OncoMatch/Clinical Trials/NCT07027124
Neoadjuvant ADT + Darolutamide With Pembrolizumab, Followed by Adjuvant Pembrolizumab in Molecularly Stratified High-Risk Prostate Cancer
Is NCT07027124 recruiting? Yes, currently enrolling (Sep 2026). This Phase 2 trial studies multiple treatments including Darolutamide and Pembrolizumab for prostate cancer.
Treatment: Darolutamide · Pembrolizumab · Lupron — This is a single-arm, phase II study of neoadjuvant combination therapy of Androgen Deprivation Therapy (ADT), \[Gonadotropin-Releasing Hormone (GnRH) agonist Leuprolide\], androgen receptor (AR)-antagonist Darolutamide and Pembrolizumab in a stratified high-risk localized prostate cancer cohort, followed by adjuvant treatment with Pembrolizumab (12 cycles) post-radical prostatectomy (RP). Patients with National Comprehensive Cancer Network (NCCN) high-risk non-metastatic prostate cancer (localized or locally advanced) (defined as Gleason ≥8, disease stage \>=cT3a, or PSA l \>20 ng/mL) will be risk-stratified at a biopsy using Decipher, a commercial standard-of-care diagnostic assay. Patients satisfying all three criteria of high-risk genomic characteristics listed below as per the Decipher grid results will be enrolled in the study: 1. Decipher Genomic classifier, GC\>0.6 2. AR activity score/AR-output gene signature (ARoS)\>11.0 3. High Luminal B score/ PAM50 subtype signature
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Endocrine / hormonal
Other
Cancer type
Prostate Cancer
Biomarker criteria
Required: GC_SCORE >0.45 (>0.45)
Decipher Genomic Classifier >0.45 (interpreted from decipher report)
Required: LUMINAL_B subtype
Luminal B subtype (interpreted from decipher report)
Disease stage
Required: Stage UNFAVORABLE INTERMEDIATE, HIGH-RISK LOCALIZED, III
Excluded: Stage IV
unfavorable intermediate and high-risk localized or locally advanced prostate cancer (Gleason score ≥7 (4+3) and absence of distant metastasis or non-regional nodal involvement
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
Prior therapy
Cannot have received: hormonal therapy
Exception: prior neoadjuvant hormonal therapy allowed if completed ≥ 12 months ago and recovered from all AEs
Subjects have had prior hormonal therapy (please see inclusion criteria for exceptions)
Cannot have received: radiation therapy for prostate cancer
Subjects have had prior radiation therapy or chemotherapy for prostate cancer
Cannot have received: chemotherapy for prostate cancer
Subjects have had prior radiation therapy or chemotherapy for prostate cancer
Cannot have received: androgen receptor inhibitor (apalutamide, darolutamide, enzalutamide, abiraterone acetate)
Subject has prior treatment with androgen receptor inhibitors, such as apalutamide, Darolutamide, enzalutamide, abiraterone acetate or other investigational CYP17 inhibitor
Cannot have received: anti-PD-1 therapy
Subject has received prior therapy with anti-PD1, anti-PDL1, anti-PDL2 or with other checkpoint inhibitors or T-cell costimulatory/inhibitory agents (e.g., CD137, OX-40, CTLA4)
Lab requirements
Blood counts
Absolute neutrophil count (ANC) ≥ 1,500/mcL; Platelets ≥ 100,000/mcl; Hemoglobin (Hb) ≥ 9 g/dL
Kidney function
Creatinine ≤ 1.5 ULN OR Creatinine clearance ≥ 30 ml/min
Liver function
total bilirubin ≤ 1.5 mg/dl (except in patients with gilbert syndrome who can have total bilirubin <3.0 mg/dl); AST ≤ 2.5 x ULN; ALT ≤ 2.5 x ULN
Adequate organ and marrow function as defined below: Hematological Absolute neutrophil count (ANC) ≥ 1,500/mcL Platelets ≥ 100,000/mcl Hemoglobin (Hb) ≥ 9 g/dL Hepatic total bilirubin ≤ 1.5 mg/dl (except in patients with gilbert syndrome who can have total bilirubin <3.0 mg/dl) Aspartate aminotransferase (AST) ≤ 2.5 x ULN Alanine aminotransferase (ALT) ≤ 2.5 x ULN Renal Creatinine ≤ 1.5 ULN OR Calculated creatinine clearance Creatinine clearance ≥ 30 ml/min
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Icahn School of Medicine at Mount Sinai · New York, New York
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT07027124 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior hormonal therapy, radiation therapy for prostate cancer, chemotherapy for prostate cancer disqualifies patients from enrollment.
Does this trial require GC_SCORE?
Yes, GC_SCORE >0.45 is a required biomarker for enrollment.
Does this trial require LUMINAL_B?
Yes, LUMINAL_B subtype is a required biomarker for enrollment.
What disease stage is eligible?
Stage UNFAVORABLE INTERMEDIATE or HIGH-RISK LOCALIZED or III is required.
Is this trial open to female patients?
No. This trial enrolls male patients only.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages