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

Study of SBRT/Olaparib Followed by Pembrolizumab/Olaparib in Gastric Cancers

Phase 2

Recruiting

Conditions: Gastric Cancer
GastroEsophageal Cancer

Interventions: Drug: Pembrolizumab
Drug: Olaparib
Radiation: Stereotactic Body Radiation Therapy

First Posted Date: 2022-05-18

Last Posted Date: 2024-11-26

Lead Sponsor: University of Colorado, Denver

Target Recruit Count: 26

Registration Number: NCT05379972

Locations: 🇺🇸
University of Colorado Health, Aurora, Colorado, United States
🇺🇸
UCHealth Memorial Hospital Central, Colorado Springs, Colorado, United States
🇺🇸
UCHealth Memorial Hospital North, Colorado Springs, Colorado, United States

and more 1 locations

A Study of NTX-1088, a Monoclonal Antibody Targeting the Poliovirus Receptor (PVR, CD155), as Monotherapy and Combined With Pembrolizumab

Phase 1

Recruiting

Conditions: Tumor, Solid
Metastatic Cancer
Cancer
Advanced Solid Tumor
Locally Advanced Solid Tumor

Interventions: Drug: NTX-1088
Drug: Pembrolizumab

First Posted Date: 2022-05-18

Last Posted Date: 2024-01-29

Lead Sponsor: Nectin Therapeutics Ltd

Target Recruit Count: 90

Registration Number: NCT05378425

Locations: 🇺🇸
Ochsner Clinic Foundation, New Orleans, Louisiana, United States
🇮🇱
Hadassah Medical Center, Jerusalem, Israel
🇮🇱
Sheba Medical Center, Ramat Gan, Israel

and more 2 locations

Pembrolizumab in Small Cell Carcinoma of Ovary - Hypercalcemic Type Patient

Not Applicable

Active, not recruiting

Conditions: Small Cell Carcinoma, Hypercalcaemic Type
Ovarian Cancer

Interventions: Drug: Pembrolizumab

First Posted Date: 2022-05-10

Last Posted Date: 2024-03-13

Lead Sponsor: University Health Network, Toronto

Target Recruit Count: 1

Registration Number: NCT05368207

Locations: 🇨🇦
Princess Margaret Cancer Centre, Toronto, Ontario, Canada

ERC1671 to Treat Malignant Gliomas When Given in Combination With GM-CSF, Cyclophosphamide, Bevacizumab and Pembrolizumab

Phase 2

Not yet recruiting

Conditions: Glioma, Malignant

Interventions: Drug: ERC1671
Drug: GM-CSF
Drug: Cyclophosphamide
Drug: Pembrolizumab

First Posted Date: 2022-05-09

Last Posted Date: 2022-05-13

Lead Sponsor: Epitopoietic Research Corporation

Target Recruit Count: 28

Registration Number: NCT05366062

Locations: 🇹🇭
Bumrungrad International Hospital, Bangkok, Vadhana, Thailand

A Study of ASP2138 Given by Itself or Given With Other Cancer Treatments in Adults With Stomach Cancer, Gastroesophageal Junction Cancer, or Pancreatic Cancer

Phase 1

Recruiting

Conditions: Gastric Adenocarcinoma
Gastroesophageal Junction (GEJ) Adenocarcinoma
Pancreatic Adenocarcinoma

Interventions: Drug: ASP2138
Drug: Pembrolizumab
Drug: Ramucirumab
Drug: Oxaliplatin
Drug: Paclitaxel
Drug: Leucovorin
Drug: Fluorouracil
Drug: Irinotecan

First Posted Date: 2022-05-09

Last Posted Date: 2024-12-20

Lead Sponsor: Astellas Pharma Global Development, Inc.

