One-dose pembrolizumab before surgery for thick primary (Stage IIb/c) melanoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, double-blind, placebo-controlled Phase II trial for patients with biopsy-confirmed thick primary melanoma without clinical lymph-node involvement. Eligible patients undergo a 3 mm punch biopsy to confirm diagnosis and are randomized to a single 400 mg dose of pembrolizumab or placebo. Four weeks after the dose they have wide local excision and sentinel lymph node biopsy according to national guidelines. The primary endpoint is pathological response after the single neoadjuvant dose, with secondary analyses of efficacy, safety, and biomarker discovery.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Patient is ≥18 years.
2. Signed informed consent.
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
4. 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
5. Patient planned for wide local excision and sentinel lymph node biopsy
6. Adequate organ function on blood test
7. 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.
8. 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.
9. 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.

Exclusion Criteria:

1. Life expectancy of less than 3 years.
2. Patients who are unable to undergo general anesthesia for any reason.
3. Clinical or radiographic evidence of nodal, satellite, in-transit or distant metastases
4. Risk for developing in-operable disease due to study procedures as judged by study investigator
5. Prior immunotherapy for any malignancy
6. Use of live vaccines four weeks before or after the last study treatment.
7. History of severe reactions to monoclonal antibodies.
8. Active autoimmune disease or a documented history of autoimmune disease requiring systemic immunomodulatory treatment. Diabetes, rheumatoid arthritis, psoriasis, atopic dermatitis and hypothyroidism are excepted.
9. 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.
10. Concomitant therapy with any other anti-cancer therapy, concurrent medical conditions requiring use of immunosuppressive medications or use of other investigational drugs.
11. Has a known additional malignancy that is progressing or requires active treatment.
12. 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.
13. 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.

Where it's running

• Sahlgrenska University Hospital
  Gothenburg, Sweden Recruiting

Study contacts

• Study coordinator: Roger Olofsson Bagge, Professor
• Email: roger.olofsson.bagge@vgregion.se
• Phone: +46 31 3421000

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• One-dose pembrolizumab before surgery for high-risk localized melanoma

  This trial gives one dose of pembrolizumab six weeks before surgery to see if it helps adults with high‑risk melanoma that appears confined on scans.

  Recruiting Phase 2 Universitair Ziekenhuis Brussel · Jette, Brussels Capital · NCT07448831

• EBNK-001 allogeneic NK cell therapy with low-dose IL-15, with or without pembrolizumab, for advanced solid tumors

  This treatment tests an off-the-shelf NK cell product (EBNK-001) given with low-dose IL-15, either alone or with pembrolizumab, in adults with advanced or metastatic solid tumors who have exhausted standard options.

  Recruiting Phase 1/2 Essen Biotech · Beijing, Beijing Municipality · NCT07410676

• LNS8801 alone or with pembrolizumab for people whose melanoma has stopped responding.

  This trial will test whether LNS8801, by itself or combined with pembrolizumab, can keep melanoma that progressed after anti‑PD‑1 therapy from growing.

  Recruiting at 9 sites Phase 2/3 Linnaeus Therapeutics, Inc. · Newport Beach, California and 8 other locations · NCT06624644

• Combining alpelisib and pembrolizumab for advanced breast cancer and melanoma

  This study is testing a new combination treatment of alpelisib and pembrolizumab to see how safe it is for people with advanced melanoma and triple-negative breast cancer.

  Recruiting Phase 1 M.D. Anderson Cancer Center · Houston, Texas · NCT06545682

• Lenvatinib and Pembrolizumab With or Without SBRT for Metastatic Kidney Cancer

  This study tests whether adding SBRT to standard lenvatinib plus pembrolizumab helps people with metastatic kidney cancer who have stable disease after initial treatment.

  Recruiting at 8 sites Phase 2 Kidney Cancer Research Bureau · Kazan' and 7 other locations · NCT07928167

• Bladder cancer: test a biomarker-guided plan after neoadjuvant therapy

  This phase 2 study tests a biomarker- and response-guided plan to preserve the bladder in patients with muscle-invasive bladder cancer after neoadjuvant therapy.

  Recruiting Phase 2 Fox Chase Cancer Center · Philadelphia, Pennsylvania · NCT07908979

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.