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 ...

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

ACE2016 in Adult Subjects With Locally Advanced or Metastatic Solid Tumors Expressing Epidermal Growth Factor Receptor (EGFR)

Phase 1

Recruiting

Conditions: Locally Advanced Solid Tumor
Metastatic Solid Tumor

Interventions: Drug: Cyclophosphamide
Drug: Fludarabine
Drug: ACE2016
Drug: Pembrolizumab

First Posted Date: 2024-05-16

Last Posted Date: 2024-12-05

Lead Sponsor: Acepodia Biotech, Inc.

Target Recruit Count: 30

Registration Number: NCT06415487

Locations: 🇺🇸
University of California San Diego, San Diego, California, United States
🇺🇸
Texas Oncology, Dallas, Texas, United States
🇨🇳
Taipei Veterans General Hospital, Taipei City, Beitou District, Taiwan

and more 6 locations

Neoadjuvant Pembrolizumab, Carboplatin and Paclitaxel in Triple-negative Breast Cancer

Phase 2

Not yet recruiting

Conditions: Triple Negative Breast Cancer

Interventions: Drug: Pembrolizumab
Drug: Carboplatin
Drug: Paclitaxel

First Posted Date: 2024-05-09

Last Posted Date: 2024-05-09

Lead Sponsor: Tel Aviv Medical Center

Target Recruit Count: 25

Registration Number: NCT06407310

A Study of Pembrolizumab in Combination With Investigational Agents in Pediatric and Young Adult Participants With Hematologic Malignancies or Solid Tumors (MK-9999-01B/LIGHTBEAM-U01)

Phase 1

Recruiting

Conditions: Neoplasm Metastasis

Interventions: Biological: Favezelimab/Pembrolizumab
Biological: Pembrolizumab
Biological: Pembrolizumab/Vibostolimab
Biological: Favezelimab
Biological: Vibostolimab

First Posted Date: 2024-05-01

Last Posted Date: 2024-12-10

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 80

Registration Number: NCT06395090

Locations: 🇺🇸
Children's Mercy Hospital ( Site 2024), Kansas City, Missouri, United States
🇺🇸
Children's Hospital of Philadelphia (CHOP) ( Site 2021), Philadelphia, Pennsylvania, United States
🇨🇳
National Taiwan University Hospital ( Site 2983), Taipei, Taiwan

and more 7 locations

Sacituzumab Tirumotecan (MK-2870) Plus Pembrolizumab Versus TPC in TNBC Who Did Not Achieve pCR (MK-2870-012)

Phase 3

Recruiting

Conditions: Triple-Negative Breast Cancer

Interventions: Biological: Pembrolizumab
Biological: sac-TMT
Drug: Capecitabine

First Posted Date: 2024-05-01

Last Posted Date: 2024-12-05

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 1530

Registration Number: NCT06393374

Locations: 🇺🇸
Oklahoma Cancer Specialists and Research Institute, LLC ( Site 0041), Tulsa, Oklahoma, United States
🇦🇹
Klinikum Wels-Grieskirchen GmbH ( Site 1205), Wels, Oberosterreich, Austria
🇫🇷
Centre Antoine-Lacassagne ( Site 1308), Nice, Alpes-Maritimes, France

and more 115 locations

Trial to Assess the Safety and Preliminary Efficacy of GEN1055 on Malignant Solid Tumors as Monotherapy and as Combination Therapy

Phase 1

Recruiting

Conditions: Malignant Solid Tumor

Interventions: Biological: GEN1055
Biological: Pembrolizumab
Drug: Standard Chemotherapy

First Posted Date: 2024-04-30

Last Posted Date: 2024-12-03

Lead Sponsor: Genmab

Target Recruit Count: 270

Registration Number: NCT06391775

Locations: 🇺🇸
Yale-New Haven Hospital, New Haven, Connecticut, United States
🇪🇸
Hospital Universtari Val D´Hebron, Barcelona, Spain
🇪🇸
Start Madrid Ciocc Hm Sanchinarro, Madrid, Spain

and more 1 locations

Phase II Study of Moderate-dose Hypofractionated RT Combined With Pembrolizumab for HCC With Diffuse Tumor Thrombosis

Phase 2

Recruiting

Conditions: Hepatocellular Carcinoma
Radiotherapy
Pembrolizumab
Tumor Thrombosis

Interventions: Radiation: Moderate-dose Hypofractionated Intensity-modulated Radiotherapy
Drug: Pembrolizumab

First Posted Date: 2024-04-29

Last Posted Date: 2024-04-29

Lead Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Target Recruit Count: 30

Registration Number: NCT06389422

Locations: 🇨🇳
National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciecnces and Peking Union Medical College, Beijing, Beijing, China

A Study of Amivantamab Alone or in Addition to Other Treatment Agents in Participants With Recurrent/Metastatic Head and Neck Cancer

Phase 1

Recruiting

Conditions: Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma

Interventions: Biological: Amivantamab
Biological: Pembrolizumab
Drug: Paclitaxel

First Posted Date: 2024-04-25

Last Posted Date: 2024-12-06

Lead Sponsor: Janssen Research & Development, LLC

Target Recruit Count: 217

Registration Number: NCT06385080

Locations: 🇨🇳
Changhua Christian Hospital, ChangHua, Taiwan
🇨🇳
Chang Kung Memorial Hospital, Kaohsiung City, Taiwan
🇨🇳
National Taiwan University Hospital, Taipei, Taiwan

and more 30 locations