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

JZP898 Intravenous Infusion as Monotherapy and Combination With Pembrolizumab in Adults With Advanced/Metastatic Solid Tumors

Phase 1

Recruiting

Conditions: Advanced Solid Tumor
Metastatic Solid Tumor

Interventions: Drug: JZP898
Drug: Pembrolizumab

First Posted Date: 2023-10-30

Last Posted Date: 2024-12-06

Lead Sponsor: Jazz Pharmaceuticals

Target Recruit Count: 177

Registration Number: NCT06108050

Locations: 🇺🇸
California Cancer Associates for Research and Excellence, Fresno, California, United States
🇺🇸
Duke University Medical Center - Duke Cancer Institute, Durham, North Carolina, United States
🇺🇸
Sidney Kimmel Cancer Center at Thomas Jefferson University Hospital, Philadelphia, Pennsylvania, United States

and more 4 locations

A Phase III Study of Dato-DXd With or Without Durvalumab Compared With Investigator's Choice of Chemotherapy in Combination With Pembrolizumab in Patients With PD-L1 Positive Locally Recurrent Inoperable or Metastatic Triple-negative Breast Cancer

Phase 3

Recruiting

Conditions: Breast Cancer

Interventions: Drug: Dato-DXd
Drug: Paclitaxel
Drug: Nab-paclitaxel
Drug: Durvalumab
Drug: Gemcitabine
Drug: Carboplatin
Drug: Pembrolizumab

First Posted Date: 2023-10-27

Last Posted Date: 2024-11-25

Lead Sponsor: AstraZeneca

Target Recruit Count: 625

Registration Number: NCT06103864

Locations: 🇻🇳
Research Site, Vinh, Vietnam

Evaluating the Efficacy and Safety of Pembrolizumab Plus Standard Chemotherapy in the Neoadjuvant Treatment of Local Advanced (LA) HNSCC

Phase 3

Recruiting

Conditions: Head and Neck Squamous Cell Carcinoma
Neoadjuvant Therapy
Pembrolizumab

Interventions: Drug: Pembrolizumab
Drug: Cisplatin
Drug: Carboplatin
Drug: Nedaplatin
Drug: Nab paclitaxel
Drug: Docetaxel
Drug: Liposomal paclitaxel
Drug: Fluorouracil

First Posted Date: 2023-10-26

Last Posted Date: 2023-10-30

Lead Sponsor: Beijing Tongren Hospital

Target Recruit Count: 272

Registration Number: NCT06102395

Locations: 🇨🇳
Beijing Tongren Hospital, Beijing, Beijing, China

A Study of Participant Reported Preference for Subcutaneous Pembrolizumab Coformulated With Hyaluronidase (MK-3475A) Over Intravenous Pembrolizumab (MK-3475) Formulation in Multiple Tumor Types (MK-3475A-F11)

Phase 2

Active, not recruiting

Conditions: Non-Small Cell Lung Cancer
Melanoma
Renal Cell Carcinoma

Interventions: Biological: Pembrolizumab co-formulated with hyaluronidase
Biological: Pembrolizumab

First Posted Date: 2023-10-25

Last Posted Date: 2024-11-29

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 144

Registration Number: NCT06099782

Locations: 🇺🇸
Russell Medical ( Site 0160), Alexander City, Alabama, United States
🇺🇸
Alaska Oncology and Hematology ( Site 0121), Anchorage, Alaska, United States
🇺🇸
Highlands Oncology Group-Research Department ( Site 0133), Springdale, Arkansas, United States

and more 42 locations

Efficacy and Safety of PD-1 Plus Chemotherapy in Poorly Differentiated Locally Advanced (LA) HNSCC

Phase 2

Recruiting

Conditions: Head and Neck Squamous Cell Carcinoma

Interventions: Drug: Pembrolizumab
Drug: Cisplatin
Drug: Paclitaxel-albumin

First Posted Date: 2023-10-25

Last Posted Date: 2024-08-09

Lead Sponsor: Beijing Tongren Hospital

Target Recruit Count: 100

Registration Number: NCT06100497

Locations: 🇨🇳
Beijing Tongren Hospital Affiliated to Capital Medical University, Beijing, Beijing, China

