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

Neoadjuvant TIL- and Response-Adapted Chemoimmunotherapy for TNBC

Phase 2

Recruiting

Conditions: Triple Negative Breast Cancer
Breast Cancer

Interventions: Drug: Carboplatin
Drug: Docetaxel
Drug: Pembrolizumab
Drug: Doxorubicin
Drug: Cyclophosphamide

First Posted Date: 2022-12-09

Last Posted Date: 2024-08-26

Lead Sponsor: University of Kansas Medical Center

Target Recruit Count: 139

Registration Number: NCT05645380

Locations: 🇺🇸
The University of Kansas Cancer Center - Clinical Research Center, Fairway, Kansas, United States
🇺🇸
The University of Kansas Cancer Center - Main Hospital, Kansas City, Kansas, United States
🇺🇸
The University of Kansas Cancer Center - Westwood, Kansas City, Kansas, United States

and more 4 locations

SKB264 in Combination With Pembrolizumab in Subjects With Selected Solid Tumors

Phase 2

Recruiting

Conditions: Solid Tumor

Interventions: Drug: SKB264
Drug: Pembrolizumab

First Posted Date: 2022-12-08

Last Posted Date: 2024-12-19

Lead Sponsor: Klus Pharma Inc.

Target Recruit Count: 240

Registration Number: NCT05642780

Locations: 🇺🇸
Community Clinical Research Center, Anderson, Indiana, United States
🇺🇸
Westchester Medical Center, Hawthorne, New York, United States
🇺🇸
Texas Oncology, P.A. Austin, TX, Austin, Texas, United States

and more 43 locations

A Feasibility Window Study of Pembrolizumab Prior to Second Evacuation for Post-molar Gestational Trophoblastic Neoplasia

Phase 2

Recruiting

Conditions: Gestational Trophoblastic Neoplasia
Gestational Trophoblastic Tumor, Recurrent
Gestational Trophoblastic Disease

Interventions: Drug: Pembrolizumab

First Posted Date: 2022-12-02

Last Posted Date: 2024-04-17

Lead Sponsor: Imperial College London

Target Recruit Count: 20

Registration Number: NCT05635344

Locations: 🇬🇧
Imperial College Healthcare NHS Trust, London, United Kingdom

A Phase II Study to Evaluate the Efficacy and Safety of Pembrolizumab in Combination With Mitotane in Patients With Advanced Adrenocortical Carcinoma

Phase 2

Completed

Conditions: Adrenocortical Carcinoma

Interventions: Drug: Mitotane
Drug: Pembrolizumab

First Posted Date: 2022-12-02

Last Posted Date: 2024-10-23

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 3

Registration Number: NCT05634577

Locations: 🇺🇸
M D Anderson Cancer Center, Houston, Texas, United States

Study of Sacituzumab Govitecan-hziy and Pembrolizumab Versus Treatment of Physician's Choice in Patients With Triple Negative Breast Cancer Who Have Residual Invasive Disease After Surgery and Neoadjuvant Therapy (ASCENT-05/AFT-65 OptimICE-RD/NSABP B-63)

Phase 3

Recruiting

Conditions: Triple Negative Breast Cancer

Interventions: Drug: Sacituzumab govitecan-hziy (SG)
Drug: Pembrolizumab
Drug: Capecitabine

First Posted Date: 2022-12-01

Last Posted Date: 2024-11-27

Lead Sponsor: Gilead Sciences

Target Recruit Count: 1514

Registration Number: NCT05633654

Locations: 🇺🇸
Alabama Oncology, Birmingham, Alabama, United States
🇺🇸
Clearview Cancer Institute, Huntsville, Alabama, United States
🇺🇸
Northwestern Medicine, Chicago, Illinois, United States

and more 162 locations

A Study of Dato-DXd With or Without Durvalumab Versus Investigator's Choice of Therapy in Patients With Stage I-III Triple-negative Breast Cancer Without Pathological Complete Response Following Neoadjuvant Therapy (TROPION-Breast03)

