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
- -
Pan Tumor Rollover Study
- Conditions
- Cancer
- Interventions
- Drug: NivolumabDrug: LeucovorinDrug: Nivolumab + RelatlimabDrug: RegorafinibDrug: CapecitabineDrug: PemetrexedDrug: EnzalutamideDrug: SunitinibDrug: PembrolizumabDrug: RelatlimabDrug: TemozolomideDrug: RucaparibDrug: IpilimumabDrug: DaratumumabDrug: FluorouracilDrug: CabozantinibDrug: TrametinibDrug: BevacizumabDrug: Oxaliplatin
- First Posted Date
- 2019-04-02
- Last Posted Date
- 2025-01-07
- Lead Sponsor
- Bristol-Myers Squibb
- Target Recruit Count
- 1500
- Registration Number
- NCT03899155
- Locations
- 🇨🇦
Princess Margaret Cancer Centre, Toronto, Ontario, Canada
🇨🇦Local Institution - 0040, Montreal, Quebec, Canada
🇨🇦Local Institution - 0308, Montreal, Quebec, Canada
Dose Escalation and Dose Expansion Study of IPN60090 in Patients With Advanced Solid Tumours
- Conditions
- Solid Tumor
- Interventions
- First Posted Date
- 2019-03-28
- Last Posted Date
- 2022-09-13
- Lead Sponsor
- Ipsen
- Target Recruit Count
- 22
- Registration Number
- NCT03894540
- Locations
- 🇺🇸
MD Anderson Cancer Center, Houston, Texas, United States
Gut Microbiome Modulation to Enable Efficacy of Checkpoint-based Immunotherapy in Pancreatic Adenocarcinoma
- Conditions
- Pancreatic Cancer
- Interventions
- First Posted Date
- 2019-03-27
- Last Posted Date
- 2020-06-26
- Lead Sponsor
- NYU Langone Health
- Registration Number
- NCT03891979
- Locations
- 🇺🇸
NYU Langone Health, New York, New York, United States
TTX-030 Single Agent and in Combination With Immunotherapy or Chemotherapy for Patients With Advanced Cancers
- Conditions
- LymphomaSolid Tumor
- Interventions
- First Posted Date
- 2019-03-21
- Last Posted Date
- 2023-10-04
- Lead Sponsor
- Trishula Therapeutics, Inc.
- Target Recruit Count
- 56
- Registration Number
- NCT03884556
- Locations
- 🇺🇸
Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey, United States
🇺🇸West Cancer Center and Research Institute, Germantown, Tennessee, United States
🇺🇸NEXT Oncology, San Antonio, Texas, United States
Pembrolizumab (MK-3475) Plus Lenvatinib (E7080/MK-7902) Versus Chemotherapy for Endometrial Carcinoma (ENGOT-en9 / MK-7902-001)
- Conditions
- Endometrial Neoplasms
- Interventions
- First Posted Date
- 2019-03-21
- Last Posted Date
- 2024-11-18
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Target Recruit Count
- 842
- Registration Number
- NCT03884101
- Locations
- 🇺🇸
UCLA Hematology and Oncology Clinic (Westwood) ( Site 0233), Los Angeles, California, United States
🇺🇸University of Rochester ( Site 0238), Rochester, New York, United States
🇧🇷Faculdade de Medicina da Universidade Federal de Minas Gerais ( Site 2708), Belo Horizonte, Minas Gerais, Brazil
A Study of Carboplatin-Paclitaxel/Nab-Paclitaxel Chemotherapy With or Without Pembrolizumab (MK-3475) in Adults With First Line Metastatic Squamous Non-small Cell Lung Cancer (MK-3475-407/KEYNOTE-407)-China Extension Study
- Conditions
- Non-small Cell Lung Cancer
- Interventions
- First Posted Date
- 2019-03-14
- Last Posted Date
- 2024-10-01
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Target Recruit Count
- 125
- Registration Number
- NCT03875092
- Locations
- 🇨🇳
Zhongshan Hospital Fudan University, Shanghai, China
First-in-Human Study of EOS100850 in Patients With Cancer
- Conditions
- Solid Tumor, Adult
- Interventions
- First Posted Date
- 2019-03-14
- Last Posted Date
- 2023-12-27
- Lead Sponsor
- iTeos Therapeutics
- Target Recruit Count
- 119
- Registration Number
- NCT03873883
- Locations
- 🇫🇷
Centre de Lutte Contre le Cancer - Institut de Cancerologie de l'Ouest - Rene Gauducheau, Saint-Herblain, France
🇺🇸Karmanos Cancer Institute, Michigan Center, Michigan, United States
🇺🇸John Theurer Cancer Center, Hackensack University Medical Center, Hackensack, New Jersey, United States
A Study to Evaluate Safety and Therapeutic Activity of RO6874281 in Combination with Pembrolizumab, in Participants with Advanced or Metastatic Melanoma
- First Posted Date
- 2019-03-14
- Last Posted Date
- 2024-10-03
- Lead Sponsor
- Hoffmann-La Roche
- Target Recruit Count
- 83
- Registration Number
- NCT03875079
- Locations
- 🇺🇸
Dana Farber Cancer Institute, Boston, Massachusetts, United States
🇫🇷Centre Eugene Marquis; Service d'oncologie, Rennes, France
🇫🇷Institut Gustave Roussy; Dermatologie, Villejuif, France
Low Dose Ipilimumab with Pembrolizumab in Treating Patients with Melanoma That Has Spread to the Brain
- Conditions
- Clinical Stage IV Cutaneous Melanoma AJCC V8Metastatic Malignant Neoplasm in the BrainMetastatic MelanomaPathologic Stage IV Cutaneous Melanoma AJCC V8
- Interventions
- First Posted Date
- 2019-03-13
- Last Posted Date
- 2024-10-03
- Lead Sponsor
- M.D. Anderson Cancer Center
- Target Recruit Count
- 26
- Registration Number
- NCT03873818
- Locations
- 🇺🇸
M D Anderson Cancer Center, Houston, Texas, United States
A Study of TRK-950 in Combinations With Anti-Cancer Treatment Regimens in Patients With Advanced Solid Tumors
- Conditions
- Solid TumorColorectal CancerGastric CancerRenal Cell CarcinomaMelanomaEpithelial Ovarian CancerPrimary Peritoneal CancerFallopian Tube CancerCholangiocarcinomaBladder Cancer
- Interventions
- First Posted Date
- 2019-03-13
- Last Posted Date
- 2024-08-02
- Lead Sponsor
- Toray Industries, Inc
- Target Recruit Count
- 187
- Registration Number
- NCT03872947
- Locations
- 🇺🇸
HOAG Memorial Hospital Presbyterian, Newport, California, United States
🇺🇸Texas Oncology, P.A. Baylor Charles A. Sammons Cancer Center, Dallas, Texas, United States
🇺🇸Northwest Cancer Specialists, Portland, Oregon, United States
Drug Development Updates
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