Chemotherapy Combined With Immunotherapy Versus Immunotherapy Alone for Older Adults With Stage IIIB-IV Lung Cancer, The ACHIEVE Trial

Phase 3

Recruiting

Conditions: Stage IIIB Lung Cancer AJCC v8
Stage IIIC Lung Cancer AJCC v8
Advanced Lung Non-Small Cell Carcinoma
Stage IV Lung Cancer AJCC v8

Interventions: Procedure: Computed Tomography
Drug: Carboplatin
Procedure: Magnetic Resonance Imaging
Biological: Pembrolizumab
Procedure: Positron Emission Tomography
Drug: Nab-paclitaxel
Other: Quality-of-Life Assessment
Drug: Paclitaxel
Other: Questionnaire Administration
Drug: Pemetrexed

First Posted Date: 2023-10-24

Last Posted Date: 2025-01-09

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 304

Registration Number: NCT06096844

Locations: 🇺🇸
Highlands Oncology Group - Fayetteville, Fayetteville, Arkansas, United States
🇺🇸
Highlands Oncology Group - Rogers, Rogers, Arkansas, United States
🇺🇸
Highlands Oncology Group, Springdale, Arkansas, United States

and more 223 locations

Phase II Investigation of Pembrolizumab in Combination With Bevacizumab and Oral Cyclophosphamide in Patients With High Grade Ovarian Cancer and Surgically Documented Minimal Residual Disease After Frontline Therapy

Phase 2

Recruiting

Conditions: Ovarian Cancer

Interventions: Drug: Pembrolizumab
Drug: Bevacizumab
Drug: Cyclophosphamide

First Posted Date: 2023-10-16

Last Posted Date: 2024-12-12

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 20

Registration Number: NCT06083844

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

NeoAdj. Therapy Comparing Sacituzumab Govitecan (SG) vs. SG+Pembrolizumab in Low-risk, Triple-neg. EBC (ADAPT-TN-III)

Phase 2

Recruiting

Conditions: Triple Negative Breast Cancer

Interventions: Drug: Sacituzumab govitecan
Drug: Pembrolizumab

First Posted Date: 2023-10-13

Last Posted Date: 2024-11-13

Lead Sponsor: West German Study Group

Target Recruit Count: 348

Registration Number: NCT06081244

Locations: 🇩🇪
Kliniken Essen-Mitte, Klinik für Senologie/Interdisziplinäres Brustzentrum, Essen, NRW, Germany
🇩🇪
Ev. Krankenhaus Bethesda Brustzentrum Niederrhein, Mönchengladbach, NRW, Germany

Study of Zanzalintinib (XL092) + Pembrolizumab vs Pembrolizumab in Subjects With PD-L1 Positive Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

Phase 2

Recruiting

Conditions: Head and Neck Squamous Cell Carcinoma

Interventions: Drug: Zanzalintinib-matched Placebo
Drug: Zanzalintinib
Biological: Pembrolizumab

First Posted Date: 2023-10-13

Last Posted Date: 2024-12-27

Lead Sponsor: Exelixis

Target Recruit Count: 600

Registration Number: NCT06082167

Locations: 🇬🇷
Exelixis Clinical Site #120, Thessaloniki, Greece
🇬🇷
Exelixis Clinical Site #128, Thessaloniki, Greece
🇭🇺
Exelixis Clinical Site #125, Budapest, Hungary

and more 131 locations

A Study of V940 Plus Pembrolizumab (MK-3475) Versus Placebo Plus Pembrolizumab in Participants With Non-small Cell Lung Cancer (V940-002)

Phase 3

Recruiting

Conditions: Non-small Cell Lung Cancer

Interventions: Biological: V940
Biological: Pembrolizumab
Other: Placebo

First Posted Date: 2023-10-11

Last Posted Date: 2025-01-08

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 868

Registration Number: NCT06077760

Locations: 🇺🇸
Alaska Oncology and Hematology ( Site 0039), Anchorage, Alaska, United States
🇺🇸
YUMA REGIONAL MEDICAL CENTER CANCER CENTER ( Site 0020), Yuma, Arizona, United States
🇺🇸
UCLA Clinical & Translational Research Center (CTRC) ( Site 0059), Los Angeles, California, United States

and more 169 locations

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