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    DRUG:

    Keytruda (pembrolizumab)

    i
    Other names: MK-3475, SCH 900475, 1374853-91-4, ORG 307488, SCH-900475, SCH900475, ORG 307488-0, MK 3475, MK3475
    Company:
    Merck (MSD)
    Drug class:
    PD1 inhibitor
    Related drugs:
    2d
    CANOPY-1: Study of Efficacy and Safety of Pembrolizumab Plus Platinum-based Doublet Chemotherapy With or Without Canakinumab in Previously Untreated Locally Advanced or Metastatic Non-squamous and Squamous NSCLC Subjects (clinicaltrials.gov)
    P3, N=673, Active, not recruiting, Novartis Pharmaceuticals | Trial completion date: Jun 2027 --> May 2026
    Trial completion date
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 IHC 22C3 pharmDx
    |
    Keytruda (pembrolizumab) • cisplatin • carboplatin • albumin-bound paclitaxel • pemetrexed • Ilaris (canakinumab)
    2d
    IIT2015-18-Mita-MK3475: Pembrolizumab in Combination With Olaparib in Advanced BRCA-mutated or HDR-defect Breast Cancer (clinicaltrials.gov)
    P2, N=14, Completed, Yuan Yuan | Active, not recruiting --> Completed | Trial completion date: Aug 2026 --> Nov 2025
    Trial completion • Trial completion date • Checkpoint inhibition • IO biomarker
    |
    BRCA (Breast cancer early onset) • CDK6 (Cyclin-dependent kinase 6)
    |
    HER-2 positive • HR positive • BRCA mutation
    |
    Keytruda (pembrolizumab) • Lynparza (olaparib)
    2d
    Rambro2: Ramucirumab and Pembrolizumab vs Pembrolizumab Monotherapy in PD-L1 Positive Head and Neck Squamous-Cell Carcinoma (clinicaltrials.gov)
    P2, N=37, Active, not recruiting, Washington University School of Medicine | Recruiting --> Active, not recruiting | N=72 --> 37 | Trial completion date: Apr 2031 --> Jun 2030 | Trial primary completion date: Apr 2028 --> Jun 2027
    Enrollment closed • Enrollment change • Trial completion date • Trial primary completion date
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression
    |
    PD-L1 IHC 22C3 pharmDx
    |
    Keytruda (pembrolizumab) • Cyramza (ramucirumab)
    2d
    Real-World Comparison of Chemo-Immunotherapy Regimens in Metastatic NSCLC With PD-L1 <50% (ALCG-01) (clinicaltrials.gov)
    P=N/A, N=400, Recruiting, Gazi University
    New trial • Real-world evidence • IO biomarker
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression
    |
    Keytruda (pembrolizumab) • Opdivo (nivolumab) • Yervoy (ipilimumab)
    2d
    Exercise to Boost Response to Checkpoint Blockade Immunotherapy (clinicaltrials.gov)
    P1, N=22, Active, not recruiting, H. Lee Moffitt Cancer Center and Research Institute | Trial completion date: Dec 2025 --> Aug 2026
    Trial completion date • Checkpoint inhibition • IO biomarker
    |
    Keytruda (pembrolizumab) • Opdivo (nivolumab) • Yervoy (ipilimumab) • Bavencio (avelumab) • Libtayo (cemiplimab-rwlc)
    2d
    Pembrolizumab and epigenetic modification with azacitidine reshapes the tumor microenvironment of platinum-resistant epithelial ovarian cancer: a phase 2 non-randomized clinical trial. (PubMed, Commun Med (Lond))
    Our findings highlight the potential of epigenetic modulators to re-shape the tumor microenvironment of PROC toward a more inflammed phenotype and may point to approaches to augment immunotherapy response.
