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)
A Study of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) as Monotherapy and in Combination With Pembrolizumab (MK-3475) in Participants With Triple-Negative Breast Cancer (MK-2870-011/TroFuse-011)
- Conditions
- Triple Negative Breast Neoplasms
- Interventions
- First Posted Date
- 2025-02-24
- Last Posted Date
- 2025-04-25
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Target Recruit Count
- 1000
- Registration Number
- NCT06841354
- Locations
- 🇺🇸
Comprehensive Cancer Centers of Nevada ( Site 0015), Las Vegas, Nevada, United States
🇺🇸Renown Regional Medical Center ( Site 0005), Reno, Nevada, United States
🇮🇱Rambam Health Care Campus ( Site 3700), Haifa, Israel
A Clinical Study of Boserolimab (MK-5890) With Pembrolizumab and Chemotherapy in People With Early Triple-Negative Breast Cancer (MK-5890-003)
- Conditions
- Early Triple Negative Breast Cancer
- Interventions
- Drug: Doxorubicin (hydrochloride)Drug: Olaparib (if approved/available locally)
- First Posted Date
- 2025-02-17
- Last Posted Date
- 2025-04-08
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Target Recruit Count
- 100
- Registration Number
- NCT06829199
- Locations
- 🇺🇸
Optum Care Cancer Center ( Site 0004), Las Vegas, Nevada, United States
🇨🇳National Cheng Kung University Hospital ( Site 0901), Tainan, Taiwan
A Single Arm, Phase 2 Study of Datopotamab Deruxtecan, Carboplatin, and Pembrolizumab for Treatment-naive Brain Metastases From NSCLC (Non-small Cell Lung Cancer)
- Conditions
- Lung CancerNon Small Cell Lung CancerBrain Metastases
- Interventions
- First Posted Date
- 2025-02-12
- Last Posted Date
- 2025-04-16
- Lead Sponsor
- Latin American Cooperative Oncology Group
- Target Recruit Count
- 46
- Registration Number
- NCT06822543
Phase II Multi-centered Study of Perioperative Ivonescimab Versus Pembrolizumab Combined with Standard of Care (SOC) in Patients with Resectable, Locally Advanced Head and Neck Squamous Cell Carcinoma
- Conditions
- Head and Neck Squamous Cell CarcinomaHead and Neck Squamous Cell Carcinoma HNSCC
- Interventions
- First Posted Date
- 2025-02-07
- Last Posted Date
- 2025-02-07
- Lead Sponsor
- Fudan University
- Target Recruit Count
- 80
- Registration Number
- NCT06814067
- Locations
- 🇨🇳
Fudan University Shanghai Cancer Center, Shanghai, Shanghai, China
PD-1 Inhibitors Maintenance for cHL Post-autoHCT
- First Posted Date
- 2025-02-06
- Last Posted Date
- 2025-04-16
- Lead Sponsor
- St. Petersburg State Pavlov Medical University
- Target Recruit Count
- 83
- Registration Number
- NCT06812858
- Locations
- 🇰🇿
National Research Oncology Center, Astana, Kazakhstan
🇷🇺National Medical and Surgical Center named after N.I. Pirogov, Moscow, Russian Federation
🇷🇺RM Gorbacheva Research Institute, Pavlov University, St. Petersburg, Russian Federation
Enfortumab Vedotin Plus Pembrolizumab With Selective Bladder Sparing for Treatment of Muscle-invasive Bladder Cancer
- Conditions
- Muscle Invasive Bladder Urothelial Carcinoma
- Interventions
- Drug: Enfortumab vedotin
- First Posted Date
- 2025-02-05
- Last Posted Date
- 2025-04-29
- Lead Sponsor
- Matthew Galsky
- Target Recruit Count
- 47
- Registration Number
- NCT06809140
- Locations
- 🇺🇸
Icahn School of Medicine at Mount Sinai, New York, New York, United States
A Study to Test Whether Treatment With BI 770371 in Combination With Pembrolizumab With or Without Cetuximab Helps People With Head and Neck Cancer Compared With Pembrolizumab Alone
- Conditions
- Head and Neck Squamous Cell Carcinoma
- Interventions
- First Posted Date
- 2025-02-04
- Last Posted Date
- 2025-05-20
- Lead Sponsor
- Boehringer Ingelheim
- Target Recruit Count
- 90
- Registration Number
- NCT06806852
- Locations
- 🇺🇸
Norton Cancer Institute, Downtown, Louisville, Kentucky, United States
🇺🇸The Ohio State University Wexner Medical Center, Columbus, Ohio, United States
🇦🇺Gosford Hospital, Gosford, New South Wales, Australia
Pembrolizumab Concurrent With and Following Carbon-ion Radiotherapy for Locally Advanced Cervical Adenocarcinoma
- Conditions
- Cervical AdenocarcinomaCervical Adenosquamous Carcinoma
- Interventions
- First Posted Date
- 2025-02-03
- Last Posted Date
- 2025-02-03
- Lead Sponsor
- Gunma University
- Target Recruit Count
- 45
- Registration Number
- NCT06805864
- Locations
- 🇯🇵
Gunma University Hospital, Maebashi, Gunma, Japan
Study of Patritumab Deruxtecan Plus Pembrolizumab With Other Anticancer Agents in Participants With High-Risk Early-Stage Triple-Negative or Hormone Receptor-Low Positive/HER-2 Negative Breast Cancer (MK-1022-010, HERTHENA-Breast-03)
- Conditions
- Breast NeoplasmsBreast Cancer
- Interventions
- First Posted Date
- 2025-01-28
- Last Posted Date
- 2025-04-23
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Target Recruit Count
- 372
- Registration Number
- NCT06797635
- Locations
- 🇺🇸
Northwest Cancer Specialists (Compass Oncology) ( Site 8003), Tigard, Oregon, United States
🇺🇸Intermountain Health St. Vincent Regional Hospital - Cancer Centers of Montana ( Site 0003), Billings, Montana, United States
🇺🇸SCRI Oncology Partners ( Site 7000), Nashville, Tennessee, United States
Study of PYX-201 in Combination With Pembrolizumab in Advanced Solid Tumors
- First Posted Date
- 2025-01-28
- Last Posted Date
- 2025-03-03
- Lead Sponsor
- Pyxis Oncology, Inc
- Target Recruit Count
- 200
- Registration Number
- NCT06795412
- Locations
- 🇺🇸
NEXT Virginia, Fairfax, Virginia, United States
Drug Development Updates
Stay informed with timely notifications on clinical trials, regulatory changes, and research advancements related to this medication.