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

Enfortumab Vedotin and Pembrolizumab Combined With Radiotherapy in Muscle Invasive Bladder Cancer

Phase 1

Not yet recruiting

Conditions: Stage IIIA Bladder Cancer AJCC v8
Bladder Cancer
Muscle-Invasive Bladder Carcinoma
Stage II Bladder Cancer AJCC v8

Interventions: Drug: Enfortumab Vedotin
Biological: Pembrolizumab
Radiation: Intensity Modulated Radiation Therapy (IMRT)
Procedure: Transurethral Resection of Bladder Tumor
Procedure: Cystoscopy (CS)
Procedure: Computed Tomography (CT)
Procedure: Magnetic Resonance Imaging (MRI)
Procedure: Positron Emission Tomography (PET)

First Posted Date: 2024-06-24

Last Posted Date: 2024-10-08

Lead Sponsor: University of California, San Francisco

Target Recruit Count: 47

Registration Number: NCT06470282

Locations: 🇺🇸
University of California, San Francisco, San Francisco, California, United States

First In Human Study of CX-801 in Advanced Solid Tumors

Phase 1

Recruiting

Conditions: Solid Tumor, Adult

Interventions: Drug: CX-801
Drug: pembrolizumab

First Posted Date: 2024-06-17

Last Posted Date: 2024-08-12

Lead Sponsor: CytomX Therapeutics

Target Recruit Count: 121

Registration Number: NCT06462794

Locations: 🇺🇸
University of California San Francisco, San Francisco, California, United States
🇺🇸
University of Pittsburgh Hillman Cancer Center, Pittsburgh, Pennsylvania, United States

A Study of MK-6837 as a Monotherapy and Combination Therapy in Participants With Advanced/Metastatic Solid Tumors (MK-6837-001)

Phase 1

Recruiting

Conditions: Neoplasm Metastasis

Interventions: Biological: MK-6837
Biological: Pembrolizumab

First Posted Date: 2024-06-14

Last Posted Date: 2024-12-05

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 100

Registration Number: NCT06460961

Locations: 🇨🇦
Princess Margaret Cancer Centre ( Site 2001), Toronto, Ontario, Canada
🇺🇸
Atlantic Health System Morristown Medical Center ( Site 4001), Morristown, New Jersey, United States
🇺🇸
Providence Portland Medical Center ( Site 4002), Portland, Oregon, United States

and more 3 locations

A Study to Learn More About How Well BAY 2927088 Works and How Safe it is Compared With Standard Treatment, in Participants Who Have Advanced Non-small Cell Lung Cancer (NSCLC) With Mutations in the Genes of Human Epidermal Growth Factor Receptor 2 (HER2)

Phase 3

Recruiting

Conditions: Advanced Non-small Cell Lung Cancer
HER2 Mutation

Interventions: Drug: BAY2927088
Drug: Pembrolizumab
Drug: Cisplatin
Drug: Carboplatin
Drug: Pemetrexed

First Posted Date: 2024-06-11

Last Posted Date: 2024-11-15

Lead Sponsor: Bayer

Target Recruit Count: 278

Registration Number: NCT06452277

Locations: 🇨🇳
Fujian Cancer Hospital, Fuzhou, Fujian, China
🇨🇳
Hunan Cancer Hospital, Changsha, Hunan, China
🇨🇳
Shanghai Chest Hospital, Shanghai Jiaotong University, Shanghai, China

and more 241 locations

A Study of SKB264 in Combination With Pembrolizumab Versus Pembrolizumab in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Phase 3

Recruiting

Conditions: Non-Small Cell Lung Cancer

Interventions: Drug: SKB264
Drug: Pembrolizumab

First Posted Date: 2024-06-07

Last Posted Date: 2024-06-07

Lead Sponsor: Sichuan Kelun Pharmaceutical Research Institute Co., Ltd.

