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

Plinabulin in Combination With Radiation/Immunotherapy in Patients With Select Advanced Cancers After Progression on PD-1 or PD-L1 Targeted Antibodies

Phase 1

Active, not recruiting

Conditions: Clinical Stage IV Merkel Cell Carcinoma AJCC v8
Advanced Bladder Carcinoma
Clinical Stage III Cutaneous Melanoma AJCC v8
Pathologic Stage IIIA Cutaneous Melanoma AJCC v8
Pathologic Stage IIID Cutaneous Melanoma AJCC v8
Stage III Lung Cancer AJCC v8
Stage IIIC Lung Cancer AJCC v8
Stage IV Bladder Cancer AJCC v8
Stage IV Lung Cancer AJCC v8
Advanced Lung Non-Small Cell Carcinoma

Interventions: Biological: Atezolizumab
Drug: Avelumab
Biological: Durvalumab
Biological: Nivolumab
Biological: Pembrolizumab
Drug: Plinabulin
Radiation: Radiation Therapy

First Posted Date: 2021-05-26

Last Posted Date: 2024-12-05

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 19

Registration Number: NCT04902040

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

Olaptesed With Pembrolizumab and Nanoliposomal Irinotecan or Gemcitabine/Nab-Paclitaxel in MSS Pancreatic Cancer

Phase 2

Not yet recruiting

Conditions: Metastatic Pancreatic Cancer

Interventions: Drug: Olaptesed pegol
Drug: Pembrolizumab

First Posted Date: 2021-05-25

Last Posted Date: 2024-06-11

Lead Sponsor: TME Pharma AG

Target Recruit Count: 60

Registration Number: NCT04901741

A Study of Pembrolizumab and Radiation Therapy in People With Mesothelioma

Phase 1

Recruiting

Conditions: Malignant Pleural Mesothelioma

Interventions: Drug: Pembrolizumab
Radiation: IMPRINT

First Posted Date: 2021-05-21

Last Posted Date: 2024-06-04

Lead Sponsor: Memorial Sloan Kettering Cancer Center

Target Recruit Count: 24

Registration Number: NCT04897022

Locations: 🇺🇸
Memorial Sloan Kettering Monmouth (Limited Protocol Activities), Middletown, New Jersey, United States
🇺🇸
Memorial Sloan Kettering Basking Ridge (Limited protocol activities), Basking Ridge, New Jersey, United States
🇺🇸
Memorial Sloan Kettering Bergen (Limited Protocol Activities), Montvale, New Jersey, United States

and more 4 locations

Study of Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy for HR+/HER2- Locally Recurrent Inoperable or Metastatic Breast Cancer (MK-3475-B49/KEYNOTE-B49)

Phase 3

Active, not recruiting

Conditions: Breast Neoplasms

Interventions: Biological: pembrolizumab
Drug: paclitaxel
Drug: nab-paclitaxel
Drug: liposomal doxorubicin
Drug: capecitabine
Drug: normal saline
Drug: dextrose

First Posted Date: 2021-05-20

Last Posted Date: 2024-11-13

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 340

Registration Number: NCT04895358

Locations: 🇺🇸
Parkview Research Center at Parkview Regional Medical Center ( Site 0071), Fort Wayne, Indiana, United States
🇺🇸
University of Illinois at Chicago ( Site 0061), Chicago, Illinois, United States
🇫🇷
Institut de Cancérologie de l'Ouest ( Site 0915), ANGERS cedex 02, Maine-et-Loire, France

and more 253 locations

Evaluation of Co-formulated Pembrolizumab/Quavonlimab (MK-1308A) Versus Other Treatments in Participants With Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Stage IV Colorectal Cancer (CRC) (MK-1308A-008/KEYSTEP-008)

Phase 2

Active, not recruiting

Conditions: Colorectal Cancer

Interventions: Biological: Pembrolizumab
Biological: Pembrolizumab/Quavonlimab
Biological: Pembrolizumab/Favezelimab
Biological: Pembrolizumab/Vibostolimab
Biological: MK-4830

First Posted Date: 2021-05-20

Last Posted Date: 2024-12-13

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 320

Registration Number: NCT04895722

Locations: 🇺🇸
University of Chicago Medical Center-Medicine - Section of Hematology/Oncology - Gastrointestinal P, Chicago, Illinois, United States
🇺🇸
UPMC Hillman Cancer Center ( Site 1516), Pittsburgh, Pennsylvania, United States
🇨🇦
The Moncton Hospital-Oncology ( Site 0307), Moncton, New Brunswick, Canada

and more 106 locations

Safety and Efficacy Study of Pembrolizumab (MK-3475) Combined With Lenvatinib (MK-7902/E7080) as First-line Intervention in Adults With Advanced Melanoma (MK-7902-003/E7080-G000-312/LEAP-003)-China Extension Study

