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

A Study to Evaluate the Safety and Therapeutic Activity of GI-102 As a Single Agent and in Combination with Conventional Anti-cancer Drugs, Pembrolizumab or Trastuzumab Deruxtecan(T-DXd) in Patients with Advanced Solid Tumors (KEYNOTE-G08)

Phase 1

Recruiting

Conditions: Advanced Solid Tumor
Metastatic Solid Tumor
Soft Tissue Sarcoma (STS)
Platinum-resistant Ovarian Cancer (PROC)
Hepatocellular Carcinoma (HCC)
Colorectal Cancer (CRC)
HER2 Negative Breast Cancer
Cutaneous Melanoma
Renal Cell Carcinoma (RCC)

Interventions: Drug: GI-102 subcutaneous (SC)
Drug: GI-102
Drug: doxorubicin
Drug: paclitaxel
Drug: eribulin
Drug: trastuzumab deruxtecan (T-DXd)
Drug: pembrolizumab
Drug: bevacizumab

First Posted Date: 2023-04-24

Last Posted Date: 2024-11-25

Lead Sponsor: GI Innovation, Inc.

Target Recruit Count: 358

Registration Number: NCT05824975

Locations: 🇺🇸
Mayo Clinic in Arizona, Scottsdale, Arizona, United States
🇺🇸
Mayo Clinic in Florida, Jacksonville, Florida, United States
🇺🇸
Mayo Clinic in Minnesota, Rochester, Minnesota, United States

and more 7 locations

The Effect of Prebiotic Inulin on Patients Affected by R/M HNSCC Treated With Immune Checkpoint Inhibitors

Not Applicable

Recruiting

Conditions: Head and Neck Squamous Cell Carcinoma

Interventions: Dietary Supplement: inulin
Drug: Nivolumab
Drug: Pembrolizumab

First Posted Date: 2023-04-20

Last Posted Date: 2023-04-20

Lead Sponsor: Fondazione del Piemonte per l'Oncologia

Target Recruit Count: 40

Registration Number: NCT05821751

Locations: 🇮🇹
Fondazione del Piemonte per l'Oncologia-IRCCS Candiolo, Candiolo, Turin, Italy

A Study of SKB264 for the Treatment of Participants With Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC)

Phase 2

Recruiting

Conditions: Non-small Cell Lung Cancer

Interventions: Drug: SKB264
Drug: Osimertinib
Drug: Pembrolizumab
Drug: Carboplatin

First Posted Date: 2023-04-18

Last Posted Date: 2024-07-31

Lead Sponsor: Klus Pharma Inc.

Target Recruit Count: 278

Registration Number: NCT05816252

Locations: 🇦🇺
St Vincent's Hospital - Kinghorn Cancer Centre, Darlinghurst, New South Wales, Australia
🇨🇳
Beijing Cancer Hospital, Beijing, Beijing, China
🇨🇳
The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, Shaanxi, China

and more 63 locations

Pembrolizumab and Radiotherapy for Oligometastatic Head and Neck Cancer

Phase 3

Not yet recruiting

Conditions: Oligometastatic Squamous Cell Carcinoma of the Head and Neck

Interventions: Drug: Pembrolizumab
Radiation: stereotattic ablation radiotherapy (SABR)

First Posted Date: 2023-04-18

Last Posted Date: 2024-02-22

Lead Sponsor: European Organisation for Research and Treatment of Cancer - EORTC

Target Recruit Count: 200

Registration Number: NCT05815927

Activity and Safety of Danvatirsen and Pembrolizumab in HNSCC

Phase 2

Recruiting

Conditions: HNSCC

Interventions: Drug: Danvatirsen
Drug: Pembrolizumab

First Posted Date: 2023-04-18

Last Posted Date: 2024-12-31

Lead Sponsor: Flamingo Therapeutics NV

Target Recruit Count: 81

Registration Number: NCT05814666

Locations: 🇺🇸
Emory University Hospital Midtown, Atlanta, Georgia, United States
🇺🇸
University of Maryland Baltimore, Greenebaum Comprehensive Cancer Center, Baltimore, Maryland, United States
🇺🇸
UT Southwestern Medical Center/Simmons Comprehensive Cancer Center, Dallas, Texas, United States

and more 28 locations

Pembrolizumab vs. Observation in People With Triple-negative Breast Cancer Who Had a Pathologic Complete Response After Chemotherapy Plus Pembrolizumab