    Clinical • P2 data • Journal • PD(L)-1 Biomarker • IO biomarker • Platinum resistant
    |
    CD8 (cluster of differentiation 8) • MUC16 (Mucin 16, Cell Surface Associated)
    |
    Keytruda (pembrolizumab) • Onureg (azacitidine oral)
    2d
    Study Testing The Safety and Efficacy of Adjuvant Temozolomide Plus TTFields (Optune®) Plus Pembrolizumab in Patients With Newly Diagnosed Glioblastoma (2-THE-TOP) (clinicaltrials.gov)
    P2, N=40, Active, not recruiting, University of Florida | Trial completion date: Dec 2025 --> Dec 2027
    Trial completion date
    |
    MGMT (6-O-methylguanine-DNA methyltransferase)
    |
    Keytruda (pembrolizumab) • temozolomide
    2d
    Study of HRO761 Alone or in Combination in Cancer Patients With Specific DNA Alterations Called Microsatellite Instability or Mismatch Repair Deficiency. (clinicaltrials.gov)
    P1, N=327, Active, not recruiting, Novartis Pharmaceuticals | Recruiting --> Active, not recruiting | Trial completion date: May 2029 --> Aug 2027 | Trial primary completion date: May 2029 --> Aug 2027
    Enrollment closed • Trial completion date • Trial primary completion date • Mismatch repair • MSI-H • dMMR
    |
    MSI-H/dMMR
    |
    Keytruda (pembrolizumab) • irinotecan • HRO761
    3d
    Immunotherapy response in microsatellite-stable poorly differentiated thyroid carcinoma with mismatch repair deficiency and high tumor mutational burden. (PubMed, Arch Endocrinol Metab)
    Based on these findings, pembrolizumab was initiated as first-line therapy...Our findings underscore that alternative biomarkers, such as somatic mutations in DNA repair genes including MSH2 and ATM, may predict unexpected responses to immune checkpoint blockade and inform therapeutic decisions, even in the context of MSS and borderline TMB. Broader implementation of molecular profiling is warranted to identify such patients.
    Journal • Mismatch repair • Tumor mutational burden • MSi-H Biomarker • PD(L)-1 Biomarker • IO biomarker
    |
    PD-L1 (Programmed death ligand 1) • TMB (Tumor Mutational Burden) • MSI (Microsatellite instability) • MSH6 (MutS homolog 6) • MSH2 (MutS Homolog 2)
    |
    PD-L1 expression • TMB-H • MSI-H/dMMR • ATM mutation
    |
    Keytruda (pembrolizumab)
    3d
    A Tale of Two Diagnoses: Pulmonary Tuberculosis and Metastatic Lung Adenocarcinoma in a High-Risk Host. (PubMed, Cureus)
    He was treated sequentially with pembrolizumab followed by combination chemo-immunotherapy after disease progression. The patient tolerated treatment well, aside from nausea and an unrelated posterior cerebral artery infarct. This case underscores the diagnostic overlap and management challenges of coexisting TB and lung cancer and highlights the need for a multidisciplinary, staged approach in high-risk individuals.
    Journal • PD(L)-1 Biomarker • IO biomarker
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression • PD-L1 overexpression
    |
    Keytruda (pembrolizumab)
    3d
    Erythematous, pruritic and indurated plaques following treatment for melanoma. (PubMed, Skin Health Dis)
    Three months prior, he had completed a 12-month course of adjuvant pembrolizumab for stage IIIC melanoma...A single course of intralesional triamcinolone acetonide 10 mg L-1 resulted in significant improvement within days, with subsequent complete resolution in a month...We highlight the successful use of intralesional steroid as treatment for drug-induced CPL with an ICI. It is important to recognize CPL as an adverse cutaneous effect of immunotherapy, and that it can present after completing treatment due to an ongoing immune response.
    Journal
    |
    CD4 (CD4 Molecule)
    |
    Keytruda (pembrolizumab)
    3d
    Study to Evaluate the Safety and Efficacy of a Combination of Favezelimab (MK-4280) and Pembrolizumab (MK-3475) in Participants With Hematologic Malignancies (MK-4280-003) (clinicaltrials.gov)
    P1/2, N=137, Completed, Merck Sharp & Dohme LLC | Active, not recruiting --> Completed
    Trial completion
    |
    Keytruda (pembrolizumab) • favezelimab (MK-4280)