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

Placebo-controlled Study Comparing Niraparib Plus Pembrolizumab Versus Placebo Plus Pembrolizumab as Maintenance Therapy in Participants With Advanced/Metastatic Non-small Cell Lung Cancer

Phase 3

Active, not recruiting

Conditions: Lung Cancer, Non-Small Cell

Interventions: Drug: Pembrolizumab
Drug: Niraparib
Drug: Placebo

First Posted Date: 2020-07-17

Last Posted Date: 2024-12-24

Lead Sponsor: GlaxoSmithKline

Target Recruit Count: 666

Registration Number: NCT04475939

Locations: 🇬🇧
GSK Investigational Site, Wrexham, United Kingdom

Sacituzumab Govitecan +/- Pembrolizumab in Metastatic TNBC

Phase 2

Recruiting

Conditions: Breast Cancer
Triple Negative Breast Cancer
PD-L1 Negative

Interventions: Drug: Sacituzumab Govitecan
Drug: Pembrolizumab

First Posted Date: 2020-07-13

Last Posted Date: 2024-04-16

Lead Sponsor: Dana-Farber Cancer Institute

Target Recruit Count: 110

Registration Number: NCT04468061

Locations: 🇺🇸
University of Chicago Medical Center, Chicago, Illinois, United States
🇺🇸
Stamford Hospital, Stamford, Connecticut, United States
🇺🇸
Eastern Maine Medical Center, Brewer, Maine, United States

and more 7 locations

A Study of SBT6050 Alone and in Combination With PD-1 Inhibitors in Subjects With Advanced HER2 Expressing Solid Tumors

Phase 1

Conditions: HER2 Positive Solid Tumors

Interventions: Drug: SBT6050
Drug: pembrolizumab
Drug: Cemiplimab

First Posted Date: 2020-07-07

Last Posted Date: 2022-06-30

Lead Sponsor: Silverback Therapeutics

Target Recruit Count: 58

Registration Number: NCT04460456

Locations: 🇺🇸
University of Pittsburgh Medical Center Hillman Cancer Center, Pittsburgh, Pennsylvania, United States
🇦🇺
Macquarie University Hospital Clinical Trials Unit, Sydney, New South Wales, Australia
🇦🇺
Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia

and more 9 locations

A Study of the Safety and Tolerance of CAN04 and Pembrolizumab in Combination With and Without Carboplatin and Pemetrexed in Subjects With Solid Tumors

Phase 1

Completed

Conditions: Carcinoma, Non-Small-Cell Lung
Urothelial Carcinoma
Head and Neck Squamous Cell Carcinoma
Malignant Melanoma

Interventions: Drug: CAN04
Drug: Pembrolizumab
Drug: Carboplatin
Drug: Pemetrexed

First Posted Date: 2020-06-30

Last Posted Date: 2023-07-14

Lead Sponsor: Cantargia AB

Target Recruit Count: 19

Registration Number: NCT04452214

Locations: 🇺🇸
Florida Cancer Specialists & Research Institute, Lake Mary, Florida, United States
🇺🇸
University of Colorado Cancer Center, Aurora, Colorado, United States
🇺🇸
Hospital of The University of Pennsylvania, Philadelphia, Pennsylvania, United States

Sacituzumab Govitecan +/- Pembrolizumab In HR+ / HER2 - MBC

Phase 2

Active, not recruiting

Conditions: Invasive Breast Cancer
Metastatic Breast Cancer
HR-Positive Breast Cancer
HER2-negative Breast Cancer

Interventions: Drug: Pembrolizumab
Drug: Sacituzumab Govitecan

First Posted Date: 2020-06-26

Last Posted Date: 2024-03-25

Lead Sponsor: Ana C Garrido-Castro, MD

Target Recruit Count: 110

Registration Number: NCT04448886

Locations: 🇺🇸
Emory University/Winship Cancer Institute, Atlanta, Georgia, United States
🇺🇸
University of Chicago Medical Center, Chicago, Illinois, United States
🇺🇸
Dana Farber Cancer Institute, Boston, Massachusetts, United States

and more 5 locations

Pembrolizumab Plus Chemotherapy in 1st Line Treatment of Pancreatic Cancer

Phase 2

Active, not recruiting

Conditions: Pancreatic Cancer
Chemotherapy Effect

Interventions: Drug: Pembrolizumab
Drug: Gemcitabine
Drug: Oxaliplatin
Drug: Nab-paclitaxel
Drug: Leucovorin
Drug: Irinotecan
Drug: 5FU

