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

A Study of the Combination of Necitumumab (LY3012211) and Pembrolizumab (MK3475) in Participants With NSCLC

Phase 1

Completed

Conditions: Stage IV Non-Small Cell Lung Cancer

Interventions: Drug: Necitumumab
Drug: Pembrolizumab

First Posted Date: 2015-05-22

Last Posted Date: 2020-10-05

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 71

Registration Number: NCT02451930

Locations: 🇺🇸
Tennessee Oncology PLLC, Nashville, Tennessee, United States
🇯🇵
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician, Sunto-Gun, Japan
🇪🇸
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Valencia, Spain

and more 1 locations

Pembrolizumab Alone and In Combination With Acalabrutinib (ACP-196) in Subjects With Advanced Non-small Cell Lung Cancer

Phase 2

Completed

Conditions: Carcinoma, Non-Small-Cell Lung

Interventions: Drug: Pembrolizumab
Drug: Acalabrutinib

First Posted Date: 2015-05-19

Last Posted Date: 2019-09-12

Lead Sponsor: Acerta Pharma BV

Target Recruit Count: 74

Registration Number: NCT02448303

Locations: 🇺🇸
Western Regional Medical Center/Cancer Treatment Center of America, Goodyear, Arizona, United States

A Study of Ramucirumab Plus Pembrolizumab in Participants With Gastric or GEJ Adenocarcinoma, NSCLC, Transitional Cell Carcinoma of the Urothelium, or Biliary Tract Cancer

Phase 1

Completed

Conditions: Gastric Adenocarcinoma
Biliary Tract Cancer
Carcinoma, Transitional Cell
Non-small Cell Lung Cancer
Adenocarcinoma of the Gastroesophageal Junction

Interventions: Drug: Ramucirumab
Drug: Pembrolizumab

First Posted Date: 2015-05-13

Last Posted Date: 2024-07-31

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 175

Registration Number: NCT02443324

Locations: 🇬🇧
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Sutton, United Kingdom
🇺🇸
Florida Cancer Specialists, Fort Myers, Florida, United States
🇺🇸
Tennessee Oncology PLLC, Nashville, Tennessee, United States

and more 4 locations

Dose Dense Paclitaxel With Pembrolizumab (MK-3475) in Platinum Resistant Ovarian Cancer

Phase 2

Completed

Conditions: Ovarian Cancer

Interventions: Drug: Pembrolizumab
Drug: Paclitaxel

First Posted Date: 2015-05-12

Last Posted Date: 2022-10-07

Lead Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Target Recruit Count: 42

Registration Number: NCT02440425

Locations: 🇺🇸
VCU Massey Cancer Center, Richmond, Virginia, United States
🇺🇸
H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida, United States
🇺🇸
Duke University, Durham, North Carolina, United States

A Study of Combination Therapies With Viagenpumatucel-L (HS-110) in Patients With Non-Small Cell Lung Cancer

Phase 1

Completed

Conditions: Non-small Cell Lung Cancer

Interventions: Biological: Viagenpumatucel-L
Drug: Nivolumab
Drug: Pembrolizumab
Drug: Pemetrexed

First Posted Date: 2015-05-08

Last Posted Date: 2023-09-21

Lead Sponsor: Heat Biologics

Target Recruit Count: 121

Registration Number: NCT02439450

Locations: 🇺🇸
UC San Diego, La Jolla, California, United States
🇺🇸
Horizon Oncology Research, Lafayette, Indiana, United States
🇺🇸
Ashland-Bellefonte Cancer Center, Ashland, Kentucky, United States

and more 13 locations

Pembrolizumab and Docetaxel or Gemcitabine Hydrochloride in Treating Patients Urothelial Cancer

Phase 1

Completed

Conditions: Recurrent Bladder Carcinoma
Stage IV Bladder Urothelial Carcinoma
Stage IV Urethral Cancer
Urethral Urothelial Carcinoma
Metastatic Urothelial Carcinoma of the Renal Pelvis and Ureter
Regional Urothelial Carcinoma of the Renal Pelvis and Ureter
Stage III Bladder Urothelial Carcinoma
Recurrent Urothelial Carcinoma of the Renal Pelvis and Ureter
Stage III Urethral Cancer

Interventions: Drug: Pembrolizumab
Drug: Docetaxel
Drug: Gemcitabine Hydrochloride

First Posted Date: 2015-05-07

Last Posted Date: 2022-10-18

Lead Sponsor: University of California, Davis

Target Recruit Count: 32

Registration Number: NCT02437370

Locations: 🇺🇸
University of California Davis Comprehensive Cancer Center, Sacramento, California, United States

Ph1b/2 Dose-Escalation Study of Entinostat With Pembrolizumab in NSCLC With Expansion Cohorts in NSCLC, Melanoma, and Colorectal Cancer

Phase 1

Completed

Conditions: Non-Small Cell Lung Cancer
Melanoma
Mismatch Repair-Proficient Colorectal Cancer

Interventions: Drug: entinostat
Drug: pembrolizumab

First Posted Date: 2015-05-07

Last Posted Date: 2023-09-21

Lead Sponsor: Syndax Pharmaceuticals

Target Recruit Count: 196

Registration Number: NCT02437136

Locations: 🇺🇸
Dana Farber Cancer Institution, Boston, Massachusetts, United States
🇺🇸
The University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States
🇺🇸
Memorial Sloan Kettering Cancer Center, New York, New York, United States

and more 8 locations

Assess the Efficacy of Pembrolizumab Plus Radiotherapy or Ablation in Metastatic Colorectal Cancer Patients

Phase 2

Active, not recruiting

Conditions: Metastatic Colorectal Cancer

Interventions: Drug: Pembrolizumab
Radiation: Radiotherapy
Procedure: Radiofrequency ablation

First Posted Date: 2015-05-07

Last Posted Date: 2024-04-09

Lead Sponsor: Memorial Sloan Kettering Cancer Center

Target Recruit Count: 34

Registration Number: NCT02437071

Locations: 🇺🇸
Memorial Sloan Kettering Cancer Center, New York, New York, United States

A Tissue Collection Study of Pembrolizumab (MK-3475) in Subjects With Resectable Advanced Melanoma

Phase 1

Completed

Conditions: Malignant Melanoma

Interventions: Drug: pembrolizumab

First Posted Date: 2015-05-05

Last Posted Date: 2022-06-16

Lead Sponsor: Abramson Cancer Center at Penn Medicine

Target Recruit Count: 33

Registration Number: NCT02434354

Locations: 🇺🇸
Abramson Cancer Center of the University of Pennsylvania, Philadelphia, Pennsylvania, United States

Phase IB Study to Evaluate the Safety of Selinexor (KPT-330) in Combination With Multiple Standard Chemotherapy or Immunotherapy Agents in Patients With Advanced Malignancies

First Posted Date: 2015-04-17

Last Posted Date: 2024-05-21

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 221

Registration Number: NCT02419495

Locations: 🇺🇸
MD Anderson in The Woodlands, Conroe, Texas, United States
🇺🇸
M D Anderson Cancer Center, Houston, Texas, United States
🇺🇸
MD Anderson West Houston, Houston, Texas, United States

and more 2 locations

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