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

A Study to Investigate the Efficacy and Safety of Trastuzumab Deruxtecan as the First Treatment Option for Unresectable, Locally Advanced/Metastatic Non-Small Cell Lung Cancer With HER2 Mutations

Phase 3

Recruiting

Conditions: Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Interventions: Drug: Trastuzumab Deruxtecan
Drug: Cisplatin
Drug: Carboplatin
Drug: Pembrolizumab
Drug: Pemetrexed

First Posted Date: 2021-09-17

Last Posted Date: 2025-01-07

Lead Sponsor: AstraZeneca

Target Recruit Count: 450

Registration Number: NCT05048797

Locations: 🇹🇷
Research Site, Çankaya, Turkey

A Safety and Efficacy Study for Combinational Treatment of DaRT and Check Point Inhibitor for Recurrent Unresectable or mHNSCC

Not Applicable

Recruiting

Conditions: Head and Neck Squamous Cell Carcinoma
Skin Cancer
Metastatic Head-and-neck Squamous-cell Carcinoma

Interventions: Device: Diffusing Alpha Radiation Emitters Therapy (DaRT)
Drug: Pembrolizumab

First Posted Date: 2021-09-16

Last Posted Date: 2024-11-20

Lead Sponsor: Alpha Tau Medical LTD.

Target Recruit Count: 48

Registration Number: NCT05047094

Locations: 🇮🇱
Sheba Medical Center, Ramat Gan, Israel
🇮🇱
Tel-Aviv Medical Center, Tel Aviv, Israel
🇮🇱
Sharett institute, Hadassah University Hospital - Ein-Kerem, Jerusalem, Israel

A Trial of Camrelizumab Combined With Famitinib Malate in Treatment Naïve Subjects With PD-L1-Positive Recurrent or Metastatic Non-Small Cell Lung Cancer

Phase 3

Recruiting

Conditions: Non-small Cell Lung Cancer

Interventions: Drug: pembrolizumab
Drug: camrelizumab + famitinib
Drug: camrelizumab

First Posted Date: 2021-09-13

Last Posted Date: 2022-11-17

Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Target Recruit Count: 450

Registration Number: NCT05042375

Locations: 🇨🇳
Shaoyang Central Hospital, Shaoyang, Hunan, China
🇨🇳
Xiangyang Central Hospital, Xiangyang, Hubei, China
🇨🇳
Hunan Cancer Hospital-Thoracic Medicine Department I, Changsha, Hunan, China

and more 77 locations

Pembrolizumab and Lenvatinib for the Treatment of Advanced, Unresectable, or Metastatic Gastroesophageal Adenocarcinoma

Early Phase 1

Recruiting

Conditions: Advanced Gastric Adenocarcinoma
Clinical Stage IVA Gastroesophageal Junction Adenocarcinoma AJCC v8
Metastatic Gastroesophageal Junction Adenocarcinoma
Pathologic Stage III Gastric Cancer AJCC v8
Pathologic Stage IIIA Gastric Cancer AJCC v8
Pathologic Stage IIIA Gastroesophageal Junction Adenocarcinoma AJCC v8
Pathologic Stage IIIB Gastric Cancer AJCC v8
Pathologic Stage IIIC Gastric Cancer AJCC v8
Postneoadjuvant Therapy Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8
Postneoadjuvant Therapy Stage IVA Gastroesophageal Junction Adenocarcinoma AJCC v8

Interventions: Drug: Lenvatinib
Biological: Pembrolizumab

First Posted Date: 2021-09-10

Last Posted Date: 2025-01-08

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 15

Registration Number: NCT05041153

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

A Phase II Study of Futibatinib and Pembrolizumab in Metastatic Microsatellite Stable Endometrial Carcinoma

Phase 2

Recruiting

Conditions: Metastatic Cancer
Endometrium Cancer
Endometrial Carcinoma

Interventions: Drug: Pembrolizumab
Drug: Futibatinib

First Posted Date: 2021-09-08

Last Posted Date: 2024-08-09

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 30

Registration Number: NCT05036681

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

PD-1 Antibody Therapy + Infliximab for Metastatic Melanoma

Phase 2

Recruiting

Conditions: Metastatic Melanoma

Interventions: Drug: Pembrolizumab
Drug: Placebo
Drug: Infliximab
Drug: Relatlimab
Drug: Nivolumab

First Posted Date: 2021-09-05

Last Posted Date: 2024-05-30

Lead Sponsor: Massachusetts General Hospital

Target Recruit Count: 36

Registration Number: NCT05034536

Locations: 🇺🇸
Massachusetts General Hospital Cancer Center, Boston, Massachusetts, United States

Phase II Trial of Pembrolizumab Plus Lenvatinib in Advanced Adrenal Cortical Carcinoma

Phase 2

Conditions: Adrenocortical Carcinoma

Interventions: Drug: Pembrolizumab / Lenvatinib

First Posted Date: 2021-09-05

Last Posted Date: 2023-11-29

Lead Sponsor: National Cancer Center, Korea

Target Recruit Count: 30

Registration Number: NCT05036434

Locations: 🇰🇷
National Cancer Center, Goyang-si, Gyeonggi-do, Korea, Republic of

Immunotherapy With Chemotherapy and Chemoradiation for Advanced Squamous Cancer of Nasal Cavity / Paranasal Sinuses (I-NAPA)

Phase 2

Recruiting

Conditions: the Nasal Cavity
Paranasal Sinuses
Squamous Cell Carcinoma

Interventions: Drug: Pembrolizumab
Drug: Docetaxel
Drug: Cisplatin
Drug: Carboplatin

First Posted Date: 2021-08-30

Last Posted Date: 2024-12-11

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 35

Registration Number: NCT05027633

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

NeoAdjuvant Pembrolizumab and STEreotactic Radiotherapy Prior to Nephrectomy for Renal Cell Carcinoma

Phase 2

Recruiting

Conditions: Renal Cell Carcinoma, Clear Cell, Somatic

Interventions: Radiation: Stereotactic Ablative Radiotherapy
Drug: Pembrolizumab
Procedure: Nephrectomy

First Posted Date: 2021-08-27

Last Posted Date: 2024-05-16

Lead Sponsor: Peter MacCallum Cancer Centre, Australia

Target Recruit Count: 20

Registration Number: NCT05024318

Locations: 🇦🇺
Princess Alexandra Hospital, Woolloongabba, Queensland, Australia
🇦🇺
Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia

Neoadjuvant Pembrolizumab in Cutaneous Squamous Cell Carcinoma

Phase 2

Recruiting

Conditions: Head and Neck Cancer
Cutaneous Squamous Cell Carcinoma of the Head and Neck

Interventions: Drug: Pembrolizumab

First Posted Date: 2021-08-27

Last Posted Date: 2022-08-01

Lead Sponsor: Queensland Health

Target Recruit Count: 27

Registration Number: NCT05025813

Locations: 🇦🇺
Chris O'Brien Lifehouse, Camperdown, New South Wales, Australia
🇦🇺
Royal Brisbane and Women's Hospital, Herston, Queensland, Australia
🇦🇺
Princess Alexandra Hospital, Woolloongabba, Queensland, Australia

Drug Development Updates

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