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 Trial to Learn if Fianlimab and Cemiplimab Are Safe and Work Better Than Anti-PD1 Alone in Adult Participants With Resectable Stage 3 or 4 Melanoma

Phase 2

Recruiting

Conditions: Melanoma

Interventions: Drug: fianlimab
Drug: pembrolizumab
Drug: cemiplimab
Drug: cemiplimab+fianlimab

First Posted Date: 2024-01-05

Last Posted Date: 2024-11-26

Lead Sponsor: Regeneron Pharmaceuticals

Target Recruit Count: 520

Registration Number: NCT06190951

Locations: 🇺🇸
California Pacific Medical Center Research Institute, San Francisco, California, United States
🇺🇸
Emory University, Atlanta, Georgia, United States
🇺🇸
Washington University School of Medicine, Saint Louis, Missouri, United States

and more 10 locations

Efficacy & Safety for LN144 with Pembrolizumab with High Risk Stage IIIb-dResectable Melanoma

Phase 1

Recruiting

Conditions: Stage IIID Melanoma
Stage IIIB Melanoma
Stage IIIC Melanoma

Interventions: Biological: LN-144
Drug: Cyclophosphamide
Drug: Mesna
Drug: Fludarabine
Biological: Interleukin-2 (IL-2)
Drug: Pembrolizumab

First Posted Date: 2024-01-05

Last Posted Date: 2024-12-05

Lead Sponsor: James Isaacs, MD

Target Recruit Count: 12

Registration Number: NCT06190249

Locations: 🇺🇸
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center, Cleveland, Ohio, United States

A First-in-Human (FIH) Study to Evaluate the Safety and Tolerability of VVD-130850 in Participants With Advanced Solid and Hematologic Tumors

Phase 1

Recruiting

Conditions: Advanced Solid Tumors
Advanced Hematologic Tumors

Interventions: Drug: VVD-130850
Drug: Pembrolizumab

First Posted Date: 2024-01-03

Last Posted Date: 2024-12-17

Lead Sponsor: Vividion Therapeutics, Inc.

Target Recruit Count: 200

Registration Number: NCT06188208

Locations: 🇦🇺
Orange Health Service, Orange, New South Wales, Australia
🇺🇸
Florida Cancer Specialists, Sarasota, Florida, United States
🇺🇸
Sarah Cannon Research Institute, Nashville, Tennessee, United States

and more 13 locations

A Study of ASP1012 in Adults With Solid Tumors

Phase 1

Recruiting

Conditions: Solid Tumor

Interventions: Drug: ASP1012
Drug: Pembrolizumab

First Posted Date: 2023-12-14

Last Posted Date: 2024-12-27

Lead Sponsor: Astellas Pharma Global Development, Inc.

Target Recruit Count: 229

Registration Number: NCT06171178

Locations: 🇺🇸
Roswell Park Cancer Institute, Buffalo, New York, United States
🇺🇸
The Angeles Clinic and Research Institute, Los Angeles, California, United States
🇺🇸
Hoag Memorial Hospital Presbyterian, Newport Beach, California, United States

and more 6 locations

Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab Versus Pembrolizumab Alone in Metastatic Non-small Cell Lung Cancer (NSCLC) With Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥ 50% (MK-2870-007)

Phase 3

Recruiting

Conditions: Non-small Cell Lung Cancer (NSCLC)

Interventions: Biological: Sacituzumab tirumotecan
Biological: Pembrolizumab

First Posted Date: 2023-12-14

Last Posted Date: 2025-01-06

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 614

Registration Number: NCT06170788

Locations: 🇯🇵
Kanagawa Cancer Center ( Site 3408), Yokohama, Kanagawa, Japan
🇯🇵
Niigata Cancer Center Hospital ( Site 3409), Niigata, Saitama, Japan
🇯🇵
The Cancer Institute Hospital of JFCR ( Site 3404), Koto, Tokyo, Japan

and more 163 locations

Pembrolizumab Followed by Chemotherapy for the Treatment of Patients With Classical Hodgkin Lymphoma