Target Recruit Count: 406

Registration Number: NCT06448312

Locations: 🇨🇳
Shanghai Oriental Hospital, Shanghai, China

A Study of VET3-TGI in Patients With Solid Tumors

Phase 1

Recruiting

Conditions: Microsatellite Stable Colorectal Cancer
Head and Neck Squamous Cell Carcinoma
Merkel Cell Carcinoma of Skin
Mesothelioma
Solid Tumor, Adult
Cervical Cancer
Renal Cell Carcinoma
Kidney Cancer
Melanoma Stage IV
Non-small Cell Lung Cancer

Interventions: Drug: VET3-TGI
Drug: Pembrolizumab

First Posted Date: 2024-06-06

Last Posted Date: 2024-12-11

Lead Sponsor: KaliVir Immunotherapeutics

Target Recruit Count: 60

Registration Number: NCT06444815

Locations: 🇺🇸
USC/Norris Comprehensive Cancer Center, Los Angeles, California, United States
🇺🇸
Community Health Network, Indianapolis, Indiana, United States
🇺🇸
Mary Crowley Cancer Research, Dallas, Texas, United States

and more 1 locations

Pembrolizumab Plus CA-4948 for the Treatment of Patients With Progressive Metastatic Urothelial Cancer Despite Prior Immunotherapy

Phase 1

Not yet recruiting

Conditions: Unresectable Urothelial Carcinoma
Metastatic Urothelial Carcinoma

Interventions: Procedure: Biopsy
Procedure: Biospecimen Collection
Procedure: Computed Tomography
Biological: Emavusertib
Procedure: Magnetic Resonance Imaging
Biological: Pembrolizumab
Procedure: Positron Emission Tomography

First Posted Date: 2024-06-03

Last Posted Date: 2024-12-19

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 25

Registration Number: NCT06439836

Pharmacokinetic Similarity Between ABP 234 and Keytruda® (Pembrolizumab)

Phase 3

Recruiting

Conditions: Early-stage Non-squamous Non-small Cell Lung Cancer (NSCLC)

Interventions: Drug: ABP 234
Drug: Pembrolizumab

First Posted Date: 2024-05-28

Last Posted Date: 2024-12-18

Lead Sponsor: Amgen

Target Recruit Count: 154

Registration Number: NCT06430866

Locations: 🇪🇸
Hospital Universitario de Jerez, Jerez de la Frontera, Spain
🇪🇸
Clinica MD Anderson International, Madrid, Spain
🇪🇸
Hospital Universitari Quiron Dexeus Barcelona, Barcelona, Spain

and more 67 locations

Measuring if Immunotherapy Plus Chemotherapy is Better Than Chemotherapy Alone for Patients With Aggressive Poorly Differentiated Sarcomas

Phase 3

Recruiting

Conditions: Unresectable Undifferentiated Pleomorphic Sarcoma
Metastatic Undifferentiated Pleomorphic Sarcoma
Stage III Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8
Stage IV Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8

Interventions: Procedure: Biospecimen Collection
Procedure: Diagnostic Imaging
Drug: Doxorubicin
Procedure: Echocardiography
Procedure: Multigated Acquisition Scan
Biological: Pembrolizumab

First Posted Date: 2024-05-21

Last Posted Date: 2024-12-20

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 180

Registration Number: NCT06422806

Locations: 🇺🇸
Keck Medicine of USC Koreatown, Los Angeles, California, United States
🇺🇸
Los Angeles General Medical Center, Los Angeles, California, United States
🇺🇸
USC / Norris Comprehensive Cancer Center, Los Angeles, California, United States

and more 135 locations

Pembrolizumab With or Without Maintenance Sacituzumab Tirumotecan (Sac-TMT; MK-2870) in Metastatic Squamous Non-small Cell Lung Cancer (NSCLC) [MK-2870-023]

Phase 3

Recruiting

Conditions: Non-small Cell Lung Cancer
NSCLC

Interventions: Biological: Pembrolizumab
Biological: sac-TMT

First Posted Date: 2024-05-20

Last Posted Date: 2024-12-06

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 851

Registration Number: NCT06422143

Locations: 🇨🇳
Peking Union Medical College Hospital ( Site 2412), Beijing, Beijing, China
🇨🇳
The First Affiliated hospital of Xiamen University-oncology ( Site 2420), Xiamen, Fujian, China
🇨🇳
West China Hospital, Sichuan University ( Site 2422), Cheng Du, Sichuan, China

and more 95 locations

Drug Development Updates

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