MedPath

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
-

Pembro+Chemo in Brain Mets

Phase 2
Terminated
Conditions
Lung Cancer
Lung Cancer Metastatic
Brain Cancer
Cancer
Interventions
First Posted Date
2021-07-16
Last Posted Date
2024-10-21
Lead Sponsor
John L. Villano, MD, PhD
Target Recruit Count
3
Registration Number
NCT04964960
Locations
🇺🇸

University of Kentucky, Markey Cancer Center, Lexington, Kentucky, United States

Pembrolizumab in Combination With Gemcitabine in People With Advanced Mycosis Fungoides or Sézary Syndrome

Phase 2
Recruiting
Conditions
Mycosis Fungoides
Mycosis Fungoides/Sezary Syndrome
Sezary Syndrome
Sézary
Advanced Mycosis Fungoides
Interventions
First Posted Date
2021-07-14
Last Posted Date
2024-11-19
Lead Sponsor
Memorial Sloan Kettering Cancer Center
Target Recruit Count
28
Registration Number
NCT04960618
Locations
🇺🇸

Memorial Sloan Kettering Bergen (Limited Protocol Activities), Montvale, New Jersey, United States

🇺🇸

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities), Basking Ridge, New Jersey, United States

🇺🇸

Memorial Sloan Kettering Monmouth (Limited Protocol Activities), Middletown, New Jersey, United States

and more 5 locations

A Study to Test BI 765179 Alone and in Combination With Ezabenlimab in Patients With Advanced Cancer (Solid Tumors) and BI 765179 in Combination With Pembrolizumab in Patients With Advanced Head and Neck Cancer

Phase 1
Recruiting
Conditions
Neoplasms
Interventions
First Posted Date
2021-07-12
Last Posted Date
2024-12-24
Lead Sponsor
Boehringer Ingelheim
Target Recruit Count
160
Registration Number
NCT04958239
Locations
🇺🇸

NEXT Oncology, San Antonio, Texas, United States

🇮🇹

Istituto Nazionale IRCCS Tumori Fondazione Pascale, Napoli, Italy

🇪🇸

Hospital Vall d'Hebron, Barcelona, Spain

and more 21 locations

Study of LY3537982 in Cancer Patients With a Specific Genetic Mutation (KRAS G12C)

Phase 1
Recruiting
Conditions
Biliary Tract Neoplasms
Carcinoma, Non-Small-Cell Lung
Colorectal Neoplasms
Ovarian Neoplasms
Endometrial Neoplasms
Pancreatic Neoplasms
Interventions
First Posted Date
2021-07-09
Last Posted Date
2024-10-26
Lead Sponsor
Eli Lilly and Company
Target Recruit Count
550
Registration Number
NCT04956640
Locations
🇫🇷

Centre Leon Berard, Lyon, Rhône-Alpes, France

🇯🇵

National Cancer Center Hospital, Chuo-ku, Tokyo, Japan

🇦🇺

Peninsula and Southeast Oncology, Frankston, Victoria, Australia

and more 46 locations

Pembrolizumab and Lenvatinib in Patients With Brain Metastases From Melanoma or Renal Cell Carcinoma

Phase 2
Recruiting
Conditions
Metastatic Melanoma
Renal Cell Carcinoma
Lenvatinib
Melanoma
Brain Metastases
PD1/PD-L1 Experienced
Pembrolizumab
Interventions
First Posted Date
2021-07-09
Last Posted Date
2024-12-24
Lead Sponsor
Yale University
Target Recruit Count
56
Registration Number
NCT04955743
Locations
🇺🇸

Yale University, New Haven, Connecticut, United States

The Purpose of the Study is to Continue to Provide Pemigatinib to Patients With Advanced Malignancies.

Phase 2
Terminated
Conditions
Advanced Malignancies
Interventions
First Posted Date
2021-07-02
Last Posted Date
2024-05-03
Lead Sponsor
Incyte Corporation
Target Recruit Count
10
Registration Number
NCT04949191
Locations
🇺🇸

Virginia Cancer Specialists, Pc, Fairfax, Virginia, United States

🇺🇸

Oncology Specialists of Charlotte, Charlotte, North Carolina, United States

🇮🇹

Istituto Nazionale Tumori Regina Elena Irccs, Rome, Italy

and more 7 locations

Efficacy and Safety of Pembrolizumab (MK-3475) Plus Lenvatinib (E7080/MK-7902) Plus Chemotherapy in Participants With Metastatic Esophageal Carcinoma (MK-7902-014/E7080-G000-320/LEAP-014)

First Posted Date
2021-07-02
Last Posted Date
2025-01-08
Lead Sponsor
Merck Sharp & Dohme LLC
Target Recruit Count
862
Registration Number
NCT04949256
Locations
🇺🇦

Regional Municipal Non-profit Enterprise "Bukovinian Clinical Oncology Center" ( Site 1819), Chernivtsi, Chernivetska Oblast, Ukraine

🇺🇦

Rivne Regional Clinical Hospital ( Site 1817), Rivne, Rivnenska Oblast, Ukraine

🇺🇸

City of Hope ( Site 0102), Duarte, California, United States

and more 195 locations

Phase I/II Trial of Pembrolizumab and Androgen-receptor Pathway Inhibitor With or Without 225Ac-J591 for Progressive Metastatic Castration Resistant Prostate Cancer

Phase 1
Recruiting
Conditions
Prostate Cancer
Interventions
Drug: 225Ac-J591
Drug: Pembrolizumab
Drug: Androgen receptor pathway inhibitor
Diagnostic Test: 68Ga-PSMA-11
First Posted Date
2021-06-30
Last Posted Date
2024-10-16
Lead Sponsor
Weill Medical College of Cornell University
Target Recruit Count
76
Registration Number
NCT04946370
Locations
🇺🇸

Dana-Farber Cancer Institute, Boston, Massachusetts, United States

🇺🇸

New York Presbyterian/Brooklyn Methodist Hospital, Brooklyn, New York, United States

🇺🇸

New York Presbyterian/Weill Cornell Medical Center, New York, New York, United States

and more 1 locations

Neoadjuvant Immunoradiotherapy in Head & Neck Cancer (NIRT 2-HNC)

Phase 2
Recruiting
Conditions
Head and Neck Cancer
Head and Neck Squamous Cell Carcinoma
Interventions
Drug: Pembrolizumab
Radiation: Stereotactic Body Radiation Therapy (5 days)
Procedure: Surgical Resection
First Posted Date
2021-06-24
Last Posted Date
2024-01-25
Lead Sponsor
Providence Health & Services
Target Recruit Count
28
Registration Number
NCT04938609
Locations
🇺🇸

University of San Diego, San Diego, California, United States

🇺🇸

Portland Providence Medical Center, Portland, Oregon, United States

🇺🇸

Providence St. Vincent Medical Center, Portland, Oregon, United States

GEN1046 Safety and PK in Subjects With Advanced Solid Malignancies

Phase 1
Completed
Conditions
Solid Tumor
Interventions
Biological: Acasunlimab
Biological: Pembrolizumab
First Posted Date
2021-06-23
Last Posted Date
2024-12-13
Lead Sponsor
Genmab
Target Recruit Count
18
Registration Number
NCT04937153
Locations
🇯🇵

National Cancer Center East, Chiba, Japan

🇯🇵

National Cancer Center Hospital, Tokyo, Japan

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