RecruitingPhase 2NCT07349303

Neoadjuvant Pembrolizumab in Patients With Stage IIb/c Melanoma

Neoadjuvant Pembrolizumab in Patients With Stage IIb/c Melanoma, a Phase II Double-blind Placebo-controlled Randomized Trial

Sponsor

Vastra Gotaland Region

Enrollment

30 participants

Start Date

Jan 15, 2026

Study Type

INTERVENTIONAL

Conditions

Melanoma (Skin Cancer)

Summary

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether giving an immunotherapy drug called pembrolizumab before surgery helps treat stage IIb/c melanoma (a serious skin cancer) more effectively. Receiving immunotherapy before surgery — called neoadjuvant therapy — may shrink the tumor and train the immune system to fight any remaining cancer cells. **You may be eligible if...** - You are 18 or older - You have confirmed stage IIb or IIc melanoma (tumor thicker than 2 mm with ulceration, or thicker than 4 mm) that has not been completely removed yet - You are planned for surgery (wide excision and sentinel lymph node biopsy) - You are in good general health (ECOG 0 or 1) - You have not received prior immunotherapy for any cancer **You may NOT be eligible if...** - Your cancer has spread to lymph nodes or other organs - You have an active autoimmune disease requiring systemic treatment (some conditions like diabetes or thyroid disease are exceptions) - You are on immune-suppressing medications (high-dose steroids) - You have a history of severe reactions to monoclonal antibody treatments - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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