Phase 3

Completed

Conditions: Malignant Melanoma

Interventions: Biological: Pembrolizumab
Drug: Placebo for lenvatinib
Drug: Lenvatinib

First Posted Date: 2021-05-17

Last Posted Date: 2024-12-02

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 131

Registration Number: NCT04889118

Locations: 🇨🇳
Nanjing Drum Tower Hospital (0609), Nanjing, Jiangsu, China
🇨🇳
Beijing Cancer Hospital (0601), Beijing, Beijing, China
🇨🇳
Sun Yat-Sen University Cancer Center (0602), Guangzhou, Guangdong, China

and more 8 locations

Lenvatinib and Pembrolizumab Maintenance Therapy for the Treatment of Patients of Advanced Unresectable Pancreatic Cancer

Phase 2

Recruiting

Conditions: Advanced Pancreatic Ductal Adenocarcinoma
Stage IIB Pancreatic Cancer AJCC v8
Stage III Pancreatic Cancer AJCC v8
Stage IV Pancreatic Cancer AJCC v8
Stage II Pancreatic Cancer AJCC v8
Stage IIA Pancreatic Cancer AJCC v8
Unresectable Pancreatic Ductal Adenocarcinoma

Interventions: Drug: Lenvatinib Mesylate
Biological: Pembrolizumab

First Posted Date: 2021-05-14

Last Posted Date: 2024-11-12

Lead Sponsor: City of Hope Medical Center

Target Recruit Count: 28

Registration Number: NCT04887805

Locations: 🇺🇸
City of Hope Medical Center, Duarte, California, United States

Study of Sitravatinib With or Without Other Anticancer Therapies Receiving Clinical Benefit From Parent Study

Phase 2

Active, not recruiting

Conditions: Advanced or Metastatic Solid Malignancies

Interventions: Drug: Sitravatinib
Drug: Nivolumab
Drug: Pembrolizumab
Drug: Enfortumab Vedotin-Ejfv
Drug: Ipilimumab

First Posted Date: 2021-05-14

Last Posted Date: 2024-06-21

Lead Sponsor: Mirati Therapeutics Inc.

Target Recruit Count: 55

Registration Number: NCT04887870

Locations: 🇺🇸
Local Institution - 516-014-004, Columbus, Ohio, United States
🇺🇸
Local Institution - 516-014-011, Albany, New York, United States
🇺🇸
Local Institution - 516-014-027, Fairfax, Virginia, United States

and more 10 locations

Study of Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy in Participants With Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma (MK-3475-585/KEYNOTE-585)-China Extension

Phase 3

Active, not recruiting

Conditions: Gastroesophageal Junction Cancer
Gastric Cancer

Interventions: Drug: Placebo
Biological: Pembrolizumab
Drug: 5-fluorouracil
Drug: Cisplatin
Drug: Capecitabine
Drug: Docetaxel
Drug: Oxaliplatin
Drug: Leucovorin

First Posted Date: 2021-05-11

Last Posted Date: 2025-01-08

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 120

Registration Number: NCT04882241

Locations: 🇨🇳
Afflilated Hospital of Bengbu Medical College-Surgical Oncology (Site 0638), Bengbu, Anhui, China
🇨🇳
Tangdu Hospital of Fourth Military Medical University of Chinese People's Liberation Army ( Site 0647), Xi'an, Shaanxi, China
🇨🇳
Beijing Friendship Hospital ( Site 0637), Beijing, Beijing, China

and more 17 locations

A Study of Disitamab Vedotin Alone or With Pembrolizumab in Urothelial Cancer That Expresses HER2

Phase 2

Recruiting

Conditions: Urothelial Carcinoma

Interventions: Drug: disitamab vedotin
Drug: pembrolizumab

First Posted Date: 2021-05-10

Last Posted Date: 2024-10-24

Lead Sponsor: Seagen Inc.

Target Recruit Count: 332

Registration Number: NCT04879329

Locations: 🇦🇺
GenesisCare North Shore (Oncology), St Leonards, Other, Australia
🇺🇸
Banner MD Anderson Cancer Center, Gilbert, Arizona, United States
🇺🇸
City of Hope, Duarte, California, United States

and more 79 locations

Drug Development Updates

Stay informed with timely notifications on clinical trials, regulatory changes, and research advancements related to this medication.

Home Terms & Conditions Privacy Policy