Status:
ACTIVE_NOT_RECRUITING
Biomarkers for Neoadjuvant Pembrolizumab in Non-Metastatic Prostate Cancer Positive by 18FDG-PET Scanning
Lead Sponsor:
CHU de Quebec-Universite Laval
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief Summary
Various approaches are currently being developed for prostate cancer immunotherapy. However, a major challenge facing the development of cancer immunotherapy is the identification of tumors that would...
Detailed Description
This is a Phase II, single-arm and open-label trial of pembrolizumab (MK-3475) in localized prostate cancer patients with newly diagnosed non-metastatic prostate cancer (Gleason grade ≥8 on biopsy) wi...
Eligibility Criteria
Inclusion
- Male Age≥ 18 years old
- Non-metastatic prostate cancer with histologically confirmed Gleason sum ≥8
- Eligible for radical prostatectomy with a delay of 6 to 9 weeks
- Intraprostatic maximum standardized uptake value (SUVmax) ≥4 at 18-FDG-PET/CT exam.
- Not be castrated or under androgen deprivation therapy
- Not have received prior neo adjuvant hormonotherapy.
- Provided archival formalin-fixed, paraffin embedded tumor biopsy of the prostate tumor lesion not previously irradiated
- Performance status of Eastern Cooperative Oncology Group 0 to 1
- Adequate organ function
Exclusion
- Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4 (Cytotoxic T-lymphocyte-Associated Protein 4), OX-40, CD137).
- Has received prior systemic anti-cancer therapy including investigational agents within 4 weeks prior to allocation.
- Has received prior radiotherapy to the prostate or other organs within 2 weeks of start of study treatment.
- Has received a live vaccine within 30 days prior to the first dose of study drug.
- Is participating or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment.
- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug
- Other primary cancer within 3 years
- Has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients.
- Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
- Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis.
- Has an active infection requiring systemic therapy.
- Has a known history of Human Immunodeficiency Virus (HIV).
- Has a known history of Hepatitis B or known active Hepatitis C virus infection. Note: no testing for Hepatitis B and Hepatitis C is required unless mandated by local health authority.
- Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
- Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
- Is expecting to father children within the projected duration of the study, starting with the screening visit through the date of prostatectomy.
Key Trial Info
Start Date :
January 10 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 30 2025
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04009967
Start Date
January 10 2020
End Date
March 30 2025
Last Update
January 13 2025
Active Locations (1)
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1
CHU de Québec-Université Laval
Québec, Canada