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

Pembro + Blina Combination in Pediatric and Young Adult Patients With Relapsed/Refractory Acute Leukemia or Lymphoma

Phase 1

Withdrawn

Conditions: Leukemia, B-cell
Lymphoma, B-Cell

Interventions: Drug: Blinatumomab
Drug: Pembrolizumab

First Posted Date: 2018-07-30

Last Posted Date: 2021-04-01

Lead Sponsor: Children's Hospital Medical Center, Cincinnati

Registration Number: NCT03605589

Locations: 🇺🇸
Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, United States

A Phase 2 Study of Sitravatinib in Combination With PD-(L)1 Checkpoint Inhibitor Regimens in Patients With Advanced or Metastatic Urothelial Carcinoma

Phase 2

Terminated

Conditions: Urothelial Carcinoma
Urothelial Carcinoma Bladder
Urothelial Carcinoma of the Renal Pelvis and Ureter
Urothelial Carcinoma Ureter
Urothelial Carcinoma Urethra

Interventions: Drug: Sitravatinib
Drug: Nivolumab
Drug: Pembrolizumab
Drug: Enfortumab vedotin

First Posted Date: 2018-07-30

Last Posted Date: 2023-08-24

Lead Sponsor: Mirati Therapeutics Inc.

Target Recruit Count: 260

Registration Number: NCT03606174

Locations: 🇺🇸
University of California Irvine, Irvine, California, United States
🇺🇸
The University of Arizona Cancer Center, Tucson, Arizona, United States
🇺🇸
Dana Farber Cancer Institute, Boston, Massachusetts, United States

and more 33 locations

Pembrolizumab in Treating Participants with Leukoplakia

Phase 2

Recruiting

Conditions: Leukoplakia
Erythroleukoplakia
Verrucous Oral Leukoplakia

Interventions: Biological: Pembrolizumab

First Posted Date: 2018-07-27

Last Posted Date: 2024-10-17

Lead Sponsor: Jonsson Comprehensive Cancer Center

Target Recruit Count: 26

Registration Number: NCT03603223

Locations: 🇺🇸
UC San Diego Moores Cancer Center, La Jolla, California, United States
🇺🇸
USC / Norris Comprehensive Cancer Center, Los Angeles, California, United States
🇺🇸
UCLA / Jonsson Comprehensive Cancer Center, Los Angeles, California, United States

Study to Evaluate the Safety and Efficacy of a Combination of Favezelimab (MK-4280) and Pembrolizumab (MK-3475) in Participants With Hematologic Malignancies (MK-4280-003)

Phase 1

Active, not recruiting

Conditions: Lymphoma, Non-Hodgkin
Lymphoma, B-Cell
Hodgkin Disease

Interventions: Biological: pembrolizumab
Biological: Favezelimab

First Posted Date: 2018-07-26

Last Posted Date: 2024-12-24

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 174

Registration Number: NCT03598608

Locations: 🇺🇸
Banner MD Anderson Cancer Center ( Site 0020), Gilbert, Arizona, United States
🇺🇸
City of Hope ( Site 0001), Duarte, California, United States
🇺🇸
Ronald Reagan UCLA Medical Center (Radiological Sciences) ( Site 0007), Los Angeles, California, United States

and more 22 locations

Pembrolizumab and EDP1503 in Advanced Melanoma

Phase 2

Active, not recruiting

Conditions: Melanoma (Skin)
Melanoma

Interventions: Drug: Pembrolizumab
Biological: EDP1503

First Posted Date: 2018-07-23

Last Posted Date: 2024-07-31

Lead Sponsor: University of Chicago

Target Recruit Count: 8

Registration Number: NCT03595683

Locations: 🇺🇸
University of Chicago Medical Center, Chicago, Illinois, United States

Pembrolizumab in Combination with Bevacizumab and Pegylated Liposomal Doxorubicin in Patients with Ovarian Cancer

Phase 1

Completed

Conditions: Ovarian Cancer

Interventions: Drug: Pembrolizumab
Drug: pegylated liposomal doxorubicin (PLD)
Drug: Bevacizumab

First Posted Date: 2018-07-23

Last Posted Date: 2024-10-18

Lead Sponsor: Gustave Roussy, Cancer Campus, Grand Paris

Target Recruit Count: 47

Registration Number: NCT03596281

Locations: 🇫🇷
Gustave Roussy, Villejuif, Val de Marne, France

NBTXR3 Activated by Radiotherapy for Patients With Advanced Cancers Treated With An Anti-PD-1 Therapy

Phase 1

Recruiting

Conditions: Metastatic Triple-Negative Breast Carcinoma
Metastasis From Malignant Tumor of Bladder (Disorder)
Immunotherapy
Radiotherapy
Squamous Cell Carcinoma of Head and Neck
Metastatic Renal Cell Carcinoma
Microsatellite Instability-High Solid Malignant Tumour
Metastasis From Malignant Melanoma of Skin (Disorder)
Metastasis From Malignant Tumor of Liver
Metastasis From Malignant Tumor of Cervix

Interventions: Drug: NBTXR3
Radiation: SABR
Drug: Nivolumab
Drug: Pembrolizumab

First Posted Date: 2018-07-17

Last Posted Date: 2024-03-22

Lead Sponsor: Nanobiotix

Target Recruit Count: 145

Registration Number: NCT03589339

Locations: 🇺🇸
Christus St. Vincent Regional Cancer Center, Santa Fe, New Mexico, United States
🇺🇸
St Luke's University Health Network, Bethlehem, Pennsylvania, United States
🇺🇸
Sanford Cancer Center, Sioux Falls, South Dakota, United States

and more 10 locations

Pembrolizumab in Relapsed or Refractory Extranodal NK/T- Cell Lymphoma, Nasal Type and EBV-associated Diffuse Large B Cell Lymphomas

Phase 1

Withdrawn

Conditions: Lymphoma

Interventions: Drug: Pembrolizumab

First Posted Date: 2018-07-13

Last Posted Date: 2021-05-07

Lead Sponsor: Abramson Cancer Center at Penn Medicine

Registration Number: NCT03586024

Locations: 🇺🇸
Abramson Cancer Center of the University of Pennsylvania, Philadelphia, Pennsylvania, United States

Pembrolizumab With Combination Chemotherapy in Treating Participants With Locally Advanced or Metastatic Small Cell/Neuroendocrine Cancers of Urothelium or Prostate

Phase 1

Completed

Conditions: Bladder Small Cell Neuroendocrine Carcinoma
Castration-Resistant Prostate Carcinoma
Metastatic Bladder Urothelial Carcinoma
Metastatic Urethral Urothelial Carcinoma
Prostate Carcinoma Metastatic in the Bone
Prostate Neuroendocrine Neoplasm
Prostate Small Cell Carcinoma
Stage III Bladder Cancer AJCC V8
Stage III Prostate Cancer AJCC V8
Stage III Urethral Cancer AJCC V8