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

CAR-macrophages for the Treatment of HER2 Overexpressing Solid Tumors

Phase 1

Active, not recruiting

Conditions: HER2-positive
Carcinoma, Hepatocellular
Lung Cancer, Non-Small-Cell
Esophagogastric Junction Neoplasms
Inflammatory Breast Cancer
Prostate Cancer
Lung Cancer, Small Cell
Bile Duct Cancer
Carcinoma, Ductal
Cancer

Interventions: Biological: CT-0508
Biological: Pembrolizumab

First Posted Date: 2020-12-09

Last Posted Date: 2024-12-18

Lead Sponsor: Carisma Therapeutics Inc

Target Recruit Count: 48

Registration Number: NCT04660929

Locations: 🇺🇸
M D Anderson Cancer Center, Houston, Texas, United States
🇺🇸
Abramson Cancer Center, Philadelphia, Pennsylvania, United States
🇺🇸
Fred Hutchinson Cancer Center, Seattle, Washington, United States

and more 4 locations

A Clinical Trial of Three Study Medicines (Encorafenib, Binimetinib, and Pembrolizumab) in Patients With Advanced or Metastatic Melanoma

Phase 3

Active, not recruiting

Conditions: Melanoma

Interventions: Drug: Encorafenib
Drug: Pembrolizumab
Drug: Binimetinib

First Posted Date: 2020-12-08

Last Posted Date: 2024-10-08

Lead Sponsor: Pfizer

Target Recruit Count: 258

Registration Number: NCT04657991

Locations: 🇩🇪
HELIOS Klinikum Erfurt, Erfurt, Germany
🇺🇸
UCLA - Hematology/Oncology - Administrative Office, Los Angeles, California, United States
🇺🇸
Ronald Reagan UCLA Medical Center Drug Information Center , Dept. of Pharmaceutical Services (Drug, Los Angeles, California, United States

and more 210 locations

GYNecological Cancers Treated with NETrin MAbs in Combination with Chemotherapy and /or Pembrolizumab

Phase 1

Active, not recruiting

Conditions: Endometrial Carcinoma
Cervix Carcinoma

Interventions: Drug: NP137
Drug: Paclitaxel
Drug: Carboplatin
Drug: Pembrolizumab

First Posted Date: 2020-12-03

Last Posted Date: 2024-10-08

Lead Sponsor: NETRIS Pharma

Target Recruit Count: 240

Registration Number: NCT04652076

Locations: 🇫🇷
Hopital de la Croix Saint Simon, Paris, France
🇫🇷
Institut Curie (Site Saint Cloud), Paris, France
🇫🇷
Institut Gustave Roussy, Paris, France

and more 11 locations

Lenvatinib and Pembrolizumab Combination Therapy In HPV-associated Recurrent Respiratory Papillomatosis Patients With Laryngeal, Tracheal, and/or Pulmonary Involvement

Phase 2

Not yet recruiting

Conditions: Human Papilloma Virus
Recurrent Respiratory Papillomatosis

Interventions: Drug: Lenvatinib
Drug: Pembrolizumab

First Posted Date: 2020-11-27

Last Posted Date: 2024-10-01

Lead Sponsor: Yale University

Target Recruit Count: 20

Registration Number: NCT04645602

Locations: 🇺🇸
Yale University, New Haven, Connecticut, United States

Olaparib in Combination With Pembrolizumab and Carboplatin as First-Line Treatment of Recurrent or Metastatic Head and Neck Squamous-Cell Carcinoma

Phase 2

Active, not recruiting

Conditions: Metastatic Head and Neck Squamous Cell Carcinoma
Recurrent Head and Neck Squamous Cell Carcinoma

Interventions: Drug: Olaparib
Drug: Pembrolizumab
Drug: Carboplatin
Procedure: Peripheral blood draw

First Posted Date: 2020-11-25

Last Posted Date: 2024-07-19

Lead Sponsor: Washington University School of Medicine

Target Recruit Count: 30

Registration Number: NCT04643379

Locations: 🇺🇸
Washington University School of Medicine, Saint Louis, Missouri, United States

