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

M7824 Versus Pembrolizumab as a First-line (1L) Treatment in Participants With Programmed Death-ligand 1 (PD-L1) Expressing Advanced Non-small Cell Lung Cancer (NSCLC)

Phase 3

Completed

Conditions: Non-small Cell Lung Cancer

Interventions: Drug: M7824
Drug: Pembrolizumab

First Posted Date: 2018-08-15

Last Posted Date: 2024-08-13

Lead Sponsor: EMD Serono Research & Development Institute, Inc.

Target Recruit Count: 304

Registration Number: NCT03631706

Locations: 🇺🇸
Cedars Sinai Medical Center - Inflammatory Bowel Disease Center (Clinic, Los Angeles, California, United States
🇺🇸
Decatur Memorial Hospital - Clinical Research, Decatur, Illinois, United States
🇺🇸
UPMC Cancer Center, Pittsburgh, Pennsylvania, United States

and more 116 locations

Safety and Efficacy of Vicriviroc (MK-7690) in Combination With Pembrolizumab (MK-3475) in Participants With Advanced/Metastatic Microsatellite Stable (MSS) Colorectal Cancer (CRC) (MK-7690-046)

Phase 2

Completed

Conditions: Colorectal Neoplasms

Interventions: Drug: Vicriviroc
Biological: Pembrolizumab

First Posted Date: 2018-08-15

Last Posted Date: 2024-11-21

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 41

Registration Number: NCT03631407

Locations: 🇺🇸
California Cancer Associates for Research & Excellence ( Site 0100), Encinitas, California, United States
🇺🇸
Baylor Scott & White Medical Center - Temple ( Site 0104), Temple, Texas, United States
🇨🇦
Cross Cancer Institute ( Site 0201), Edmonton, Alberta, Canada

and more 5 locations

Study of Efficacy and Safety of Pembrolizumab Plus Platinum-based Doublet Chemotherapy With or Without Canakinumab in Previously Untreated Locally Advanced or Metastatic Non-squamous and Squamous NSCLC Subjects

Phase 3

Active, not recruiting

Conditions: Non-small Cell Lung Cancer

Interventions: Drug: canakinumab
Drug: canakinumab-matching placebo
Drug: pembrolizumab
Drug: carboplatin
Drug: cisplatin
Drug: pemetrexed
Drug: paclitaxel
Drug: nab-paclitaxel

First Posted Date: 2018-08-15

Last Posted Date: 2024-10-07

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 673

Registration Number: NCT03631199

Locations: 🇺🇸
Pacific Shores Medical Group ., Long Beach, California, United States
🇺🇸
USC Kenneth Norris Comprehensive Cancer Center ., Los Angeles, California, United States
🇺🇸
Advent Health Cancer Institute, Orlando, Florida, United States

and more 2 locations

Investigating the Safety and Efficacy of Rituximab and Pembrolizumab in Relapsed/Refractory Waldenström's Macroglobulinaemia

Phase 2

Completed

Conditions: Waldenstrom Macroglobulinemia

Interventions: Drug: Pembrolizumab
Drug: Rituximab

First Posted Date: 2018-08-14

Last Posted Date: 2024-11-07

Lead Sponsor: University College, London

Target Recruit Count: 17

Registration Number: NCT03630042

Locations: 🇬🇧
Derriford Hospital, Univeristy Hospitals Plymouth NHS Trust, Plymouth, Devon, United Kingdom
🇬🇧
Churchill Hospital, Oxford Univeristy NHS Foundation Trust, Oxford, Oxfordshire, United Kingdom
🇬🇧
UCLH, Univeristy College London Hospitals NHS Foundation Trust, London, Greater London, United Kingdom

and more 6 locations

Study of Tisagenlecleucel in Combination With Pembrolizumab in r/r Diffuse Large B-cell Lymphoma Patients

Phase 1

Completed

Conditions: Diffuse Large B-cell Lymphoma

Interventions: Biological: Tisagenlecleucel
Drug: Pembrolizumab

First Posted Date: 2018-08-14

Last Posted Date: 2022-08-15

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 12

Registration Number: NCT03630159

Locations: 🇺🇸
Emory University School of Medicine SC CTL019, Atlanta, Georgia, United States
🇺🇸
University of Kansas Hospital and Medical Center U of Kansas Cancer Center, Kansas City, Kansas, United States
🇺🇸
University of Chicago Medical Center Hematology and Oncology, Chicago, Illinois, United States

and more 1 locations

Study of Pembrolizumab With Pemetrexed and Oxaliplatin in Chemo-Refractory Metastatic Colorectal Cancer Patients

