Actively Recruiting
A Phase 2 Clinical Trial on Neoadjuvant Pembrolizumab in Patients Diagnosed With High-risk Melanoma Without Clinical Evidence of Metastatic Dissemination
Led by Universitair Ziekenhuis Brussel · Updated on 2026-03-09
49
Participants Needed
1
Research Sites
178 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating whether a single dose of the immunotherapy drug pembrolizumab given before surgery can help the immune system better fight high-risk melanoma. This study focuses on adults whose melanoma has no visible signs of spreading on scans, aiming to see if early treatment can reduce microscopic cancer cells in the lymph nodes. The study is a Phase 2 clinical trial exploring the potential benefits of this neoadjuvant (pre-surgery) approach compared to standard post-surgery treatment. Participants receive one intravenous infusion of pembrolizumab six weeks before their scheduled sentinel lymph node biopsy and surgery. After surgery, patients with stage IIB, IIC, or III melanoma continue with standard immunotherapy every six weeks for one year. Those with stage IB or IIA melanoma proceed directly to follow-up care. The treatment plan includes surgery to remove the melanoma and check lymph nodes for cancer spread. During the five-year follow-up period, participants undergo regular physical exams, blood tests, and full-body imaging scans every four months to detect any recurrence of melanoma. Optional quality of life and cognitive function questionnaires are also included. Some participants may have blood tests to measure circulating tumor DNA, which could help predict relapse risk. Safety and treatment effects are closely monitored throughout the study.
CONDITIONS
Brief Title
A Phase II Clinical Trial on Neo-adjuvant Pembrolizumab in Patients With pT3b-T4a/b cN0M0 Melanoma.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years of age or older at the time of informed consent
- Histologically confirmed high-risk primary cutaneous melanoma classified as pT1b-3a with high-risk Merlin™ test or pT3b-4b regardless of Merlin™ test
- Suitable candidate for sentinel lymph node biopsy
- No signs of metastatic spread confirmed by PET/CT scan, lymph node ultrasound, and clinical exam
- No prior systemic treatment for melanoma
- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2 within 7 days before first treatment dose
- Adequate organ function based on local standards
- Female participants must be surgically sterile, postmenopausal, or if of childbearing potential, use effective contraception and have negative pregnancy tests
- Male participants with partners of childbearing potential must use effective contraception or have had a vasectomy
- Able to provide informed consent and comply with study requirements
You will not qualify if you...
- Diagnosis of uveal melanoma, mucosal melanoma, or melanoma with unknown primary origin
- Active autoimmune disease requiring systemic treatment
- History of previous cancers except certain in situ or non-melanoma skin cancers unless disease-free for at least 3 years
- Known infection with HIV, hepatitis B, or hepatitis C unless cleared
- Serious or unstable medical or psychiatric conditions that may affect safety or study compliance
- Active infection at screening
- Known allergy to pembrolizumab or related substances
- History of organ transplant or candidates for transplantation
- Previous exposure to checkpoint inhibitors
- Conditions or treatments that may interfere with study participation or results
- Psychiatric or substance abuse disorders affecting cooperation
- Contraindications for whole-body PET/CT or MRI evaluation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - 6 weeks
Participants receive a single infusion of pembrolizumab six weeks before surgery to help the immune system attack melanoma cells.
1 infusion visit
Duration - 1 day
Participants undergo surgery including sentinel lymph node biopsy and, if needed, wide local excision to remove melanoma tissue.
1 surgical visit
Duration - 1 year
Participants with stage IIB, IIC, or III melanoma after surgery receive standard immunotherapy every six weeks for one year.
Immunotherapy visits every 6 weeks for up to 1 year; participants with stage IB or IIA melanoma do not receive this treatment.
Duration - 5 years
All participants are monitored closely for five years with regular physical exams, blood tests, imaging every four months, and optional quality of life assessments.
Physical exams and blood tests every few months; full-body imaging every 4 months
Trial Site Locations
Total: 1 location
1
UZ Brussel
Jette, Brussels Capital, Belgium, 1090
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here