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 Radiotherapy and Pembrolizumab in People with Adrenocortical Carcinoma

Phase 2

Recruiting

Conditions: Adrenocortical Carcinoma
ACC
Metastatic Adrenocortical Carcinoma

Interventions: Radiation: Ablative Radiotherapy
Drug: Pembrolizumab

First Posted Date: 2023-10-04

Last Posted Date: 2024-10-14

Lead Sponsor: Memorial Sloan Kettering Cancer Center

Target Recruit Count: 12

Registration Number: NCT06066333

Locations: 🇺🇸
Memorial Sloan Kettering Westchester (All Protocol Activities), Harrison, New York, United States
🇺🇸
Memorial Sloan Kettering Suffolk-Commack, Commack, New York, United States
🇺🇸
Memorial Sloan Kettering Basking Ridge (All Protocol Activities), Basking Ridge, New Jersey, United States

and more 4 locations

A Safety Trial of GEN1042 in Japanese Subjects With Malignant Solid Tumors

Phase 1

Recruiting

Conditions: Malignant Solid Tumor

Interventions: Biological: GEN1042
Drug: Pembrolizumab
Drug: Cisplatin
Drug: Carboplatin
Drug: 5-Fluorouracil

First Posted Date: 2023-09-28

Last Posted Date: 2024-12-20

Lead Sponsor: Genmab

Target Recruit Count: 42

Registration Number: NCT06057038

Locations: 🇯🇵
National Cancer Center East, Kashiwa, Japan
🇯🇵
National Cancer Center Hospital, Tokyo, Japan

Study of ALE.C04 in Patients With Head and Neck Cancer

Phase 1

Recruiting

Conditions: Head and Neck Cancer
Head and Neck Squamous Cell Carcinoma

Interventions: Drug: ALE.C04
Drug: Pembrolizumab

First Posted Date: 2023-09-26

Last Posted Date: 2024-07-09

Lead Sponsor: Alentis Therapeutics AG

Target Recruit Count: 220

Registration Number: NCT06054477

Locations: 🇫🇷
Centre Hospitalier Universitaire (CHU) de Bordeaux - Hospitalier Saint-Andre, Bordeaux, France
🇫🇷
Oncopole Claudius Regaud, Iuct-Oncopole, Toulouse, France
🇪🇸
Vall d'Hebron Institute of Oncology, Barcelona, Spain

and more 19 locations

Neoadjuvant Sacituzumab Govitecan Plus Pembrolizumab in Resectable Non-Small Cell Lung Cancer

Phase 2

Recruiting

Conditions: Lung Cancer

Interventions: Drug: Sacituzumab Govitecan
Drug: Pembrolizumab

First Posted Date: 2023-09-26

Last Posted Date: 2024-02-29

Lead Sponsor: Chinese University of Hong Kong

Target Recruit Count: 37

Registration Number: NCT06055465

Locations: 🇭🇰
Department of Oncology, Princess Margaret Hospital, Hong Kong, Hong Kong
🇭🇰
Department of Clinical Oncology, Prince of Wales Hospital, Hong Kong, Hong Kong
🇭🇰
Department of Clinical Oncology, Queen Elizabeth Hospital, Hong Kong, Hong Kong

and more 1 locations

Pulsed Dose Chemotherapy Plus Pembrolizumab in Recurrent/Metastatic HNSCC

Phase 2

Recruiting

Conditions: Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma (R/M HNSCC)

Interventions: Drug: Pembrolizumab
Drug: Carboplatin
Drug: Paclitaxel

First Posted Date: 2023-09-25

Last Posted Date: 2024-02-07

Lead Sponsor: Dan Zandberg

Target Recruit Count: 15

Registration Number: NCT06052839

Locations: 🇺🇸
UPMC Hillman Cancer Center, Pittsburgh, Pennsylvania, United States

Sacituzumab Tirumotecan (MK-2870) as Monotherapy and in Combination With Pembrolizumab in Participants With Advanced Solid Tumors (MK-2870-008)

Phase 1

Active, not recruiting

Conditions: Programmed Cell Death-1 (PD1, PD-1)
Programmed Cell Death 1 Ligand 1(PDL1, PD-L1)
Solid Tumors
Non-small Cell Lung Cancer
Programmed Cell Death 1 Ligand 2 (PDL2, PD-L2)

Interventions: Biological: Sacituzumab tirumotecan
Biological: Pembrolizumab

First Posted Date: 2023-09-22

Last Posted Date: 2024-12-27

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 36

Registration Number: NCT06049212

Locations: 🇯🇵
Aichi Cancer Center Hospital ( Site 0006), Nagoya, Aichi, Japan
🇯🇵
National Cancer Center Hospital East ( Site 0002), Kashiwa, Chiba, Japan
🇯🇵
National Hospital Organization Shikoku Cancer Center ( Site 0008), Matsuyama, Ehime, Japan

and more 4 locations

Safety and Efficacy of NEO212 in Patients with Astrocytoma IDH-mutant, Glioblastoma IDH-wildtype or Brain Metastasis

Phase 1

Recruiting

Conditions: Glioblastoma, IDH-wildtype
Head and Neck Squamous Cell Carcinoma
Melanoma
Merkel Cell Carcinoma
Mismatch Repair Deficient Solid Malignant Tumor
Microsatellite Instability-High Colorectal Cancer
Colorectal Cancer
Microsatellite Instability-High Solid Malignant Tumor
Non-small Cell Lung Cancer
Renal Cell Carcinoma

Interventions: Drug: NEO212 Oral Capsule
Drug: FOLFIRI Protocol
Drug: Ipilimumab
Drug: Regorafenib
Drug: Pembrolizumab
Drug: Carboplatin
Drug: Paclitaxel
Drug: Bevacizumab
Drug: Nivolumab

First Posted Date: 2023-09-21

Last Posted Date: 2024-10-16

Lead Sponsor: Neonc Technologies, Inc.

Target Recruit Count: 134

Registration Number: NCT06047379

Locations: 🇺🇸
Precision NextGen Oncology, Beverly Hills, California, United States
🇺🇸
Northwest Medical Specialties, Tacoma, Washington, United States