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pembrolizumab + darolutamide + leuprolide
- Development stage
- Unknown
- Lead developer
- Merck
- Modality
- Monoclonal Antibodies → Antibody-Based Therapeutics, Peptides, Small Molecules
- Administration
- Intravenous, Oral, Subcutaneous, Intramuscular
01
Overview
This investigational combination regimen consists of the PD-1 inhibitor pembrolizumab, the androgen receptor antagonist darolutamide, and the GnRH agonist leuprolide. It is currently being evaluated in a Phase II clinical trial (NCT07027124) led by the Icahn School of Medicine at Mount Sinai for the treatment of high-risk localized prostate cancer. The protocol utilizes a neoadjuvant approach followed by radical prostatectomy and adjuvant pembrolizumab. Patients are molecularly stratified using the Decipher genomic assay to identify those with high-risk genomic characteristics (GC > 0.6, high AR activity, and Luminal B subtype) who are most likely to benefit from this intensive chemo-hormonal-immunotherapy approach. Pembrolizumab acts as an immune checkpoint inhibitor to enhance T-cell response, while darolutamide and leuprolide provide potent androgen deprivation to suppress tumor growth.
- Brand names
- KeytrudaNubeqaLupronEligard
- Other names
- pembrolizumab + darolutamide + leuprolide combination regimenpembrolizumab-Icahn School of Medicine at Mount Sinai-prostate cancer
02
Targets
GnRHR (Gonadotropin-releasing hormone receptor)PDCD1 (Programmed cell death protein 1 receptor)AR (Adrenergic receptors)
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