Target Recruit Count: 305

Registration Number: NCT05365581

Locations: 🇰🇷
Site KR82003, Seocho-gu, Seoul, Korea, Republic of
🇰🇷
Site KR82005, Seodaemun-gu, Seoul, Korea, Republic of
🇰🇷
Site KR82001, Guro-gu, Seoul, Korea, Republic of

and more 35 locations

Seleno-L Methionine (SLM)-Axitinib-Pembrolizumab

Phase 1

Recruiting

Conditions: Clear Cell Renal Cell Carcinoma
Clear Cell Renal Cell Carcinoma Metastatic

Interventions: Drug: Selenomethionine (SLM)
Drug: Axitinib
Drug: Pembrolizumab

First Posted Date: 2022-05-06

Last Posted Date: 2024-12-17

Lead Sponsor: Bilal G. Rahim

Target Recruit Count: 55

Registration Number: NCT05363631

Locations: 🇺🇸
University of Iowa Hospitals & Clinics, Iowa City, Iowa, United States

ATATcH Alternating Treatment Plans for Advanced Cancer

Phase 2

Recruiting

Conditions: Head and Neck Cancer
Lung Cancer

Interventions: Drug: 5Fluorouracil
Drug: Paclitaxel
Drug: Pemetrexed
Drug: Carboplatin
Drug: Pembrolizumab

First Posted Date: 2022-05-03

Last Posted Date: 2024-04-10

Lead Sponsor: Rutgers, The State University of New Jersey

Target Recruit Count: 150

Registration Number: NCT05358548

Locations: 🇺🇸
RWJBarnabas Health - Monmouth Medical Center, Long Branch, New Jersey, United States
🇺🇸
RWJBarnabas Health - Newark Beth Israel Medical Center, Newark, New Jersey, United States
🇺🇸
Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey, United States

and more 8 locations

A Phase II Study of the Combination of Azacitidine and Pembrolizumab for Patients Relapsed/Refractory Hodgkin's Lymphoma

Phase 2

Recruiting

Conditions: Hodgkin's Lymphoma

Interventions: Drug: Azacytidine
Drug: Pembrolizumab

First Posted Date: 2022-05-02

Last Posted Date: 2024-11-08

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 24

Registration Number: NCT05355051

Locations: 🇺🇸
MD Anderson Cancer Center, Houston, Texas, United States

To Access the Safety and Effects of Intravenous Administration of AMX-818 Alone and in Combination With Pembrolizumab in Adult Participants With Locally Advanced or Metastatic HER2-Expressing Cancers

Phase 1

Recruiting

Conditions: Locally Advanced or Metastatic HER2-Expressing Cancers

Interventions: Drug: AMX-818
Drug: pembrolizumab

First Posted Date: 2022-05-02

Last Posted Date: 2024-06-07

Lead Sponsor: Amunix, a Sanofi Company

Target Recruit Count: 645

Registration Number: NCT05356741

Locations: 🇵🇹
Investigational site number #200, Porto, Portugal
🇫🇷
Investigational site number #150, Toulouse, France
🇪🇸
Investigational site number #253, Pozuelo de Alarcón, Spain

and more 7 locations

Clinical Study of Fianlimab in Combination With Cemiplimab Versus Pembrolizumab in Adolescent and Adult Patients With Previously Untreated Unresectable Locally Advanced or Metastatic Melanoma

Phase 3

Recruiting

Conditions: Melanoma

Interventions: Drug: Fianlimab
Drug: Pembrolizumab
Drug: Cemiplimab
Drug: Placebo

First Posted Date: 2022-04-29

Last Posted Date: 2024-10-30

Lead Sponsor: Regeneron Pharmaceuticals

Target Recruit Count: 1535

Registration Number: NCT05352672

Locations: 🇺🇸
Atlantic Health System - Morristown Medical Center, Morristown, New Jersey, United States
🇦🇷
Fundacion Cenit para la Investigacion en Neurociencias, Buenos Aires, Argentina
🇦🇷
DIABAID - Instituto de Asistencia Integral en Diabetes, Buenos Aires, Argentina

and more 216 locations

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