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

Metformin Plus/Minus Fasting Mimicking Diet to Target the Metabolic Vulnerabilities of LKB1-inactive Lung Adenocarcinoma

Phase 2

Conditions: Advanced LKB1-inactive Lung Adenocarcinoma

Interventions: Drug: Metformin Hydrochloride
Drug: Cisplatin
Drug: Carboplatin
Drug: Pemetrexed
Dietary Supplement: Fasting-mimicking diet
Drug: Pembrolizumab

First Posted Date: 2018-10-17

Last Posted Date: 2020-11-16

Lead Sponsor: Marina Garassino

Target Recruit Count: 64

Registration Number: NCT03709147

Locations: 🇮🇹
Marina Chiara Garassino, Milan, Italy

Pilot Immunotherapy Study With Letetresgene Autoleucel (Lete-cel, GSK3377794)T-cells in New York Esophageal Squamous Cell Carcinoma-1 (NY-ESO-1)/ LAGE-1a-positive Advanced Non-small Cell Lung Cancer (NSCLC) Either Alone or in Combination With Pembrolizumab

Phase 1

Terminated

Conditions: Neoplasms

Interventions: Drug: Lete-cel
Drug: Pembrolizumab

First Posted Date: 2018-10-17

Last Posted Date: 2024-02-23

Lead Sponsor: GlaxoSmithKline

Target Recruit Count: 34

Registration Number: NCT03709706

Locations: 🇬🇧
GSK Investigational Site, Manchester, United Kingdom

Clinical Trial of Safety, Tolerability and Antitumor Activity of Genetically Engineered T Cells in Combination With Anti-Cancer Agents in Relapsed and Refractory Synovial Sarcoma Expressing New York Esophageal Antigen-1 (NY-ESO-1) and/or LAGE-1a

Phase 2

Withdrawn

Conditions: Neoplasms

Interventions: Drug: GSK3377794
Drug: Pembrolizumab
Drug: Fludarabine
Drug: Cyclophosphamide

First Posted Date: 2018-10-05

Last Posted Date: 2019-10-29

Lead Sponsor: GlaxoSmithKline

Registration Number: NCT03697824

A Study to Compare the Administration of Pembrolizumab After Surgery Versus Administration Both Before and After Surgery for High-Risk Melanoma

Phase 2

Active, not recruiting

Conditions: Acral Lentiginous Melanoma
Clinical Stage IV Cutaneous Melanoma AJCC v8
Clinical Stage III Cutaneous Melanoma AJCC v8
Mucosal Melanoma

Interventions: Procedure: Biospecimen Collection
Procedure: Computed Tomography
Procedure: Magnetic Resonance Imaging
Biological: Pembrolizumab
Procedure: Therapeutic Conventional Surgery

First Posted Date: 2018-10-05

Last Posted Date: 2024-12-04

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 313

Registration Number: NCT03698019

Locations: 🇺🇸
Kaiser Permanente Sacramento Medical Center, Sacramento, California, United States
🇺🇸
Lutheran Hospital - Cancer Centers of Colorado, Golden, Colorado, United States
🇺🇸
Good Samaritan Hospital - Cancer Centers of Colorado, Lafayette, Colorado, United States

and more 817 locations

Pembrolizumab in Treating Patients with Stage IB-IV Mycosis Fungoides

Phase 2

Completed

Conditions: Mycosis Fungoides
Sezary Syndrome
Stage IB Mycosis Fungoides and Sezary Syndrome AJCC V8
Stage II Mycosis Fungoides and Sezary Syndrome AJCC V8
Stage IIA Mycosis Fungoides and Sezary Syndrome AJCC V8
Stage IIB Mycosis Fungoides and Sezary Syndrome AJCC V8
Stage III Mycosis Fungoides and Sezary Syndrome AJCC V8
Stage IIIA Mycosis Fungoides and Sezary Syndrome AJCC V8
Stage IIIB Mycosis Fungoides and Sezary Syndrome AJCC V8
Stage IV Mycosis Fungoides and Sezary Syndrome AJCC V8