First Posted Date: 2020-06-25

Last Posted Date: 2024-04-19

Lead Sponsor: Seoul National University Hospital

Target Recruit Count: 77

Registration Number: NCT04447092

Locations: 🇰🇷
Seoul National University Hospital, Seoul, Korea, Republic of

Pre-op Pembro + Radiation Therapy in Breast Cancer (P-RAD)

Phase 2

Recruiting

Conditions: Triple Negative Breast Cancer
Biopsy-proven, Positive Lymph Node(s)
Hormone Receptor Positive (HR+), HER2-negative Breast Cancer

Interventions: Radiation: Radiation Therapy Boost
Drug: Pembrolizumab
Drug: Paclitaxel
Drug: Carboplatin
Drug: Cyclophosphamide
Drug: Doxorubicin
Drug: Capecitabine

First Posted Date: 2020-06-23

Last Posted Date: 2024-03-19

Lead Sponsor: Laura M. Spring, MD

Target Recruit Count: 120

Registration Number: NCT04443348

Locations: 🇺🇸
Duke University Medical Center, Durham, North Carolina, United States
🇺🇸
University of North Carolina Medical Center, Chapel Hill, North Carolina, United States
🇺🇸
Johns Hopkins, Baltimore, Maryland, United States

and more 7 locations

AN0025 and Pembrolizumab Combination in Advanced Solid Tumors

Phase 1

Active, not recruiting

Conditions: NSCLC, Squamous or Non-Squamous
Triple-negative Breast Cancer
Microsatellite Stable (MSS) Colorectal Cancer (CRC)
Cervical Cancer
Urothelial Carcinoma of the Bladder

Interventions: Drug: AN0025
Drug: Pembrolizumab

First Posted Date: 2020-06-16

Last Posted Date: 2024-06-27

Lead Sponsor: Adlai Nortye Biopharma Co., Ltd.

Target Recruit Count: 63

Registration Number: NCT04432857

Locations: 🇺🇸
MD Anderson Cancer Center, Houston, Texas, United States
🇺🇸
University of Virginia, Richmond, Virginia, United States
🇫🇷
Centre Léon Bérard, Lyon, France

and more 3 locations

Cisplatin+Pembrolizumab+RT in Vulvar Cancer

Phase 2

Recruiting

Conditions: Vulvar Cancer
Vulvar Squamous Cell Carcinoma

Interventions: Drug: Cisplatin
Drug: Pembrolizumab
Radiation: Radiation Therapy

First Posted Date: 2020-06-12

Last Posted Date: 2024-03-13

Lead Sponsor: Massachusetts General Hospital

Target Recruit Count: 24

Registration Number: NCT04430699

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

Tucatinib Plus Trastuzumab and Oxaliplatin-based Chemotherapy or Pembrolizumab-containing Combinations for HER2+ Gastrointestinal Cancers

Phase 1

Active, not recruiting

Conditions: GEJ Adenocarcinoma
Cholangiocarcinoma
Gallbladder Carcinoma
Colorectal Carcinoma
Esophageal Adenocarcinoma
Gastric Adenocarcinoma

Interventions: Drug: tucatinib
Drug: trastuzumab
Drug: oxaliplatin
Drug: leucovorin
Drug: fluorouracil
Drug: pembrolizumab
Drug: capecitabine

First Posted Date: 2020-06-12

Last Posted Date: 2024-10-15

Lead Sponsor: Seagen Inc.

Target Recruit Count: 40

Registration Number: NCT04430738

Locations: 🇺🇸
University of Chicago Medical Center, Chicago, Illinois, United States
🇺🇸
Duke University Medical Center, Durham, North Carolina, United States
🇯🇵
National Cancer Center Hospital, Chuo-ku, Other, Japan

and more 19 locations

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