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

Phase 2 Futibatinib in Combination With PD-1 Antibody Based Standard of Care in Solid Tumors

Phase 2

Recruiting

Conditions: Esophageal Squamous Cell Cancer
Locally Advanced Unresectable or Metastatic Solid Tumors Including Esophageal Cancer
Siewert Type 1 GEJ Cancer
Pancreatic Cancer
Esophageal Adenocarcinoma

Interventions: Drug: Futibatinib
Drug: Pembrolizumab
Drug: Cisplatin
Drug: 5-FU
Drug: Oxaliplatin
Drug: Leucovorin
Drug: Irinotecan
Drug: Levoleucovorin

First Posted Date: 2023-07-14

Last Posted Date: 2024-12-02

Lead Sponsor: Taiho Oncology, Inc.

Target Recruit Count: 66

Registration Number: NCT05945823

Locations: 🇺🇸
University of California Los Angeles UCLA - Cancer Care - Santa Monica, Santa Monica, California, United States
🇺🇸
Rocky Mountain Cancer Centers Midtown, Denver, Colorado, United States
🇺🇸
Mount Sinai Comprehensive Cancer Center, Miami Beach, Florida, United States

and more 19 locations

Pembro Plus CAR T-cell Therapy in R/R in PMBCL

Phase 2

Recruiting

Conditions: Primary Mediastinal Large B-cell Lymphoma (PMBCL)
Primary Mediastinal Large B Cell Lymphoma
Primary Mediastinal Large B-Cell Lymphoma Refractory
Primary Mediastinal Large B-Cell Lymphoma Recurrent
Epstein-Barr Virus Positive Diffuse Large B-Cell Lymphoma
T-Cell/Histiocyte-Rich Large B-Cell Lymphoma

Interventions: Drug: Pembrolizumab
Drug: Lymphodepletion Chemotherapy
Drug: Chimeric Antigen Receptor (CAR) Therapy Infusion
Procedure: Leukapheresis

First Posted Date: 2023-07-07

Last Posted Date: 2024-12-18

Lead Sponsor: Jennifer Crombie, MD

Target Recruit Count: 35

Registration Number: NCT05934448

Locations: 🇺🇸
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
🇺🇸
Memorial Sloan Kettering Cancer Center, New York, New York, United States

A Clinical Study of V940 Plus Pembrolizumab in People With High-Risk Melanoma (V940-001)

Phase 3

Active, not recruiting

Conditions: Melanoma

Interventions: Biological: Pembrolizumab
Biological: V940
Other: Placebo

First Posted Date: 2023-07-06

Last Posted Date: 2024-11-18

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 1089

Registration Number: NCT05933577

Locations: 🇨🇳
Chang Gung Memorial Hospital at Kaohsiung (Site 4000), Kaohsiung, Taiwan
🇨🇳
National Cheng Kung University Hospital-Clinical Trial Center ( Site 4004), Tainan, Taiwan
🇨🇳
National Taiwan University Hospital (Site 4001), Taipei, Taiwan

and more 162 locations

Shorter Chemo-Immunotherapy Without Anthracycline Drugs for Early-Stage Triple Negative Breast Cancer

Phase 3

Recruiting

Conditions: Anatomic Stage II Breast Cancer AJCC v8
Anatomic Stage IIIA Breast Cancer AJCC v8
Anatomic Stage I Breast Cancer AJCC v8
Anatomic Stage IIIB Breast Cancer AJCC v8
Early Stage Triple-Negative Breast Carcinoma

Interventions: Procedure: Biospecimen Collection
Drug: Carboplatin
Drug: Cyclophosphamide
Drug: Docetaxel
Biological: Pembrolizumab
Drug: Doxorubicin
Other: Quality-of-Life Assessment
Drug: Paclitaxel
Other: Questionnaire Administration
Procedure: Surgical Procedure

First Posted Date: 2023-07-03

Last Posted Date: 2024-10-31

Lead Sponsor: SWOG Cancer Research Network

Target Recruit Count: 2400

Registration Number: NCT05929768

Locations: 🇺🇸
Northwestern Medicine Cancer Center Warrenville, Warrenville, Illinois, United States
🇺🇸
Cedars Sinai Medical Center, Los Angeles, California, United States
🇺🇸
Cancer Center of Kansas-Independence, Independence, Kansas, United States

and more 427 locations

A Study Comparing 3 Study Medicines (Encorafenib, Binimetinib, Pembrolizumab) to 2 Study Medicines (Ipilimumab and Nivolumab) in Patients With Advanced Melanoma

Phase 2

Active, not recruiting

Conditions: Melanoma

Interventions: Drug: encorafenib
Drug: ipilimumab
Drug: binimetinib
Drug: nivolumab
Drug: pembrolizumab