Phase 3

Recruiting

Conditions: Early Stage Triple-Negative Breast Carcinoma
Anatomic Stage I Breast Cancer AJCC v8
Anatomic Stage III Breast Cancer AJCC v8
Anatomic Stage II Breast Cancer AJCC v8

Interventions: Other: Patient Observation
Biological: Pembrolizumab
Procedure: Biopsy
Procedure: Biospecimen Collection
Other: Questionnaire Administration
Other: Quality-of-Life Assessment

First Posted Date: 2023-04-14

Last Posted Date: 2024-12-27

Lead Sponsor: Alliance for Clinical Trials in Oncology

Target Recruit Count: 1295

Registration Number: NCT05812807

Locations: 🇺🇸
Stamford Hospital/Bennett Cancer Center, Stamford, Connecticut, United States
🇺🇸
Memorial Regional Hospital/Joe DiMaggio Children's Hospital, Hollywood, Florida, United States
🇺🇸
Health Central, Ocoee, Florida, United States

and more 663 locations

Phase II Study Evaluating the Efficacy and Safety of Ociperlimab in Combination With Tislelizumab and Chemotherapy as First-line Treatment for Participants With Advanced Triple Negative Breast Cancer

Phase 2

Withdrawn

Conditions: Triple Negative Breast Cancer

Interventions: Drug: Ociperlimab
Drug: Tislelizumab
Drug: Nab-paclitaxel
Drug: Paclitaxel
Drug: Placebo
Drug: Carboplatin
Drug: Pembrolizumab
Drug: Gemcitabine

First Posted Date: 2023-04-12

Last Posted Date: 2023-07-24

Lead Sponsor: Novartis Pharmaceuticals

Registration Number: NCT05809895

A Study of Immune Checkpoint Inhibitor Combinations With Axitinib in Participants With Untreated Locally Advanced Unresectable or Metastatic Renal Cell Carcinoma

Phase 2

Active, not recruiting

Conditions: Renal Cell Carcinoma

Interventions: Drug: Pembrolizumab
Drug: Tobemstomig
Drug: Tiragolumab
Drug: Axitinib

First Posted Date: 2023-04-10

Last Posted Date: 2024-10-24

Lead Sponsor: Hoffmann-La Roche

Target Recruit Count: 210

Registration Number: NCT05805501

Locations: 🇺🇸
Vanderbilt University Medical Center; Vanderbilt University, Nashville, Tennessee, United States
🇺🇸
EMORY UNIVERSITY; Bone Marrow & Stem Cell Transplant Center, Atlanta, Georgia, United States
🇺🇸
SCRI Oncology Partners, Nashville, Tennessee, United States

and more 60 locations

A Study of Tegavivint (BC2059) in Patients With Advanced Hepatocellular Carcinoma

Phase 1

Recruiting

Conditions: Advanced Hepatocellular Carcinoma

Interventions: Drug: Tegavivint
Drug: Pembrolizumab

First Posted Date: 2023-04-04

Last Posted Date: 2024-08-27

Lead Sponsor: Iterion Therapeutics

Target Recruit Count: 108

Registration Number: NCT05797805

Locations: 🇺🇸
MD Anderson Cancer Center, Houston, Texas, United States
🇺🇸
Fred Hutchinson Cancer Center, Seattle, Washington, United States
🇺🇸
Levine Cancer Institute, Charlotte, North Carolina, United States

and more 5 locations

Study of Efficacy and Safety of Ociperlimab in Combination With Tislelizumab and Platinum-based Doublet Chemotherapy as First-line Treatment for Participants With Locally Advanced or Metastatic NSCLC.

Phase 3

Withdrawn

Conditions: Non-small Cell Lung Cancer (NSCLC)

Interventions: Drug: Placebo
Drug: Ociperlimab
Drug: Pembrolizumab
Drug: Tislelizumab
Drug: Carboplatin
Drug: Cisplatin
Drug: Pemetrexed
Drug: Paclitaxel
Drug: Nab-paclitaxel

First Posted Date: 2023-03-30

Last Posted Date: 2023-07-24

Lead Sponsor: Novartis Pharmaceuticals

Registration Number: NCT05791097

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