Actively Recruiting
Neoadjuvant Pembrolizumab in Patients With Stage IIb/c Melanoma
Led by Vastra Gotaland Region · Updated on 2026-01-21
30
Participants Needed
1
Research Sites
278 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
A phase II double-blind placebo-controlled randomized trial. Patients with a clinical suspicion of a thick primary melanoma without clinical suspicion or evidence of lymph-node engagement will undergo a 3 mm punch biopsy to verify the diagnosis and ascertain eligibility. Patients will receive 1 cycle of pembrolizumab 400 mg or placebo and 4 weeks later undergo a wide local excision and sentinel lymph node biopsy according to the national guideline recommendations . The primary objective is to evaluate the pathological response of one cycle of neoadjuvant pembrolizumab in patients with biopsy-proven stage IIb/c melanoma. Secondary objectives include efficacy and safety analysis, as well as biomarker discovery.
CONDITIONS
Official Title
Neoadjuvant Pembrolizumab in Patients With Stage IIb/c Melanoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient is 18 years or older
- Signed informed consent
- ECOG performance status of 0-1
- Histologically confirmed primary cutaneous melanoma stage IIb/c (Breslow >2.0 mm with ulceration OR Breslow >4.0mm without ulceration) with a minimum diameter of 5 mm not completely removed by biopsy
- Planned for wide local excision and sentinel lymph node biopsy
- Adequate organ function on blood test
- Female patients of childbearing potential must have a negative pregnancy test within 72 hours before treatment
- Female patients of childbearing potential must use adequate contraception during the study and for 150 days after last dose
- Male patients of childbearing potential must use adequate contraception during the study and for 150 days after last dose
You will not qualify if you...
- Life expectancy less than 3 years
- Unable to undergo general anesthesia
- Evidence of nodal, satellite, in-transit, or distant metastases
- Risk for inoperable disease due to study procedures
- Prior immunotherapy for any malignancy
- Use of live vaccines four weeks before or after study treatment
- History of severe reactions to monoclonal antibodies
- Active autoimmune disease or history requiring systemic immunomodulatory treatment, except diabetes, rheumatoid arthritis, psoriasis, atopic dermatitis, hypothyroidism
- Need for systemic corticosteroids (>10 mg prednisone daily) or other immunosuppressive drugs within 14 days before study drug
- Concurrent anticancer therapy or investigational drugs
- Known additional progressing malignancy requiring active treatment
- Pregnant, breastfeeding, or planning conception during study through 150 days after last dose
- Any condition or therapy that may interfere with participation or study results as judged by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Sahlgrenska University Hospital
Gothenburg, Sweden, 41345
Actively Recruiting
Research Team
R
Roger Olofsson Bagge, Professor
CONTACT
A
Axel Nelson, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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