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AzTrials

Melanoma (Skin Cancer)Phase 2NEOPRIMENCT07349303

Neoadjuvant Pembrolizumab in Patients With Stage IIb/c Melanoma

A Phase 2 study testing Pembrolizumab in people with Melanoma (Skin Cancer), run by Vastra Gotaland Region at 1 site in Sweden.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Melanoma (Skin Cancer)
What is being tested?
Pembrolizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
30 participants
Where
1 siteSweden
Study dates
15 Jan 2026to 15 May 2031
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Roger Olofsson Bagge, Professor contact

+46 31 3421000

roger.olofsson.bagge@vgregion.se

Axel Nelson, MD, PhD contact

axel.nelson@vgregion.se

Sweden1 site, 1 recruiting

  • Sahlgrenska University Hospital

    Gothenburg, 41345

    Recruiting

Other trials in Sweden

About this study

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

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.

Being tested
Pembrolizumab, Placebo
Keywords
IMMUNOTHERAPY, PRIMARY CUTANOUS MELANOMA, NEOPRIME trial, NEOADJUVANT TREATMENT
Medical subject headings
Melanoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07349303
Study groupRoleWhat they receive
PembrolizumabExperimentalPatients will receive one dose of intravenous pembrolizumab and then 4 weeks later undergo WLE and SLNB.
Receives: Drug: Pembrolizumab
PlaceboPlacebo comparatorPatients will receive one dose of intravenous placebo and then 4 weeks later undergo WLE and SLNB.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 48 month

Secondary outcomes (10)

  1. Frequency and severity of adverse events (AEs) and serious adverse events (SAEs)

    The proportion of patients with adverse events (AE) as described in CTCAE version 5.0, from the initiation of study treatment until 100 days after the end of treatment:

    1. Proportion of patients with an AE by CTCAE term and grade.
    2. Proportion of patients with grade 3/4 AEs by AE term.
    3. The duration of events reported in (a)
    4. Proportion of patients with requirement to delay surgery due to an AE.
    5. Proportion of patients with a requirement to permanently discontinue study treatment due to an AE.
    6. The proportion of patients with a requirement for oral or parenteral steroid treatment for immunology-related adverse events.
    7. The proportion of patients with post-operative complications (e.g. seroma formation, wound infection or lymphoedema) and duration of events.

    Measured: 48 month

  2. Feasibility of neoadjuvant therapy in stage II melanoma

    1. Proportion of eligible patients who consent to the study.
    2. Proportion of included patients who complete all treatment according to protocol.

    Measured: 48 month

  3. Sentinel lymph node positivity rate

    1. The proportion of patients undergoing a sentinel node biopsy who have a positive result in the lymph node.
    2. The number of sentinel nodes identified and the number harvested.
    3. The proportion of patients with a positive sentinel node biopsy who undergo completion lymph node dissection.

    Measured: 48 month

  4. Local recurrence rate

    The proportion of patients after surgery with histologically confirmed diagnosis of local disease recurrence, as detected by the patient, on physical examination or during imaging surveillance.

    Measured: 48 month

  5. Regional recurrence rate

    The proportion of patients after surgery with histologically confirmed diagnosis of regional disease recurrence, as detected by the patient, on physical examination or during imaging surveillance

    Measured: 48 month

  6. Event free survival (EFS)

    The proportion of patients that did not undergo surgery or histologically confirmed diagnosis of disease recurrence (local, regional, and distant), as detected by the patient, on physical examination or during imaging surveillance, or death from any cause.

    Measured: 48 month

  7. To assess recurrence free survival (RFS).

    The proportion of patients after surgery with histologically confirmed diagnosis of disease recurrence (local, regional, and distant), as detected by the patient, on physical examination or during imaging surveillance, or death from any cause.

    Measured: 48 month

  8. Distant metastasis-free survival (DMFS)

    The proportion of patients after surgery with histologically confirmed diagnosis of disease distant recurrence, as detected by the patient, on physical examination or during imaging surveillance, or death from any cause.

    Measured: 48 month

  9. Melanoma specific survival (MSS)

    The proportion of patients who die, from the initiation of study treatment to the date of death from melanoma.

    Measured: 48 month

  10. Overall survival (OS)

    The proportion of patients who die, from the initiation of study treatment to the date of death from any cause.

    Measured: 48 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jan 2026
  2. Study start15 Jan 2026
  3. Primary completion15 May 2029 (estimated)
  4. Study completion15 May 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07349303
Sponsor's protocol ID
2024-519594-19-00
Other IDs
2024-519594-19-00
Acronym
NEOPRIME
Status last verified
Jan 2026
First submitted
8 Jan 2026
Last updated
26 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pembrolizumab in people with Melanoma (Skin Cancer), run by Vastra Gotaland Region at 1 site in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Roger Olofsson Bagge, Professor (+46 31 3421000, roger.olofsson.bagge@vgregion.se), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pathological response rate (time frame: 48 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07349303.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2026.

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