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Could six months of immunotherapy be enough for melanoma? major trial launches

NCT ID NCT06488482

Disease control Sponsor: Uppsala University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This large phase 3 trial is testing whether giving immunotherapy for 6 months after surgery for high-risk melanoma is as effective as the standard 12-month course. The study aims to enroll 1,792 adults who have had their melanoma surgically removed. If shorter treatment works, it could mean fewer side effects and less time in the hospital for patients.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
nivolumab or pembrolizumab (immunotherapy drugs, also known as Opdivo and Keytruda)
What this could lead to
If successful, this could show that a shorter course of immunotherapy after melanoma surgery is just as effective as the standard one-year treatment, reducing side effects and hospital visits.
What could go wrong
This is an early-stage comparison study, and it's possible that 6 months of treatment may not prevent cancer recurrence as well as 12 months. Also, previous studies have not shown that this type of immunotherapy improves overall survival.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 1,792 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2024

Expected to finish

Sep 2033

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Provision of written informed consent for participation. 2. ≥ 18 years of age. 3. Performance status ECOG/WHO 0-1. 4. Adequate organ functions as per standards for immunotherapy. 5. Radical surgery for CMM (including acral) stage IIb-c, III (including in transit) and IV. Stage III CMM patients with unknown primary and stage IIb-c CMM patients who have not undergone sentinel node procedure are eligible. 6. A complete physical examination within 28 days prior to randomization 7. Previous adjuvant treatment with BRAF + MEK inhibitors is allowed. 8. Neoadjuvant treatment with immunotherapy for two months (currently pembrolizumab every third weeks three times or nivolumab every fourth week two times) is allowed providing that a complete or near complete pathological response was not achieved and patients with clear progressive disease according to the pathology report are not eligible. 9. All participants who have not received neo-adjuvant treatment must have disease-free status documented by radiological assessment within 28 days prior to randomization while 6 weeks is sufficient for neo-adjuvant treated patients. 10. Participants must be off immunosuppressive doses of systemic steroids (\>10 mg/day prednisone or equivalent) for a minimum of 14 days prior to study drug administration. 11. Sufficient renal function for radiological assessments with i.v. contrast. 12. Peri-operative radiation therapy is allowed. 13. Patients who experience a locoregional lymph node relapse, i.e. stage III disease or operable stage IV at a time-point later than primary diagnosis are welcome to participate. Exclusion Criteria: 1. The patient is, in the opinion of the investigator, assessed as unfit to receive systemic adjuvant treatment. 2. Serious and/or uncontrolled medical disorder that in the opinion of the investigator is contraindicated. 3. An active, known, or suspected autoimmune disease. Participants with type I diabetes mellitus, hypothyroidism requiring hormone replacement only and skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment are eligible. 4. Life-expectancy less than 2 years due to concurrent disease (e.g., cardiac disease and liver cirrhosis). 5. Inability to provide informed consent or refusal to do so. 6. Inability to comply with the study protocol. 7. Participation in other clinical trials interfering with the current study protocol. 8. Existing or previous malignancies within the past 5 years (except for in situ breast and in situ cervical cancer, melanoma in situ, malignant melanoma, non-melanoma skin cancer and low risk prostate cancer). 9. Pregnancy or planned pregnancy. 10. Ocular and mucosal melanoma.

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Conditions

The condition(s) this trial relates to.

cutaneous melanoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

High-risk melanoma

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    26 sites in 3 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Akershus University Hospital

    RECRUITING

    Oslo, Norway

  • Eskilstuna Hospital

    RECRUITING

    Eskilstuna, Sweden

  • Falu Hospital

    RECRUITING

    Falun, Sweden

  • Gävle Hospital

    RECRUITING

    Gävle, Sweden

  • Haukeland University Hospital

    RECRUITING

    Bergen, Norway

  • Helsinki University Hospital

    RECRUITING

    Helsinki, Finland

  • Kalmar Hospital

    RECRUITING

    Kalmar, Sweden

  • Karlstad Hospital

    RECRUITING

    Karlstad, Sweden

  • Karolinska University Hospital

    RECRUITING

    Stockholm, Sweden

  • Kuopio University Hospital

    RECRUITING

    Kuopio, Finland

  • Linköping University Hospital

    RECRUITING

    Linköping, Sweden

  • North Norway University Hospital

    RECRUITING

    Tromsø, Norway

  • Oslo University Hospital

    RECRUITING

    Oslo, Norway

  • Ryhov Hospital

    RECRUITING

    Jönköping, Sweden

  • Sahlgrenska University Hospital

    RECRUITING

    Gothenburg, Sweden

  • Skåne University Hospital

    RECRUITING

    Lund, Sweden

  • Sorlandet Hospital

    RECRUITING

    Kristiansand, Norway

  • Stavanger University Hospital

    RECRUITING

    Stavanger, Norway

  • Sundsvall Hospital

    RECRUITING

    Sundsvall, Sweden

  • Tampere University Hospital

    RECRUITING

    Tampere, Finland

  • Trondheim University Hospital

    RECRUITING

    Trondheim, Norway

  • Turku University Hospital

    RECRUITING

    Turku, Finland

  • Västmanland Hospital

    RECRUITING

    Västerås, Sweden

  • Växjö Hospital

    RECRUITING

    Vaxjo, Sweden

  • Ålesund Hospital

    RECRUITING

    Ålesund, Norway

  • Örebro University Hospital

    RECRUITING

    Örebro, Sweden

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