posted Date: 2022-07-18

Last Posted Date: 2022-07-18

Lead Sponsor: China Medical University, China

Target Recruit Count: 1

Registration Number: NCT05461235

Modulation of the Gut Microbiome With Pembrolizumab Following Chemotherapy in Resectable Pancreatic Cancer

Phase 2

Recruiting

Conditions: Pancreatic Cancer

Interventions: Procedure: Biopsy
Drug: FOLFIRINOX
Drug: Ciprofloxacin
Drug: Metronidazole
Drug: Pembrolizumab
Procedure: Surgical Resection

First Posted Date: 2022-07-18

Last Posted Date: 2024-10-15

Lead Sponsor: Icahn School of Medicine at Mount Sinai

Target Recruit Count: 25

Registration Number: NCT05462496

Locations: 🇺🇸
Icahn School of Medicine at Mount Sinai, New York, New York, United States

MNK Inhibitor AUM001 in Combination With Either Pembrolizumab or Irinotecan to Treat Metastatic Colorectal Cancer

Phase 2

Recruiting

Conditions: Metastatic Colorectal Cancer

Interventions: Drug: Tinodasertib
Drug: Pembrolizumab
Drug: Irinotecan

First Posted Date: 2022-07-18

Last Posted Date: 2024-07-09

Lead Sponsor: AUM Biosciences Pte Ltd

Target Recruit Count: 120

Registration Number: NCT05462236

Locations: 🇦🇺
Ballarat Oncology and Haematology, Wendouree, Victoria, Australia
🇦🇺
Pindara Private Hospital, Gold Coast Cancer Care, Benowa, Queensland, Australia
🇦🇺
Cabrini Hospital, Malvern, Victoria, Australia

and more 2 locations

Pembrolizumab With Chemotherapy and MK-4830 for Treating Participants With Ovarian Cancer (MK-4830-002)

Phase 2

Completed

Conditions: High-grade Serous Ovarian Carcinoma
Ovarian Carcinoma

Interventions: Biological: Pembrolizumab
Drug: Paclitaxel
Drug: Carboplatin
Biological: Avastin
Biological: MK-4830
Drug: Docetaxel

First Posted Date: 2022-07-07

Last Posted Date: 2024-12-17

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 160

Registration Number: NCT05446870

Locations: 🇨🇳
Changhua Christian Hospital-Obstetrics and Gynecology ( Site 1203), Changhua County, Changhua, Taiwan
🇪🇸
Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 1101), Barcelona, Spain
🇪🇸
Hospital Universitario 12 de Octubre-Medical Oncology ( Site 1104), Madrid, Madrid, Comunidad De, Spain

and more 42 locations

ONC-392 and Pembrolizumab in Platinum Resistant Ovarian Cancer

Phase 2

Active, not recruiting

Conditions: Ovarian Cancer
High Grade Serous Adenocarcinoma of Ovary
Primary Peritoneal Carcinoma
Fallopian Tube Cancer

Interventions: Drug: ONC-392
Drug: Pembrolizumab

First Posted Date: 2022-07-06

Last Posted Date: 2024-10-24

Lead Sponsor: OncoC4, Inc.

Target Recruit Count: 58

Registration Number: NCT05446298

Locations: 🇺🇸
Cancer Treatment Centers of America, Phoenix. 403, Goodyear, Arizona, United States
🇺🇸
Honor Health, USOR, 406, Phoenix, Arizona, United States
🇺🇸
Nuvance Health System, 401, Danbury, Connecticut, United States

and more 18 locations

A Study in People With Colorectal Cancer to Test Whether Ezabenlimab or Pembrolizumab in Combination With BI 765063 Lead to Side Effects or Delays in Surgery

Phase 1

Terminated

Conditions: Colorectal Cancer

Interventions: Drug: BI 765063
Drug: Ezabenlimab
Drug: Pembrolizumab

First Posted Date: 2022-07-06

Last Posted Date: 2023-12-29

Lead Sponsor: Boehringer Ingelheim

Target Recruit Count: 2

Registration Number: NCT05446129

Locations: 🇺🇸
Mount Sinai School of Medicine, New York, New York, United States

A Study of TTI-101 as Monotherapy and in Combination in Participants With Locally Advanced or Metastatic, and Unresectable Hepatocellular Carcinoma

Phase 1

Recruiting

Conditions: Hepatocellular Carcinoma

Interventions: Drug: TTI-101
Drug: Pembrolizumab
Drug: Atezolizumab
Drug: Bevacizumab

First Posted Date: 2022-07-01

Last Posted Date: 2024-11-27

Lead Sponsor: Tvardi Therapeutics, Incorporated

Target Recruit Count: 166

Registration Number: NCT05440708

Locations: 🇺🇸
The Kirklin Clinic of University of Alabama Birmingham Hospital, Birmingham, Alabama, United States
🇺🇸
University of California San Diego, La Jolla, California, United States
🇺🇸
Norris Comprehensive Cancer Center, Los Angeles, California, United States

and more 18 locations

Drug Development Updates

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