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

Pembrolizumab and Lenvatinib for Platinum- Sensitive Recurrent Ovarian Cancer

Phase 2

Recruiting

Conditions: Ovarian Neoplasms
Genital Neoplasms, Female
Neoplasm of Stomach
Urogenital Neoplasms
Neoplasms, Glandular and Epithelial
Carcinoma, Ovarian Epithelial
Ovarian Diseases
Ovarian Epithelial Tumor

Interventions: Drug: Pembrolizumab
Drug: Lenvatinib

First Posted Date: 2020-08-19

Last Posted Date: 2023-06-08

Lead Sponsor: Sheba Medical Center

Target Recruit Count: 24

Registration Number: NCT04519151

Locations: 🇮🇱
Sheba Medical center, Ramat Gan, Israel

TOPAZ: Tucatinib in COmbination With Pembrolizumab And TrastuZumab in Patients With HER2-Positive Breast Cancer Brain Metastases

Phase 1

Withdrawn

Conditions: Brain Metastases
HER2-positive Breast Cancer
Breast Cancer
CNS Disease

Interventions: Drug: Tucatinib
Drug: Pembrolizumab
Drug: Trastuzumab

First Posted Date: 2020-08-13

Last Posted Date: 2022-07-01

Lead Sponsor: Reva Basho

Registration Number: NCT04512261

Locations: 🇺🇸
Cedars-Sinai Medical Center, Los Angeles, California, United States

A Single-Arm Pilot Study of Adjuvant Pembrolizumab Plus Trastuzumab in HER2+ Esophagogastric Tumors With Persistent Circulating Tumor DNA Following Curative Resection

Phase 2

Terminated

Conditions: Gastric Tumor
Esophageal Cancer
Gastroesophageal Junction Tumor
Esophagogastric Tumors
Gastric Cancer
Esophageal Neoplasms
Esophageal Tumor
GastroEsophageal Cancer
Gastroesophageal Junction Adenocarcinoma
Gastroesophageal Junction Cancer

Interventions: Drug: Trastuzumab
Drug: Pembrolizumab

First Posted Date: 2020-08-12

Last Posted Date: 2023-02-01

Lead Sponsor: Memorial Sloan Kettering Cancer Center

Target Recruit Count: 1

Registration Number: NCT04510285

Locations: 🇺🇸
Memorial Sloan Kettering Cancer Center (All Protocol Activities), New York, New York, United States
🇺🇸
Memorial Sloan Kettering Bergen (Limited Protocol Activities), Montvale, New Jersey, United States
🇺🇸
Memorial Sloan Kettering Commack (Limited Protocol Activities), Commack, New York, United States

and more 4 locations

Study of Pembrolizumab With Bendamustine in Hodgkin Lymphoma

Phase 2

Recruiting

Conditions: Refractory Cancer
Classical Hodgkin Lymphoma
Relapsed Cancer

Interventions: Drug: Pembrolizumab
Drug: Bendamustine Hydrochloride

First Posted Date: 2020-08-12

Last Posted Date: 2024-03-22

Lead Sponsor: University Health Network, Toronto

Target Recruit Count: 37

Registration Number: NCT04510636

Locations: 🇨🇦
Princess Margaret Cancer Centre, Toronto, Ontario, Canada

A Study of Pembrolizumab (MK-3475) Plus Carboplatin and Paclitaxel as First-line Treatment of Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma (MK-3475-B10/KEYNOTE B10)

