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

Sotorasib Activity in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation (CodeBreak 101)

Phase 1

Recruiting

Conditions: Advanced Solid Tumors
Kirsten Rat Sarcoma (KRAS) pG12C Mutation

Interventions: Drug: Sotorasib
Drug: RMC-4630
Drug: Afatinib
Drug: MVASI® (bevacizumab-awwb)
Drug: Atezolizumab
Drug: TNO155
Drug: BI 1701963
Drug: AMG 404
Drug: Trametinib
Drug: Pembrolizumab
Drug: Palbociclib
Drug: Everolimus
Drug: IV Chemotherapy (Regimen 1)
Drug: Carboplatin, pemetrexed, docetaxel, paclitaxel
Drug: Panitumumab
Drug: IV Chemotherapy (Regimen 2)

First Posted Date: 2019-12-04

Last Posted Date: 2025-01-03

Lead Sponsor: Amgen

Target Recruit Count: 1200

Registration Number: NCT04185883

Locations: 🇺🇸
Arizona Oncology Associates Professional Corporation, Tucson, Arizona, United States
🇺🇸
City of Hope National Medical Center, Duarte, California, United States
🇺🇸
University of California San Diego Moores Cancer Center, La Jolla, California, United States

and more 87 locations

Talabostat and Pembrolizumab for the Treatment of Advanced Solid Cancers

Phase 2

Active, not recruiting

Conditions: Advanced Malignant Solid Neoplasm
Recurrent Malignant Solid Neoplasm

Interventions: Biological: Pembrolizumab
Drug: Talabostat Mesylate

First Posted Date: 2019-11-20

Last Posted Date: 2024-10-28

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 15

Registration Number: NCT04171219

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

Pembrolizumab and Hypofractionated Stereotactic Radiotherapy in Patients With Malignant Pleural Mesothelioma

Phase 1

Terminated

Conditions: Advanced Malignant Pleural Mesothelioma

Interventions: Drug: Pembrolizumab
Radiation: Stereotactic Body Radiotherapy (SBRT)

First Posted Date: 2019-11-18

Last Posted Date: 2023-08-07

Lead Sponsor: Royal Marsden NHS Foundation Trust

Target Recruit Count: 3

Registration Number: NCT04166734

Locations: 🇬🇧
Royal Marsden NHS Foundation Trust, Chelsea, United Kingdom
🇬🇧
Beatson West of Scotland Cancer Centre, Glasgow, United Kingdom

Plasma-Adapted First-Line Pembro in NSCLC

Phase 2

Active, not recruiting

Conditions: NSCLC Stage IV
Metastatic Non-Small Cell Lung Cancer

Interventions: Drug: Pembrolizumab
Diagnostic Test: InVision
Drug: PEMETREXED
Drug: CARBOPLATIN
Drug: PACLITAXEL

First Posted Date: 2019-11-18

Last Posted Date: 2024-12-03

Lead Sponsor: Julia K. Rotow, MD

Target Recruit Count: 40

Registration Number: NCT04166487

Locations: 🇺🇸
Brigham and Women's Hospital, Boston, Massachusetts, United States
🇺🇸
Dana-Farber at Steward St. Elizabeth's Medical Center, Brighton, Massachusetts, United States
🇺🇸
Dana Farber Cancer Institute, Boston, Massachusetts, United States

and more 2 locations

Ph II Study of Cabozantinib With Pembrolizumab in Metastatic Gastric and Gastroesophageal Adenocarcinoma

Phase 2

Active, not recruiting

Conditions: Gastric Adenocarcinoma
GastroEsophageal Cancer

Interventions: Drug: Cabozantinib
Drug: Pembrolizumab

First Posted Date: 2019-11-15

Last Posted Date: 2024-06-07

Lead Sponsor: University of California, Irvine

Target Recruit Count: 20

Registration Number: NCT04164979

Locations: 🇺🇸
Chao Family Comprehensive Cancer Center, University of California, Irvine, Orange, California, United States

KEYMAKER-U01 Substudy 01A: Efficacy and Safety Study of Pembrolizumab (MK-3475) With or Without Chemotherapy When Used With Investigational Agents in Treatment-naïve Participants With Stage IV Non-small Cell Lung Cancer (NSCLC) (MK-3475-01A/KEYMAKER-U01A)

Phase 2

Recruiting

Conditions: Carcinoma, Non-Small-Cell Lung

Interventions: Biological: Pembrolizumab
Drug: Carboplatin
Biological: MK-0482
Drug: Pemetrexed
Biological: HER3-DXd
Biological: Ifinatamab Deruxtecan (I-DXd)
Drug: Paclitaxel
Biological: Vibostolimab
Biological: MK-4830
Biological: Boserolimab