Phase 2

Recruiting

Conditions: Classic Hodgkin Lymphoma

Interventions: Procedure: Biopsy
Procedure: Biospecimen Collection
Procedure: Computed Tomography
Drug: Dacarbazine
Drug: Doxorubicin
Procedure: Echocardiography
Procedure: Multigated Acquisition Scan
Biological: Pembrolizumab
Procedure: Positron Emission Tomography
Drug: Vinblastine

First Posted Date: 2023-12-11

Last Posted Date: 2024-03-08

Lead Sponsor: Northwestern University

Target Recruit Count: 30

Registration Number: NCT06164275

Locations: 🇺🇸
Stanford Cancer Center, Stanford, California, United States
🇺🇸
Northwestern University, Chicago, Illinois, United States
🇺🇸
Cadence Health - CDH, Warrenville, Illinois, United States

Study of RAS(ON) Inhibitor Combinations in Patients with Advanced RAS-mutated NSCLC

Phase 1

Recruiting

Conditions: Non-Small Cell Lung Cancer, NSCLC
KRAS, NRAS, HRAS-mutated NSCLC
KRAS G12C-mutated Solid Tumors, Lung Cancer
Lung Cancer Stage IV, Advanced Solid Tumor, Cancer
RAS G12D-mutated NSCLC

Interventions: Drug: RMC-6291
Drug: RMC-6236
Drug: Pembrolizumab
Drug: Cisplatin
Drug: Carboplatin
Drug: Pemetrexed
Drug: RMC-9805

First Posted Date: 2023-12-08

Last Posted Date: 2025-01-07

Lead Sponsor: Revolution Medicines, Inc.

Target Recruit Count: 484

Registration Number: NCT06162221

Locations: 🇺🇸
City of Hope - Duarte, Duarte, California, United States
🇺🇸
New York University Langone Health, New York, New York, United States
🇮🇹
IRCCS Instituto Nazionale tumori Ragina Elena, Rome, Italy

and more 46 locations

Pembrolizumab + N-803 Alone or in Combination With PD-L1 t-haNK Cells for Resectable Head and Neck Squamous Cell Carcinoma

Phase 2

Not yet recruiting

Conditions: Stage IV Squamous Cell Carcinoma of the Head and Neck
Stage II Squamous Cell Carcinoma of the Head and Neck
Stage III Squamous Cell Carcinoma of the Head and Neck

Interventions: Drug: N-803
Drug: pembrolizumab
Biological: PD-L1 t-haNK cells

First Posted Date: 2023-12-08

Last Posted Date: 2025-01-10

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 40

Registration Number: NCT06161545

Locations: 🇺🇸
National Institutes of Health Clinical Center, Bethesda, Maryland, United States

T Cells and Pembrolizumab for Recurrent and Newly Diagnosed Glioblastoma

Phase 1

Recruiting

Conditions: Glioblastoma Multiforme
Astrocytoma, Grade IV

Interventions: Biological: Allogeneic cytomegalovirus-specific T cells
Drug: Pembrolizumab

First Posted Date: 2023-12-06

Last Posted Date: 2024-05-31

Lead Sponsor: Queensland Institute of Medical Research

Target Recruit Count: 58

Registration Number: NCT06157541

Locations: 🇦🇺
Princess Alexandra Hospital, Woolloongabba, Queensland, Australia
🇦🇺
Newro Foundation, Bowen Hills, Queensland, Australia
🇦🇺
Royal Brisbane and Women's Hospital, Herston, Queensland, Australia

and more 1 locations

Beamion LUNG-2: A Study to Test Whether Zongertinib (BI 1810631) Helps People With Advanced Non-small Cell Lung Cancer With HER2 Mutations Compared With Standard Treatment

Phase 3

Recruiting

Conditions: Lung Cancer, Non-squamous, Non-small Cell

Interventions: Drug: zongertinib
Drug: pembrolizumab
Drug: cisplatin
Drug: carboplatin
Drug: pemetrexed

First Posted Date: 2023-11-30

Last Posted Date: 2025-01-09

Lead Sponsor: Boehringer Ingelheim

Target Recruit Count: 270

Registration Number: NCT06151574

Locations: 🇨🇦
BC Cancer Agency - Vancouver, Vancouver, Canada
🇨🇦
Princess Margaret Cancer Centre, Toronto, Canada
🇨🇦
McGill University Health Centre (MUHC), Montreal, Canada

and more 110 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