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

Study of Neoadjuvant Enfortumab Vedotin and Pembrolizumab in Cisplatin-eligible Upper Tract Urothelial Cancer

Phase 2

Not yet recruiting

Conditions: Urothelial Carcinoma

Interventions: Drug: Enfortumab vedotin
Drug: Pembrolizumab

First Posted Date: 2024-04-10

Last Posted Date: 2024-12-04

Lead Sponsor: University of Michigan Rogel Cancer Center

Target Recruit Count: 32

Registration Number: NCT06356155

Locations: 🇺🇸
University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan, United States

Phase III, Open-label, Study of First-line Dato-DXd in Combination With Rilvegostomig for Advanced Non-squamous NSCLC With High PD-L1 Expression (TC ≥ 50%) and Without Actionable Genomic Alterations

Phase 3

Recruiting

Conditions: Non-Small Cell Lung Cancer

Interventions: Drug: Pembrolizumab
Drug: Datopotamab Deruxtecan
Drug: Rilvegostomig

First Posted Date: 2024-04-10

Last Posted Date: 2024-11-20

Lead Sponsor: AstraZeneca

Target Recruit Count: 675

Registration Number: NCT06357533

Locations: 🇬🇧
Research Site, Truro, United Kingdom

Carboplatin/Paclitaxel + Pembrolizumab for Locoregionally Advanced Penile Cancer

Phase 2

Recruiting

Conditions: Urologic Neoplasms
Penile Squamous Cell Carcinoma
Urogenital Neoplasms
Penile Cancer
Locally Advanced Penile Carcinoma
Male Urogenital Diseases

Interventions: Drug: Carboplatin/Paclitaxel
Drug: Pembrolizumab
Procedure: Partial or total penectomy with inguinal and/or pelvic lymph node dissection

First Posted Date: 2024-04-09

Last Posted Date: 2024-08-16

Lead Sponsor: The Netherlands Cancer Institute

Target Recruit Count: 27

Registration Number: NCT06353906

Locations: 🇳🇱
NKI-AVL, Amsterdam, Noord-Holland, Netherlands

Neoadjuvant INBRX-106 (Hexavalent OX40 Agonist) in Combination With Pembrolizumab as a Chemotherapy-sparing Regimen for Stage II TNBC (Triple Negative Breast Cancer) Patients

Phase 2

Not yet recruiting

Conditions: Triple Negative Breast Cancer

Interventions: Drug: Pembrolizumab
Drug: INBRX-106

First Posted Date: 2024-04-09

Last Posted Date: 2024-07-26

Lead Sponsor: Providence Health & Services

Target Recruit Count: 12

Registration Number: NCT06353997

Locations: 🇺🇸
Ellison Institute of Technology (EITM), Los Angeles, California, United States
🇺🇸
Providence Portland Cancer Institute - Franz Clinic, Portland, Oregon, United States
🇺🇸
Providence St. Vincent Medical Center, Portland, Oregon, United States

and more 1 locations

ZAP-IT: ZN-c3 + Carboplatin + Pembrolizumab in mTNBC

Phase 1

Recruiting

Conditions: Breast Cancer Female
Breast Cancer
Hormone Receptor Negative Malignant Tumor Breast Triple
HER2-negative Breast Cancer
Triple Negative Breast Cancer

Interventions: Drug: Azenosertib
Drug: Carboplatin
Drug: Pembrolizumab

First Posted Date: 2024-04-08

Last Posted Date: 2024-12-18

Lead Sponsor: Filipa Lynce, MD

Target Recruit Count: 78

Registration Number: NCT06351332

Locations: 🇺🇸
Dana-Farber Cancer Institute, Boston, Massachusetts, United States

A Study of MK-1084 Plus Pembrolizumab (MK-3475) in Participants With KRAS G12C Mutant, Metastatic Non-small Cell Lung Cancer (NSCLC) With Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥50% (MK-1084-004)