Phase 3

Recruiting

Conditions: Breast Cancer

Interventions: Drug: Dato-DXd
Drug: Capecitabine
Drug: Durvalumab
Drug: Pembrolizumab

First Posted Date: 2022-11-29

Last Posted Date: 2024-12-20

Lead Sponsor: AstraZeneca

Target Recruit Count: 1075

Registration Number: NCT05629585

Locations: 🇬🇧
Research Site, Taunton, United Kingdom

Study of JK08 in Patients With Unresectable Locally Advanced or Metastatic Cancer

Phase 1

Active, not recruiting

Conditions: Metastatic Cancer
Small-cell Lung Cancer
Urothelial Carcinoma
Pancreatic Adenocarcinoma
Thyroid Cancer
Tumor, Solid
Advanced Solid Tumor
Non-small Cell Lung Cancer
Squamous Cell Carcinoma of Head and Neck
Luminal Breast Cancer

Interventions: Drug: JK08
Drug: Pembrolizumab
Drug: Lenvatinib Pill

First Posted Date: 2022-11-17

Last Posted Date: 2024-10-15

Lead Sponsor: Salubris Biotherapeutics Inc

Target Recruit Count: 263

Registration Number: NCT05620134

Locations: 🇧🇪
Institut Jules Bordet, Brussels, Belgium
🇧🇪
UZA, Edegem, Belgium
🇧🇪
UZ Ghent, Ghent, Belgium

and more 8 locations

EPOCH: Eribulin and Pembrolizumab in Ovarian/Uterine Carcinosarcoma

Phase 2

Recruiting

Conditions: Ovarian Carcinosarcoma
Uterine Carcinosarcoma

Interventions: Drug: Eribulin Mesylate
Drug: Pembrolizumab

First Posted Date: 2022-11-17

Last Posted Date: 2024-02-08

Lead Sponsor: Australia New Zealand Gynaecological Oncology Group

Target Recruit Count: 30

Registration Number: NCT05619913

Locations: 🇦🇺
Prince of Wales Hospital, Randwick, New South Wales, Australia
🇬🇧
Imperial College London, London, United Kingdom
🇦🇺
Royal Brisbane and Women's Hospital, Herston, Queensland, Australia

and more 3 locations

Study of GT103 in Combination With Pembrolizumab in Refractory, Metastatic Non-Small Cell Lung Cancer

Phase 2

Active, not recruiting

Conditions: Recurrent Non Small Cell Lung Cancer
Non Small Cell Lung Cancer
Metastatic NSCLC

Interventions: Drug: Pembrolizumab
Drug: GT103

First Posted Date: 2022-11-15

Last Posted Date: 2024-07-19

Lead Sponsor: Jeffrey Clarke

Target Recruit Count: 21

Registration Number: NCT05617313

Locations: 🇺🇸
University of Virginia Health System, Charlottesville, Virginia, United States
🇺🇸
University of Illinois Cancer Center, Chicago, Illinois, United States
🇺🇸
Indiana University Melvin and Bren Simon Comprehensive Cancer Center, Indianapolis, Indiana, United States

and more 3 locations

A Study of LOXO-435 in Participants With Cancer With a Change in a Gene Called FGFR3

Phase 1

Recruiting

Conditions: Neoplasm Metastasis
Urinary Bladder Neoplasms
Ureteral Neoplasms

Interventions: Drug: LOXO-435
Drug: Pembrolizumab

First Posted Date: 2022-11-14

Last Posted Date: 2024-11-18

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 180

Registration Number: NCT05614739

Locations: 🇦🇺
Calvary Mater Newcastle, Waratah, New South Wales, Australia
🇫🇷
Gustave Roussy, Villejuif Cedex, France
🇮🇹
UOC Fase I - Fondazione Policlinico Universitario A. Gemelli IRCCS - Universita Cattolica del Sacro Cuore, Roma, Italy

and more 54 locations

Drug Development Updates

Stay informed with timely notifications on clinical trials, regulatory changes, and research advancements related to this medication.

Home Terms & Conditions Privacy Policy