Phase 1

Conditions: Metastatic Colorectal Cancer

Interventions: Drug: Pembrolizumab
Drug: Pemetrexed
Drug: Dexamethasone
Drug: Oxaliplatin
Dietary Supplement: Folic Acid
Dietary Supplement: Vitamin B-12

First Posted Date: 2018-08-13

Last Posted Date: 2022-06-10

Lead Sponsor: NSABP Foundation Inc

Target Recruit Count: 33

Registration Number: NCT03626922

Locations: 🇺🇸
Cancer Care Specialists of Central Illinois, Decatur, Illinois, United States
🇺🇸
Decatur Memorial Hospital, Decatur, Illinois, United States
🇺🇸
Minnesota Oncology-Minneapolis, Minneapolis, Minnesota, United States

and more 12 locations

Denosumab + PD-1 in Subjects With Stage III/ IV Melanoma

Phase 2

Completed

Conditions: Melanoma Stage Iii
Melanoma Stage Iv
Cutaneous Melanoma
Melanoma
Melanoma (Skin)

Interventions: Drug: Denosumab
Drug: Pembrolizumab
Drug: Nivolumab

First Posted Date: 2018-08-08

Last Posted Date: 2024-08-12

Lead Sponsor: UNC Lineberger Comprehensive Cancer Center

Target Recruit Count: 25

Registration Number: NCT03620019

Locations: 🇺🇸
Dartmouth-Hitchcock Medical Center, Manchester, New Hampshire, United States
🇺🇸
UNC Lineberger Comprehensive Cancer Center, Chapel Hill, North Carolina, United States

Phase II Study of Second- Line Pembrolizumab Plus GVD for Relapsed or Refractory Hodgkin Lymphoma

Phase 2

Recruiting

Conditions: Hodgkin Lymphoma
Relapsed or Refractory Hodgkin Lymphoma

Interventions: Drug: pembrolizumab
Drug: gemcitabine
Drug: vinorelbine
Drug: liposomal doxorubicin
Procedure: Stem cell mobilization and collection

First Posted Date: 2018-08-07

Last Posted Date: 2024-12-18

Lead Sponsor: Memorial Sloan Kettering Cancer Center

Target Recruit Count: 257

Registration Number: NCT03618550

Locations: 🇺🇸
University of Miami, Miami, Florida, United States
🇺🇸
Memorial Sloan Kettering Basking Ridge, Basking Ridge, New Jersey, United States
🇺🇸
Memorial Sloan Kettering Monmouth, Middletown, New Jersey, United States

and more 5 locations

Pembrolizumab/Placebo Plus Trastuzumab Plus Chemotherapy in Human Epidermal Growth Factor Receptor 2 Positive (HER2+) Advanced Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma (MK-3475-811/KEYNOTE-811)

Phase 3

Active, not recruiting

Conditions: Gastric Neoplasms
Gastroesophageal Junction Adenocarcinoma

Interventions: Biological: Placebo
Biological: Pembrolizumab
Drug: Cisplatin
Drug: 5-FU
Drug: Oxaliplatin
Drug: Capecitabine
Drug: S-1
Biological: Trastuzumab

First Posted Date: 2018-08-03

Last Posted Date: 2024-11-19

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 738

Registration Number: NCT03615326

Locations: 🇪🇸
Hospital Universitario Central de Asturias ( Site 1402), Oviedo, Asturias, Spain
🇺🇸
Cancer Treatment Centers of America-Eastern Regional Medical Center ( Site 0025), Philadelphia, Pennsylvania, United States
🇺🇸
University of Rochester ( Site 0041), Rochester, New York, United States

and more 189 locations

Lenvatinib and Pembrolizumab Simultaneous Combination Study

Phase 2

Completed

Conditions: Advanced Gastric Cancer

Interventions: Drug: Lenvatinib
Drug: Pembrolizumab

First Posted Date: 2018-08-01

Last Posted Date: 2021-04-26

Lead Sponsor: National Cancer Center Hospital East

Target Recruit Count: 29

Registration Number: NCT03609359

Locations: 🇯🇵
NationalCCHE, Kashiwa, Tokyo, Japan

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