Phase 4

Completed

Conditions: Squamous Cell Carcinoma of Head and Neck

Interventions: Drug: Pembrolizumab
Drug: Carboplatin
Drug: Paclitaxel

First Posted Date: 2020-07-28

Last Posted Date: 2024-11-22

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 101

Registration Number: NCT04489888

Locations: 🇺🇸
Washington University School of Medicine ( Site 0240), Saint Louis, Missouri, United States
🇺🇸
Perlmutter Cancer Center at NYU Langone Hospital - Long Island ( Site 0262), Mineola, New York, United States
🇺🇸
UPMC Hillman Cancer Center ( Site 0253), Pittsburgh, Pennsylvania, United States

and more 32 locations

TTX-080 HLA-G Antagonist in Subjects with Advanced Cancers

Phase 1

Recruiting

Conditions: Cancer

Interventions: Drug: TTX-080
Drug: FOLFIRI
Drug: pembrolizumab
Drug: cetuximab

First Posted Date: 2020-07-24

Last Posted Date: 2024-12-05

Lead Sponsor: Tizona Therapeutics, Inc

Target Recruit Count: 240

Registration Number: NCT04485013

Locations: 🇺🇸
Arizona Oncology Associates, Tucson, Arizona, United States
🇺🇸
University of Southern California, Los Angeles, California, United States
🇺🇸
Hoag Memorial Hospital, Newport Beach, California, United States

and more 35 locations

B7H3 CAR T Cell Immunotherapy for Recurrent/Refractory Solid Tumors in Children and Young Adults

Phase 1

Active, not recruiting

Conditions: Hepatoblastoma
Wilms Tumor
Carcinoma
Ewing Sarcoma
Retinoblastoma
Clear Cell Sarcoma
Osteosarcoma
Neuroblastoma
Pediatric Solid Tumor
Germ Cell Tumor

Interventions: Biological: second generation 4-1BBζ B7H3-EGFRt-DHFR
Biological: second generation 4-1BBζ B7H3-EGFRt-DHFR(selected) and a second generation 4-1BBζ CD19-Her2tG
Drug: Pembrolizumab

First Posted Date: 2020-07-23

Last Posted Date: 2024-12-04

Lead Sponsor: Seattle Children's Hospital

Target Recruit Count: 68

Registration Number: NCT04483778

Locations: 🇺🇸
Seattle Children's Hospital, Seattle, Washington, United States

Pembrolizumab and Olaparib in Cervical Cancer Patients

Phase 2

Active, not recruiting

Conditions: Cervical Cancer
Cervical Carcinoma

Interventions: Drug: pembrolizumab
Drug: olaparib

First Posted Date: 2020-07-23

Last Posted Date: 2024-04-05

Lead Sponsor: John Diaz

Target Recruit Count: 8

Registration Number: NCT04483544

Locations: 🇺🇸
Miami Cancer Institute at Plantation, Plantation, Florida, United States
🇺🇸
Miami Cancer Institute, Miami, Florida, United States

Study of AMG 330 in Combination With Pembrolizumab in Adult With Relapsed or Refractory Acute Myeloid Leukemia

Phase 1

Terminated

Conditions: Relapsed or Refractory Acute Myeloid Leukemia

Interventions: Drug: AMG 330
Drug: Pembrolizumab

First Posted Date: 2020-07-21

Last Posted Date: 2024-03-08

Lead Sponsor: Amgen

Target Recruit Count: 1

Registration Number: NCT04478695

Locations: 🇺🇸
University of Texas MD Anderson Cancer Center, Houston, Texas, United States
🇺🇸
City of Hope National Medical Center, Duarte, California, United States

LUMINOS-101: Lerapolturev (PVSRIPO) and Pembrolizumab in Patients with Recurrent Glioblastoma

Phase 2

Completed

Conditions: Supratentorial Glioblastoma
Brain Tumor
Glioblastoma
Recurrent Glioblastoma

Interventions: Biological: lerapolturev
Biological: pembrolizumab

First Posted Date: 2020-07-21

Last Posted Date: 2024-10-02

Lead Sponsor: Istari Oncology, Inc.

Target Recruit Count: 25

Registration Number: NCT04479241

Locations: 🇺🇸
Dana Farber Cancer Institute, Boston, Massachusetts, United States
🇺🇸
The Ohio State University, Columbus, Ohio, United States
🇺🇸
Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States

and more 7 locations

Drug Development Updates

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