Pembrolizumab Plus Olaparib in Patients With Recurrent Cervical Cancer

Phase 2

Conditions: Cervical Cancer

Interventions: Drug: Pembrolizumab
Drug: Olaparib

First Posted Date: 2020-11-24

Last Posted Date: 2022-08-09

Lead Sponsor: Saitama Medical University International Medical Center

Target Recruit Count: 28

Registration Number: NCT04641728

Locations: 🇯🇵
Saitama Medical Uiversity International Medical Center, Hidaka, Saitama, Japan

Pembrolizumab as Neoadjuvant Therapy for Resectable Stage IA3 to IIA Non-Small Cell Lung Cancer (NSCLC)

Phase 2

Recruiting

Conditions: Lung Cancer, Nonsmall Cell

Interventions: Drug: Pembrolizumab
Drug: Carboplatin
Drug: Paclitaxel
Drug: Pemetrexed

First Posted Date: 2020-11-20

Last Posted Date: 2023-03-22

Lead Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre

Target Recruit Count: 44

Registration Number: NCT04638582

Locations: 🇨🇦
McGill University Health Center, Montréal, Quebec, Canada

Trying to Find the Correct Length of Treatment With Immune Checkpoint Therapy

Phase 3

Active, not recruiting

Conditions: Locally Advanced Urothelial Carcinoma
Locally Advanced Urethral Urothelial Carcinoma
Locally Advanced Renal Pelvis Urothelial Carcinoma
Locally Advanced Ureter Urothelial Carcinoma
Metastatic Urethral Urothelial Carcinoma
Metastatic Bladder Urothelial Carcinoma
Metastatic Renal Pelvis Urothelial Carcinoma
Metastatic Ureter Urothelial Carcinoma
Metastatic Urothelial Carcinoma
Locally Advanced Bladder Urothelial Carcinoma

Interventions: Drug: Pembrolizumab
Drug: Nivolumab
Drug: Atezolizumab
Drug: Durvalumab
Drug: Avelumab

First Posted Date: 2020-11-20

Last Posted Date: 2024-07-31

Lead Sponsor: Alliance for Clinical Trials in Oncology

Target Recruit Count: 3

Registration Number: NCT04637594

Locations: 🇺🇸
CHI Health Saint Francis, Grand Island, Nebraska, United States
🇺🇸
CHI Health Good Samaritan, Kearney, Nebraska, United States
🇺🇸
Dana-Farber Cancer Institute, Boston, Massachusetts, United States

and more 374 locations

Study of Pembrolizumab (MK-3475) in Combination With Adjuvant Chemotherapy With or Without Radiotherapy in Participants With Newly Diagnosed Endometrial Cancer After Surgery With Curative Intent (MK-3475-B21 / KEYNOTE-B21 / ENGOT-en11 / GOG-3053)

Phase 3

Active, not recruiting

Conditions: Endometrial Neoplasms

Interventions: Biological: Pembrolizumab
Drug: Carboplatin
Drug: Placebo for pembrolizumab
Drug: Paclitaxel
Drug: Docetaxel
Drug: Cisplatin
Radiation: External Beam Radiotherapy (EBRT)
Drug: Cisplatin (as radiosensitizer)
Radiation: Brachytherapy

First Posted Date: 2020-11-18

Last Posted Date: 2024-11-19

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 990

Registration Number: NCT04634877

Locations: 🇨🇦
Kingston Health Sciences Centre ( Site 3003), Kingston, Ontario, Canada
🇺🇸
University of South Alabama, Mitchell Cancer Institute ( Site 3058), Mobile, Alabama, United States
🇺🇸
WK Physicians Network/Gynecologic Oncology Associates ( Site 3047), Shreveport, Louisiana, United States

and more 228 locations

CMP-001 in Combination With Pembrolizumab in Subjects With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

Phase 2

Terminated

Conditions: Squamous Cell Carcinoma of Head and Neck

Interventions: Drug: CMP-001
Drug: Pembrolizumab

First Posted Date: 2020-11-18

Last Posted Date: 2024-10-23

Lead Sponsor: Regeneron Pharmaceuticals

Target Recruit Count: 24

Registration Number: NCT04633278

Locations: 🇺🇸
University of Chicago Medical Center, Chicago, Illinois, United States
🇺🇸
University of Southern California: Norris Oncology/Hematology - Newport Beach, Newport Beach, California, United States
🇺🇸
University of California - San Diego, La Jolla, California, United States

and more 16 locations

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