Interventions: Biological: Pembrolizumab

First Posted Date: 2018-10-04

Last Posted Date: 2024-12-09

Lead Sponsor: Mayo Clinic

Target Recruit Count: 9

Registration Number: NCT03695471

Locations: 🇺🇸
Mayo Clinic in Florida, Jacksonville, Florida, United States

Window of Opportunity Pilot Study of Pembrolizumab in Obesity-driven Endometrial Cancer

Early Phase 1

Terminated

Conditions: Endometrial Cancer
Uterine Cancer

Interventions: Drug: Pembrolizumab
Procedure: Hysterectomy

First Posted Date: 2018-10-03

Last Posted Date: 2023-11-28

Lead Sponsor: UNC Lineberger Comprehensive Cancer Center

Target Recruit Count: 3

Registration Number: NCT03694834

Locations: 🇺🇸
Lineberger Comprehensive Cancer Center, Chapel Hill, North Carolina, United States

First-time-in-human (FTIH) Study of GSK3145095 Alone and in Combination With Other Anticancer Agents in Adults With Advanced Solid Tumors

Phase 2

Terminated

Conditions: Neoplasms, Pancreatic

Interventions: Drug: GSK3145095
Drug: Pembrolizumab

First Posted Date: 2018-09-24

Last Posted Date: 2020-07-31

Lead Sponsor: GlaxoSmithKline

Target Recruit Count: 8

Registration Number: NCT03681951

Locations: 🇺🇸
GSK Investigational Site, Houston, Texas, United States

Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy in Participants Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma (MK-3475-859/KEYNOTE-859)

Phase 3

Active, not recruiting

Conditions: Stomach Neoplasms

Interventions: Biological: Pembrolizumab
Drug: Cisplatin
Drug: 5-fluorouracil
Drug: oxaliplatin
Drug: Placebo for Pembrolizumab
Drug: capecitabine

First Posted Date: 2018-09-18

Last Posted Date: 2024-12-02

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 1579

Registration Number: NCT03675737

Locations: 🇨🇷
CIMCA Centro de Investigacion y Manejo del Cancer ( Site 3001), San Jose, Costa Rica
🇨🇷
Policlinico San Bosco ( Site 3002), San Jose, Costa Rica
🇨🇷
ICIMED - Instituto de Investigacion en Ciencias Medicas ( Site 3000), San Jose, Costa Rica

and more 212 locations

Immunotherapy +/- EGFR Inhibitor In Advanced/Metastatic cSCC: Tackling Primary And Secondary Resistance

Phase 2

Conditions: Skin Neoplasm

Interventions: Drug: Pembrolizumab
Drug: Cetuximab

First Posted Date: 2018-09-11

Last Posted Date: 2018-09-11

Lead Sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Target Recruit Count: 43

Registration Number: NCT03666325

Locations: 🇮🇹
ASST Spedali Civili di Brescia, Brescia, BS, Italy
🇮🇹
Istituto IRCCS AOU S. Martino, Genova, Italy
🇮🇹
Istituto Europeo di Oncologia, Milan, MI, Italy

and more 4 locations

Biomarkers of Response to Pembrolizumab Combined With Chemotherapy in Non-Small Cell Lung Cancer (KEYNOTE-782, MK-3475-782)

Phase 2

Completed

Conditions: Non-Small Cell Lung Cancer

Interventions: Drug: Pembrolizumab
Drug: Pemetrexed
Drug: Carboplatin
Drug: Cisplatin

First Posted Date: 2018-09-10

Last Posted Date: 2024-08-22

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 118

Registration Number: NCT03664024

Locations: 🇨🇦
CISSS de la Monteregie-Centre ( Site 0801), Greenfield Park, Quebec, Canada
🇭🇺
Jasz Nagykun Szolnok Megyei Hetenyi Geza Korhaz Rendelointezet ( Site 0401), Szolnok, Hungary
🇮🇱
Meir Medical Center ( Site 0501), Kfar-Saba, Israel

and more 12 locations

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