Phase 3

Recruiting

Conditions: Non-small Cell Lung Cancer

Interventions: Drug: MK-1084
Other: Placebo
Biological: Pembrolizumab

First Posted Date: 2024-04-03

Last Posted Date: 2025-01-08

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 600

Registration Number: NCT06345729

Locations: 🇺🇸
Beverly Hills Cancer Center ( Site 0116), Beverly Hills, California, United States
🇺🇸
Orchard Healthcare Research Inc. ( Site 0115), Skokie, Illinois, United States
🇺🇸
St. Vincent Frontier Cancer Center-Research ( Site 0105), Billings, Montana, United States

and more 110 locations

Study of BBO-8520 in Adult Subjects with KRASG12C Non-small Cell Lung and Colorectal Cancer

Phase 1

Recruiting

Conditions: Non-small Cell Lung Cancer
Metastatic Non-Small Cell Lung Cancer
NSCLC
KRAS G12C
Metastatic Lung Cancer
Advanced Lung Carcinoma
Colorectal Cancer
Metastatic Colorectal Cancer
CRC
Advanced Colorectal Carcinoma

Interventions: Drug: BBO-8520
Drug: Pembrolizumab

First Posted Date: 2024-04-02

Last Posted Date: 2024-10-30

Lead Sponsor: TheRas, Inc., d/b/a BridgeBio Oncology Therapeutics

Target Recruit Count: 229

Registration Number: NCT06343402

Locations: 🇺🇸
University of California - San Diego Moores Cancer Center, La Jolla, California, United States
🇺🇸
UCLA Health - Santa Monica Cancer Care, Santa Monica, California, United States
🇺🇸
Yale Cancer Center, New Haven, Connecticut, United States

and more 12 locations

Study of Suratadenoturev (OBP-301) in Combination With Pembrolizumab in Esophagogastric Adenocarcinoma

Phase 2

Recruiting

Conditions: Gastroesophageal Junction Adenocarcinoma
Esophageal Adenocarcinoma
Gastric Adenocarcinoma

Interventions: Drug: OBP-301
Drug: Pembrolizumab

First Posted Date: 2024-04-01

Last Posted Date: 2024-05-07

Lead Sponsor: Weill Medical College of Cornell University

Target Recruit Count: 27

Registration Number: NCT06340711

Locations: 🇺🇸
Weill Cornell Medicine/NewYork-Presbyterian Hospital, New York, New York, United States

AMG 193 Alone or in Combination With Other Therapies in Subjects With Advanced Thoracic Tumors With Homozygous MTAP-deletion (Master Protocol)

Phase 1

Recruiting

Conditions: Thoracic Tumors
Non-small Cell Lung Cancer

Interventions: Drug: AMG 193
Drug: Carboplatin
Drug: Sotorasib
Drug: Paclitaxel
Drug: Pembrolizumab
Drug: Pemetrexed

First Posted Date: 2024-03-27

Last Posted Date: 2024-12-27

Lead Sponsor: Amgen

Target Recruit Count: 500

Registration Number: NCT06333951

Locations: 🇺🇸
University of California Irvine, Orange, California, United States
🇺🇸
Comprehensive Blood and Cancer Center, Bakersfield, California, United States
🇺🇸
City of Hope National Medical Center, Duarte, California, United States

and more 28 locations

A Study of DM919 Alone and in Combination With Pembrolizumab in Advanced Solid Tumors

Phase 1

Recruiting

Conditions: Advanced Solid Tumor

Interventions: Drug: DM919
Drug: Pembrolizumab

First Posted Date: 2024-03-25

Last Posted Date: 2024-08-06

Lead Sponsor: D2M Biotherapeutics Inc.

Target Recruit Count: 160

Registration Number: NCT06328673

Locations: 🇺🇸
NEXT Oncology, San Antonio, Texas, United States
🇨🇳
The Cancer Institute and Hospital, Chinese Academy of Medical Sciences(CAMS), Beijing, China

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