Neoadjuvant Pembrolizumab in Patients With Stage IIb/c Melanoma

NCT07349303 | Recruiting Phase 2 DMC

• 1 other identifier: 2024-519594-19-00
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Melanoma (Skin Cancer)

Keywords

IMMUNOTHERAPY; PRIMARY CUTANOUS MELANOMA; NEOPRIME trial; NEOADJUVANT TREATMENT

Outcome Measures

Primary Outcomes (1)

• Pathological response rate

  Pathological response rate in the primary tumor according to adapted guidelines of the International Neoadjuvant Consortium (14) The pathological response will be described: * Complete pathological response (pCR) - 0% viable tumor cells in the surgical specimen * Near complete pathological response (near pCR) - ≤10% viable tumor * Partial pathological response (pPR) - \>10%-≤50% viable tumor * No pathological response (pNR) - \>50% viable tumor The proportion of patients with a pCR, near pCR or pPR will determine the pathological response rate.

  48 month

Secondary Outcomes (10)

• Frequency and severity of adverse events (AEs) and serious adverse events (SAEs)

  48 month

• Feasibility of neoadjuvant therapy in stage II melanoma

  48 month

• Sentinel lymph node positivity rate

  48 month

• Local recurrence rate

  48 month

• Regional recurrence rate

  48 month

Study Arms (2)

Pembrolizumab

EXPERIMENTAL

Patients will receive one dose of intravenous pembrolizumab and then 4 weeks later undergo WLE and SLNB.

Drug: Pembrolizumab

Placebo

PLACEBO COMPARATOR

Patients will receive one dose of intravenous placebo and then 4 weeks later undergo WLE and SLNB.

Drug: Placebo

Interventions

Pembrolizumab DRUG

Immunotherapy

Pembrolizumab

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient is ≥18 years.
• Signed informed consent.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
• Histopathologically 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 the diagnostic biopsy
• Patient planned for wide local excision and sentinel lymph node biopsy
• Adequate organ function on blood test
• Female patient of childbearing potential should have a negative urine or serum pregnancy test within 72 hours prior to receiving the first treatment. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
• Female patients of childbearing potential must be willing to use an adequate method of contraception, for the course of the study through 150 days after the last dose of study medication. Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject.
• Male patients of childbearing potential must agree to use an adequate method of contraception, starting with the first dose of study therapy through 150 days after the last dose of study therapy. Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject.

You may not qualify if:

• Life expectancy of less than 3 years.
• Patients who are unable to undergo general anesthesia for any reason.
• Clinical or radiographic evidence of nodal, satellite, in-transit or distant metastases
• Risk for developing in-operable disease due to study procedures as judged by study investigator
• Prior immunotherapy for any malignancy
• Use of live vaccines four weeks before or after the last study treatment.
• History of severe reactions to monoclonal antibodies.
• Active autoimmune disease or a documented history of autoimmune disease requiring systemic immunomodulatory treatment. Diabetes, rheumatoid arthritis, psoriasis, atopic dermatitis and hypothyroidism are excepted.
• A condition requiring systemic treatment with either corticosteroids (\>10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids and adrenal replacement doses \>10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease.
• Concomitant therapy with any other anti-cancer therapy, concurrent medical conditions requiring use of immunosuppressive medications or use of other investigational drugs.
• Has a known additional malignancy that is progressing or requires active treatment.
• Pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 150 days after the last dose of study drug.
• A history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the patient's participation for the full duration of the study, or is not in the best interest of the patient to participate in the opinion of the treating investigator.

Sponsors & Collaborators

• Vastra Gotaland Region: lead

Study Sites (1)

Sahlgrenska University Hospital

Gothenburg, 41345, Sweden

RECRUITING

MeSH Terms

Conditions

Melanoma

Interventions

pembrolizumab

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Roger Olofsson Bagge, Professor

CONTACT

+46 31 3421000; roger.olofsson.bagge@vgregion.se

Axel Nelson, MD, PhD

CONTACT

axel.nelson@vgregion.se

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2026
• First Posted: January 16, 2026
• Study Start: January 15, 2026
• Primary Completion (Estimated): May 15, 2029
• Study Completion (Estimated): May 15, 2031
• Last Updated: January 21, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)