First Posted Date: 2023-07-03

Last Posted Date: 2024-12-03

Lead Sponsor: Pfizer

Target Recruit Count: 150

Registration Number: NCT05926960

Locations: 🇮🇹
Istituto Nazionale Tumori IRCCS Fondazione Pascale, Napoli, Italy
🇮🇹
Istituto Europeo di Oncologia IRCCS, Milano, Italy
🇸🇰
Nemocnica Poprad, a.s., Poprad, Slovakia

and more 60 locations

Pembrolizumab in Locally Advanced Sinonasal Carcinoma

Phase 2

Not yet recruiting

Conditions: Sinonasal Undifferentiated Carcinoma

Interventions: Drug: Pembrolizumab
Drug: Cisplatin
Drug: Docetaxel
Drug: Carboplatin

First Posted Date: 2023-06-29

Last Posted Date: 2024-12-18

Lead Sponsor: Istituti Clinici Scientifici Maugeri SpA

Target Recruit Count: 28

Registration Number: NCT05925491

Locations: 🇮🇹
Istituti Clinici Scientifici Maugeri, Pavia, Lombardia, Italy

PET Adapted Brentuximab Vedotin and Pembrolizumab in Combination With Doxorubicin and Dacarbazine in Classic Hodgkin Lymphoma

Phase 2

Recruiting

Conditions: Hodgkin Lymphoma

Interventions: Drug: Brentuximab vedotin
Drug: Doxorubicin Hydrochloride
Drug: Pembrolizumab
Drug: Dacarbazine

First Posted Date: 2023-06-28

Last Posted Date: 2024-11-20

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 50

Registration Number: NCT05922904

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

Enfortumab Vedotin Schedule De-escalation in Metastatic Urothelial Carcinoma

Phase 2

Recruiting

Conditions: Urothelial Carcinoma
Metastatic Urothelial Carcinoma
Locally Advanced Urothelial Carcinoma

Interventions: Drug: Enfortumab vedotin
Drug: Pembrolizumab

First Posted Date: 2023-06-28

Last Posted Date: 2024-07-12

Lead Sponsor: Fox Chase Cancer Center

Target Recruit Count: 70

Registration Number: NCT05923190

Locations: 🇺🇸
Fox Chase Cancer Center - Philadelphia, Philadelphia, Pennsylvania, United States

Vaccine Therapy Plus Pembrolizumab in Treating Advanced Ovarian, Fallopian Tube, or Primary Peritoneal Cavity Cancer

Phase 1

Recruiting

Conditions: Fallopian Tube Carcinosarcoma
Primary Peritoneal Carcinosarcoma
Recurrent Fallopian Tube Carcinoma
Recurrent Fallopian Tube Clear Cell Adenocarcinoma
Recurrent Fallopian Tube Endometrioid Adenocarcinoma
Recurrent Fallopian Tube High Grade Serous Adenocarcinoma
Recurrent Ovarian Carcinoma
Recurrent Ovarian Carcinosarcoma
Recurrent Ovarian Clear Cell Adenocarcinoma
Recurrent Ovarian Endometrioid Adenocarcinoma

Interventions: Procedure: Biopsy
Procedure: Biospecimen Collection
Procedure: Computed Tomography
Procedure: Magnetic Resonance Imaging
Biological: Multi-epitope Folate Receptor Alpha-loaded Dendritic Cell Vaccine
Biological: Pembrolizumab
Procedure: Pheresis

First Posted Date: 2023-06-27

Last Posted Date: 2024-11-26

Lead Sponsor: Mayo Clinic

Target Recruit Count: 40

Registration Number: NCT05920798

Locations: 🇺🇸
Mayo Clinic in Arizona, Scottsdale, Arizona, United States
🇺🇸
Mayo Clinic in Florida, Jacksonville, Florida, United States
🇺🇸
Mayo Clinic in Rochester, Rochester, Minnesota, United States

A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)

Phase 3

Recruiting

Conditions: Non-Small Cell Lung Cancer (NSCLC)

Interventions: Drug: Sotorasib
Drug: Pembrolizumab

First Posted Date: 2023-06-27

Last Posted Date: 2024-12-13

Lead Sponsor: Amgen

Target Recruit Count: 750

Registration Number: NCT05920356

Locations: 🇧🇷
Associação Beneficente de Canoas, Canoas, Rio Grande Do Sul, Brazil
🇨🇳
Fujian Provincial Hospital, Fuzhou, Fujian, China
🇨🇳
Chi Mei Hospital, Liouying, Tainan, Taiwan

and more 322 locations

Drug Development Updates

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