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
- -
Targeting ODC as an Immunotherapeutic Target in STK11 (LKB1) Pathway-Deficient NSCLC (DFMO)
- Conditions
- Interventions
- First Posted Date
- 2024-01-23
- Last Posted Date
- 2024-12-06
- Target Recruit Count
- 45
- Registration Number
- NCT06219174
- Locations
- 🇺🇸
Moffitt Cancer Center, Tampa, Florida, United States
LUNAR-2: TTFields With Pembrolizumab + Platinum-based Chemotherapy for Metastatic NSCLC
- Conditions
- Interventions
- First Posted Date
- 2024-01-22
- Last Posted Date
- 2024-11-22
- Lead Sponsor
- NovoCure GmbH
- Target Recruit Count
- 734
- Registration Number
- NCT06216301
- Locations
- 🇺🇸
St. Jude Herritage Medical Group, Fullerton, California, United States
🇺🇸Edward Cancer Center, Naperville, Illinois, United States
🇪🇸Hospital Universitario Arnau de Vilanova, Lleida, Spain
Allogeneic Gammadelta T Cells Combined With Interferon-α1b or PD-1 Monoclonal Antibody in Stage III-IV Amenable to Surgical Resection Melanoma
- Conditions
- Interventions
- First Posted Date
- 2024-01-18
- Last Posted Date
- 2024-01-25
- Lead Sponsor
- Xijing Hospital
- Target Recruit Count
- 10
- Registration Number
- NCT06212388
BI-1910 as a Single Agent and in Combination With Pembrolizumab for the Treatment of Advanced Solid Tumors
- Conditions
- Interventions
- First Posted Date
- 2024-01-16
- Last Posted Date
- 2024-07-23
- Lead Sponsor
- BioInvent International AB
- Target Recruit Count
- 104
- Registration Number
- NCT06205706
- Locations
- 🇵🇱
Uniwersytecki Szpital Kliniczny, Poznań, Poland
🇵🇱Instytut Centrum Zdrowia Matki Polki, Łódź, Poland
🇪🇸Hospital Fundacion Jimenez Diaz, Madrid, Spain
Drug Screening Using IMD in Bladder Cancer
- Conditions
- Interventions
- Device: Implantable Micro-DeviceDrug: MethotrexateDrug: CarboplatinDrug: AvelumabDrug: PaclitaxelDrug: VinblastineDrug: Gemcitabine/Cisplatin IDrug: Methotrexate/Vinblastine/Doxorubicin/Cisplatin/AvelumabDrug: Gemcitabine/Cisplatin IIDrug: CisplatinDrug: NivolumabDrug: PembrolizumabDrug: Gemcitabine/CarboplatinDrug: Methotrexate/Vinblastine/Doxorubicin/CisplatinDrug: Gemcitabine/Cisplatin/NivolumabDrug: ErdafitinibDrug: Paclitaxel/Docetaxel/IfosfamideDrug: GemcitabineDrug: Gemcitabine/Carboplatin/NivolumabDrug: EnfortumabDrug: Sacituzumab
- First Posted Date
- 2024-01-12
- Last Posted Date
- 2024-01-12
- Lead Sponsor
- Brigham and Women's Hospital
- Target Recruit Count
- 18
- Registration Number
- NCT06204614
- Locations
- 🇺🇸
Brigham and Women's Hospital, Boston, Massachusetts, United States
A Trial to Learn if Fianlimab and Cemiplimab Are Safe and Work Better Than Anti-PD1 Alone in Adult Participants With Resectable Stage 3 or 4 Melanoma
- Conditions
- Interventions
- First Posted Date
- 2024-01-05
- Last Posted Date
- 2024-11-26
- Lead Sponsor
- Regeneron Pharmaceuticals
- Target Recruit Count
- 520
- Registration Number
- NCT06190951
- Locations
- 🇺🇸
California Pacific Medical Center Research Institute, San Francisco, California, United States
🇺🇸Emory University, Atlanta, Georgia, United States
🇺🇸Washington University School of Medicine, Saint Louis, Missouri, United States
Efficacy & Safety for LN144 with Pembrolizumab with High Risk Stage IIIb-dResectable Melanoma
- First Posted Date
- 2024-01-05
- Last Posted Date
- 2024-12-05
- Lead Sponsor
- James Isaacs, MD
- Target Recruit Count
- 12
- Registration Number
- NCT06190249
- Locations
- 🇺🇸
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center, Cleveland, Ohio, United States
A First-in-Human (FIH) Study to Evaluate the Safety and Tolerability of VVD-130850 in Participants With Advanced Solid and Hematologic Tumors
- Conditions
- Interventions
- First Posted Date
- 2024-01-03
- Last Posted Date
- 2024-12-17
- Lead Sponsor
- Vividion Therapeutics, Inc.
- Target Recruit Count
- 200
- Registration Number
- NCT06188208
- Locations
- 🇦🇺
Orange Health Service, Orange, New South Wales, Australia
🇺🇸Florida Cancer Specialists, Sarasota, Florida, United States
🇺🇸Sarah Cannon Research Institute, Nashville, Tennessee, United States
Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab Versus Pembrolizumab Alone in Metastatic Non-small Cell Lung Cancer (NSCLC) With Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥ 50% (MK-2870-007)
- Conditions
- Interventions
- First Posted Date
- 2023-12-14
- Last Posted Date
- 2024-12-05
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Target Recruit Count
- 614
- Registration Number
- NCT06170788
- Locations
- 🇲🇽
Higiea Oncologia ( Site 0721), Mexico City, Distrito Federal, Mexico
🇲🇽Centro de Atención e Investigación Cardiovascular del Potosí ( Site 0713), San Luis Potosí, San Luis Potosi, Mexico
🇲🇽Clinica Integral Internacional de Oncología ( Site 0714), Puebla, Mexico
A Study of ASP1012 in Adults With Solid Tumors
- First Posted Date
- 2023-12-14
- Last Posted Date
- 2024-12-13
- Lead Sponsor
- Astellas Pharma Global Development, Inc.
- Target Recruit Count
- 229
- Registration Number
- NCT06171178
- Locations
- 🇺🇸
Hoag Memorial Hospital Presbyterian, Newport Beach, California, United States
🇺🇸The Angeles Clinic and Research Institute, Los Angeles, California, United States
🇺🇸Emory Winship Cancer Institute, Atlanta, Georgia, United States
Drug Development Updates
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