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 Phase Ⅲ Clinical Study of HLX22 in Combination With Trastuzumab and Chemotherapy for the Treatment of Gastroesophageal Junction and Gastric Cancer

Phase 3

Not yet recruiting

Conditions: Gastric Cancer
HER2-positive Gastric Cancer
Gastroesophageal-junction Cancer
Monoclonal Antibody

Interventions: Drug: HLX22
Drug: Pembrolizumab
Drug: Trastuzumab
Drug: Oxaliplatin
Drug: Capecitabine

First Posted Date: 2024-08-01

Last Posted Date: 2024-08-01

Lead Sponsor: Shanghai Henlius Biotech

Target Recruit Count: 550

Registration Number: NCT06532006

Locations: 🇨🇳
Beijing Cancer Hospital, Beijing, Beijing, China

TIL Therapy Combined With Pembrolizumab for Advanced or Metastatic Refractory Stomach and Esophageal Cancer

Phase 1

Recruiting

Conditions: Stomach Cancer
Stomach Cancer Recurrent
Stomach Cancer, Adenocarcinoma
Esophageal Cancer
Esophageal Cancer Metastatic to Bone
Esophageal Cancer Metastatic to Lung
Esophageal Cancer Metastatic to Liver

Interventions: Biological: Tumor Infiltrating Lymphocytes (TIL)
Drug: Cyclophosphamid
Drug: Fludarabine
Drug: Interleukin-2
Drug: Pembrolizumab

First Posted Date: 2024-08-01

Last Posted Date: 2024-11-12

Lead Sponsor: Essen Biotech

Target Recruit Count: 75

Registration Number: NCT06532799

Locations: 🇨🇳
District One Hospital, Beijing, Beijing, China

TIL Gean Therapy Combined With Immunotherapy for Advanced or Metastatic Refractory Breast Cancer

Phase 1

Recruiting

Conditions: Breast Cancer
Breast Carcinoma
Breast Cancer Triple Negative
Breast Cancer Metastatic

Interventions: Biological: Tumor Infiltrating Lymphocytes (TIL)
Drug: Cyclophosphamid
Drug: Fludarabine
Drug: Interleukin-2
Drug: Pembrolizumab

First Posted Date: 2024-08-01

Last Posted Date: 2024-11-12

Lead Sponsor: Essen Biotech

Target Recruit Count: 85

Registration Number: NCT06532812

Locations: 🇨🇳
District One Hospital, Beijing, Beijing, China

ERectile Dysfunctions, gOnadotoxicity and Sexual Health Assessment in Men With Lung Cancer

Recruiting

Conditions: Hypogonadism, Male
NSCLC Stage IV
Sex Disorder
Erectile Dysfunction

Interventions: Drug: Alectinib
Drug: Osimertinib
Drug: Pembrolizumab
Drug: Cemiplimab
Drug: Brigatinib
Drug: Sotorasib
Drug: Lorlatinib 100 mg
Drug: Dabrafenib
Drug: Nivolumab
Drug: Trametinib
Drug: Carboplatin
Drug: Pemetrexed
Drug: Selpercatinib
Drug: Paclitaxel

First Posted Date: 2024-08-01

Last Posted Date: 2024-08-09

Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Target Recruit Count: 80

Registration Number: NCT06532149

Locations: 🇮🇹
Fondazione Policlinico Gemelli IRCCS, Rome, Italy

Biological Tumor Infiltrating Lymphocytes Therapy With Immunotherapy for Colon and Rectum Cancer

Phase 1

Recruiting

Conditions: Colorectal Cancer
Colon Cancer
Rectum Cancer

Interventions: Biological: Tumor Infiltrating Lymphocytes (TIL)
Drug: Cyclophosphamide
Drug: Fludarabine
Drug: Interleukin-2
Drug: Pembrolizumab

First Posted Date: 2024-07-31

Last Posted Date: 2024-11-05

Lead Sponsor: Essen Biotech

Target Recruit Count: 85

Registration Number: NCT06530303

Locations: 🇨🇳
District One Hospital, Beijing, Beijing, China

A Study Comparing the Combination of Pembrolizumab and Sacituzumab Govitecan Versus Sacituzumab Govitecan Alone in the Treatment of Advanced Urothelial Cancer

Phase 3

Not yet recruiting

Conditions: Locally Advanced Urothelial Carcinoma
Metastatic Urothelial Carcinoma

Interventions: Procedure: Biospecimen Collection
Procedure: Computed Tomography
Procedure: Magnetic Resonance Imaging
Other: Questionnaire Administration
Biological: Pembrolizumab
Biological: Sacituzumab Govitecan

First Posted Date: 2024-07-29

Last Posted Date: 2024-12-04

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 384

Registration Number: NCT06524544

A Phase 3 Study to Evaluate Petosemtamab Plus Pembrolizumab Vs Pembrolizumab in First-line Treatment of Head and Neck Cancer

Phase 3

Recruiting

Conditions: Head and Neck Squamous Cell Carcinoma

Interventions: Drug: Petosemtamab
Drug: Pembrolizumab

First Posted Date: 2024-07-29

Last Posted Date: 2024-12-17

Lead Sponsor: Merus N.V.

Target Recruit Count: 500

Registration Number: NCT06525220

Locations: 🇰🇷
Site 45, Seoul, Korea, Republic of
🇺🇸
Site 36, La Jolla, California, United States
🇺🇸
Site 43, Philadelphia, Pennsylvania, United States

and more 43 locations