First Posted Date: 2019-11-15

Last Posted Date: 2024-11-26

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 450

Registration Number: NCT04165070

Locations: 🇺🇸
Cleveland Clinic Main ( Site 0006), Cleveland, Ohio, United States
🇺🇸
The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive C, Columbus, Ohio, United States
🇺🇸
Abramson Cancer Center of the University of Pennsylvania ( Site 0010), Philadelphia, Pennsylvania, United States

and more 36 locations

KEYMAKER-U01 Substudy 3: Efficacy and Safety Study of Pembrolizumab (MK-3475) When Used With Investigational Agents in Participants With Advanced Non-small Cell Lung Cancer (NSCLC), Previously Treated With Anti-programmed Cell Death Receptor Ligand 1 (PD-L1) Therapy (MK-3475-01C/KEYMAKER-U01C)

Phase 2

Active, not recruiting

Conditions: Carcinoma, Non-Small-Cell Lung

Interventions: Biological: Pembrolizumab
Biological: Boserolimab
Biological: MK-4830
Biological: MK-0482
Drug: diphenhydramine
Drug: acetaminophen

First Posted Date: 2019-11-15

Last Posted Date: 2024-12-12

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 135

Registration Number: NCT04165096

Locations: 🇺🇸
Cleveland Clinic Main ( Site 0006), Cleveland, Ohio, United States
🇺🇸
Banner MD Anderson Cancer Center ( Site 0001), Gilbert, Arizona, United States
🇺🇸
City of Hope ( Site 0014), Duarte, California, United States

and more 36 locations

KEYMAKER-U01 Substudy 2: Efficacy and Safety Study of Pembrolizumab (MK-3475) When Used With Investigational Agents in Treatment-naïve Participants With Anti-programmed Cell Death Receptor Ligand 1 (PD-L1) Positive Advanced Non-small Cell Lung Cancer (NSCLC) (MK-3475-01B/KEYMAKER-U01B)

Phase 2

Active, not recruiting

Conditions: Carcinoma, Non-Small-Cell Lung

Interventions: Biological: Pembrolizumab
Biological: MK-4830
Biological: MK-0482

First Posted Date: 2019-11-15

Last Posted Date: 2024-11-18

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 120

Registration Number: NCT04165083

Locations: 🇺🇸
MedStar Franklin Square Medical Center ( Site 0033), Baltimore, Maryland, United States
🇺🇸
Abramson Cancer Center of the University of Pennsylvania ( Site 0010), Philadelphia, Pennsylvania, United States
🇺🇸
Massachusetts General Hospital ( Site 0003), Boston, Massachusetts, United States

and more 36 locations

Testing the Addition of an Anti-cancer Drug, Pembrolizumab, to the Usual Intravesical Chemotherapy Treatment (Gemcitabine) for the Treatment of BCG-Unresponsive Non-muscle Invasive Bladder Cancer

Phase 2

Recruiting

Conditions: Bladder Urothelial Carcinoma In Situ
Non-Muscle Invasive Bladder Urothelial Carcinoma
Stage 0a Bladder Cancer AJCC v8
Stage 0is Bladder Cancer AJCC v8
Stage I Bladder Cancer AJCC v8

Interventions: Procedure: Biopsy
Procedure: Biospecimen Collection
Procedure: Computed Tomography
Procedure: Cystoscopy
Drug: Gemcitabine Hydrochloride
Procedure: Magnetic Resonance Imaging
Biological: Pembrolizumab
Procedure: Transurethral Resection of Bladder Tumor

First Posted Date: 2019-11-15

Last Posted Date: 2025-01-09

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 161

Registration Number: NCT04164082

Locations: 🇺🇸
Mountain Blue Cancer Care Center - Swedish, Englewood, Colorado, United States
🇺🇸
Rocky Mountain Cancer Centers - Swedish, Englewood, Colorado, United States
🇺🇸
Swedish Medical Center, Englewood, Colorado, United States

and more 388 locations

A Study of LY3200882 and Pembrolizumab in Participants With Advanced Cancer

Phase 1

Withdrawn

Conditions: Advanced Cancer

Interventions: Drug: LY3200882
Drug: Pembrolizumab

First Posted Date: 2019-11-12

Last Posted Date: 2020-02-19

Lead Sponsor: Eli Lilly and Company

Registration Number: NCT04158700

Locations: 🇪🇸
Institut Catala d'Oncologia, L'Hospitalet de Llobregat, Barcelona, Spain
🇪🇸
Hospital Madrid Norte Sanchinarro, Madrid, Spain
🇪🇸
Hospital Clinic I Provincial, Barcelona, Spain

and more 3 locations

Drug Development Updates

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