Pembrolizumab

Generic Name: Pembrolizumab

Brand Names: Keytruda

Drug Type: Biotech

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)

Clinical Trials

SSGJ-707 in Advanced Non-Small Cell Lung Cancer

Phase 3

Not yet recruiting

Conditions: Advanced Non-Small Cell Lung Cancer

Interventions: Drug: SSGJ-707
Drug: Pembrolizumab

First Posted Date: 2025-05-20

Last Posted Date: 2025-05-20

Lead Sponsor: Shenyang Sunshine Pharmaceutical Co., LTD.

Target Recruit Count: 420

Registration Number: NCT06980272

Locations: 🇨🇳
The Shanghai East Hospital, Shanghai, China

A Study of BL-B01D1+PD-1/PD-L1 Monoclonal Antibody in Patients With Advanced Biliary Tract Cancer

Phase 2

Not yet recruiting

Conditions: Advanced Biliary Tract Cancer

Interventions: Drug: BL-B01D1
Drug: Pembrolizumab

First Posted Date: 2025-05-18

Last Posted Date: 2025-05-18

Lead Sponsor: Sichuan Baili Pharmaceutical Co., Ltd.

Target Recruit Count: 46

Registration Number: NCT06978114

Locations: 🇨🇳
Zhongshan Hospital Fudan University, Shanghai, Shanghai, China

Pembrolizumab + Paclitaxel +/- Bevacizumab for Triple-negative Breast Cancer

Phase 2

Recruiting

Conditions: Recurrent Triple-Negative Breast Cancer

Interventions: Drug: Pembrolizumab
Drug: Paclitaxel
Drug: Bevacizumab

First Posted Date: 2025-05-16

Last Posted Date: 2025-05-16

Lead Sponsor: Yukinori Ozaki

Target Recruit Count: 44

Registration Number: NCT06976944

Locations: 🇯🇵
National Hospital Organization Nagoya Medical Center, Nagoya-shi, Aichi, Japan
🇯🇵
Nagoya University Hospital, Nagoya-shi, Aichi, Japan
🇯🇵
Nagoya City University Hospital, Nagoya-shi, Aichi, Japan

and more 11 locations

A Clinical Study of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) in People With Breast Cancer (MK-2870-032)

Phase 3

Not yet recruiting

Conditions: Breast Neoplasms
Triple Negative Breast Neoplasms
HR Low-Positive/HER2-Negative Breast Neoplasms

Interventions: Biological: Sacituzumab tirumotecan
Drug: Rescue Medication
Biological: Pembrolizumab
Drug: Carboplatin
Drug: Paclitaxel
Drug: Doxorubicin
Drug: Epirubicin
Drug: Cyclophosphamide
Drug: Capecitabine
Drug: Olaparib

First Posted Date: 2025-05-13

Last Posted Date: 2025-05-13

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 2400

Registration Number: NCT06966700

Study of HC006 in Combination With a PD-1 Inhibitor in Patients With Advanced Solid Tumors

Phase 1

Not yet recruiting

Conditions: Advanced Cancer

Interventions: Drug: HC006
Drug: KEYTRUDA ®( Pembrolizumab)

First Posted Date: 2025-05-09

Last Posted Date: 2025-05-09

Lead Sponsor: HC Biopharma Inc.

Target Recruit Count: 252

Registration Number: NCT06963814

A Study of BL-B01D1 + Axitinib Without or With Pembrolizumab in Patients With Locally Advanced or Metastatic Renal Cancer

Phase 2

Not yet recruiting

Conditions: Renal Cancer

Interventions: Drug: BL-B01D1
Drug: axitinib
Drug: pembrolizumab

First Posted Date: 2025-05-08

Last Posted Date: 2025-05-08

Lead Sponsor: Sichuan Baili Pharmaceutical Co., Ltd.

Target Recruit Count: 120

Registration Number: NCT06962787

Locations: 🇨🇳
Fudan University Shanghai Cancer Center, Shanghai, Shanghai, China

A Clinical Study of V940 and Pembrolizumab (MK-3475) in People With Melanoma (V940-012/INTerpath-012)

Phase 2

Not yet recruiting

Conditions: Malignant Melanoma

Interventions: Biological: V940
Biological: Pembrolizumab
Other: Placebo

First Posted Date: 2025-05-07

Last Posted Date: 2025-05-07

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 160

Registration Number: NCT06961006

Safety and Preliminary Efficacy of VIR-5525 and VIR-5525 + Pembrolizumab in Participants With Locally Advanced or Metastatic Solid Tumors

Phase 1

Recruiting

Conditions: Solid Tumor Malignancies
EGFR Positive Solid Tumors
EGFR

Interventions: Drug: VIR-5525
Drug: Pembrolizumab

First Posted Date: 2025-05-07

Last Posted Date: 2025-05-13

Lead Sponsor: Vir Biotechnology, Inc.

Target Recruit Count: 450

Registration Number: NCT06960395

Locations: 🇺🇸
Honor Health Research Institute, Scottsdale, Arizona, United States
🇦🇺
Wollongong Hospital, Wollongong, New South Wales, Australia
🇦🇺
Princess Alexandra Hospital, Woolloongabba, Queensland, Australia